We believe that CDMOs can and should be leaders in developing the next treatment innovations in the orphan drug space. With extensive scientific experience in developing and scaling up to trial and commercial stages, contract development and manufacturing organizations are positioned to help create more innovations to treat rare diseases.
\nDevelopers and pharmaceutical companies that want to be successful in the orphan drug space should look for CDMOs like AGC Biologics that have the historical expertise and can offer end-to-end clinical and commercial manufacturing services, as well as the latest materials needed (pDNA, mRNA) to bring innovative orphan drugs to the market.
\nCDMOs offering robust analytical method development by way of rapid methods and reliable assays are also vital, as they are positioned to offer their customers a competitive advantage at a commercial scale but, more importantly, will be able to shorten cycle time to enable faster access for patients.
\nLastly, contract manufacturing and development organizations can offer vast experience in process characterization and validation; they understand the key elements needed for regulatory filings. This expertise allows the process to be developed with the end product in mind.
\n","showOnHomepage":true,"author":{"title":"Andrea C. Porchia, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/agc-biologics-logo-md.png","mediaDetails":{"height":95,"width":466}}},"authorFields":{"title":"General Manager of AGC Biologics’ Copenhagen Facility","linkedin":"https://www.linkedin.com/in/andrea-porchia-3884955","email":"acp@agcbio.com","company":{"title":"AGC Biologics"}}}},{"answer":"The next innovations in rare disease treatments will likely leverage investments into novel biologic drug modalities, such as oligonucleotide therapeutics and gene editing treatments. These novel modalities offer unique therapeutic routes for mitigating orphan diseases by modulating desired protein expression in target patient populations. The R&D pipeline of the top five companies — Novartis, Bristol Myers Squibb, Pfizer, Roche, and Sanofi — continues to maintain strong focus on rare diseases.
\n","showOnHomepage":true,"author":{"title":"Sergey Vlasenko, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Vlasenko_Agilent.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Associate Vice President Pharma and Biopharma End Markets","linkedin":"https://www.linkedin.com/in/sergey-vlasenko-645a477/","email":null,"company":{"title":"Agilent Technologies, Inc"}}}},{"answer":"Many orphan disease indications involve neurological disorders that are difficult to treat due to limitations with currently available therapies, such as an inability to cross selective tissue barriers like the blood–brain barrier (BBB), resulting in disease progression, neuroinflammation, and cognitive loss. Future treatment innovations for neurological disorders will be focused on identifying ways to cross tissue barriers and precisely deliver drugs to where they need to be to achieve therapeutic effects. At Ashvattha Therapeutics, we are leveraging our hydroxyl dendrimer (HD) platform to develop a new class of precision medicines that comprise potent small molecule drugs attached to HD molecules that are small enough to cross tissue barriers and selectively treat diseased cells in regions of inflammation. We’ll also see treatment innovations that aim to increase drug uptake while reducing systemic toxicity. One approach showing promising potential is HDs, because they bypass healthy cells and are only taken up by inflammatory cells in diseased tissue.
\nThe powerful selectivity of HD therapeutics limits off-target effects, and previously toxic drugs take on the safety profile of HDs when conjugated together, creating a potentially safer treatment option. This approach allows for molecules considered effective but associated with toxic side effects to be reconsidered — attaching them to an HD and, as a result, broadening the possibilities for therapeutic benefit.
\n","showOnHomepage":true,"author":{"title":"Jeff Cleland, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Ashvattha_therapeutics_logo.jpg","mediaDetails":{"height":627,"width":1200}}},"authorFields":{"title":"Chief Executive Officer, President, and Chairman","linkedin":"https://www.linkedin.com/in/jeffrey-cleland-633574/","email":null,"company":{"title":"Ashvattha Therapeutics"}}}},{"answer":"We see huge potential for growth in precision medicine, particularly precision oncology, in the near future. Viewing future treatment options for patients with genetically defined cancers through the lens of precision oncology is driving innovation in indications that have historically been untreatable. There has been significant success across our industry in the past few years, with new drugs and clinical trials focused on applying next-generation sequencing of tumors to specifically target genetically defined cancers, in improving clinical benefits for cancer patients. At Aadi, we focus on genetically defined cancers with alterations in mTOR pathway genes to unlock clinical benefits for people with mTOR-driven cancers. As shown in recent data at AACR, an aberrant mTOR pathway has been implicated in several different types of cancer. We are currently exploring the implications of alterations to the genes TSC1 and TSC2, which are known to play essential roles in the mTOR pathway, in combination with our precision targeted therapeutic nab-sirolimus. The innovative nab technology has the potential to make mTOR drugs more effective in cancer treatment when compared with mTOR inhibitors alone. Our early clinical data suggests the potential for using this approach to precision therapy in cancers with TSC1/2 alterations. While optimal target engagement is the goal of all precision medicines, the efficacy of a well-designed compound is enhanced by the identification of a specific target — something that we believe will continue to ring true for other indications across the sector.
\n","showOnHomepage":true,"author":{"title":"Neil Desai, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Aadi-Logo-1.png","mediaDetails":{"height":298,"width":418}}},"authorFields":{"title":"Chief Executive Officer, Founder, and President","linkedin":"https://www.linkedin.com/in/neil-desai-bb0053211","email":null,"company":{"title":"Aadi Bioscience"}}}},{"answer":"Now that LNPs for the delivery of mRNA have been very widely clinically demonstrated after the vaccination drive during COVID-19, I think we will see a further expansion of not only nucleic acid therapies but other forms of delivery vectors. Non-viral gene delivery is attractive for a number of reasons — favorable immunogenicity, control of formulation, and so on –– but there are options with the biological space where the superior tropism of the alternative vectors offers an advantage. This is particularly true of exosomes, which have a similar immunogenic profile and can take much larger payloads, but also engineered variants such as lentivirus (LV) / adeno-associated virus (AAV) and related vectors, such as anellovirus. All offer viable delivery platforms for genetic therapies.
\nThe advances in the field of non-plasmid DNA payloads are also moving at pace, with a number of companies developing linear DNA solutions that allow for more efficient construction of DNA sequences for therapeutic delivery.
\n","showOnHomepage":true,"author":{"title":"Ian Scanlon","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Astrea_Bioseparations_LOGO.jpg","mediaDetails":{"height":524,"width":1000}}},"authorFields":{"title":"Subject Matter Expert","linkedin":"https://www.linkedin.com/in/ian-scanlon-9327145/","email":"i.scanlon@astrea-bio.com","company":{"title":"Astrea Bioseparations"}}}},{"answer":"Biologics, which include recent innovations like cell and gene therapy, monoclonal antibody treatments, and mRNA-based treatments, have seen enormous growth in the past few years, and most notably in the past years alone. What is further noteworthy is that the COVID-19 pandemic has catapulted these technologies not only into a high growth phase but further into the daily lexicon of everyday citizens. The speed, sophistication, and specificity of such treatments have brought forth a deluge of investment in this space. Furthermore, some regulatory and acceptance barriers have now been overcome by necessity (e.g., COVID-19 vaccines) and consequently (likely) reduced future barriers to entry. While monoclonal antibody treatments have been used for some time, hundreds more are in clinical trials, and we are really only beginning to see the benefits of mRNA technology for both prophylaxis and treatments — with pipelines very heavily populated in early clinical trials. In this space, there will be considerable opportunities for innovation, most notably in the areas of oncology, neurology, and cardiovascular. It is worth noting that a sizable proportion of these new treatments are considered first-in-class, meaning that the next decade of approvals will include many novel and innovative treatments to some of healthcare’s biggest and most specific challenges. While the treatments themselves are the most visible innovations, they require a litany of ingredients during the upstream manufacturing and formulation of the drug products; this is where our focus remains on continuing to bring innovative, functional ingredients capable of ensuring efficacy, stability, and optimization of these innovative treatments.
\n","showOnHomepage":true,"author":{"title":"Frank Romanski, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Dr. Frank Romanski_BASF_Corp_web.png","mediaDetails":{"height":263,"width":211}}},"authorFields":{"title":"Global Technical Marketing Manager, Pharma Solutions","linkedin":"https://www.linkedin.com/in/frank-romanski-ph-d-1a480542/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Reducing the time between testing, diagnosis, and treatment, for any disease, represents the greatest opportunity to decrease human suffering. Early detection of cancer has long been the key to saving lives. For infectious diseases, rapid detection can also be the difference between containment/cure and further spread. Sexually transmitted infections (STIs) remain at all-time highs in the United States, with 42 million total cases of human papillomavirus (HPV), more than 1.5 million cases of chlamydia and gonorrhea annually, and only a 12% screening rate for STIs. Under the current care paradigm, patients often receive their test results days later. The gap between identifying and treating the disease leads to continued infection spread. Furthermore, 40% of patients who leave the clinic without treatment fail to adhere to recommendations. Untreated disease can lead to cases of infertility, ectopic pregnancies, pelvic inflammatory disease, further spread, and compounding of the problem.
\nPoint-of-care testing allows testing to be rapidly performed onsite and for the results to be delivered during the same healthcare provider visit, so that that a patient can leave with counseling from a clinician and a prescription in hand. For the two most tested-for STIs, chlamydia and gonorrhea, decreasing the time between test and treat can arrest infection spread, reduce the incidenc
\n","showOnHomepage":true,"author":{"title":"Jeff Luber","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Binx_Health_Logo.jpg","mediaDetails":{"height":497,"width":950}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jeffrey-r-luber-2003154/","email":"jeff.luber@mybinxhealth.com","company":{"title":"Binx Health"}}}},{"answer":"Oncology stays prevalent as a major focus therapeutic area and remains an unmet medical need. We are seeing a paradigm shift toward biologics and new drug modalities accelerated by COVID-19 and facilitated by collaborations within the industry, mergers, and acquisitions. I would expect the use of ribonucleic acid as an active pharmaceutical ingredient to continue, which will ensure further innovation in drug delivery systems like lipid nanoparticles.
\nWe are starting to see the increased use of techniques such as magnetic resonance for the characterization, analysis, and testing of biologics, biosimilars, and new drug modalities. Recent technological advances in both liquid and solid-state high resolution magnetic resonance allow quality assessment of formulated biotherapeutic peptides, proteins, and antibodies to be performed in physiological conditions, without the need of labelled compounds. On the other hand, benchtop magnetic resonance is emerging as a powerful process analytical technology tool, able to test these complex molecules in their container (vials or syringes).
\n","showOnHomepage":true,"author":{"title":"Anna Codina, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Brukerlogo.svg","mediaDetails":{"height":0,"width":0}}},"authorFields":{"title":"Director, Pharmaceutical Business Unit","linkedin":"https://www.linkedin.com/in/anna-codina-5041b21b/","email":"Anna.Codina@bruker.com","company":{"title":"Bruker Daltonics"}}}},{"answer":"Over the last decade, cell therapies like chimeric antigen receptor (CAR)-T cell therapies have demonstrated their ability to save patient lives. Beginning in 2017, the U.S. FDA approved a number of gene-modified cell therapies to treat hematologic malignancies in patients that had failed multiple treatment regimens.
\nGiven the unprecedented response rates of CAR-T cell therapies, these treatments are now being approved for use in earlier lines of treatment. For example, Kite Gilead’s CAR-T therapy, Yescarta, was approved in April 2022 as a second-line treatment for large B cell lymphoma (LBCL). In the United States alone, more than 18,000 people are diagnosed with LBCL each year, and about 40% fail first-line treatment. Now, a growing number of these patients will be eligible for treatment with CAR-T cells.
\nHowever, approved CAR-T cell therapies are currently only offered as autologous treatments to patients with blood-based cancers. The impact of these groundbreaking therapies will truly be felt when they expand into solid tumor indications with even larger patient populations. At Cellares, we’re building automated and high-throughput technologies to resolve the manufacturing bottleneck and enable access to cell therapies for all the patients who need them. Our technology can support both autologous and allogeneic cell therapy approaches, which reflects our expectation that both modalities will play a significant role in the future. Perhaps even more exciting is the prospect of cell therapies being used to treat autoimmune and infectious diseases as well.
\n","showOnHomepage":true,"author":{"title":"Fabian Gerlinghaus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/F_Gerlinghaus_Cellares.png","mediaDetails":{"height":287,"width":211}}},"authorFields":{"title":"Co-founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/fabian-gerlinghaus/","email":null,"company":{"title":"Cellares"}}}},{"answer":"There have been many advances (gene therapy, ASO, siRNA) in recent years to develop treatments and expand access to therapies for patients with unmet medical needs, particularly in patients living with rare genetic conditions, and, while the work is far from complete in that field, I predict that the next wave of innovations will focus on treating non-genetic illnesses. After a long drought, prevalent conditions like depression, chronic pain, migraines, and epilepsy could rise to the forefront of innovation and benefit from new treatment approaches. Over a billion people live with these conditions worldwide, and, despite their prevalence, improved treatment options for these diseases remain disproportionate to the number of people living with them.
\nIn the past couple of years, the drug discovery industry has revolutionized itself on several fronts: novel drug targets now come with much stronger human genetic (population) validation and patient stratification; our war chest of types of drugs has expanded significantly, allowing us to drug targets previously characterized as undruggable, and we’re learning to build upon old molecules with proven human efficacy by dialing out unwanted side effects or dialing up beneficial mechanisms of action. For instance, equipped with an improved understanding of the polypharmacology of psychoactive molecules, which act on multiple targets, we can unlock the next generation of treatment for some of these widespread indications. Hopefully, these treatments allow for improved patient compliance and superior efficacy against complex diseases, as well as an improved safety profile compared with standard of care — and, with non-genetic diseases facing widespread unmet need in the treatment landscape, these elements are key to safe and effective drug development.
\n","showOnHomepage":true,"author":{"title":"David Fischer, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/David Fischer_CharlesRiver_web.png","mediaDetails":{"height":277,"width":211}}},"authorFields":{"title":"Executive Director","linkedin":"https://www.linkedin.com/in/dffischer/","email":null,"company":{"title":"Stilmas"}}}},{"answer":"There are two categories that I would highlight, an early-stage and a maturing one.
\nThe earlier one is gene therapy, especially a focus on single-gene–associated diseases, such as different classes of neuromuscular disorder. The challenge with these has been several-fold. First, finding rare disease patients is, in itself, difficult. These diseases present with early symptoms that could be the manifestation of a range of diseases. Second, dosing has proven complex, with liver toxicities and other adverse effects leading to death or organ injury. The promise with gene therapy is enormous, advances are being made in delivery, and the tools to monitor are improving, but this is a new area, and we will see new hurdles.
\nOn the maturing side, CAR-T are highly targeted, engineered immune cells that can target a number of advanced leukemias and lymphomas. There are seven approved CAR-T therapies, with many more available under institutional protocols at leading cancer centers, and approximately 500 in clinical development. While response rates are positive — 40–80% — they are not assured. But we’re now seeing autologous and allogenic CAR-T, allowing this to advance to a range of different treatment and administration approaches. There are still challenges. Identifying patients that meet the criteria for treatment is difficult — most have a history of failing other treatments before being CAR-T eligible. And cytokine release syndrome, which results from rapid immune activation by “armed” CAR-Ts, is the most significant treatment-related toxicity. However, safety has significantly improved with greater experience in administration. This is an area of enormous potential being realized and advancing rapidly.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"The cell therapy space is poised to explode, with growing patient and doctor demand for these potentially curative therapies and the industry scrambling to meet it. Recent reports have estimated that about a fifth of eligible patients die waiting up to two months for a dose of these patient-derived CAR-T therapies to be manufactured.
\nThat’s just among patients who qualified because they failed all other treatments. Even among this group in desperate need, many were ineligible if they were too ill to produce enough immune cells. And the makers of these bespoke medicines have begun securing approvals to move earlier in the course of treatment, meaning that the industry is ramping up efforts to produce even better medicines for more patients, faster.
\nMuch of the effort is focused on new technology to automate many of the manual and labor-intensive steps to improve quality, reduce costs, and shorten manufacturing time. It also has the potential to expand access for currently ineligible patients.
\nFor example, automated cell separation can increase the number of cells that can be turned into a therapy. That’s important not just for cancer patients, who often have disease- or medicine-suppressed immune systems, but also to treat patients with autoimmune diseases, with infectious diseases like HIV, or those who’ve had a transplant. The same technologies could also reduce the need for cell expansion, the most time-consuming piece of CAR-T manufacturing, and reduce labor requirements amid the staffing shortage — all helping more patients get more cell therapies, faster.
\n","showOnHomepage":true,"author":{"title":"Tony Ward","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Curate_biosciences_logo.png","mediaDetails":{"height":137,"width":369}}},"authorFields":{"title":"Chief Operating Officer and Chief Technology Officer","linkedin":"https://www.linkedin.com/in/tonyward2","email":"curatebiosciences@consortpartners.com","company":{"title":"Curate Biosciences"}}}},{"answer":"It is a great achievement that humans are living longer. 13% of the global population will be over 65 years old by 2030, and this percentage will continue to grow over the next few decades. At the same time, we need to age while in good health and enjoy good quality of life. The rise in chronic diseases affecting the population, such as heart disease, diabetes, and cancer, will dramatically increase over the next 10–15 years. Barring any future pandemics, the prevalence of chronic disease is set to outpace infectious diseases within the next decade. This is why society needs to solve how we will age in good health.
\nThe development of personalized therapies for tackling chronic and rare diseases using mRNA will become more prevalent. The successful use of mRNA for COVID-19 vaccines proved that this technology is effective and can be scaled up quickly and manufactured on a global scale. For personalized therapies targeting cancer, this speed will be critical. Treatments, using specific molecular features from an individual’s tumor, must be developed within 1–2 months after tissue collection. For the 18 million people a year who are battling cancer, the clinical trial results of personalized therapies are promising.
\nIf we are to successfully treat or cure chronic diseases and improve human health, the collaboration among scientists, the pharmaceutical industry, and governments that we saw during the COVID-19 pandemic must continue.
\n","showOnHomepage":true,"author":{"title":"Emmanuel Ligner","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Cytiva_Transparent_Logo.png","mediaDetails":{"height":517,"width":545}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/emmanuel-ligner-967b9016/","email":"emmanuel.communications@cytiva.com","company":{"title":"Cytiva"}}}},{"answer":"Definitely central nervous system (CNS) disorders, such as strokes, movement disorders, Guillain-Barré syndrome, Parkinson’s disease, multiple sclerosis, amyotrophic lateral sclerosis (ALS), Huntington’s disease, and Alzheimer’s disease. CNS as a therapeutic area had fallen by the wayside relative to rare/orphan indications and oncology. One in three people in the world are affected by these diseases, and the burden of deaths and disability caused by CNS disorders is increasingly being recognized as a global public health challenge, which is set to rise further over the next few decades as a result of the growing aging population.
\nThis space was lagging due to the lack of efficacy in approved treatments driven previously by a poor understanding of biomarkers and genetic factors that impacted neurological systems. Powerful laboratory analyses and imaging modalities have dramatically broadened the depth of knowledge needed to innovate in CNS. Furthermore, the continued fast pace of the medical device area, especially in neuromodulation, implantables, and wearables, provides yet another avenue for treatment of patients suffering from treatment-resistant depression or PTSD. Extensive research and clinical trials have begun to prove neuromodulation’s ability to decrease chronic pain and improve the quality of life for CNS patients. The other crucial piece of the puzzle in CNS is being able to assess efficacy using validated clinical scales and assessments that capture baseline patient status throughout the course of the clinical study and beyond. CNS trials are no different than oncology, in that they generate significant volumes of clinical data from disparate sources. It’s important to evaluate this data using a technology that offers real-time data visualizations and reports to identify relevant insights sooner and mitigate the risks that may affect the quality or safety of a study.
\n","showOnHomepage":true,"author":{"title":"Temitope Keyes","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/encapsia_logo.png","mediaDetails":{"height":416,"width":1091}}},"authorFields":{"title":"Executive Director, Business Development","linkedin":"https://www.linkedin.com/in/temitopekeyes/","email":"tkeyes@cmedtechnology.com","company":{"title":"Encapsia"}}}},{"answer":"We are fortunate to see innovation advancing in many therapy areas right now, and some of the next exciting and significant advancements are in ophthalmology. As our population continues to age, diseases in the back of the eye, such as wet age-related macular degeneration (wet AMD), diabetic retinopathy, diabetic macular edema, and retinal vein occlusion, represent a growing area of significant unmet need.
\nPrior innovations in intraocular injections allowing delivery of sight-preserving therapies directly to the tissue in the back of the eye represented a true turning point in the treatment of these diseases, but the next treatment innovations are targeted at increasing the longevity of action and durability of treatment to relieve patients and their caregivers of the burden of visiting their doctor ever month or two in order to maintain their vision.
\nWe know that, in the real world, a year or two into their disease, patients can lose much of the visual gains, because they can’t keep up with visits or their treatments. These next treatment innovations on the horizon aimed at maintaining visual gains over the longer term are poised to address what is arguably the largest unmet need in the landscape right now in this area. With trials moving forward every day, it is a truly promising time for patients with serious eye disorders.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"Solutions for women’s reproductive health remain costly, inconvenient, and, in extreme cases, deadly. This space represents significant unmet medical need, with over 9 million women struggling with infertility and over 13 million women who are candidates for permanent birth control in the United States alone. Technologies on both ends of the reproductive spectrum are antiquated and have significant limitations, providing significant opportunity to be replaced with next treatment innovations.
\nFor instance, intrauterine insemination (IUI) is the oldest technique in artificial insemination. It remains the first-line treatment option despite low success rates. On the opposite end of the spectrum, the first tubal ligation was performed in 1880, and it remains the only form of permanent birth control. As a surgical approach, tubal ligation has possible risks that include bleeding or damage to the bowel, bladder, or major blood vessels. This is why, at Femasys, we are developing first-in-class solutions to meet women’s unmet medical needs. Our in-office procedures for front-end infertility and permanent birth control are designed to be safe, natural, and minimally invasive.
\nTo my disbelief, conversations around Roe v. Wade have resurfaced, but I am hopeful that the attention that women’s healthcare is receiving will finally push the industry toward greater acknowledgment of the need for advancements and innovation. As a community, we’ll need to work together to ensure that women are able to access improved options for their specific needs. Women deserve to make informed choices when it comes to their reproductive health, and I believe that we’ll begin to see changes in the space in the coming months.
\n","showOnHomepage":true,"author":{"title":"Kathy Lee-Sepsick","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Femasys_logo.jpg","mediaDetails":{"height":222,"width":738}}},"authorFields":{"title":"Founder, Chief Executive Officer, and President","linkedin":"https://www.linkedin.com/in/kathy-lee-sepsick-6b680b7/","email":null,"company":{"title":"Femasys"}}}},{"answer":"Advances in antigen-specific tolerization will enable innovative treatments for underserved patients with autoimmune disease. These approaches aim to reeducate a patient’s immune system to recognize disease-causing autoantigens as self-proteins, thereby halting or even reversing disease progression. Such strategies will find early applications in orphan indications with well-characterized mechanisms of pathogenesis and a clear understanding of causative autoantigens, such as thyroid eye disease, myasthenia gravis, and pemphigus vulgaris. Methods in preclinical and clinical development include administration with tolerizing nanoparticles, co-administration with tolerogenic co-factors, and engineering of autologous and allogeneic immune cells. Recently, companies like GRO Biosciences have developed techniques to induce recognition of autoantigens as self-proteins by the introduction of glycosylated amino acids. Decorating an antigen with known tolerizing glycans results in presentation of the antigen in a tolerogenic context, ultimately providing durable tolerance via establishment of antigen-specific T regulatory cells.
\nBeyond autoimmune disease, antigen-specific tolerization will also underlie new treatments for patients suffering from orphan diseases with therapies hampered by neutralizing antibodies. Protein-based medicines like enzyme replacement therapies — as well as vectors for the delivery of gene therapies — are frequently impaired by a neutralizing immune response. Many techniques developed for tolerization of endogenous proteins may be applied to such exogenous therapies, allowing for a new generation of treatments with unprecedented safety and efficacy.
\n","showOnHomepage":true,"author":{"title":"Dan Mandell, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/GRO-Biosciences-Logo.png","mediaDetails":{"height":129,"width":233}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/dan-mandell-9962456","email":"dan.mandell@grobio.com","company":{"title":"GRO Biosciences"}}}},{"answer":"GSK’s purpose is to unite science, talent, and technology to get ahead of diseases together. We will do this by prioritizing innovation in vaccines and specialty medicines, maximizing opportunities to prevent and treat diseases. Our aim is to positively impact the health of more than 2.5 billion people over the next ten years.
\nOur current pipeline consists of 43 medicines and 21 vaccines, almost half of which address infectious diseases.
\nOur approach to research and development focuses on science related to the immune system, the use of human genetics, and advanced technologies. It will help us to accelerate the pace at which we develop and deliver transformational medicines and to increase our focus on specialty medicines in areas such as oncology.
\nIn addition, in our vaccines business, we focus on accelerating key assets in our pipeline and looking at innovative technologies so that we can unlock potential in emerging fields. As GSK’s eight consecutive years at the top of the Access to Medicine Index show, diseases affecting the developing world continue to be a key focus for our organization.
\n","showOnHomepage":true,"author":{"title":"Jamila Louahed, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/GSK_logo.png","mediaDetails":{"height":480,"width":640}}},"authorFields":{"title":"Vice President, Head of Vaccines Global Research and Development, Belgium R&D Center","linkedin":"https://www.linkedin.com/in/jamila-louahed-6b225628","email":null,"company":{"title":"GSK"}}}},{"answer":"Investments in biotechnology have reached record-breaking levels. This surge is attributed to gene therapies and cell-based immuno-oncology. Oncology remains the primary indication targeted, with strong pipelines in blood-forming malignancies, breast tumors, and melanomas. There is also growing interest within allogeneic cell-based immunotherapies for cancer treatment, which are appealing due to their cost-effectiveness and global accessibility.
\nIn addition, we’re seeing advancements from biotech start-ups and innovators that target rare diseases, such as ALS, hemophilia, and sickle-cell disease. Yet, the clinical pipelines appear equally invested in prevalent diseases, targeting indications such as diabetes, osteoarthritis, Alzheimer’s, and Parkinson’s.
\nThe global SARS-CoV-2 pandemic has also accelerated the development of nucleic acid therapies with large curative potential. It will be exciting to see how this new field of therapeutics will advance treatment of solid tumors, infectious diseases — including influenza and RSV — and metabolic and cardiovascular diseases.
\n","showOnHomepage":true,"author":{"title":"Caroline Cooreman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Cooreman_Iff.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Business Development Manager, Biotechnology","linkedin":null,"email":null,"company":{"title":"IFF"}}}},{"answer":"New rare diseases are discovered every year. Most are inherited and caused by genetic mutations or other anomalies. Others are attributed to environmental factors. These unmet medical needs call for innovation; however, there is risk in creating therapies for rare diseases due to development costs and return on investment. To help, financial incentives have been implemented to foster orphan drug development. Another issue is that only five percent of rare diseases have an approved treatment, and consequently, there are still many unmet patient needs. According to some forecasts, orphan drug growth could be as much as 11% annually through 2024 and possibly out to 2026. Trends suggest that the greatest opportunities will be in biologics, particularly for rare cancers, and treatments for CNS disorders such as ALS, as well as diseases related to lipid metabolism and lipid build-up in the body, which can include any number of rare diseases, such as Gaucher or Batten diseases. There are other rare metabolic and autoimmune diseases. Beyond these are those treatments targeted at rare pediatrics disorders. In biologics, RNA vaccines are a promising pathway toward personalized medicine development and treatment for rare diseases, and new platform technologies for cell and gene therapies are also very promising. For example, CRISPR-Cas9 or siRNA have shown good results in controlling gene expression. 3D printing could also be a valuable tool for personalized medicine manufacture, owing to its flexibility, control, and scale in treating rare diseases.
\n","showOnHomepage":true,"author":{"title":"Joseph Zeleznik","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/imcd-logo-colour-rgb-scaled.jpg","mediaDetails":{"height":764,"width":2560}}},"authorFields":{"title":"Technical Director, North America","linkedin":"https://www.linkedin.com/in/joe-zeleznik-1453576/","email":"joseph.zeleznik@imcdus.com","company":{"title":"IMCD"}}}},{"answer":"We at Inteliquet (an IQVIA company) don’t see this issue in terms of one orphan space or another. We rather see it in terms of the opportunity to have the infrastructure to serve more orphan spaces and unmet medical needs that have not been successfully solved with manual efforts and legacy systems. Solving for one space or one unmet need has limited value if we as an industry do not apply the learnings to other areas of need.
\nThis means that if we advance how we engage patients on their healthcare journey and support treatment backed by data — beginning at the healthcare organization’s point of care — the most challenging rare and orphan spaces can find treatments that may have otherwise eluded them. This is important, because clinical trials may be able to meet feasibility for these faster than ever. Addressing an unmet medical need for an oncology patient is not just about identifying a potential treatment that may work for them. Reducing the timeline to identify that treatment is not only innovative, but critical.
\nNow that healthcare organizations are able to more easily manage and normalize patient data for answers to timely questions around personalized medicine and clinical trials as a care option, we can realize the promise of convergence that better serves patients, including those often marginalized because of hard-to-study, hard-to-treat conditions and small patient populations. This means that opportunity lies within rare and orphan disease states with care options where patients may not have equal opportunity to benefit from telehealth.
\nOverall, cancer is complicated and a leading cause of death. We still have much work to do to improve the patient journey for all oncology patients, including those with rare and orphan cancers. The interest in oncology remains very high where patient matching through the intelligent use of healthcare data and artificial intelligence (AI)-enhanced biomarker matching can answer questions of study feasibility that may provide breakthroughs to save time and lives, now and in the future.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"It's hard to predict innovation, but we are seeing a lot of promising activity in fetal–maternal health, which I am excited about, as this is an area that has often been neglected, and early development lays the foundation for future health. We will also certainly see innovation in how therapies are used, as the rapid point-of-care diagnostics systems fully commoditized because of COVID-19 find other creative uses. For example, it may make many drugs with narrow therapeutic windows much more feasible candidates for development, or support drugs that need to be deployed in response to rapidly changing physiological conditions in non-hospitalized patients. Delivery of genomic medicines is currently a major challenge, but I think there will be near term significant innovation there, and I believe it will be via non-viral approaches.
\n","showOnHomepage":true,"author":{"title":"Alex Morgan, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Khosla_ventures_logo.png","mediaDetails":{"height":129,"width":389}}},"authorFields":{"title":"Partner","linkedin":"https://www.linkedin.com/in/genomicsdoc/","email":"alex@khoslaventures.com","company":{"title":"Khosla Ventures"}}}},{"answer":"The next treatment innovation will come in the transplant ecosystem. This unmet need, due to a lack of organs available for transplantation, is a worldwide problem that leaves thousands waiting every year. There are more than 100,000 people on the United States national transplant waiting list, and more patients could benefit from an organ transplant but aren't eligible. In addition, these procedures are extremely costly and invasive. The price tag for a transplant is nearly $800,000, and patients often need days in a hospital to recover. Researchers have been pursuing potential solutions like xenotransplantation for decades, but, even if successful, it relies on one-to-one organ replacements. These current solutions fall short of meeting transplant needs and do not address the financial and patient concerns. Lightspeed Venture Partners’ portfolio company Satellite Bio is developing a new category of regenerative medicine called Tissue Therapeutics, which turns virtually any cell type into bioengineered tissues at scale that can be integrated into the body to restore natural function. The company’s Satellite Adaptive Tissues (SATs) can be placed in remote locations within the body to deliver the comprehensive cellular response needed to repair or even replace critical organ function in patients with diseases caused by the interaction of genetic and environmental factors. These Tissue Therapeutics can be a stopgap treatment for people waiting for a transplant, improving their quality of life. Satellite Bio is first focused on a liver therapeutic due to the need for new, innovative chronic liver disease treatments.
\n","showOnHomepage":true,"author":{"title":"Ling Wong, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Lightspeed_venture_partners_logo.png","mediaDetails":{"height":225,"width":225}}},"authorFields":{"title":"Senior Advisor to Lightspeed and General Partner and Founder at Highbury Group","linkedin":"https://www.linkedin.com/in/lingwong1/","email":"lightspeed@consortpartners.com","company":{"title":"Lightspeed Venture Partners"}}}},{"answer":"Dry powder inhalers (DPIs) are the preferred treatment method for patients with lung disease. In recent years, 30–50% of active pharmaceutical ingredients (APIs) for inhalation delivery are biotherapeutics. Biotherapeutics are fairly delicate in comparison with small molecules and require special formulation and manufacturing considerations to enable use as a dry powder inhaler. Lonza’s work in spray drying of monoclonal antibodies and other biotherapeutics for dry powder inhalation can help realize the benefits of DPIs for a different class of actives.
\nMore than 12 monoclonal antibodies are commercially approved as injectables for the treatment of lung diseases, including asthma, lung cancer, and lung infections. As injectables, these treatments are invasive, require cold-chain storage, and must be administered by a trained individual. In addition, treatments are administered systemically, which can lead to adverse effects in healthy tissue. Particularly for lung cancer, local treatment is a promising means to isolate potent compounds at the affected tissues. Local treatment of lung disease with monoclonal antibodies could improve treatment options for patients.
\nAdvantages of monoclonal antibody (or other biotherapeutic) DPI therapies manufactured by spray-drying include reduced dose and systemic side effects, avoidance of cold-chain storage requirements, reduced cost of treatment, and the possibility of simple, at-home administration.
\nIn a recent publication, Lonza’s team demonstrated a respirable, bioactive spray-dried powder containing bevacizumab (a treatment for non-small cell lung cancer) with 12-month stability at 25 ºC. In a follow-up study, the authors combined this formulation into a single dry powder with cancer-relevant small molecules.
\n","showOnHomepage":true,"author":{"title":"Kimberly Shepard, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/45.gif","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Associate Director, Principal Engineer R&D, Small Molecules","linkedin":"https://www.linkedin.com/in/kimberly-shepard-40b09820/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"It’s a really exciting time to be in this industry. We’re at the forefront of reshaping modern medicine, moving from treating a disease or condition to potentially curing and eliminating it. This is particularly true with the help of novel modalities like nucleic acid–based therapies, such as mRNA and cell and gene therapies.
\nTraditionally, gene therapies have primarily targeted rare diseases with small patient populations. Looking at the clinical pipeline, we see a shift to larger patient populations. To ensure that all patients who could benefit from these potentially curative treatments have access, it’s imperative that we invest now in improving scale-up and manufacturing. As manufacturing practices advance, biosafety testing must also evolve to deliver faster results and to safeguard the continued quality and safety of these therapies.
\nEmerging biotechs are a big driver of innovation and diversification of drug pipelines to support the growing demand for curative treatments. These small- and medium-sized firms need partners with the capabilities and resources to help scale up their molecules. This has led to an acceleration in outsourcing efforts to help speed up time to market, with biotechs leveraging the scientific, operational, and regulatory expertise of contract development and manufacturing organizations (CDMOs) or contract testing organizations (CTOs.)
\nWhile many companies focus solely on development, manufacturing, or testing, we are a true “CTDMO” and seamlessly integrate our CDMO services with biosafety testing. This integration enables us to reduce interfaces and streamline the development and release timelines, ultimately bringing new, curative therapies to patients sooner.
\n","showOnHomepage":true,"author":{"title":"Dirk Lange","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/grid_millipore.jpg","mediaDetails":{"height":176,"width":272}}},"authorFields":{"title":"Head of Life Science Services","linkedin":"https://www.linkedin.com/in/langedirk/","email":null,"company":{"title":"MilliporeSigma"}}}},{"answer":"Many researchers consider the brain the “final frontier” of medical innovation. While this offers exciting new possibilities for future drug development, we cannot forget that we are currently in a mental health epidemic. The need to find faster, more durable, and more effective brain health treatments has never been greater. Added stressors from the COVID-19 pandemic and other global crises have only worsened the situation for those currently suffering from brain health disorders. The one-year prevalence of anxiety disorders in the United States is approximately 21%, over 50 million U.S. adults live with chronic pain, and roughly 250 people die each day as a result of substance abuse disorders. Most drugs in development for brain health are either reformulations of existing drugs or offer only marginal improvements in symptom reduction.
\nWe will see the next treatment innovations in the brain health space derived from psychedelic compounds. We are witnessing a dramatic change in attitudes toward a once stigmatized class of drugs, now greeted with optimism by the medical community, patients, regulators, and investors based on rigorous scientific data demonstrating the potential of these compounds to provide meaningful improvements for patients for whom current treatments have not been successful. At MindMed, we are developing a pipeline of drug candidates to treat brain health disorders, with and without acute perceptual effects, based on LSD, MDMA, and an ibogaine derivative. Our product candidates are based on scientific evidence demonstrating their potential to treat brain health disorders.
\n","showOnHomepage":true,"author":{"title":"Rob Barrow","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Barrow_MindMed.png","mediaDetails":{"height":279,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/robert-barrow-b50836a","email":null,"company":{"title":"MindMed"}}}},{"answer":"Oncology will see a flood of treatment innovations in the coming years as we pivot from broad, one-size-fits-all therapies to personalized medicine. The future of cancer treatment is one of the increasingly complex therapy combinations and surveillance modalities as new niches are identified and targeted.
\nTo most effectively implement treatment regimens and track disease progression, as well as the emergence of treatment resistance, clinicians and researchers will require a greater understanding of genotypic and phenotypic disease subtypes and their respective response to therapy, as well as patient-specific metadata, comorbidities, and even microbiome genetic variation. Thankfully, sequencing technology is evolving to provide higher, more precise resolution for each patient and each tumor, essentially making all cancers “rare” diseases that require personalized treatment and surveillance.
\nSingle-cell characterization of DNA, protein, gene expression, epigenetic, and functional differences offer novel treatment targets with great promise to improve outcomes. In the meantime, we’re seeing single-cell technologies begin to reshape clinical paradigms: researchers are uncovering mechanisms of resistance to BTK inhibitors in B cell cancers and IDH inhibitors in acute myeloid leukemia and are developing patient surveillance strategies based on the identification of novel risk factors for leukemia in patients with Shwachman-Diamond syndrome, to name just a few. Treatment innovation is about more than just new drugs — it’s also about changing patient experiences by using existing therapies better.
\n","showOnHomepage":true,"author":{"title":"Todd Druley, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Mission_Bio_logo.png","mediaDetails":{"height":200,"width":300}}},"authorFields":{"title":"Chief Medical Officer","linkedin":"https://www.linkedin.com/in/todd-druley-md-phd-9ba85214/","email":"missionbio@consortpartners.com","company":{"title":"Mission Bio"}}}},{"answer":"We are very hopeful that the treatment of schizophrenia, a devastating and intractable disease affecting some 1% of the global population, will begin to see meaningful new developments in the near future. A particular issue with schizophrenia is the high percentage of patients who, over a period of time, develop an inadequate or failed response to the current generation of antipsychotic treatments. For these individuals — by some estimates as high as 60% of all schizophrenia patients — there exists only one approved monotherapy, clozapine, an effective therapy but one with significant potential side effects that tend to limit its broad usage. But there has been exciting progress in the CNS field over the past year, along with a recognition that treatment resistance — not only for schizophrenia but for a number of other psychiatric disorders — is an area that must be considered for current and future therapeutic directions.
\n","showOnHomepage":true,"author":{"title":"Stefan Weber","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/newron-logo-2020_2.png","mediaDetails":{"height":249,"width":426}}},"authorFields":{"title":"Chief Executive Officer and Executive Director","linkedin":"https://www.linkedin.com/in/stefan-weber-58b7962b/","email":"stefan.weber@newron.com","company":{"title":"Newron Pharmaceuticals"}}}},{"answer":"Our team at Outlook Therapeutics recognizes a unique unmet medical need in ophthalmology. There are currently a handful of approved anti-VEGF treatment options available for wet age-related macular degeneration (AMD) patients. Meanwhile, 50% of anti-VEGF injections for treatment of wet AMD are off-label bevacizumab, which come from compounding pharmacies and are not designed for ophthalmic use. Bevacizumab is a molecule that has been used to treat retinal disorders for several years but has never received approval from major regulatory agencies to be used as an ophthalmic drug solution.
\nWe believe there is a significant unmet need for an approval by the U.S. FDA for an ophthalmic bevacizumab for treatment of wet AMD. If approved, we hope to see our ophthalmic bevacizumab, ONS-5010, become a valuable on-label therapy offering clinicians and their patients a safe and effective ophthalmic formulation of a treatment whose value has been proven over many years of clinical practice. Recent independent market research conducted by Spherix Global Insights indicates that 80% of retina specialists surveyed hold the view that Outlook Therapeutics’ ONS-5010 would represent an advancement if approved by the FDA.
\n","showOnHomepage":true,"author":{"title":"Russ Trenary","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Outlook_therapeutics_logo.png","mediaDetails":{"height":164,"width":601}}},"authorFields":{"title":"President, Chief Executive Officer, and Board Member","linkedin":"https://www.linkedin.com/in/russ-trenary-15419510/","email":"russtrenary@OutlookTherapeutics.com","company":{"title":"Outlook Therapeutics"}}}},{"answer":"The industry continues to shift away from broad, generalized treatment modalities to more individualized treatment approaches. Personalized medicine through development of advanced therapy medicinal products (ATMPs) continues to hold the potential to revolutionize clinical and therapeutic strategies. The industry is shifting from a model of treating symptoms to one that is based on curing diseases. These therapies tend to require an advanced manufacturing process and specialized handling. Because of this, injectable-based products with cold-chain supply requirements will continue to take more market share.
\nIn addition to personalized medicines, biologics, peptide-, and protein-based compounds continue to be a focus area for clinical development organizations, with a large share of these compounds focused on the central nervous system (CNS), oncology, and rare diseases. This will increase the need for highly potent active pharmaceutical ingredients (HPAPIs), as they allow for more targeted therapies to be developed with reduced, generalized adverse effects.
\n","showOnHomepage":true,"author":{"title":"Craig LaMarca","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PCI_Pharma_logo.svg","mediaDetails":{"height":0,"width":0}}},"authorFields":{"title":"General Manager, Boston Clinical Trial Services","linkedin":"https://www.linkedin.com/in/craig-lamarca-b74413a/","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"There are three areas in rare disease drug development that in particular need advancements: (1) development of therapies for multifactorial diseases, (2) treatment of very small patient populations that require a bespoke therapeutic approach, and (3) improvements in the delivery of drugs, both nucleic acids and proteins, to tissues currently not accessible or poorly accessible by existing therapies and modalities. The third category is particularly pertinent for the treatment of rare neuromuscular and neurologic diseases. For people with diseases like Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1), treatment is mainly supportive. No curative therapies exist because of limitations in delivering therapies to affected tissues. Therapies for DMD and DM1 must address the root cause of disease to make a meaningful impact on quality of life. Fortunately, broadening research in the space suggests that we are on the cusp of transformative therapies for these disorders.
\nAt PepGen, we are focused on advancing a new generation of therapeutics through our Enhanced Delivery Oligonucleotides (EDOs), which are designed to dramatically increase therapeutic uptake by the tissues most affected in neuromuscular and neurologic disease. Our preclinical data demonstrates that our EDOs have sustained effects in tissues including skeletal muscle, heart, and diaphragm. Our lead program in DMD is now in human trials. We believe that the future of treatments for rare neuromuscular diseases is brightened by the commitment of our team and others working in parallel with patients and their families to develop targeted therapies that can stop or reverse disease progression and have a long-term impact on quality of life.
\n","showOnHomepage":true,"author":{"title":"Michelle Mellion, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Pepgen_logo.jpeg","mediaDetails":{"height":124,"width":407}}},"authorFields":{"title":"Senior Vice President and Head of Clinical Development","linkedin":"https://www.linkedin.com/in/michelle-mellion-38216aa3/","email":null,"company":{"title":"PepGen"}}}},{"answer":"The attention being paid to orphan indications has continued to increase over the past decade. According to Research and Markets, growth in the space is expected to increase from $190.8 billion in 2021 to $248.2 billion in 2026. This includes a range of modalities, with the most promising drugs being large molecule or advanced therapy medicinal products (ATMPs).
\nSteady demand has continued for large molecule drugs, such as monoclonal antibodies. Titers have increased from approximately 0.1 g/L two decades ago to more than 10 g/L today, requiring more integrated and automated platform approaches.
\nATMPs are expected to continue growing exponentially as well, but these treatments also present challenges, one of the greatest being that they are dependent on viral vectors for delivery. As such, the viral vector industry is seeing significant increases in upstream and downstream production of viral vectors in the next couple of years.
\nBoth the European Medicines Agency (EMA) and the U.S. FDA expect that there will be 10–20 ATMP approvals each year by 2025. And with more than $30 billion invested in the field and the number of assets moving from drug discovery and preclinical into phase I and phase II, the pace is not slowing down. Still, a slow rate of ATMP regulatory approvals has increased the complexity of these therapies and the need to look closely at the highly novel technologies used in their production.
\n","showOnHomepage":true,"author":{"title":"Roel Gordijn","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Polyplus-transfection_Logo.png","mediaDetails":{"height":656,"width":1694}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://www.linkedin.com/in/roel-gordijn-33390b13/","email":"rgordijn@polyplus-transfection.com","company":{"title":"Polyplus-transfection®"}}}},{"answer":"I believe that there are two areas that seem poised for breakthrough innovation. The first is the use of allogeneic cell therapies for the treatment of cancers, including solid tumors. While this has proven a difficult challenge medically and scientifically, we are seeing incremental progress across the industry in terms of new advancements and progress that suggest that breakthrough innovation is coming soon. The second is the treatment of rare monogenetic diseases — especially in infants and juveniles. Most genetic diseases are present from birth, and there is enormous unmet need to treat many of these conditions that are often otherwise fatal for these children at a very early age. Recent advancements in technological innovation in genetic engineering are finally putting effective treatments within reach. At Poseida, we are investing in these innovations and seeing progress that makes us proud to play a role in both areas.
\n","showOnHomepage":true,"author":{"title":"Mark Gergen","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Poseida_therapeutics_logo.jpg","mediaDetails":{"height":800,"width":800}}},"authorFields":{"title":"Chief Executive Officer and Director","linkedin":null,"email":"mgergen@poseida.com","company":{"title":"Poseida Therapeutics"}}}},{"answer":"Biology is extraordinarily complex, and so, for far too long, our industry has fallen short in addressing many intractable diseases, especially in areas like neuroscience and fibrosis. Today, the majority of companies researching these diseases are pursuing a limited number of similar target hypotheses based on the relatively narrow understanding of biology we’ve elucidated to date, even in many cases pursuing study after study against the same targets that have failed in clinical trials already. It’s clear to us that, in the face of the enormous complexity of biology, all our biases as humans may be standing in the way of better medicines.
\nFortunately, the convergence of new technologies is helping unravel the complexity of biology in a less biased way. Rather than approaching these diseases with a specific set of hypotheses informed by the literature, we can build and navigate maps of biology that may help us identify novel therapeutics and unlock novel biological insights outside of what is known today. That’s our focus at Recursion, where we apply machine learning to our proprietary high-dimensional data sets of genome-scale biology and chemistry to identify relationships between biological contexts and chemical entities. This enables us to expand the scope of potential therapeutic candidates and accelerate the drug discovery process.
\nI’m particularly excited about our work in neuroscience and fibrosis, where we’re partnering with experienced, top-tier biopharma leaders to explore these areas together. Each of us brings something unique to the partnership, and I believe that together we have the potential to radically improve people’s lives.
\n","showOnHomepage":true,"author":{"title":"Chris Gibson, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Recursion_pharmaceuticals_logo.jpeg","mediaDetails":{"height":664,"width":742}}},"authorFields":{"title":"Co-Founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/chris-gibson-5ab66065/","email":"chris@recursion.com","company":{"title":"Recursion"}}}},{"answer":"Alzheimer’s disease is the most common form of dementia and is expected to affect over 50 million people by 2030. There is no cure despite decades and billions of dollars invested into clinical research. It is one of the biggest threats to our aging population. The disease is disruptive to patients, caregivers, and entire families, and it poses large strains on our healthcare systems.
\nDespite daunting results of clinical trials in the last two decades, thanks to recent innovations such as digital and blood biomarkers, we are getting better at diagnosing patients earlier in the process. These solutions are available at a large scale and relatively low cost.
\nWhile biological underpinnings are undisputed, the disease phenotypes may hold key indicators that help shed light on pathophysiological processes of the disease. The ability to better differentiate the various clinical disease expressions — typically assessed through neuropsychological tests and, more recently, supported by digital biomarkers — is crucial for the development of new approaches. Through the addition of wearable data that is able to detect subtle changes in everyday behavior, we will be able to gain insight into the patient’s behavior leading up to the disease and into changes over the disease course. Increasing diversity and researching a broader patient variety will further grow our overall knowledge of Alzheimer’s disease and its risk factors. Together, I believe that these components will improve our understanding of the natural history and progression of Alzheimer’s disease and thus lay the foundation for novel treatment approaches of this devastating disease.
\n","showOnHomepage":true,"author":{"title":"Irene Meier, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/8615.jpg","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Clinical Trial Lead","linkedin":"https://www.linkedin.com/in/irene-meier-42bba2121/","email":"reifyhealth@pancomm.com","company":{"title":"Reify Health"}}}},{"answer":"I strongly believe that personalized medicine and the treatment of rare diseases will continue to gain significance. As a premium service provider, Rentschler Biopharma offers innovative solutions to ensure the best results in collaboration with our clients. This translates to fast and high-quality product development all the way to market production. In the future, small- or medium-sized bioreactors up to 3,000 L will play an increasingly important role. This is also one of the reasons why Rentschler Biopharma is investing in four 2,000 L single-use bioreactors at our site in Milford, MA. In this way, we are contributing, within a strong network and together with our clients, to providing a better life for patients with serious or rare diseases. Furthermore, new modalities will also open up new possibilities. The COVID-19 pandemic has demonstrated how innovative drugs based on mRNA can play a key role. In addition, viral vectors and oncolytic viruses will bring breakthroughs as well. As an innovative company, Rentschler Biopharma has therefore also invested in advanced therapy medicinal products (ATMPs) at our center of excellence, Rentschler ATMP, in Stevenage, U.K. We plan to partner with entrepreneurial players, enabling them to transform their ideas into products with the potential to treat and even cure patients.
\n","showOnHomepage":true,"author":{"title":"Christiane Bardroff","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/87.gif","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Senior Vice President of Client Program Management and Senior Vice President of Clinical and Commercial Manufacturing","linkedin":"https://www.linkedin.com/in/christiane-bardroff-6305a69b/","email":"communications@rentschler-biopharma.com","company":{"title":"Rentschler Biopharma SE"}}}},{"answer":"Recently, more therapeutic options have become available for patients with hard-to-cure diseases as more innovative biologics are being developed. It is certainly great news for patients, healthcare providers, and many other stakeholders. However, healthcare costs continue to rise due to the high price tags of these innovative biologics, and “unequal access” to medicines will continue to be an issue; as a result, there will be a growing number of patients with unmet medical needs who cannot afford these innovative biologics.
\nBiosimilars, on the other hand, can increase patient access to innovative drugs at a significantly reduced price after the loss of exclusivity of the original biologics. In turn, the healthcare savings generated by biosimilars can create “legroom” for healthcare budgets to be invested in next-generation innovations, such as cell and gene therapies, that can tackle diseases with high unmet needs.
\nAnd we should not forget that innovation happens not just in orphan or rare disease areas with no viable treatment but also in therapeutic areas with viable treatments, where innovation is driven by competition among biosimilars as well as between biosimilars and reference biologics. Biosimilars are not just biologics that “replicate” reference products; biosimilar companies seek to improve their products by adding value-added features around biosimilar formulation and/or devices.
\nAt Samsung Bioepis, we believe in the value of biosimilars: by being more affordable, they are the pressure valve that allows innovations in next-generation biologics. And by stimulating market competition, biosimilars drive the market to seek higher-quality biologics with value-added features through innovative use of science and technology.
\n","showOnHomepage":true,"author":{"title":"Kyung-Ah Kim, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Samsung_Bioepis_Logo.jpg","mediaDetails":{"height":627,"width":1200}}},"authorFields":{"title":"Executive Vice President and Leader of the Development Division","linkedin":"https://www.linkedin.com/in/kyung-ah-kim-b539954/","email":null,"company":{"title":"Samsung Bioepis"}}}},{"answer":"Undoubtedly, the microbiome space promises the next generation of novel therapeutic targets and treatment modalities. Microbiome-modulating therapies for C. difficile infections have made the news lately, but targets across psychiatric, cardiovascular, and metabolic health have also seen an uptick in mechanistic insights.
\nAt Seed Health, we’re working to realize the potential of microbes to steward the future of microbial intervention for both consumer probiotics and therapeutics. One area ripe for innovation is irritable bowel syndrome (IBS), a chronic disorder that impacts millions. While some aspects can be treated pharmacologically, treatment for many symptoms are limited to experimental dietary and lifestyle recommendations. Recently, the U.S. FDA authorized an IND to evaluate the impact of DS-01™ — our multi-strain 2-in-1 probiotic and prebiotic — on the gut microbiota of patients with IBS.
\nAnother is vaginal health. While UTIs continue to impact millions of women worldwide, antibiotics are currently the only frontline treatment — despite the alarming rise in antibiotic resistance, infection recurrence, and patient side effects. Emerging from 15 years of research, our partner company, LUCA Biologics, develops living medicines targeting the vaginal microbiome for urogenital and reproductive health.
\nThe final is mental well-being. The gut microbiome has emerged as one of the critical regulators of brain function, but existing treatments in mental health do not yet consider or target the underlying role of the gut microbiome. While research is still underway, the potential to modulate the gut microbiota for neuropsychiatric health could unlock a promising future for the millions who experience and suffer from these conditions.
\n","showOnHomepage":true,"author":{"title":"Dirk Gevers, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/SeedHealth_Green_Logo-scaled.jpg","mediaDetails":{"height":1341,"width":2560}}},"authorFields":{"title":"Chief Scientific Officer","linkedin":"https://www.linkedin.com/in/dirkgevers/","email":"seed@consortpartners.com","company":{"title":"Seed Health"}}}},{"answer":"The autoimmune disease space will see significant advancements due to the need for more tolerable and effective treatment options that mitigate unwanted immune responses. Autoimmune diseases afflict ~4.5% of the world population and more than 24 million people in the United States. The current standard of care is broad immunosuppression, which is often associated with side effects and leaves patients vulnerable to serious infection and malignancies. Targeted immune tolerance to autoantigens would provide a transformative solution for patients without the risks associated with immunosuppression. IL-2 therapies have gained traction due to their expansion of regulatory T (Treg) cells. Selecta’s approach co-administers IL-2 with our precision immune tolerance platform ImmTOR® (ImmTOR-ILTM). Not only does this approach expand Treg cells via IL-2, but the addition of ImmTOR® increases the magnitude and durability of antigen-specific Treg cells, providing targeted immune tolerance to autoantigens and avoiding chronic and systemic immune suppression. We are investigating ImmTOR® in primary biliary cholangitis (PBC), a chronic, progressive liver disorder where the immune system mistakenly attacks tissue in the liver, causing inflammation, damage, and scarring of the small bile ducts. Treatments to help slow progression and prevent complications are available. However, they ultimately fail to control PBC, and patients require a liver transplant. Co-administration of ImmTOR® with PDC-E2, the autoantigen implicated in PBC, has the potential to restore antigen-specific immune tolerance in the liver to directly address the precise cause and prevent liver transplant. Through ImmTOR®-driven antigen-specific immune tolerance, we have the potential to provide a true innovative solution for autoimmune disease.
\n","showOnHomepage":true,"author":{"title":"Carsten Brunn, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Brunn_Selecta.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/carsten-brunn-a8b287a","email":null,"company":{"title":"Selecta Biosciences"}}}},{"answer":"The biopharma industry has always been one to push the envelope of better treatment options. Without innovation, modern medicine and patient care would remain stagnant to classic modalities that often leave much room for improvement. A prime example of this is the treatment for type 1 diabetes. Since the discovery of insulin in the early 20th century, little has been done to alter the way we treat diabetes to provide a significant improvement in quality of life and disease outcomes. Patients are reliant on multiple insulin injections daily, followed by repeated blood glucose checks to ensure that their blood sugar is in an acceptable range, and still the long-term prognosis for these people is poor.
\nAt Sernova, we saw this unmet need and sought to develop a “functional cure” for insulin-dependent diabetes. We designed our Cell Pouch SystemTM, a small, implantable medical device with immune-protected therapeutic cells placed deep under the skin to create a vascularized, organ-like environment for new insulin-producing cells to produce insulin naturally as required, without the need for injections. To solve the limitation of donor islets used in our first clinical trials, which have already shown encouraging initial results, we partnered with Evotec to obtain a virtually unlimited supply of insulin-producing, ethically derived induced pluripotent stem cells (iPSCs), allowing us to potentially treat millions of people with insulin-dependent diabetes. As the cell therapeutics field evolves, I believe that we will see these treatment innovations leading to “functional cures” for a multitude of chronic diseases.
\n","showOnHomepage":true,"author":{"title":"Philip M. Toleikis, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Sernova_corp_logo.jpg","mediaDetails":{"height":822,"width":1300}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/dr-philip-toleikis-085151a","email":null,"company":{"title":"Sernova"}}}},{"answer":"A rare disease often takes years and a highly innovative clinician to diagnose. Most clinicians are evaluating a symptom or symptom cluster based on their clinical education, patient population, and pharmaceutical education. If these mechanisms for diagnosing a rare disease are all there is, medical progress is stymied. Clinical education does not generally focus on the “rare” diagnosis, but the “most likely.” A clinician’s patient population likely cannot inform a “rare” diagnosis. Pharma education is not sufficient. Less than 10% of known rare disease have an approved treatment.
\nWith molecular diagnostics, it’s reasonable to expect valuable information from a molecular test result. But molecular testing is still not mainstream, and clinician ordering behavior varies widely. A multi-national study on molecular diagnostic uptake in oncology found, “across countries and cancer types, uptake rates for molecular testing ranged between two percent and 98 percent.” If molecular testing is not better adopted in oncology, we have very little innovation that can take place for rare diseases.
\nWe need innovation to remove barriers to clinicians ordering molecular diagnostics from a clinical, operational, and financial perspective, paired with new solutions to support data-based decision making when a molecular diagnostic test result is received. The ability to find the smallest populations with rare disease requires automation, deep data, and simple-to-consume clinical hypothesis generation and, more importantly, corporate collaborations around innovation.
\n","showOnHomepage":true,"author":{"title":"Carla Balch","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Balch_Spesana.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/carla-balch-hates-cancer/","email":null,"company":{"title":"Spesana"}}}},{"answer":"Addressing cancer treatment resistance is a major hurdle in the development of current therapies. Over the course of a patient’s life, most cancers will develop mutations that are resistant to treatment, rendering current therapies ineffective and leaving patients with little to no options. These mutations can present a “whack-a-mole” problem, as new mutations crop up in response to each line of targeted therapy. I am hopeful that researchers will prioritize the development of effective treatments that tackle treatment resistance by targeting both cancer-causing and resistance mutations that arise.
\nGastrointestinal tumors (GIST) represent a perfect example — it is an area of high unmet medical need largely driven by known mutations in a single protein called KIT. Even though we know how this cancer tends to mutate in response to each successive line of targeted therapy, there isn’t yet a drug that effectively addresses GIST in the face of all possible mutations that can emerge. Therefore, patients often progress through successive lines of treatment as their cancer develops resistance to each line until they run out of targeted treatment options. We see this phenomenon in other cancers as well, including in subsets of non-small cell lung cancer (NSCLC).
\nAt Theseus Pharmaceuticals, we aim to outsmart treatment resistance in these cancers by developing small molecule “pan-variant inhibitor” therapies that successfully target cancer cells in the face of any cancer-causing and resistance mutations with a single agent. We believe that effective drugs in this space must be rationally designed to be effective against all known mutations instead of attacking only a few mutations at a time.
\n","showOnHomepage":true,"author":{"title":"Tim Clackson, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Theseus_Pharmaceuticals_Logo.jpg","mediaDetails":{"height":201,"width":600}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/tim-clackson-8579b96","email":null,"company":{"title":"Theseus Pharmaceuticals"}}}},{"answer":"The orphan space represents significant future growth for the pharma industry. Recent data show that more than 50% of drugs approved by the U.S. FDA in the last two years are used to treat rare diseases. Univar Solutions supports the rare disease sector no differently than we support organizations focused on treating common illnesses.
\nRegarding unmet medical needs, it seems that biopharmaceuticals can’t reach the market fast enough, because many ingredients and excipients used in these applications haven’t been qualified yet. Suppliers that produce these ingredients and excipients are working to expand and accelerate the qualification of their biopharmaceutical ingredient and excipients portfolios. We need to give the medical community access to more excipients and ingredients to accelerate biopharmaceutical production and work with governing bodies to support this cause.
\nAs these organizations reach commercialization, we work closely alongside them, sourcing the specialty excipients and ingredients that they require to bring products to market, including offering support with inventory planning and supply chain risk mitigation. As a value-added partner, there are instances where we have invested in our infrastructure to accommodate the unique ingredient handling needs that our customers in the orphan space have in order to do our part to help keep communities healthy.
\n","showOnHomepage":true,"author":{"title":"James Peterson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Peterson_Univar_Solutions.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Vice President, Pharmaceutical Ingredients","linkedin":"https://www.linkedin.com/in/james-paterson/8597b749/","email":null,"company":{"title":"Univar"}}}},{"answer":"A new generation of product modalities is being developed for the treatment of cancers, genetic diseases, neural degeneration diseases, and emerging infectious diseases. These modalities include monoclonal antibodies, antibody–drug conjugates, bispecific or multispecific antibodies, CAR-T cell therapies, and gene therapies, including mRNA. While more and more antibody-based molecules have been used for treating blood and solid cancers, new CAR-T cell therapies have recently been approved for rare blood cancer treatment. Gene therapies are being developed for the treatment of orphan diseases due to genetic defects that deliver certain genes into the cells via viral vectors, and vaccines act by delivering mRNA encapsulated by lipid nanoparticles (LNP-mRNA), which produce certain proteins, into the body. With the recent broad successes in using adenovirus vectors and LNP-mRNA encoding a subunit of the SARS-CoV-2 virus for the development of vaccines against COVID-19, now used globally, these innovations are now being adopted to develop both prophylactic and therapeutic treatments for other infectious diseases, rare diseases, and cancers. Manufacturing this new generation of complex product modalities requires innovative bioprocessing technology platforms. The biopharmaceutical industry needs to further rise to meet these new challenges in developing comprehensive manufacturing technologies to produce these therapeutics and vaccines faster and more cost-effectively than thought possible just a couple of years ago.
\n","showOnHomepage":true,"author":{"title":"Weichang Zhou, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/7050.gif","mediaDetails":{"height":84,"width":137}}},"authorFields":{"title":"Chief Technology Officer and Executive Vice President","linkedin":"https://www.linkedin.com/in/weichang-zhou-93574430/","email":"weichang_zhou@wuxibiologics.com","company":{"title":"WuXi Biologics"}}}},{"answer":"There is an exciting and growing clinical pipeline of rare disease drugs, with more than 700 candidates in development for a broad range of diseases, including rare cancers and autoimmune, infectious, and neurologic diseases, among many others. Disease selection for rare disease drug development is informed by the unmet need, with priorities in many cases given to diseases with the most severe presentation or highest prevalence. However, the key and most relevant aspect is disease knowledge. As such, the largest treatment innovations will most likely continue to be for those rare diseases where we have gained the most understanding of the underlying cause of disease, which will enable the screening and development of novel drugs that tackle the specific pathways to provide disease-modifying treatments versus tackling symptoms individually. Luckily, advances in genomics and technological tools are speeding up our understanding of the genetic factors of these diseases. At X4, our lead drug candidate, for instance, could potentially be the first disease-modifying treatment for the rare immunodeficiency WHIM syndrome, which typically results from mutations in a gene called CXCR4 that is involved in healthy maturation and trafficking of white blood cells. In parallel to our regulatory pathway, with anticipated phase III data in the fourth quarter of 2022, we continue to prioritize novel research to better elucidate genetic variants associated with the disease to increase our ability to identify undiagnosed patients and explore new rare disease indications that could benefit from mavorixafor’s mechanism of action. In addition to treatment innovation, I anticipate that there will be an increasing effort by biopharmaceutical industries to access the large undiagnosed rare disease population that could benefit from promising treatments.
\n","showOnHomepage":true,"author":{"title":"Paula Ragan, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Ragan_X4_Pharmaceuticals.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Chief Executive Officer and President","linkedin":"https://www.linkedin.com/in/paula-ragan-ph-d-a4111a2/","email":null,"company":{"title":"X4 Pharmaceuticals"}}}},{"answer":"There have been significant advancements in nucleic acid–based therapeutics, including mRNA-based COVID-19 vaccines and AAV-based gene therapies for rare diseases. This has resulted in interest in other nucleic acid delivery modalities, which have advantages over RNA and viral approaches. This era of non-viral DNA-delivered therapeutics has the potential to allow for gene therapies to be developed for diseases that affect larger patient populations.
\nAt Xalud, we’ve developed XT-150, a locally injectable plasmid DNA (pDNA) gene therapy that expresses IL-10v, a proprietary version of the cytokine IL-10. XT-150 enables the body to supplement IL-10 locally at the site of inflammation and break the proinflammatory cycle. In addition, since XT-150 uses pDNA delivery, it doesn’t have the safety issues that the viral approach has presented, such as genomic integration and immune response. Xalud has a robust pipeline across multiple inflammatory and neurological indications, with a lead program in osteoarthritis of the knee in phase IIb. In multiple clinical studies completed to date, XT-150 has demonstrated durable efficacy, no dosing restrictions, and a highly favorable safety profile.
\nIn the years ahead, we believe that through non-viral approaches, gene therapy will continue to expand beyond rare monogenic conditions to highly prevalent diseases that affect tens of millions of patients, with the hope of providing new treatment modalities for them globally.
\n","showOnHomepage":true,"author":{"title":"Diem Nguyen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Xalud_therapeutics_logo.png","mediaDetails":{"height":538,"width":1000}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/diem-nguyen-11a3702/","email":null,"company":{"title":"Xalud Therapeutics"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-what-do-you-consider-the-biggest-challenge-that-the-pharma-biopharma-industry-currently-faces/","uri":"/roundtable/articles-what-do-you-consider-the-biggest-challenge-that-the-pharma-biopharma-industry-currently-faces/","slug":"articles-what-do-you-consider-the-biggest-challenge-that-the-pharma-biopharma-industry-currently-faces","title":"What do you consider the biggest challenge that the pharma/biopharma industry currently faces?","roundtable":{"topic":"Challenges","question":"What do you consider the biggest challenge that the pharma/biopharma industry currently faces?","roundtable":[{"answer":"A big challenge is addressing the development and manufacturing of advanced therapies. Pipelines of cell and gene therapies are increasing, and their complexity demands new methods and real-time analytics for process efficiency and predictability. An end-to-end connected bioprocess is required, which is a key component of Biopharma 4.0. All systems and equipment need to be connected digitally to run, control, and improve the process via feedback loops and machine learning / artificial intelligence. Our challenge is to put these technologies in place now to keep up with demand and to be ready as U.S. FDA guidelines turn into regulations.
\n","showOnHomepage":true,"author":{"title":"Kevin J. Knopp, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_J_Knopp_908_Devices.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/kjknopp","email":null,"company":{"title":"908 Devices"}}}},{"answer":"One of the biggest challenges that our industry faces is with the supply chain. This issue has been exacerbated by the COVID-19 pandemic as well.
\nThe longer it takes to get supplies to develop pharmaceuticals, the longer it takes to bring a product to market. For developers and pharma companies, this can mean the difference between being first to market or coming out behind other established products, risking the loss of permanent market share that the company needs.
\nWhen you work with CDMOs with a global network, like AGC Biologics, we have extensive material sourcing resources, effective bargaining power, and a worldwide inventory of supplies to leverage. These characteristics provide us with the flexibility and power to develop and manufacture your product — even during a pandemic-induced supply shortage.
\nOne thing that we are very proud of at AGC Biologics is our ability to address our clients’ needs. It is this knowledge and experience with managing challenges that enable us to resolve any issues during the development and manufacturing process and meet important clinical and commercial deadlines.
\n","showOnHomepage":true,"author":{"title":"Andrea C. Porchia, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/agc-biologics-logo-md.png","mediaDetails":{"height":95,"width":466}}},"authorFields":{"title":"General Manager of AGC Biologics’ Copenhagen Facility","linkedin":"https://www.linkedin.com/in/andrea-porchia-3884955","email":"acp@agcbio.com","company":{"title":"AGC Biologics"}}}},{"answer":"Decreasing the cost of bringing new biologic entities (NBEs) to market and improving R&D cycle times remain the biggest challenges in the industry. Right now, that cost stands at $2 billion per NBE and an average of seven years of development. To drive a more productive future for R&D with more equitable and quick access to new therapies, the industry should continue to nurture collaborative work, expanded use of novel analytical tools, wider adoption of digital technologies, and streamlining of drug development protocols.
\n","showOnHomepage":true,"author":{"title":"Sergey Vlasenko, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Vlasenko_Agilent.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Associate Vice President Pharma and Biopharma End Markets","linkedin":"https://www.linkedin.com/in/sergey-vlasenko-645a477/","email":null,"company":{"title":"Agilent Technologies, Inc"}}}},{"answer":"The COVID-19 pandemic disrupted supply chains worldwide, with cascading impacts that led to global shortages of goods and materials. Pharmaceutical shortages — especially for compounds classified as “essential medicines” — became perhaps the most pressing and urgent challenge to solve, with the lack of critical medicines disproportionately affecting the world’s most vulnerable populations.
\nPharma has long needed new, agile manufacturing technologies and methods to overcome medicine shortages, respond to sudden spikes in demand, and address long-term sustainability concerns. While the broader pharma industry has tried to optimize supply chains to cut costs and make production lines viable, it has relied on legacy technologies for many decades and has been slow to embrace new production approaches. This is particularly evident in the case of plant-based medicines, which rely on traditional agricultural cultivation and are therefore vulnerable to variables such as climate events, pest and disease issues, soil health, geopolitical crises, and more. As a result, many active pharmaceutical ingredients (APIs) — and the common and essential medicines they’re used to produce — have a fragile supply chain that is unpredictable, inefficient, and expensive.
\nThanks to new advancements in biomanufacturing and synthetic biology, what typically takes years and happens almost exclusively outside of the United States can now be done on demand in weeks, at a lower cost, and domestically. We now have the ability to transform the pharma supply chain and overcome one of pharma’s most pressing challenges to provide patients and doctors with essential medicines when and where they’re needed.
\n","showOnHomepage":true,"author":{"title":"Christina Smolke, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Antheia_Bio_Logo.png","mediaDetails":{"height":119,"width":505}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/christina-smolke-87a8b3b6/","email":"christina@antheia.bio","company":{"title":"Antheia"}}}},{"answer":"Currently, the pharma/biotech industry is facing challenges in the capital markets due to the undervaluing of companies. Fortunately, with time, the capital markets will ultimately correct themselves, and funding will continue for companies with innovative medicines to treat unmet medical needs; however, an even greater challenge is standing out among the competition in an already crowded market. A key differentiator for successful companies will be their ability to deliver truly transformative medicines. Developing drugs that work will not be enough to set companies apart. The therapies need to improve the patient’s health and be simple and convenient to administer. For example, wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) patients require an injection into the eye every 6–8 weeks, administered in a doctor’s office, to prevent disease progression and blindness. For patients, an injection into the eye is not only uncomfortable but also requires time or another person to provide transportation to and from the appointment, which can be a burden.
\nAt Ashvattha Therapeutics, our approach is to not only focus on making precision medicine more precise but also be a disruptive treatment for diseases with a high patient burden. Our clinical candidate designed to treat wet-AMD and DME, D-4517.2, stands to relieve patients of this uncomfortable injection directly in the eye by providing a once per month subcutaneous injection, similar to insulin injections, that patients can self-administer in the comfort of their home.
\n","showOnHomepage":true,"author":{"title":"Jeff Cleland, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Ashvattha_therapeutics_logo.jpg","mediaDetails":{"height":627,"width":1200}}},"authorFields":{"title":"Chief Executive Officer, President, and Chairman","linkedin":"https://www.linkedin.com/in/jeffrey-cleland-633574/","email":null,"company":{"title":"Ashvattha Therapeutics"}}}},{"answer":"The industry needs to address the issues around sustainability, resource management, process design, and process efficiency, which will become increasingly important. The challenges observed with the availability of critical components for up and downstream manufacturing, particularly disposable plastics, must be considered when designing new pharma processes, from discovery through clinical and beyond.
\n","showOnHomepage":true,"author":{"title":"Ian Scanlon","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Astrea_Bioseparations_LOGO.jpg","mediaDetails":{"height":524,"width":1000}}},"authorFields":{"title":"Subject Matter Expert","linkedin":"https://www.linkedin.com/in/ian-scanlon-9327145/","email":"i.scanlon@astrea-bio.com","company":{"title":"Astrea Bioseparations"}}}},{"answer":"A clear challenge of the pharmaceutical industry has been highlighted by the recent pandemic, and that is the overreliance on single-sourced materials and vulnerabilities within the global supply chain. Like any other manufactured product, pharma and biopharma products are a sum of the parts, and missing any one individual component can ultimately lead to a critical drug shortage. However, what is unique to the pharmaceutical industry is the exceptionally high quality and regulatory standards. Therefore, a system built for the health and safety of patients can unfortunately make it challenging to quickly substitute missing ingredients, alter a process, or change manufacturing sites. Consequently, building up resilience and redundancy into supply chains, as well as a pivot to reliability over cost (including onshoring) of pharmaceutical manufacturing, will rapidly become a key focus and a perhaps the biggest short-term challenge of the industry. Building further upon this, many ingredients utilized in the rapidly expanding biopharma space are single-sourced, not necessarily made to cGMP standards, and not entirely fit-for-purpose. This leaves an enormous challenge of ensuring reliable supply for dozens if not hundreds of components, and therefore perhaps an order of magnitude more complicated than historical small molecule drug sourcing. Thus, the challenge of building and launching innovative treatments will be only as good as our ability to build redundancy and reliability into the ingredient supply for the patients that ultimately depend on them.
\n","showOnHomepage":true,"author":{"title":"Frank Romanski, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Dr. Frank Romanski_BASF_Corp_web.png","mediaDetails":{"height":263,"width":211}}},"authorFields":{"title":"Global Technical Marketing Manager, Pharma Solutions","linkedin":"https://www.linkedin.com/in/frank-romanski-ph-d-1a480542/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Healthcare inequity. If you look at a map of the United States and ask where high-quality healthcare is accessible to the broadest populations, the U.S. looks like a checkerboard, with vast “healthcare deserts” and millions located many miles from the care that those in more affluent areas often enjoy. This is not a failure of medicine but a failure of business model. Centralized care, where testing is available often in brick-and-mortar locations (doctor’s offices, hospitals, pharmacies, etc.) requires that people come to the care rather than the care coming to the people. For a mom who cannot get childcare, a veteran who can’t come into a VA hospital, or a college student who is too embarrassed or afraid to come into a student health clinic for testing, this “last mile” challenge creates real barriers to high-quality care delivery and outcomes. There is no shortage of great (awe-inspiring) technologies on the market. Looking at “how” care is delivered is as critical to healthcare equity as “what” care is delivered. This will be critical to ensuring access to reaching the many underserved today.
\n","showOnHomepage":true,"author":{"title":"Jeff Luber","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Binx_Health_Logo.jpg","mediaDetails":{"height":497,"width":950}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jeffrey-r-luber-2003154/","email":"jeff.luber@mybinxhealth.com","company":{"title":"Binx Health"}}}},{"answer":"The current global supply chain issues are an unresolved challenge for the pharmaceutical industry. The pandemic has put stress on the supply chain and manufacturing, forcing the adoption of new technologies, regardless of the regulatory burden that this implies. Although the concept of portable, continuous, miniature, and modular manufacturing units has become a reality, it is not yet accessible across the pharmaceutical and biopharmaceutical ecosystem.
\nBruker has joined forces with NovAliX, Alysophil, and Dedietrich Process Systems to bring to market a new approach to active pharmaceutical ingredient (API) production. The partnership aims to provide a complete, standalone, and location-independent API manufacturing solution to a pharmaceutical company or contract manufacturing organization. The partnership will leverage combination breakthrough synthesis, continuous flow chemistry, and in-flow analysis with artificial intelligence to create this next-generation, autonomous, and optimal production unit.
\n","showOnHomepage":true,"author":{"title":"Anna Codina, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Brukerlogo.svg","mediaDetails":{"height":0,"width":0}}},"authorFields":{"title":"Director, Pharmaceutical Business Unit","linkedin":"https://www.linkedin.com/in/anna-codina-5041b21b/","email":"Anna.Codina@bruker.com","company":{"title":"Bruker Daltonics"}}}},{"answer":"Unfortunately, there are multiple manufacturing bottlenecks that create a major obstacle for development across the entire field. First, there’s a major talent crunch in the pharmaceutical and biotech world; the demand for skilled labor far outpaces supply everywhere. As the industry progresses, and more therapeutics are U.S. FDA–approved for larger patient populations, the need for larger manufacturing teams of highly skilled professionals becomes even more acute. It can take months to identify and hire the right personnel, and then up to nine months to train someone on GMP manufacturing processes, but unfortunately the average employee retention is only a year and a half.
\nThis is very inefficient and a major pain point for cell therapy manufacturers. The introduction of automated technologies, like the Cell Shuttle, will allow smaller teams to manufacture more products. Particularly in cell and gene therapy manufacturing, labor is a major contributor to the manufacturing cost per dose. It's widely acknowledged that cell therapy manufacturing is a lengthy, time-consuming, and expensive process. Current processes require teams of highly trained professionals spending weeks in expensive cleanrooms, executing on the order of 50 manual processing steps on a plethora of benchtop instruments — all to produce one therapy for one patient at a time.
\nAdditionally, human error invariably leads to manufacturing issues. Some manufacturers have reported process failure rates of up to 18%. The introduction of true end-to-end automation will help accelerate and improve cell therapy manufacturing and alleviate the shortage of qualified personnel.
\n","showOnHomepage":true,"author":{"title":"Fabian Gerlinghaus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/F_Gerlinghaus_Cellares.png","mediaDetails":{"height":287,"width":211}}},"authorFields":{"title":"Co-founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/fabian-gerlinghaus/","email":null,"company":{"title":"Cellares"}}}},{"answer":"Developing novel therapies and bringing them to physicians and patients is a long and difficult process. Drug development remains one of the highest-risk processes within the life sciences industry, with approximately 10–15 years of clinical work necessary to bring a compound from discovery to patients, and with most therapies never making it through development due to lack of efficacy / tolerability issues. Diseases related to neurodegeneration and psychiatric disorders bring another level of challenge for scientists, given the complexity of the brain.
\nHistorically, most scientific and technological approaches have lacked the specificity and precision with which to identify and validate new targets to develop therapies to alleviate symptoms or treat neurodegenerative disorders. The current standard for drug development for central nervous system (CNS) or neurodegenerative disorders has been to utilize mouse models; however, because of the brain’s complexity, this approach has significant shortcomings. Additionally, because the pathophysiology for many CNS disorders remains unknown, drug development is a lengthy and costly process that is accompanied by a high degree of uncertainty that drugs in development will succeed. At Cerevance, we are focused on tackling these shortcomings and are using postmortem brain tissue combined with machine learning to discover key biomarkers that play an influential role in neurological disease progression and the specific brain circuits and/or cells that are disrupted by neurological disease.
\nTo foster new and interruptive methods for treating neurodegenerative diseases, it is critical that more precise, highly specific means be implemented while placing a greater emphasis on the utilization of human data.
\n","showOnHomepage":true,"author":{"title":"Craig Thompson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/cerevance_logo_rgb.png","mediaDetails":{"height":301,"width":2251}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/craig-thompson-nd/","email":null,"company":{"title":"Cerevance"}}}},{"answer":"The discovery of new therapies is hugely expensive, with cost estimates ranging from $2–4 billion. The economics of pharma and biotech is placing the discovery of new drugs under enormous strain, which represents a significant and immediate challenge. This has been brought into focus by the debate around antibacterial drugs. It is readily accepted that the absence of new antibiotics will turn routine infections and operations into life-threatening conditions. Despite this, few new antibiotics have reached patients in the last decade, and the primary reason is the uncertainty over recouping research and development costs. Even the advent of precision medicine, hailed by many as a huge advance for previously untreatable conditions, is challenging the economics of pharma and biotech. Therapies can require expensive and complex cell manipulations for the treatment of, in extreme cases, a single patient. The onus is on pharma and biotech to reduce the costs of discovery and development of new therapies, where efficacy and safety are still the biggest reasons for clinical attrition. Big data, machine learning, and artificial intelligence promise much in identifying optimal disease intervention points and pressure testing biochemical pathways from a safety perspective to drive down attrition rates and hence reduce costs. Identifying cheaper and scalable manufacturing processes is also key to democratising healthcare. The onus is on pharma and biotech to become more efficient and reduce costs by the adoption of new technologies and ideas rather than demanding that individuals, insurance, and healthcare providers pay more and more to access treatments.
\n","showOnHomepage":true,"author":{"title":"Justin Bryans, DPhil FRSC CChem","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/138.gif","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Chief Scientific Officer (Early Discovery)","linkedin":"https://www.linkedin.com/in/justin-bryans-91a31b4/","email":"justin.bryans@crl.com","company":{"title":"Stilmas"}}}},{"answer":"Diverse patient populations, whether defined by race, ethnicity, gender, geography, or socioeconomic factors, have historically been underrecruited in clinical trials — an issue that is currently top of mind for the pharma and biopharma industry. This is a multifactorial issue that can be driven by proximity to trial sites, cultural preferences, health literacy, language barriers, income, access to transportation, or ability to take time from work to receive care. While past approaches using traditional clinical trial sites yield predictable results, they also yield low recruitment of diverse patient populations. The industry needs new approaches, using real-world data and advanced analytics, to locate and engage with underrepresented patient populations.
\nClinical trials are the evidence that a drug will be effective and safe in a patient population. Given the diversity of the U.S. population, it’s important that clinical trials demonstrate the same clinical endpoints across an equally diverse study population. In addition, as pragmatic clinical trials look beyond the science of the drug into the effectiveness of how therapies are delivered, it’s equally important to look at the drivers of healthcare disparities and identify opportunities to address them to truly move the needle toward more diverse recruitment in clinical trials.
\n","showOnHomepage":true,"author":{"title":"Kenneth Park, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Clarify_Health_Logo_2022.png","mediaDetails":{"height":271,"width":1000}}},"authorFields":{"title":"Senior Vice President and General Manager of Life Sciences","linkedin":"https://www.linkedin.com/in/kenneth-park-2aa8b01/","email":"clarifyhealth@pancomm.com","company":{"title":"Clarify Health"}}}},{"answer":"The pipeline of biomedical innovations has been exceptionally strong across many diseases. However, lower clinical trial access to patients, the pandemic further diminishing patient participation and new study starts, limited research infrastructure and budgets at healthcare providers, and rather burdensome legacy trial technologies have reduced the throughput potential for these innovations. These inefficiencies are, in part, increasing the cost of new medicines and lowering the pace of patient access to the latest innovations. Looking ahead, we have the tools for a better way of operating. Providers at the community and regional health levels are eager for new ways of working and supporting efficient research operations. While some of the new AI digital solutions for patient matching to trials, decentralized solutions, and digital integrated solutions lack certain functionalities of legacy systems, they offer performance, acceleration, and cost advantages unachievable by these older technologies. As the pipeline accelerates, evidence is generated more rapidly, value will improve, and outcomes benefits will accelerate. So, to the spirit of the question, this presents the biggest challenge and the highest promise.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"Healthcare is generally a reactive field, rather than a proactive one, and that tends to drive thinking in biopharma as well. This plays out as a focus on treatment over prevention, effectively engineering fixes instead of preventing problems.
\nThere’s a paradigm shift underway, though, fueled by new technology. Many see opportunities for early intervention for better living, saving lives, and preventing problems.
\nIn the cell therapy manufacturing space, we’ve seen how this thinking has led to real challenges. In the decade since the first cell therapy clinical trials began curing patients, the main approach to scaling up for patients has been to focus on scaling up patient cells ex vivo. To do so, myriad engineering steps have been tested and employed, with the goal of producing enough therapeutic cells after the fact, with mixed results.
\nAccumulating data suggests that younger cells can be more potent than engineered cell populations that have been expanded over the course of weeks. New technologies like microfluidics will change this landscape altogether, by capturing greater numbers of more-potent naive cells from patients to be turned into medicines faster.
\nTime will tell if an approach like this will make the lengthy, manual, and burdensome expansion steps obsolete. But there’s clearly an urgent need for the entire industry to shift its mindset.
\n","showOnHomepage":true,"author":{"title":"Tony Ward","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Curate_biosciences_logo.png","mediaDetails":{"height":137,"width":369}}},"authorFields":{"title":"Chief Operating Officer and Chief Technology Officer","linkedin":"https://www.linkedin.com/in/tonyward2","email":"curatebiosciences@consortpartners.com","company":{"title":"Curate Biosciences"}}}},{"answer":"Cytiva has done some interesting research here — we surveyed hundreds of industry leaders for our Biopharma Resilience Index to find the top five areas of priority. They are supply chain, talent, strength of the R&D ecosystem, quality and agility in manufacturing processes, and government policy. The underlying challenge across these priorities is: how do we effectively harness digital and automated solutions?
\nAs our industry incorporates more digital and automated solutions, we have begun to generate and accumulate an enormous volume of process data, and we need to turn those data into decisions. To be useful, data need to come with context about what they describe and how events in upstream and downstream processes relate. Currently, data sets are being collected and stored in various databases or on the instrument itself. Moving the data to a central location will not solve the problem — data must be written in comparable formats with comparable context (i.e., written in the same “language”). Today, there is no such language common to suppliers, leaving our industry without interoperability between data sources.
\nThis interoperability would allow for “smart” suppliers and a “smart” supply chain. A smart supplier is one who understands that data, as assets, are supplied and consumed along the value chain alongside physical products. As such, smart suppliers create products that integrate into customers’ data systems, enabling suppliers and their customers to capture, curate, and harness those data for superior products, higher efficiencies, and reduced supply chain risk, all at lower overall costs.
\nThe push to create a “smart” bioprocessing ecosystem has been difficult because it requires a coordination of change — a kind of phase transition to a new way of working. It requires vendors to supply equipment and control systems that speak a common language, data systems that aggregate data and their context, and analytics that generate insight from it all. The good news is that the pace is quickening, with more companies building data capabilities and standards into their fundamental way of working.
\n","showOnHomepage":true,"author":{"title":"Emmanuel Ligner","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Cytiva_Transparent_Logo.png","mediaDetails":{"height":517,"width":545}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/emmanuel-ligner-967b9016/","email":"emmanuel.communications@cytiva.com","company":{"title":"Cytiva"}}}},{"answer":"The biggest challenge the pharma/biopharma industry currently faces is what we call the data–insight gap. The volume of human molecular data is growing exponentially, but our analytical capabilities are growing linearly, at best. The result: timely, expensive, and inefficient ways to develop drugs. At CytoReason, we develop computational disease models capable of digesting, organizing, and making sense of multiple data types and sources from multiple diseases and treatments. These disease models are created by leading biologists and bioinformaticians, and they are backed by top-tier publications with the latest omics data and cell-focused natural language processing. The data in the models is broken down by each disease indication, tissue type, patient population, and disease severity. Our artificial intelligence technology then turns this big data into useful, actionable insights, so that pharma companies can make drugs faster, more cheaply, and more efficiently. CytoReason is one of the few companies that provides a comprehensive map of human diseases. Our disease models allow for comparisons across treatments, patient groups, and disease mechanisms, using deep mRNA data. The insights give scientists a bird's-eye view of entire drug portfolios.
\n","showOnHomepage":true,"author":{"title":"David Harel","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/CytoReason_Logo.jpg","mediaDetails":{"height":675,"width":1055}}},"authorFields":{"title":"Co-Founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/dharel","email":null,"company":{"title":"CytoReason"}}}},{"answer":"The reliance on manual and siloed processes across all areas of drug development continues to hold the life sciences industry back. We have seen remarkable progress over the last two years in accelerating digital transformation in clinical development, but there remain significant opportunities to take the volumes of new data streams available in trials and turn them into insights and evidence about new therapies exponentially faster. The process of clinical development continues to be too slow and too costly to allow the industry and patients to fully benefit from the coming wave of immunotherapies that have the opportunity to transform human health. Adopting new technologies, digital trial models, and analytics and AI at scale to keep up with the scientific breakthroughs that are coming remains our biggest challenge.
\n","showOnHomepage":true,"author":{"title":"Raj Indupuri","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Indupuri_eClinicalSolutions.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/rajindupuri/","email":null,"company":{"title":"eClinical Solutions"}}}},{"answer":"Drug discovery, development, and clinical trials are more complex now than they have ever been before, ironically due to the innovations in characterizing biochemical, hormonal, and genomic factors that impact patient health. Patients are located around the globe, so data is cascading in from a variety of sources, including real-world evidence, wearables, imaging, biomarker labs, and electronic patient-reported outcomes (ePRO) / electronic clinical outcome assessment (eCOA). The technology used by the industry has not kept pace with the advancement of today’s modern world. Existing combined solutions are unable to meet the challenges and adjust to the dynamic world of decentralized trials (DCTs), digital transformation, and data science.
\nThe industry needs a single source of truth to analyze, process, and visualize data, in real-time, so that DCTs can run seamlessly and ensure clean, accurate data they can trust. One that can capture the range of different data types that are needed, whether that be from traditional sources or more innovative data points. Encapsia was designed with all this in mind, to help implement a single platform, offering all parties a holistic and real-time view of all their trial data, with visibility of trends across patients, sites, and trials.
\n","showOnHomepage":true,"author":{"title":"Temitope Keyes","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/encapsia_logo.png","mediaDetails":{"height":416,"width":1091}}},"authorFields":{"title":"Executive Director, Business Development","linkedin":"https://www.linkedin.com/in/temitopekeyes/","email":"tkeyes@cmedtechnology.com","company":{"title":"Encapsia"}}}},{"answer":"In an increasingly noisy digital environment, pharma companies face their biggest challenge in delivering the right message. Pharma companies need to reach the right clinician at the right time to impact point-of-care decisions that result in optimal patient outcomes. However, the speed of AI/ML, science, and drug discovery is rapidly increasing by the day, and clinicians are being inundated by the flow of information to their screens and inboxes. This creates a narrowing window of opportunity to craft the ideal engagement opportunity with clinicians. Pharma marketers have to determine how they can craft personalized campaigns that cut through the noise and information-overload facing clinicians.
\n","showOnHomepage":true,"author":{"title":"Matt Titus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Epocrates_logo.jpg","mediaDetails":{"height":250,"width":512}}},"authorFields":{"title":"Vice President and Chief Commercial Officer","linkedin":"https://www.linkedin.com/in/matt-titus-30b01b17/","email":"epocrates@pancomm.com","company":{"title":"epocrates"}}}},{"answer":"When considering the largest challenges faced by industry, it is first important to distinguish between large pharma and smaller companies. Small pharma and biotechs tend to be more comfortable with risks in developing innovative therapies, but the single greatest challenge facing small industry is an ongoing need to secure capital. This requires striking the right balance between risk and reward for investors. Higher-risk therapies require a large market size and patient need as well as likelihood of reimbursement to ensure that companies can provide a return to investors given the large risks they are taking.
\nIn many cases, this means an initial focus in disease areas that have validated targets and are well researched before securing funding to explore the use of therapies in these diseases. However, once the challenge is met in attracting investment to pursue the promise of a therapy, this opens greater opportunity for other indications to pursue that can benefit ever-broader patient populations.
\nWe are living this experience at EyePoint, where our experimental therapy is first undergoing clinical trials in wet age-related macular degeneration (wet AMD). We are then working to explore the treatment potential in several other eye disorders, including diabetic retinopathy, diabetic macular edema, and retinal vein occlusion. As we continue to instill confidence in the potential of our therapy, we are excited to potentially benefit a large number of patients with serious eye disorders.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"The industry is currently facing challenging market conditions. Securing the funding necessary to continue to develop and advance product candidates is more difficult in these circumstances. I have spoken to several other industry leaders who are feeling pressures around meeting their performance goals in this environment. It is a collective challenge under normal conditions but certainly exacerbated by these unprecedented market conditions across many companies of different sizes and stages.
\nAdditionally, we’re seeing ripple effects of the COVID-19 global pandemic and how companies have had to change their working models over the past 2+ years in ways they likely never imagined. And now we are all challenged on how practically to shift back to a semblance of original practices in a safe and efficient manner while maintaining elements of the alternative methods of conducting business that have emerged.
\nSupply chain issues remain challenging, and recovery and stabilization, I fear, are many years away. Many small companies have faced challenges like this before, but supply chain issues are affecting companies at large. Challenges are, in some ways, beneficial because they encourage you to consider different paths that you may not have thought about otherwise. In remaining flexible, you can find yourself in a unique situation that is sometimes better than your originally intended destination.
\n","showOnHomepage":true,"author":{"title":"Kathy Lee-Sepsick","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Femasys_logo.jpg","mediaDetails":{"height":222,"width":738}}},"authorFields":{"title":"Founder, Chief Executive Officer, and President","linkedin":"https://www.linkedin.com/in/kathy-lee-sepsick-6b680b7/","email":null,"company":{"title":"Femasys"}}}},{"answer":"The pharmaceutical industry is undergoing rapid changes due to the development of several technologies. The prominent trends include artificial intelligence (AI), automation, and other industry 4.0 technologies. GSK is investing in AI, also through external collaborations, with the aim of reducing the time and money needed to develop the medicines and vaccines of the future. Having the right talent with deep expertise across a number of relevant areas will continue to be a key factor in achieving these goals.
\nThere is also an opportunity to demonstrate the value of innovation in the pharma industry to the public and key decision makers. As the COVID-19 pandemic has shown, the public health impact of effective preventative and therapeutic solutions for infectious diseases is significant, yet the costs and lead times of developing those treatments can be further reduced. The emphasis on health resilience and the role that preventative care can play in improving health outcomes is likely to increase. For example, vaccination programs represent significant value for societies, as they typically have significant impact and are cost effective.
\nCompanies across all sectors are increasingly focused on optimizing the social and environmental impact of their operations. GSK set ambitious new environmental sustainability goals at the end of 2030 and has established an enterprise transformation program addressing climate, water, waste, and biodiversity across our operations.
\n","showOnHomepage":true,"author":{"title":"Jamila Louahed, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/GSK_logo.png","mediaDetails":{"height":480,"width":640}}},"authorFields":{"title":"Vice President, Head of Vaccines Global Research and Development, Belgium R&D Center","linkedin":"https://www.linkedin.com/in/jamila-louahed-6b225628","email":null,"company":{"title":"GSK"}}}},{"answer":"Currently, the high cost of advanced biotherapies reduces the size of the addressable target population. There are several challenges that must be overcome to bring biologic drugs to market. For instance, proteins and monoclonal antibodies are experiencing increasing pressure from drug pricing standards and patent cliffs, while cell and gene therapies often face scale-up challenges and industry-wide capacity restraints.
\nCell and gene therapies continue to fuel the biopharma pipeline. However, there are significant challenges pertaining to the inherent variability of cells, the personalization of drug therapies, and the broad range of technologies utilized. While CMC standards for cell and gene therapies are well-established for proteins and monoclonal antibodies, they are not yet befitting and pose a significant obstacle in obtaining biologics licensing applications (BLAs).
\nIn the Pharma Solutions division of IFF, we’re learning more about how our excipient expertise can add value to this burgeoning space. Backed by decades of expertise in polymer design, we bring formulators and drug manufacturers solutions and expertise to navigate the current and future challenges — in small and large molecules — as well as in the biologic drug development space.
\n","showOnHomepage":true,"author":{"title":"Caroline Cooreman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Cooreman_Iff.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Business Development Manager, Biotechnology","linkedin":null,"email":null,"company":{"title":"IFF"}}}},{"answer":"There are numerous challenges that pharma/biopharma companies are facing and will continue to face going forward. They include supply chain and staffing issues, adapting to emerging technologies such as continuous manufacturing and 3D printing, and the knowledge gap that continues to widen related to material science and excipient technology in particular. With time, supply chain and staffing issues will resolve themselves. This should open numerous opportunities for renewed product development. Regarding new technologies, and continuous manufacturing specifically, implementing new equipment requires capital expenditures and an understanding of the differences between batch and continuous processing. With the various initiatives and opportunities, one challenge that continues to grow is the knowledge gap in material science and excipient technology, in part, due to fewer academic institutions performing research in the area of excipients. And, as excipients are critical to successful drug product development and manufacture, excipient knowledge is essential. Partnerships between drug product manufacturers and excipient suppliers, distributors included, help bridge the knowledge gap. Understanding excipient performance and the synergies that some excipient combinations create can enhance drug product quality and performance, leading to an effective therapy. This is true regardless of dosage form type and design or route of administration.
\n","showOnHomepage":true,"author":{"title":"Joseph Zeleznik","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/imcd-logo-colour-rgb-scaled.jpg","mediaDetails":{"height":764,"width":2560}}},"authorFields":{"title":"Technical Director, North America","linkedin":"https://www.linkedin.com/in/joe-zeleznik-1453576/","email":"joseph.zeleznik@imcdus.com","company":{"title":"IMCD"}}}},{"answer":"The pharma and biopharma industries’ biggest challenge is also one at the healthcare provider site level: technology needs to be an enabler that empowers the human worker and moves healthcare forward by making intuitive decisions automatically. Transforming the patient journey is the responsibility of the entire healthcare and life sciences ecosystem. Through modern technology and expertise, we are able to equip healthcare providers, clinical research coordinators, and care teams with access to AI-enhanced patient insights like never before.
\nThe key is that this information must be useful and presented at the right time and in the right format to streamline and accelerate complex clinical trial processes from feasibility to prescreening and connecting eligible patients to the trial that’s best for their unique situation. The response to this certainly should not be adding “more technology” without purpose. Instead, we must harmonize the data that we have, thoughtfully ensuring that users are augmented based on the information already at their disposal; taking waste out of healthcare and clinical trial processes; and delivering better outcomes that are more meaningful to patients, caregivers, and researchers.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"The lack of good new targets and new approaches to the biology of disease in a few major cases is a major challenge. Neurodegenerative disease is a great example, where it seems likely that the mechanisms that we have been targeting with considerable effort may not be the right ones; this work is challenged because our models of disease in most cases are quite poor. Another major area is around the age-related degeneration of lung function. Here, the lack of success I attribute more to lack of attention, say, as compared to cancer, as there is an order of magnitude fewer different cell types involved and the models are better; however, unlike cancer, where a handful of universal treatments seems less feasible, a handful of treatments for most of declining pulmonary function may be more achievable. Declining pulmonary function with age and exposures is of similar significance in morbidity and mortality to cancer as a whole, neurodegenerative conditions, and cardiovascular disease, so it's worth the continued effort.
\n","showOnHomepage":true,"author":{"title":"Alex Morgan, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Khosla_ventures_logo.png","mediaDetails":{"height":129,"width":389}}},"authorFields":{"title":"Partner","linkedin":"https://www.linkedin.com/in/genomicsdoc/","email":"alex@khoslaventures.com","company":{"title":"Khosla Ventures"}}}},{"answer":"Scalability is one of the biggest challenges facing the biopharma industry. My background in bioengineering taught me the importance of innovations that don’t solve just one problem but have the potential to solve many. Oftentimes, medical solutions such as autologous cell therapies and organ transplants are a one-to-one fix — one treatment is developed at a time for one patient. We need one-to-many solutions to more efficiently treat patients with life-threatening illnesses. Within the organ disease ecosystem, Satellite Bio is developing a regenerative solution that can turn a single organ into many Tissue Therapeutics with a minimally invasive procedure. And Satellite Bio is also scalable across disease spaces and implementation. While the company’s first product is aimed at treating chronic liver disease, it’s not limited to just one organ type; Satellite’s platform has the potential to explore the application of Tissue Therapeutics in other cell types. Satellite anticipates that the procedure for patients to receive SATs will be much less invasive than an organ transplant, accelerating the rate at which patients can receive treatment. Innovative, lifesaving, and scalable treatments are necessary and important to ensure that they are able to rapidly reach the hands of patients in need.
\n","showOnHomepage":true,"author":{"title":"Ling Wong, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Lightspeed_venture_partners_logo.png","mediaDetails":{"height":225,"width":225}}},"authorFields":{"title":"Senior Advisor to Lightspeed and General Partner and Founder at Highbury Group","linkedin":"https://www.linkedin.com/in/lingwong1/","email":"lightspeed@consortpartners.com","company":{"title":"Lightspeed Venture Partners"}}}},{"answer":"One of the main challenges we observe today is that the complexity of small molecules in the pipeline is increasing. Twenty years ago, a 3–5 step synthesis was considered the norm. In comparison, today it is not rare to have more than 20 steps during synthesis, including several advanced building blocks. This presents a supply chain challenge; each molecule requires a specific supply chain strategy including potential fallback scenarios. For our clients, partnering with experts in the field who can support beyond pure technical capabilities immensely helps navigate this landscape — this is especially true for small emerging biotech companies.
\nOf course, the COVID-19 crisis has been and still is a challenge to our supply chain. In the beginning of the pandemic, the focus was concentrated on the availability of personal protection equipment. Over time, it has shifted to the timely delivery of raw materials, especially from suppliers in Asia. One of the methods we’ve employed at Lonza is implementing a thorough tracking system for material supply that allows us to spot potential risks ahead of time and address them before they escalate.
\nLonza’s global small molecule network has multiple sites across three regions: the Americas, Europe, and Asia. This allows us to guarantee backup solutions from different continents and secure supply chains. Our fully integrated offering enables a simplified supply chain with shorter and accelerated timelines, spanning drug substance to drug product development and manufacturing, including particle engineering, solid-state services, and bioavailability enhancement.
\n","showOnHomepage":true,"author":{"title":"Silke Erbeck, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/45.gif","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Executive Director, Head of Supply Chain & Project Management","linkedin":"https://www.linkedin.com/in/silke-erbeck-606a39a2/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"High rates of clinical failure in late-stage drug development are a consequence of multiple factors; one of the more significant factors is the lack of effective translation of biology from preclinical (non-human) proof-of-concept testing to mirror the human condition. Metabolomics is the single, unique omic that is sufficiently phylogenetically conserved across species, providing the ideal platform for seamless translation of biology from preclinical model systems to humans. Inclusion of metabolomics to augment genomics and proteomics technologies will provide significant synergies in establishing molecular benchmarks of efficacy and have significant impact on new drugs under development.
\nMetabolomics, the large-scale study of all small molecules in a biological system, is the only omics technology that provides a complete current-state functional readout of a biological system. Metabolomics helps researchers see beyond the genetic variation of individuals, capturing the combined impact of genetic and external factors such as the effect of drugs, diet, lifestyle, and the microbiome on human health. By measuring thousands of discrete chemical signals that form biological pathways in the body, metabolomics can reveal important biomarkers, enabling a better understanding of a drug’s mechanism of action, pharmacodynamics, and safety profile, as well as individual responses to therapy, ultimately leading to better drug development and true precision medicine. Metabolomics both deconvolutes and enhances other omics technologies, ensuring that genomics and proteomics investments are fully captured.
\n","showOnHomepage":true,"author":{"title":"Rohan Hastie, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Metabolon-logo.png","mediaDetails":{"height":150,"width":800}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/rohan-ro-hastie-6b57764/","email":"ebamonti@metabolon.com","company":{"title":"Metabolon"}}}},{"answer":"While emerging biotechs face their own set of challenges, contract development and manufacturing organizations (CDMOs) are challenged with standardizing production for novel modalities such as cell and gene therapies (CGT), improving yield and scalability, and ensuring that processes follow current good manufacturing practices (cGMP) and regulatory standards.
\nThe U.S. FDA predicts that it will approve 10–20 CGT products per year by 2025. These innovative therapies offer the potential for one-time treatments to cure diseases and conditions that were historically untreatable. And what’s exciting is that CGT has just started on its industrialization journey, with plenty of opportunities to improve the efficiency and robustness of processes. For example, no template currently exists to produce these therapies. Manufacturers must carve out their own paths from development to production and approval. Our goal in product and technology innovation is to shorten the process of moving lifesaving therapies into the clinic and to patients faster. For instance, our VirusExpress™ lentiviral production platform increases dose yields and reduces process development time by approximately 40%.
\nAdditionally, the industry continues to work toward a fully automated Bioprocessing 4.0 for monoclonal antibody therapies. Our focus here over the past several years has made great strides in intensifying processes, developing and integrating software for automation and data retrieval, and incorporating real-time in-line testing. The next generation of processing will be an evolution that will afford manufactures more speed-to-market, facility flexibility, and cost savings.
\n","showOnHomepage":true,"author":{"title":"Andrew Bulpin, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Bulpin_MilliporeSigma.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Head of Process Solutions Strategic, Marketing and Innovation","linkedin":"https://www.linkedin.com/in/andrew-bulpin-49298b3","email":null,"company":{"title":"MilliporeSigma"}}}},{"answer":"Our mission is about more than just making medications. We’re working within, and striving to improve, the health system at large. We see the main challenges facing the industry as they relate to the mental health sector as separate but related pieces of the same issue. There is a huge need to better understand individual responses to novel mental health treatments that are validated through both appropriate biomarker analysis and an increase in the inclusion of diverse populations for which to develop new treatments.
\nPsychiatry, in particular, is an area long overdue for a paradigm shift. Unlike other therapeutic areas, there are currently no validated biomarkers for predicting, diagnosing, or assessing psychiatric treatments. We are working daily to address this disparity and hope to drive future innovation in this space. In addition to the need for a comprehensive set of psychiatric biomarkers, we must extend the diversity of the populations that we include in our trials evaluating new treatments, not only in mental health, but across the sector. There is a stark absence of differentiated treatments for diverse populations at present. A recent study from the University of Cincinnati has shown that two people receiving identical treatment for depression can have very different outcomes depending on their race, education level, and employment status. Although we have decades of evidence that gender, race, and other factors influence whether and how a patient is diagnosed and what treatment they receive, current treatment options for mental health largely remain a one-size fits all approach.
\n","showOnHomepage":true,"author":{"title":"Rob Barrow","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Barrow_MindMed.png","mediaDetails":{"height":279,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/robert-barrow-b50836a","email":null,"company":{"title":"MindMed"}}}},{"answer":"The cell and gene therapy revolution has begun, but clinical and regulatory roadblocks are preventing these treatments from quickly — and safely — reaching the hands of patients in a scalable manner. A handful of gene therapies have been approved for several orphan diseases, including Duchenne muscular dystrophy and sickle cell disease, and several approved cell therapies, such as chimeric antigen receptor (CAR)-T cell therapies, offer hope to cancer patients who have failed all other lines of treatment.
\nThis is only the first wave of cell and gene therapies — the U.S. FDA expects the majority of new drug approvals to be in this space over the coming years. But to reach that explosive growth, cell and gene therapy developers need to overcome clinical delays and regulatory holds that have been plaguing the field. Effectively scaling up the manufacturing and clinical testing of these treatments will require clear industry and regulatory standards on quality and safety.
\nRegulators, doctors, and patients need more comprehensive assessments to be assured that dangerous clones or infectious agents are not making their way into patients, that cells are being modified and edited consistently, and that the resulting cells are fit for purpose. Single-cell characterization at every step of the drug development process — from early-stage research, through the clinic, and to manufacturing — can provide a clear picture of what’s been modified within a cell, and whether those changes could cause any health concerns in patients.
\n","showOnHomepage":true,"author":{"title":"Todd Druley, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Mission_Bio_logo.png","mediaDetails":{"height":200,"width":300}}},"authorFields":{"title":"Chief Medical Officer","linkedin":"https://www.linkedin.com/in/todd-druley-md-phd-9ba85214/","email":"missionbio@consortpartners.com","company":{"title":"Mission Bio"}}}},{"answer":"Genomics’ role in the life science vision “is only as credible as its implementation,” as Sir Jonathon Symonds commented in a Public Policy Project panel. The 2021 UK Public Policy Projects Genomics Revolution report goes on to say that “the diversity of genomic data must be improved to avoid the risk of health data poverty, and by extension, health inequalities.”
\nWe agree that implementation matters. With the abundance of data now available to inform drug discovery and research decisions, our customers tell us that one of the biggest challenges that the industry is currently facing is what I like to refer to as “science friction.” Discovery and research productivity are seriously impeded by high-friction software tools and obstacles to data integration across both modalities and studies. This means that researchers are wrestling with the fundamentals of data storage, data formats, and data normalization, as well as grappling with different software packages and versions and struggling to run analytical tools at scale in a cost-effective way.
\nWe applaud the many global initiatives to increase diversity in population studies like 54gene and DNA do Brasil. With more representative data pools, projects like these will provide the data foundation to drive more effective personalized medicine treatments that will cut health outcome inequalities.
\nAs Professor John Quackenbush said: “technology is advancing at such a pace that today we can assemble datasets that give us a foothold in addressing questions that were unanswerable even two or three years ago.” Assembling new data sets addresses only half the challenge. Agile science platforms with integrative analytics and superior cloud economics are equally critical to reducing the science friction around leveraging data abundance and diversity.
\n","showOnHomepage":true,"author":{"title":"Marilyn Matz","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Matz_Paradigm4.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/marilynmatz/","email":null,"company":{"title":"Paradigm4"}}}},{"answer":"With the continued, increased prevalence of biologics and ATMP compounds, pharma and biopharma organizations face the challenge of expanded regulatory scrutiny and complex supply chain management. Regulators are in a precarious position to ensure that proper checks and balances are in place to guarantee product integrity and safety without compromising innovation and the speed of development. A collaborative approach to addressing the challenges among both regulatory bodies and clinical development organizations will be paramount to success.
\nInherently, more advanced therapeutic compounds come with more complex supply chain processes. Pharma organizations will need to manage supply extremely carefully, given that development costs continue to increase. It’s not unusual to see new drug batches with commercial values in the hundreds of millions of dollars. Ensuring accurate levels of supply to address patient forecasting and recruitment while staying within reasonable cost measures will be increasingly challenging. This is compounded by the difficult handling requirements of these compounds, such as cold and ultra-cold storage. In the current geopolitical climate, these difficulties are even more pronounced, with a reduced number of flights and shipping options, increased fuel costs, and overall inflation that is typically exceeding the standard producer price index (PPI). The challenge is not small, but success means bringing life-changing therapies to patients and changing millions of lives for the better.
\n","showOnHomepage":true,"author":{"title":"Craig LaMarca","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PCI_Pharma_logo.svg","mediaDetails":{"height":0,"width":0}}},"authorFields":{"title":"General Manager, Boston Clinical Trial Services","linkedin":"https://www.linkedin.com/in/craig-lamarca-b74413a/","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"Many industries have been adapting to digital transformation, and, for the pharma/biopharma space, it has become a necessity. The pandemic has forced most industries to evolve their remote or virtual work capabilities in order to maintain operations, creating a need for systems that didn’t exist before. From a technology perspective, companies need to find a way to get disparate data systems to communicate or at least speak a common language. When important patient information is missed because data systems are siloed, the result is incorrect or inaccurate care. To alleviate these challenges, companies are turning toward real-time data, which has been historically siloed across and within these disparate care settings. By breaking down the silos and adopting common languages like ICD and LOINC codes, the research community can gain access to real-world patient data in a way that becomes meaningful. Over the last two decades, organizations have collected a significant amount of real-world data on patient therapy and treatment information, including detailed outcomes that result from treatments. Couple that with Big Pharma's ability to digest this data, then focus research efforts on prevention and treatment, and you have a powerful combination. Having access to this data can accelerate innovation designed to protect the most vulnerable populations among us, ultimately improving care outcomes for all.
\n","showOnHomepage":true,"author":{"title":"Jeff Wessinger","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PointClickCareLogoCMYK.jpg","mediaDetails":{"height":512,"width":1024}}},"authorFields":{"title":"Vice President and General Manager, Life Sciences","linkedin":"https://www.linkedin.com/in/jeffwessinger/?originalSubdomain=ca","email":"pointclickcare@pancomm.com","company":{"title":"PointClickCare"}}}},{"answer":"Viral vectors are a key bottleneck in ATMP manufacturing and a main driver of the high costs of these products, accounting for as much as 40% of the cost of goods for gene and adoptive cell therapies (APMHE 61629).
\nEnabling technologies and a platform approach can help to streamline the process, but the focus remains on trying to decrease the cost of the entire process. Enabling higher titers in scalable processes will help to overcome these challenges. For instance, innovative reagents can boost the yield and productivity of viral vector processes, and processes are currently being validated at the 500-, 1,000-, and 2,000-L scales.
\nAnother challenge is the time it takes to obtain regulatory approval for viral vector–based gene-replacement therapies. It would be good practice for new therapeutic innovators to develop a high-titer scalable process with regulatory approval in mind. This means selecting suppliers that provide reagents, consumables, and equipment with robust regulatory packages so that, in the end, a high-yield process with easy regulatory acceptance has been developed.
\n","showOnHomepage":true,"author":{"title":"Roel Gordijn","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Polyplus-transfection_Logo.png","mediaDetails":{"height":656,"width":1694}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://www.linkedin.com/in/roel-gordijn-33390b13/","email":"rgordijn@polyplus-transfection.com","company":{"title":"Polyplus-transfection®"}}}},{"answer":"The productivity of our industry R&D is declining; we spend more than $2 billion to bring each new medicine to patients, yet 90% of all clinical trials fail. If we can improve the efficiency of this process, we can bring better medicines to patients faster and more cheaply, creating a more sustainable R&D model.
\nAt Recursion, we’re tackling this issue by reshaping the traditional pharma pipeline. In its ideal state, a drug discovery funnel would be shaped like the letter “T,” where a broad universe of possible therapeutics is narrowed immediately to the best candidate, which would advance through subsequent steps of the process quickly and with no attrition. Our Recursion OS has enabled us to identify low-viability programs earlier in the research cycle, spend 50–60% less per program from discovery to IND, and advance programs to a validated lead in one-third of the time compared with industry averages. We do this by leveraging our proprietary Maps of Biology to infer hundreds of billions of relationships between disease models and therapeutic candidates that go beyond hypothesized and therefore human-biased targets. We then validate and prioritize the most promising candidates early in the research process. Ultimately, we believe that this approach is allowing us to industrialize drug discovery with less bias, more speed, and more scale.
\n","showOnHomepage":true,"author":{"title":"Chris Gibson, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Recursion_pharmaceuticals_logo.jpeg","mediaDetails":{"height":664,"width":742}}},"authorFields":{"title":"Co-Founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/chris-gibson-5ab66065/","email":"chris@recursion.com","company":{"title":"Recursion"}}}},{"answer":"Improving the diversity of clinical trials is one of the biggest challenges that the industry faces today. The U.S. FDA has recognized this and recently released guidance encouraging pharmaceutical sponsors to develop plans to address discrepancies in enrollment from underrepresented ethnic populations in the United States. In our research, we've found that these discrepancies can appear at the earliest parts of clinical recruitment. For example, Black trial candidates are around 40% less likely to move into screening for a trial than white candidates, with the key difference emerging at the pre-screening to in-screening transition. To even start to address this inequality requires capturing and reporting demographic information early enough to effect change. This has historically been a significant challenge to the industry.
\nAt Reify Health, we are leveraging StudyTeam and Care Access to meet patients where they are, understand their unique needs and backgrounds at the earliest stages of recruitment, and pinpoint the qualitative and quantitative reasons limiting underrepresented groups from full participation in clinical studies. Beyond providing visibility, we will develop tools and techniques to address these limitations, and understand which interventions are best suited for the unique needs of specific study.
\nFinally, just as many studies are global in nature, so are the challenges of addressing clinical diversity. It will take years of concerted, systemic effort, but I'm confident that by working together and marshaling our collective resources, we can ensure that everyone, regardless of background, can benefit from life-saving clinical research.
\n","showOnHomepage":true,"author":{"title":"Josh Brandoff","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/8615.jpg","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Head of Data","linkedin":"https://www.linkedin.com/in/brandoff/","email":"reifyhealth@pancomm.com","company":{"title":"Reify Health"}}}},{"answer":"One of the biggest challenges faced by the industry is definitely the uncertainty in supply chains. Market-approved therapeutics, which are integral to patient healthcare, are obviously affected by this. However, this also affects products in development and in clinical studies and subsequently goes on to affect their \"time to market.\" The scarcity of raw materials and long delivery times are challenging for all parties involved. This is one of the reasons why Rentschler Biopharma relies on a strong network and reliable partners to effectively reduce this risk.
\nThe geopolitical landscape also plays a major role in this context. I am convinced that this can only be solved through a multi-level approach: a combination of fostering innovative solutions, with right-first-time precision, in a strong community. Thus, we can continue to offer premium solutions to our clients and high-quality therapeutics to patients.
\n","showOnHomepage":true,"author":{"title":"Christiane Bardroff","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/87.gif","mediaDetails":{"height":85,"width":145}}},"authorFields":{"title":"Senior Vice President of Client Program Management and Senior Vice President of Clinical and Commercial Manufacturing","linkedin":"https://www.linkedin.com/in/christiane-bardroff-6305a69b/","email":"communications@rentschler-biopharma.com","company":{"title":"Rentschler Biopharma SE"}}}},{"answer":"Fast advancement of technology development in the biotherapeutics industry resulted in the birth of various drug modalities that are designed to work optimally for many diseases with high unmet needs. However, high quality management and good manufacturing control of recent emerging technologies are still the biggest challenges facing the industry.
\nOver the past decades, the biosimilar industry paved an important path for high quality management while innovating process science to improve the efficiency of process development. What we learned from biosimilar development can certainly help the biopharma industry find solutions for its manufacturing challenges.
\n","showOnHomepage":true,"author":{"title":"Kyung-Ah Kim, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Samsung_Bioepis_Logo.jpg","mediaDetails":{"height":627,"width":1200}}},"authorFields":{"title":"Executive Vice President and Leader of the Development Division","linkedin":"https://www.linkedin.com/in/kyung-ah-kim-b539954/","email":null,"company":{"title":"Samsung Bioepis"}}}},{"answer":"IDC predicts in its Futurescape Worldwide Life Sciences 2022 Predictions that, by 2026, two-thirds of life sciences companies will adopt the intelligent lab of the future, leveraging digital transformation and integrating the Internet of Lab Things (IoLT).
\nThere is a clear race within the pharma/biopharma industry, particularly within R&D, to use experiment data for purposes outside of its original experimental context. In its simplest form, if past experiments and their data were available in a frictionless manner, we could reduce the number of repeated experiments. If we could use historical formulation analysis data to predict the “sweet spot” for a new product formulation, this would again reduce the number of physical experiments required and reduce timelines. Digital twins of bioreactors and bioprocesses could also reduce development time.
\nTo enable this level of data science, lab systems and data flows need to be integrated to a degree that is unprecedented. Applications for experimental design, compound registration, electronic lab notebooks (ELNs), laboratory information management systems (LIMSs), scientific data management systems (SDMSs), instrument systems, and even different sites and geographies need to be end-to-end integrated in such a way that the data they produce is highly cross-linked and available.
\nThe challenge of removing silos and harmonizing data is not new, but the degree to which this digital transformation needs to be delivered will test many organizations over the coming years.
\n","showOnHomepage":true,"author":{"title":"Geoff Parker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Scimcon_logo.png","mediaDetails":{"height":125,"width":404}}},"authorFields":{"title":"Co-Founder and Lead Consultant","linkedin":"https://www.linkedin.com/in/geoff-parker-3717bab/","email":"gparker@scimcon.com","company":{"title":"Scimcon"}}}},{"answer":"While the biopharma industry has proven adept at producing small molecule and biologic therapies that treat broad disease categories in large numbers of people, the next opportunity lies in new modalities. Because venturing into new modalities requires de-risking, it’s a space best suited for companies, like ours, with a distributed financial support model — at least until the field has been able to demonstrate development and successful commercialization.
\nStill, it’s not easy — microbiome as a field is innovating along three axes: new science, new modality, and new business model. It's challenging to get one, let alone all three, right. That’s what drew me to Seed: in contrast with single-technology, single-platform companies, our platform-based approach enables rapid, efficient advancement of microbial research from discovery to market. This approach, paired with a deep commitment to scientific excellence and rigor, is necessary to realize the future of the field.
\nWe know that the microbiome is the primary interface between humans and the environment, and we’re beginning to understand how that environment drives disease development and progression — two factors that heavily influence how we develop personalized therapies and identify unique targets. Because each person’s unique microbiome can drive the development or progression of disease, there is potential to design interventions based on microbial makeup. With advancements in sequencing technologies, large multi-omics data sets, and novel computational techniques, we can also realize the potential of microbes — as both living medicines and probiotics — to modulate this ecology for key health outcomes.
\n","showOnHomepage":true,"author":{"title":"Dirk Gevers, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/SeedHealth_Green_Logo-scaled.jpg","mediaDetails":{"height":1341,"width":2560}}},"authorFields":{"title":"Chief Scientific Officer","linkedin":"https://www.linkedin.com/in/dirkgevers/","email":"seed@consortpartners.com","company":{"title":"Seed Health"}}}},{"answer":"The biggest challenge that the pharma and biopharma industries currently face is unwanted immunogenicity. Immunogenicity is the ability of a substance or antigen, such as a foreign or potentially dangerous protein, to provoke an antigen-specific immune response. Although immunogenicity is needed to defend the body, it can also result in unwanted immune responses to lifesaving therapies or to auto-antigens that can lead to autoimmune disease. Many strategies to address unwanted immunogenicity target downstream immune effectors and are not antigen-specific, resulting in broad immune suppression that introduces patients to significant risk of infection and other malignancies. We think that the key to overcoming this big challenge of unwanted immunogenicity is to specifically stop the immune cascade before it begins. Our ImmTOR® platform technology is designed to induce antigen-specific immune tolerance prior to the initiation of the immune cascade through communication of a tolerogenic message to antigen-presenting cells. This tolerogenic message results in an induction and expansion of antigen-specific T regulatory (Treg) cells and mitigation of an unwanted immune response. Our approach has broad applicability as showcased in our three focus areas: re-imaging immunotherapy for autoimmune disease, unlocking the potential of gene therapy, and amplifying the efficacy of biologic therapy. Through overcoming unwanted immunogenicity without broad immune suppression, the biotech and biopharma industry will be able to provide therapeutic solutions to patients without the serious side effects seen across these treatment landscapes today.
\n","showOnHomepage":true,"author":{"title":"Carsten Brunn, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Brunn_Selecta.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/carsten-brunn-a8b287a","email":null,"company":{"title":"Selecta Biosciences"}}}},{"answer":"From the point of view of a primary packaging manufacturer, the biggest challenge to the pharma industry today is manufacturing operation disruption caused by the COVID-19 pandemic and compounded by the war in Ukraine. These events have significantly impacted global supply chains in terms of access to raw materials (including packaging components), and it is increasingly challenging to transport them from the supplier. Continuous labor shortages are driving productivity down and delaying necessary validation and qualification activities, further exasperating final drug product availability. Energy market increases have also impacted operating costs for suppliers in industries with a heavy dependence on energy, such as glass manufacturing. These factors combine to drive up supply chain and operating costs, causing back orders.
\nTo mitigate these types of supply chain challenges, the industry is focusing more on the development and manufacturing of drug products and partnering with suppliers to take on more of the non-core activities. For example, we are seeing an acceleration towards the implementation of ready-to-use (RTU) primary packaging components as a preferred solution. Filling machine equipment manufacturers are also answering to this trend by providing more options to handle RTU and non-RTU components to allow for maximum flexibility for pharma companies. SGD Pharma’s Sterinity platform of molded glass vials has also been strengthened to offer sterile RTU vials to its customers and meet their demand for added services to be provided by suppliers.
\n","showOnHomepage":true,"author":{"title":"Nadir Lahmeur","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/SGDPharma_blanc@2x.png","mediaDetails":{"height":306,"width":306}}},"authorFields":{"title":"General Manager (Americas)","linkedin":"https://www.linkedin.com/in/nadir-lahmeur-66a2a31/","email":"marketing@sgdgroup.com","company":{"title":"SGD Pharma"}}}},{"answer":"One of the biggest challenges facing the biopharma industry is siloed and disconnected data at scale and not enough multimodal data (imaging–radiomic, genomic, proteomic, biologic, toxicity, structured, and unstructured clinical data) being leveraged to fully understand a patient’s profile in the context of other patients. When data is not siloed and all stakeholders can contribute and share various pieces of a biological puzzle, it can reveal the full spectrum of a disease for better drug development.
\nAnother major challenge is overcoming the hurdles associated with clinical trials. These challenges include lack of testing globally to match patients to the right trials due to centralized approaches, slow recruitment of patients to trials, inability to follow patients longitudinally to fully understand their response to a particular drug, and the ability to develop and launch predictive algorithms developed in support of trials into clinical routine. Big data approaches are increasingly becoming vital to discover new treatments for diseases, to find the right patients, and to bring a product to market. But these challenges must be addressed in order to speed up the drug development process and focus on patient-centered care.
\n","showOnHomepage":true,"author":{"title":"Peter Casasanto","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/SOPHiA-GENETICS-Logo.png","mediaDetails":{"height":505,"width":1667}}},"authorFields":{"title":"Chief BioPharma Officer","linkedin":"https://www.linkedin.com/in/petercasasanto/","email":"PCasasanto@sophiagenetics.com","company":{"title":"SOPHiA Genetics"}}}},{"answer":"There are decades of infrastructure and business processes on which pharma executives make decisions, and which are likely not attuned to true innovation. Research and development groups are inherently innovative, investigating new science, exploring every option to bring new drugs to market, and requiring deep financial support to do so. Alternatively, a company’s commercial effort is based on structures, project decision rules, and budgets that adhere to what has been done in years past. Innovation happens when a company balances the drive toward drug discovery and commercial success across all aspects of the company, allowing innovation to pull through to the commercial teams and budgets.
\nInnovation can spark with one success in an unlikely place supported by one executive. I have seen lasting innovation happen in this way across my career. But pharma faces challenges from operational and discovery boundaries set by financial expectations. It would be wise for leaders to set a budget for a Tiger Team charged with investigating new ideas and proving collaborations that point to creative new directions.
\n","showOnHomepage":true,"author":{"title":"Carla Balch","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Balch_Spesana.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/carla-balch-hates-cancer/","email":null,"company":{"title":"Spesana"}}}},{"answer":"Cancer remains a leading cause of death worldwide. Advancing therapeutics that can benefit the largest number of cancer patients and improve survival and quality of life remains a great challenge for our industry. Immune evasion has long been recognized as a limitation to using the body’s own defense system to fight cancer. The arrival of immune checkpoint inhibitors (ICIs) greatly expanded the cancer immunotherapy toolbox and transformed the treatment landscape. By targeting immune checkpoints, such as PD-(L)1, ICIs enhance T cell activation to kill tumors. Though ICIs have earned some notable clinical successes, the ongoing challenge is to develop combination agents with a strong synergistic, not just additive, effect with ICIs. Clinical data from combinations of ICIs with existing chemotherapy and targeted agents appears to be falling short. Novel approaches are needed.
\nWe believe that this challenge is two-fold: achieve cancer control while also ensuring durable anti-cancer immunity for patients to not only survive but thrive. Our strategy has the potential to enhance immunotherapy by creating an optimal environment to achieve synthetic lethality and induce tumor necrosis, a type of immunogenic cell death that targets cancer cells, cancer stem cells, and tumor-associated macrophages, and also to convert the tumor microenvironment from immune-evasive to immune-responsive. Once the tumor microenvironment is primed, ICIs’ potency is amplified and further leads to T cell activation for tumor killing. We hope to see the industry continue to think outside the box and invest in creative strategies to enhance the effectiveness of immunotherapies and offer patients with difficult-to-treat cancers transformative treatment options.
\n","showOnHomepage":true,"author":{"title":"Ray Lee, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Teclison_logo.png","mediaDetails":{"height":168,"width":491}}},"authorFields":{"title":"Founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/ray-lee-38204321/","email":null,"company":{"title":"Teclison"}}}},{"answer":"When you ponder the myriad of market, environmental, and regulatory issues that have seemingly converged simultaneously, several challenges rise to the top. Supply disruptions related to sourcing, availability, and logistics continue unabated worldwide. From raw material manufacturing disruptions and transportation challenges to surging demand from biopharmaceutical manufacturers for critical ingredients, the pharmaceutical ingredient supply chain crunch has been significant and has mirrored those of many other markets, with increased prices and longer lead times for specialty ingredients and chemicals from many suppliers globally.
\nLooking closer at the biopharmaceutical industry, demand for innovative chemistries driven by COVID-19 and mRNA technologies remains very high. Suppliers and manufacturers are challenged to keep up with orders for materials such as bio buffers, amino acids, cell culture media, and other key chemistries. Many suppliers are receiving volume orders well above historical levels. Adding in the increased consumer demand for medical procedures that individuals may have placed on hold or producers formulating alternatives to prevent prevalent illnesses, we’re still witnessing a market asking for more than the current supply.
\nAs resources are more limited and supply chain shortages continue, pharma and biopharma companies must innovate to meet demand. Increasingly, pharmaceutical manufacturers are turning to partners for innovation and technical support, supply chain guidance, and industry foresight on regulations, trends, and market dynamics. As an ally to pharmaceutical manufacturers, we come in with our supply chain foresight, global distribution network, and direct accessibility to raw materials from leading brands to support our customers and address the current challenges that they face.
\n","showOnHomepage":true,"author":{"title":"James Peterson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Peterson_Univar_Solutions.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Vice President, Pharmaceutical Ingredients","linkedin":"https://www.linkedin.com/in/james-paterson/8597b749/","email":null,"company":{"title":"Univar"}}}},{"answer":"In the pharmaceutical industry, it usually takes over 10 years and costs on average U.S. $1 billion to bring a new drug to the market. However, the COVID-19 pandemic over the last two years challenged this status quo, as the industry tries to speed up the development process and to supply new treatments for the fast-spreading infectious disease within less than two years and at affordable costs. Our industry has also been demonstrating its ability to act collaboratively and quickly. By offering a highly vetted and true one-stop discovery, development, and GMP manufacturing platform, we consistently reduced the standard timeline of CMC development activities from initiation of cell line development to investigational new drug (IND) filing from 24 months to 12 months, and then to nine months and six months in the past five years. Now with the COVID-19 pandemic, we achieved a record-breaking 2.5-month timeline for a number of anti-COVID-19 neutralizing monoclonal antibody (mAb) projects. In addition, timelines from IND to Emergency Use Authorization (EUA) or Biologics Licensing Application (BLA) have been dramatically reduced. Of significant note, in one example, a neutralizing mAb was developed from the start of cell line development activities to EUA within an unprecedented timeline of 14 months. Thousands of kilograms of this neutralizing mAb were manufactured within months for therapeutic applications across the globe. What the industry learned from the COVID-19 projects should be applied in the expedited development of other biologics for treatment of diseases such as cancers, autoimmune diseases, neural degeneration, and rare diseases. Going forward, the biggest challenges for biologics development remain in terms of achieving the fastest speed and lowest costs as possible. Patients don’t need to wait 10 years for a treatment or have to die of the disease due to the expensive drug development and manufacturing cost. More high-quality biologics would be available and affordable due to expedited timelines and widespread use of advanced enabling technology platforms.
\n","showOnHomepage":true,"author":{"title":"Weichang Zhou, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/7050.gif","mediaDetails":{"height":84,"width":137}}},"authorFields":{"title":"Chief Technology Officer and Executive Vice President","linkedin":"https://www.linkedin.com/in/weichang-zhou-93574430/","email":"weichang_zhou@wuxibiologics.com","company":{"title":"WuXi Biologics"}}}},{"answer":"The biopharmaceutical industry has fostered undeniable scientific and technical progress in the last decades, placing the sector on the cutting edge of innovation. However, there is one domain that the biopharma industry has paid only minimal attention to so far: ecology. Indeed, developing and operating a biopharmaceutical process requires massive amounts of raw materials and consumables; several thousand liters of raw materials like cell culture media, buffer, and cleaning solutions, together with an impressive amount of plastics, are necessary to produce one kilogram of biopharmaceutical product. Besides being detrimental to the environment, this also raises the question of supply and the associated risks of shortages. Sustainability is thus an outstanding challenge that the biopharmaceutical industry needs to face. This will require developing greener processes — i.e., consuming fewer resources and generating less waste. This will also require reducing the number of experimental trials necessary to develop a process. Part of the solution may lie in digital initiatives along three focus areas: (i) the structuration and standardization of experimental results in order to ensure data completeness and reusability; (ii) the implementation of predictive simulation to virtually test a wide range of process conditions; and (iii) the rational evaluation and comparison of various process scenarios based on well-defined criteria to select the most appropriate options.
\n","showOnHomepage":true,"author":{"title":"Lucrèce Nicoud, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Ypso-facto_logo.jpg","mediaDetails":{"height":250,"width":1150}}},"authorFields":{"title":"Head of Innovation","linkedin":"https://fr.linkedin.com/in/lucr%C3%A8ce-nicoud-809161107","email":"lucrece.nicoud@ypso-facto.com","company":{"title":"Ypso-Facto"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-whats-the-key-to-being-a-leader-in-the-industry/","uri":"/roundtable/articles-q-whats-the-key-to-being-a-leader-in-the-industry/","slug":"articles-q-whats-the-key-to-being-a-leader-in-the-industry","title":"Q: What’s the key to being a leader in the industry?","roundtable":{"topic":"Leadership","question":"What’s the key to being a leader in the industry?","roundtable":[{"answer":"Perspective and agility. Being agile can mean flexible, but in a modern business setting it has more to do with a mindset that is adaptable through feedback. Perspective, for me, means removing the blinkers that we naturally acquire when we think it is necessary to focus. A leader must have priorities, but the pharma industry is providing many new inputs at this time. Balancing the absolute need to preserve the highest quality for actives, inactive ingredients, and solutions with a need to remove — or make more transparent — the blinkers we use to focus on development channels is an evolving skill. A specific example of this blinkered thought relates to my experiences with quality by design (QbD). I have often made a statement that excipient innovation has been held back. Why? Because many formulators and material scientists felt that the variances that could exist with excipients should be processed out. But oftentimes we needed this “variance” to make a particular formulation effective. If we processed the variance out, an essential medicine could not be produced. This could lead to normalizing excipient performance yet completely squandering opportunities to utilize natural performance. Not only that, but QbD in other industries strived to make great, efficient, and long-lasting design, and it also searched for the innovative new materials to make their completed products better. Leaders in drug discovery, drug delivery, biopharma, and ingredient/excipient technology should find more time to understand each other in practice, not just on paper. This will also come as AI enters a new phase of value.
\nWe are going through some of the fastest-paced change I have seen in my 20+ years in the pharmaceutical industry. The recent U.S. FDA (CDER) directive to allow “novel” excipient review prior to use in drug formulations means that leaders in the industry need to assemble and develop diverse teams. We have seen the global pandemic bring unprecedented speed to development of therapy. These “waves” are not common in our industry, and we should have effective and agile leadership to sort out the value and benefits for innovation across the product inputs and processes.
\n","showOnHomepage":true,"author":{"title":"Alen Guy, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Guy_IMCD.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Technical Director, the Pharmaceutical Business Group","linkedin":"https://www.linkedin.com/in/alen-guy-07a4444/?originalSubdomain=de","email":null,"company":{"title":"IMCD"}}}},{"answer":"Alcami leads within the CDMO sector through convenience of offerings and reduction of complexity in processes offered to customers. True beneficiaries of such an approach are smaller-scale companies, which are the innovation engines of the pharmaceutical industry responsible for an increasing rate of new drug approvals.
\nIn a time of uncertainty fueled by resource constraints and supply chain issues, Alcami embraces change by being dexterous and adapting to client needs by utilizing new technologies and empowering our frontline team. Strong organizational culture and robust quality systems, supported by compliant but lean processes, are at the core of Alcami.
\nAlcami delivers high-standard work with realistic expectations based on self-awareness, strong communication, integrity, and transparency. The partnership between Alcami and customers begins at the early stages of drug development, from understanding client needs through the development of customized solutions that ensure success at the commercialization stage.
\nThe strategic and operational changes at Alcami — combined with the highly talented business development team and intellectual horsepower of phenomenal operational teams — have resulted in significant growth for the company based on customer intimacy and a focus on finding solutions.
\nIn summary, what makes Alcami the true north of CDMOs is a high-quality cGMP operation supported by versatile development teams and a robust regulatory approach, technical competence, customer-centric culture, and a meaningful partnership approach to business. With our advantageous locations in the Carolinas and Missouri next to innovative pharmaceutical and biotech hubs, Alcami is perfectly positioned to support U.S.-based customers.
\n","showOnHomepage":true,"author":{"title":"Anna Dormady","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Dormady_Alcami.png","mediaDetails":{"height":289,"width":211}}},"authorFields":{"title":"Director of Laboratory Operation, Morrisville, NC","linkedin":"https://www.linkedin.com/in/anna-dormady-b8a2067/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"It’s about always being there for our customers. We help them with the answers that they need, using our unparalleled portfolio of solutions and unrivaled technical service in critical application areas, such as immediate and controlled release. Our strong and timely regulatory and quality support, a global manufacturing footprint, and an outstanding team of resilient people with vast experience support our customers’ every need.
\nIn our long and rich history as the leading supplier of excipients and ingredients for the pharmaceutical industry, there have been challenges — small and large — but our customers know that they can always count on us to be with them through change and support their needs.
\n","showOnHomepage":true,"author":{"title":"Dago Caceres","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Caceres_DOW.png","mediaDetails":{"height":238,"width":211}}},"authorFields":{"title":"Global Strategy Director","linkedin":"https://www.linkedin.com/in/dago-caceres-6491a4/","email":null,"company":{"title":"IFF"}}}},{"answer":"At BASF, we believe that true leadership involves more than innovation or a healthy bottom line. It involves building diverse teams and fostering an inclusive culture where everyone has a true sense of belonging and can contribute to the business in meaningful ways.
\nIn our experience, prioritizing diversity and inclusion (D&I) has taken collaboration and innovation to a whole new level. When people feel included, valued, and recognized, they tend to also feel empowered to bring their ideas forward, take risks, and challenge the status quo. They bring a deeper understanding of our customers and their needs from both a global and local perspective, allowing us to provide more personalized service and solutions. This ensures that strategic initiatives are driven forward in the most productive, efficient, and profitable way, while creating a high level of employee engagement and satisfaction. We regularly gather feedback from our employees to keep an open dialogue and put actions in place when needed.
\n","showOnHomepage":true,"author":{"title":"David Freidinger","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Freidinger_BASF.png","mediaDetails":{"height":253,"width":211}}},"authorFields":{"title":"Vice President of Global Business Management","linkedin":"https://www.linkedin.com/in/david-freidinger-a8a49814/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"We are in an industry that is being transformed and transforming — and leadership is defined by how we respond, the new approaches we can provide, and the generation of evidence that the new approaches are working. Some of this industry transformation has occurred as a result of the COVID-19 pandemic and the new care management and clinical delivery approaches that were initiated as a result. Traditional ways of interacting with patients and conducting clinical trials have been challenged. As industry leaders, we are similarly transforming ourselves out of a deep and profound responsibility to patients.
\nLeaders know that beneficial disruption does not reflect a disdain for past approaches, but rather how that knowledge is applied to changing what data, technologies, and people can achieve comparable or superior outcomes with greater productivity, lower cost, and more rapidly. The transformation of RWD into RWE for regulatory decisions is a perfect example of this — once deemed inferior to RCT studies, they’re now all part of a single, integrated “System of Evidence.” So, key to being a leader is (1) being guided by this imperative of accelerating and assuring new, innovative, medicines to patients; (2) operating with the highest ethics and independence in an industry where foundational trust is hard-won and easy to lose; (3) staying committed to concepts of health equity and elimination of research disparities; and (4) challenging all legacy notions for how research should be conducted while providing higher precision, confidence, and generalizability to the new research approaches we advance.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"Many factors contribute to strong leadership in the pharmaceutical and biotech industries, but two absolutely vital elements are authentically embodying and exemplifying integrity and grit. Being an effective and successful leader requires being well trusted, as we are entrusted with the health and lives of patients; this often results from a culmination of several factors, including transparency, knowledge, and operating with a truly people- and patient-first approach. And perseverance and determination are also essential, particularly in today’s healthcare landscape, as, given the enormous complexity of our industry, there are many obstacles and issues that inevitably arise and must be worked through. Science is not easy — but, when done right, the benefits are tremendous.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"The key to being a leader in any industry is being strategic, developing unique ideas and approaches, and, importantly, doing the hard, hard work of pressure testing current best standards, pushing them to a new level, and then championing adoption.
\nIt’s about identifying the tough challenges and being willing to work with the people who are trying to solve them day in and day out and to partner with them. Once you’ve found how to start moving the needle, and proven it, it’s about sharing the good word and bringing more along.
\nIn our industry, and for us, it’s about the many interrelated things necessary to unlock clinical research, access to scientific breakthroughs beyond the confines of academic centers, and engagement with real-world studies — and continuing to improve. How can we take what makes America’s top institutions so successful, and bring more cancer centers serving more of America into that process?
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"Leadership today requires strategic innovation, which comes with a keen focus on what physicians need in order to practice precision medicine. That also means having deliberate focus on how the economics of medicine can be simplified through Prior Authorization automation. The Spesana Platform serves clinical, operational, and financial needs.
\nIf we improve the user experience — of physicians, nurse navigators, administrators, and patients — with an elegant, data-driven workflow and highly sensitive molecular diagnostics to improve patients’ outcomes, then we can significantly improve upon the unnecessarily complicated processes that exist now.
\nLeaders will increase the velocity of patients moving to the right specialists. Beyond that, clinical collaborations to allow physicians, patients, and insurance teams to come together around the best available therapies are paramount.
\n","showOnHomepage":true,"author":{"title":"Carla Balch","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Balch_Spesana.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/carla-balch-hates-cancer/","email":null,"company":{"title":"Spesana"}}}},{"answer":"The biopharma industry is changing relentlessly, requiring biopharma leaders to quickly navigate through fast-moving market dynamics while overcoming complex challenges. Biopharma leaders must consider four factors in order to succeed in advancing biologics to the market, especially considering the shifting market dynamics: agility, capacity, innovations in technologies, and end-to-end capabilities.
\nIn order to successfully meet the urgent need of new projects, a company must find ways to demonstrate a high degree of responsiveness to react to the changing requirements for product demand, particularly during the pandemic crisis.
\nThis demand will need to be supported by available manufacturing capacity at multiple scales to accommodate both clinical and commercial supply of products in order to provide speed to market for the supply of critical medical treatments. We currently have several projects underway to maximize our manufacturing capacity footprint, including the ongoing construction and validation of Plant 4 and more.
\nA biopharma company must be able to balance and accommodate the needs of rapidly changing projects involving novel technologies, and this can be done by implementing continuous innovation with new modalities to supply next-generation therapeutics. In addition to launching the supply of mRNA drug substance in 2022, our planned expansion of Plant 5 is expected to begin construction within this year and will offer multimodal products, including cell and gene therapies and next-gen vaccines utilizing mRNA, pDNA, and viral vectors, all at a single site.
\nLast but not least, a biopharma company must strategically plan out resources to get a molecule across to the finish line from one location, minimizing time loss due to shipping, tech transfer, et cetera. A company should be well-equipped with end-to-end capabilities or outsource to a CDMO with such service offerings across all areas of product development, clinical and commercial manufacturing, and fill/finish of drug product for speedy delivery to market.
\n","showOnHomepage":true,"author":{"title":"Kevin Sharp","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Sharp_Samsung_Biologics.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Vice President of Global Sales and Head of Strategic Operations Team","linkedin":"https://www.linkedin.com/in/kevintsharp/","email":null,"company":{"title":"Durbin"}}}},{"answer":"In recent years, and in light of the global pandemic, the biopharmaceutical industry has faced many challenges and undergone significant change. The binary-choice model of in- versus outsourcing has been replaced by close and flexible collaboration models, where Lonza is a leader with solutions such as Ibex. In addition, the customer base for CDMOs has diversified, as emerging and small biotechs now make up approximately 80% of the total development pipeline.
\nA key offering component of a leading CDMO is being able to develop and manufacture complete offerings at different scales, as this allows companies to manage market variability, project economy, product life cycle, and unexpected needs for more product.
\nAs an industry leader, Lonza creates a customer-centric offering by ensuring quality and increasing flexibility to customers of all sizes. The wide range of modalities and technologies we support, along with locations and asset size, continue to evolve with evolving customer needs. We invest in multipurpose, large-scale manufacturing capacity, as well as dedicated suites. Our end-to-end offering spans the entire life cycle of a molecule across late discovery, preclinical and clinical testing, and commercial supply. Our teams provide additional value through their extensive expertise and regulatory experience.
\n","showOnHomepage":true,"author":{"title":"Jean-Christophe Hyvert","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_C_Hyvert_Lonza.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President, Biologics and Cell & Gene","linkedin":null,"email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"It is a very exciting time to be in the healthcare business. New technologies are emerging rapidly to tackle diseases that we were previously unable to treat. However, we are working in a complex landscape, and there are key qualities and capabilities required to navigate and maximize the benefits of emerging technologies.
\nA customer-centric approach is essential, so being a leader necessarily means being fully integrated along the value chain. By putting the customer and ultimately the patient first, we can think beyond simply solving a problem to create solutions that are really needed.
\nStrong core competencies must be complemented by versatility and flexibility when it comes to choosing the best technical solution. A partner must be able to select the perfect technology to match a specific drug, formulation, and application requirement. Parenteral CDMO services and solutions that can add value at any product development stage, including clinical phase–appropriate support, are crucial for success going forward.
\n","showOnHomepage":true,"author":{"title":"Jane Meyer","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Meyer_Evonik.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":", Global Head, Parenteral Drug Delivery Solutions","linkedin":"https://www.linkedin.com/in/janemmeyer/","email":null,"company":{"title":"Evonik"}}}},{"answer":"One key is to anticipate, identify, and cater to clients’ needs. For example, with WuXi Biologics' \"follow and win-the-molecule\" strategy, we have seized many opportunities in the growing market of biologics start-ups, recognizing that small biotech companies usually need to use external technologies regarding new modalities, such as ADCs or bispecifics. Foreseeing their demand for end-to-end services, we built a comprehensive, open-access platform so that they can focus on their R&D efforts instead of infrastructure investments. With this strategy, we have been enabling 480 programs for global clients — 156 of them in 2021 — and have one of the largest portfolios of complex biologics, including mAbs, bispecifics, ADCs, and fusion proteins. Now, we are proud to see nine commercial manufacturing projects as successful results of this strategy.
\nAt the same time, it is important to stay flexible and be able to address the evolving demands of diverse clients. A great portion of the small business clients WuXi Biologics serves in the development phase then become bigger companies and stay with us as they enter the manufacturing phase. As we empower clients to grow and be successful, we become their long-term partners.
\nContinual innovation is another key. After a successful first decade, WuXi Biologics is now entering a new era of our “CRDMO” business model. We define WuXi Biologics as a contract research development and manufacturing organization because, as opposed to traditional CMO or CRO companies, our core expertise is in discovery and development services, as well as large-scale manufacturing. We are pioneers in adopting disposable manufacturing technologies in large-scale commercial manufacturing, too, which gives us more flexibility and better efficiency by allowing us to combine multiple disposable bioreactors. In this way, we can better cater to diversified needs and fuel up client innovation.
\n","showOnHomepage":true,"author":{"title":"Chris Chen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Chen_WuXi_Biologics.png","mediaDetails":{"height":254,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":null,"email":null,"company":{"title":"WuXi Biologics"}}}},{"answer":"All great leaders, regardless of industry, must actively listen to their customers and employees to completely understand their needs. To offer a customer-leading experience means providing specialized solutions for every client. For example, in the restaurant industry, they cater and design meals to each diner’s needs. It’s not that different in the pharmaceutical supply chain business. If a client requests a product manufactured and packaged specific to their unique demands, companies must deliver quality, science, and expertise to their liking. This is how you gain repeat clients, and your reputation develops as a leader.
\nListening to the needs and concerns of your employees is also vital. There must be two-way communication, allowing all members of your organization to voice their opinions and beliefs so that employers can address issues and prevent conflicts. This creates an inclusive, trustworthy culture and generates a more productive work environment.
\nAt PCI, we understand that we cannot properly execute our vision without listening to the needs of our clients and employees.
\n","showOnHomepage":true,"author":{"title":"Tim Roberts","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Roberts_PCI.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://linkedin.com/in/tim-roberts-a83a775","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"To be a successful leader, you must be team focused and open minded and maintain perseverance. There are several challenges that come from starting a company from the ground up, and I’ve always strived to create a culture where we can learn from our successes and failures and continuously improve. A few key traits that have been core to my success are ambition, transparency, and obsession. Ambition is probably the most significant one that led to our early success. SOPHiA GENETICS was founded in Switzerland, and there are not many Swiss companies that have the ambition to lead the way in a very competitive industry. I knew this when I started the company, and it’s something that has driven me since day one. It’s also imperative to be transparent, even when the message is constructive — otherwise, we can never improve. This doesn’t just apply to my colleagues, but to our customers as well and the data insights we provide them. This is the reason why we want to break down data silos and share knowledge globally. The final trait that has served me well, despite perhaps its negative connotation, is my tendency to obsess over things. I’ve always known where I wanted to be, and because I remain committed to that vision, that sometimes means that I’m my own toughest critic. When I chart a course, I keep moving in that direction until I’ve achieved my objective.
\n","showOnHomepage":true,"author":{"title":"Jurgi Camblong, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Camblong_Sophia_Genetics.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/jurgicamblong/","email":null,"company":{"title":"SOPHiA Genetics"}}}},{"answer":"The industry SOCMA represents is very specialized, making high-grade, value-add products that go into almost everything people use daily, as well as active pharmaceutical ingredients (APIs) that are critical to pharma health care. The contract development manufacturing organizations (CDMOs, which are tollers) and their design teams play an integral part in ongoing pandemic recovery. The ability to deliver customized solutions to each of our members is vital to their pursuit of innovation and is the foundation of SOCMA’s mission to provide such unique solutions and services. Bringing the industry together to share best practices, connect with new partners, and provide personalized regulatory assistance is key to the success of our members. What underpins SOCMA’s ability to deliver these critical tools and resources to our members is our ability to be agile, adapting to the ever-changing needs of the companies we represent — and we will continue to lead our members into the future, always in the name of safety and innovation.
\n","showOnHomepage":true,"author":{"title":"Paul Hirsh","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Hirsh_SOCMA.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Senior Vice President, Industry Relations","linkedin":"http://www.linkedin.com/in/paul-hirsh-b4148185","email":null,"company":{"title":"SOCMA"}}}},{"answer":"Leaders in this industry are only as good as the team behind them. The key to being a successful leader lies in bringing together a diverse group of employees who have a wide variety of work and life experiences, who share the same vision of reaching an aspirational goal and who are not afraid to ask hard questions. Everyone has strengths and weaknesses. But when you find people who can fill each other’s gaps and fortify each other’s strengths, you can make big strides toward the company’s ultimate objective.
\nIn the life sciences, a leader needs to be able to see the bigger picture in order to be fearlessly audacious when it comes to executing a company’s greater plan. But leading needs to be balanced with listening intently to the team, so that the finer nuances of the day-to-day challenges are not missed. At Skye, the team makes it easy for me to lead. We all work tirelessly to make our goal of bringing a potentially life-changing drug for glaucoma patients to market. Their steadfast dedication and true accountability give me the confidence to take Skye to new heights.
\n","showOnHomepage":true,"author":{"title":"Punit Dhillon","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Dhillon_Skye_Bioscience.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Chair","linkedin":"https://www.linkedin.com/in/punit-dhillon/","email":null,"company":{"title":"Skye Bioscience"}}}},{"answer":"As a provider of solutions, we view leadership as dependent on the value your customers and suppliers find in your services and offerings. Our goal is to be the most valued ingredient distributor on the planet by exceeding expectations, building trust, and treating our customers’ challenges and obstacles as if they were our own.
\nOur customers value our ability to navigate the present challenges while looking ahead and helping them plan and prepare for what’s coming. Given our scale and line of sight across the entire raw material supply chain, we look to identify shifts and potential disruptions before others and use those insights to help our customers make better decisions.
\nCustomers also value our reliability for the what-ifs and our flexibility to pivot and course-correct quickly and efficiently. Whether it’s a natural disaster impacting supply or a new regulation forcing a consideration of a different ingredient, we have the expertise, global material accessibility, and distribution footprint to help our customers mitigate risk and costly business disruptions.
\nMost importantly, serving the biopharmaceutical and pharmaceutical industries requires an all-in commitment starting with the executive level and continuing down to the drivers delivering the product to our customers’ docks. Our organizational leaders at Univar Solutions recognize the importance of our role in this industry with the willingness to continuously invest and strengthen the value that we provide our customers and suppliers. In total, every individual — our field, corporate, and warehouse staff — contributes to a team fully dedicated to serving this crucial industry with ethics, integrity, and the service excellence it takes to lead.
\n","showOnHomepage":true,"author":{"title":"James Peterson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Peterson_Univar_Solutions.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Vice President, Pharmaceutical Ingredients","linkedin":"https://www.linkedin.com/in/james-paterson/8597b749/","email":null,"company":{"title":"Univar"}}}},{"answer":"Collaboration is the catalyst for scientific innovation. As such, leaders need to be focused on how they can make the world a better place, together. Think about what your products, solutions, and research bring to the table, as well as what other players in the industry can bring. You may have a gap that another company’s product or research can fill, and vice versa. Each of us have different strengths and weaknesses, and to identify those within ourselves and others will result in strategic partnerships that highlight our strong suits and solve important problems. By promoting industry-wide collaboration, we can all focus on the overall mission of making the world a better place.
\n","showOnHomepage":true,"author":{"title":"Jeff Mazzeo","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Mazzeo_Waters.png","mediaDetails":{"height":254,"width":211}}},"authorFields":{"title":"Vice President of Scientific Operations and Marketing","linkedin":"https://www.linkedin.com/in/jeff-mazzeo-8651587","email":null,"company":{"title":"Waters Corporation"}}}},{"answer":"Be nimble. COVID-19 and its variant waves, remote employees, supply chain demands, market volatility — all these issues have shown us that we need to be perceptive and to react quickly to multiple headwinds. Being nimble is critical for business continuity. I’ll also add that a leader needs to be more employee-centric. There’s a massive change taking place in the workforce today, with many people demanding fulfilling work and personal lives and switching jobs — or opting out of the workforce — if their needs aren’t being met. We all want the best talent and the best people to grow our companies. We need to listen more and ensure our teams are engaged, to build a more vibrant culture.
\n","showOnHomepage":true,"author":{"title":"Kevin J. Knopp, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_J_Knopp_908_Devices.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/kjknopp","email":null,"company":{"title":"908 Devices"}}}},{"answer":"Clinical trials tend to be so large and complex that it can be difficult to know whether the innovation you are pursuing is really moving the needle. It is possible to draw a conclusion of causation when really what you are seeing is correlation.
\nAt Reify Health, we have chosen to innovate in areas where we can clearly tie results to value, and we have tried to create a culture of looking objectively at the results we are seeing. Did we really achieve the result we set out to achieve? And are we actually making a significant difference here?
\nTo create change in any industry, you have to focus on answering those questions, but I think a relentless focus on creating and demonstrating real value is especially important for leading change in clinical trials.
\n","showOnHomepage":true,"author":{"title":"Ralph Passarella","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Passarella_Reify_Health.png","mediaDetails":{"height":279,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/ralphpassarella/","email":null,"company":{"title":"Reify Health"}}}},{"answer":"The key to being a successful leader in the life sciences industry is never losing focus on why your company exists — “What is the challenge that you’re directly fixing” and “Who are the people you’re looking to help” are always top of mind. For eClinical Solutions, our mission is to make the clinical data acquisition and analysis process easier and faster for pharmaceutical companies with modern technology and digital capabilities. We are constantly asking ourselves how we can transform the way we do business in order to make the work of our team members and clients more rewarding and to deliver faster results to the patients waiting for treatments.
\nAs a leader in the industry, it’s critical to always be looking ahead to what’s next for both the industry and your company’s products and services. At eClinical Solutions, we’re focused on anticipating the future as much as possible and solving emerging problems to ensure that the company evolves constantly with market changes and customer needs. By being able to quickly pivot and, when possible, get ahead of industry trends, companies will be able to better support the growing needs of all stakeholders in the clinical development process.
\n","showOnHomepage":true,"author":{"title":"Raj Indupuri","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Indupuri_eClinicalSolutions.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/rajindupuri/","email":null,"company":{"title":"eClinical Solutions"}}}},{"answer":"I think the key to being a leader in the industry is staying focused on who the customer is and how to be most impactful for that customer. While it can be tempting to get distracted by what competitors are doing or novel technologies, true industry leaders define their vision and direction from their customers’ needs, which stems from a deep understanding of customers. At epocrates, we are laser-focused on clinicians. We know that our commercial clients turn to us because we have a highly engaged audience of clinicians who use epocrates every day to make decisions about how to treat patients. Everything at epocrates originates from that clinician customer obsession. For example, we constantly think about: “What industry trends are likely to affect clinicians and how?”, “What technology is best suited to solving the challenges of clinicians?”, “How are clinicians attempting to solve challenges that they have now and how can we help?”, and “What new policies are developing that could impact how clinicians work?” We are always coming back to that “true north” of customer needs, which is crucial for industry leadership.
\n","showOnHomepage":true,"author":{"title":"Diane Bartoli","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Bartoli_epocrates.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"General Manager","linkedin":"https://www.linkedin.com/in/diane-bartoli/","email":null,"company":{"title":"epocrates"}}}},{"answer":"To be a true leader in the industry, it’s important to be driven by a genuine focus and dedication to provide treatment options that can better the lives of patients — significantly, not just incrementally. At 9 Meters, we have a highly experienced leadership team with complementary backgrounds who share the common goal of improving the treatment landscape for those suffering from rare and debilitating gastrointestinal conditions. We approach the objective of leadership in the gastrointestinal (GI) arena through building a diversified pipeline of products that address profoundly unmet medical needs and by working closely with healthcare providers and patient advocates supporting those with serious GI disorders.
\n","showOnHomepage":true,"author":{"title":"John Temperato","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Temperato_9Meters.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President, Chief Executive Officer, and Director","linkedin":"https://www.linkedin.com/in/john-temperato-62aba52/","email":null,"company":{"title":"9 Meters Biopharma"}}}},{"answer":"A key facet of being a leader in the biotech industry is building a team of the best and brightest talent that share a mission of developing something truly transformative in the industry. Basing our company in Pittsburgh, one of the United States’ top emerging health technology hubs, has positioned us to form a truly remarkable team. A good leader knows that the “ship” is only as good as the crew and that our crew shares our passion for developing personalized immuno-oncology therapies.
\nHowever, the work doesn’t stop there, as it’s imperative that we push beyond conventional boundaries and develop strong, lasting working relationships. A leader must be open to change and home in on maintaining strong relationships with their staff. I believe this is what has made our company so successful in a world with COVID-19 when our work dynamic has completely shifted. Our core values of respect, innovation, collaboration, and executional excellence have enabled us to continue pushing the envelope no matter the circumstances. I’m honored to be CEO of this incredible company and look forward to continuing the fantastic work we are doing at BlueSphere Bio for years to come.
\n","showOnHomepage":true,"author":{"title":"David Apelian, Ph.D., M.D.,","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Apelian_BlueSphereBio.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/david-apelian-64a7662/","email":null,"company":{"title":"BlueSphere Bio"}}}},{"answer":"Developing and communicating a vision, common goals, and values are essential to being a leader. In the biotech industry, the common goals are to bring new potential drugs to the patients to positively impact their lives. These are powerful and highly rewarding motivations to align a team that is multidisciplinary by nature and often multicultural. In a biotech experiencing rapid growth, the long-term vision to build a fully integrated, sustainable organization with a social impact based on shared values is another set of motivations that serves as a common guide of the organization.
\nBeing able to adapt and be reactive while keeping the high-level objectives and the long-term vision in mind is another core characteristic that leaders in the industry must demonstrate. The ability to pivot in real time is especially valuable, since biopharma can present many twists and turns along the way. We have all seen how COVID-19 abruptly required us to change our ways of working, recruiting, and adapting drug development plans, as the majority of the world shifted to the virtual setting.
\nFinally, cultivating a mindset of optimism, resilience, and empathy, even when things are not going as planned, and encouraging others through challenging times are other vital characteristics of a leader. It is highly unlikely that any leader in this space will face a road that has no obstacles or setbacks. During these times, maneuvering around and executing alternate plans to achieve the same outcome while motivating others around you will be tremendously important.
\n","showOnHomepage":true,"author":{"title":"Thierry Abribat, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Abribat_Amolyt_Pharma.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/thierry-abribat-aa0489b4/","email":null,"company":{"title":"Amolyt Pharma"}}}},{"answer":"There are several qualities that are needed to be successful as a leader in this industry: scientific and business knowledge, passion, tenacity, and ingenuity, among others. To be a good leader, you must surround yourself with the right people who share in the company’s vision and be open to their input. No accomplishment is a result of one person’s work, and I know that firsthand from holding leadership positions at several companies over the last 30+ years. At Elicio, I'm privileged to work with a team of brilliant scientists who, like myself, have been impacted by cancer and are driven to find solutions to combat it. As we advance our pipeline of lymph node–targeted therapies through the clinic, I rely on their counsel to make informed decisions.
\nHaving a genuine passion for what your company is working on is also key. There will be long days and setbacks along the way. Truly loving what you do doesn’t necessarily make any of that easier, but it does give you a sense of purpose that can carry you through those rough times. It also makes the exciting moments, like clinical and regulatory milestones, feel that much more meaningful. I continue to find inspiration in the progress that our team is making toward treating these challenging diseases.
\n","showOnHomepage":true,"author":{"title":"Robert Connelly","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Connelly_Elicio_Therapeutics.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/robert-connelly-b0445516/","email":null,"company":{"title":"Elicio Therapeutics"}}}},{"answer":"To be a leader in this industry, it’s critical to have a meaningful and impactful pipeline with the potential to transform the lives of patients. At Araris, our novel antibody–drug conjugate (ADC) linker technology allows for the production of a wide range of potentially safer and more efficacious ADC therapies for various cancer indications. However, the team behind the pipeline is just as important. A strong management team, stable investor base, and external validation through partnerships also solidifies a company’s place in the industry. Our company is backed by an expert leadership team, a scientifically diverse group of advisors, and sound biotech investment firms, giving us the support to advance our therapies forward. Lastly, communication is key. A strong leader clearly communicates key data and discoveries within their industry to drive innovation forward and move one step closer to bringing effective treatments to patients.
\n","showOnHomepage":true,"author":{"title":"Philipp Spycher","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Spycher_Araris.png","mediaDetails":{"height":250,"width":211}}},"authorFields":{"title":"Co-founder and CEO","linkedin":"https://www.linkedin.com/in/philipp-spycher-45958640/","email":"pspycher@ararisbiotech.com","company":{"title":"Araris Biotech"}}}},{"answer":"As someone with more than 20 years of leadership experience across multiple industries, two key areas come to mind. The first is to combine a deep understanding of the particular scientific niche that you’re focused on with the tools to explain it without jargon to a layperson. For example, if you work on cancer treatments (which is part of what my company, Anixa Biosciences, does), you can probably easily talk about all of the nuances of different therapeutic modalities, which is great. But arguably more important is knowing how to explain your differentiators to someone with no scientific background. Part of our job as leaders in this industry is learning how to pull back the curtain on the work we’re doing and make it digestible for all audiences, rather than leaning into the complexity. Ultimately, if our work is successful, our products will be used by patients, and we want them to understand what we do and trust the efforts we made to make our treatments as safe as possible.
\nAnother key to being a leader in this space is building a strong team of experts to surround you in order to provide counsel and help you navigate through this rapidly evolving industry. Whether it’s strategizing on clinical trial design, discussing how to go about your next financing, or initiating conversations about a new partnership or collaboration, a strong leader knows the limits of their own expertise and has a network of people that they can engage with when needed.
\n","showOnHomepage":true,"author":{"title":"Amit Kumar, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Kumar_Anixa_Biosciences.png","mediaDetails":{"height":281,"width":211}}},"authorFields":{"title":"President, and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/amit-kumar-9851b521/","email":null,"company":{"title":"Anixa Biosciences"}}}},{"answer":"As a leader, one must think big picture in addition to keeping end goals top of mind in order to drive a company forward and execute decisions at the right time. It’s important to think about overall strategy and the benefits from all angles to determine value for project management, identifying what to pursue and what to abandon, in addition to having agility in the decision process. For me, two important aspects for effective industry leadership are prioritization and focus, crucial for applying the right amount of time and energy in order to get a product to market faster and deliver medicines to patients in need.
\nWhile some of these aspects require experience and natural intuition, a leader is only as good as the team and must have clear communication with personnel in order to bounce off ideas to eventually reach sound consensus. The ability to build and maintain a strong collaborative team and a trustworthy relationship allows the company as a whole to function better, to solve problems, and ultimately to be successful in our goals.
\n","showOnHomepage":true,"author":{"title":"Judy Chou, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Chou_AltruBio.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":null,"email":null,"company":{"title":"AltruBio, Inc."}}}},{"answer":"I believe there are three critical components to being a successful leader in this industry: vision, authenticity, and enabling the success of others.
\nVision: The path to creating a new drug that will change a patient’s life, from the starting point of an idea in a laboratory to the approved treatment, is a long and perilous path through the woods with many twists and turns. To lead the team and not get lost, one has to be able to see and communicate the vision of that destination, of bringing forward a drug that can fundamentally improve the life of oneliving with a disease.
\nAuthenticity: A leader is more than just actions. People will join a leader who is committed, who cares, and who is authentic. This authenticity will carry one through the challenges that a company faces over time, bringing the community together to help advance the effort and give confidence to the investors who join us on the voyage.
\nEnable success: What we are trying to do requires the efforts of many people working together as a team. To achieve team success,leaders must enable the success of everyone on their team. This includes providing clear direction and supporting intellectual, technical,and financial endeavors to create an environment where every individual feels that they are appreciated and can grow. This is a continuous effort that a company’s leader has to be committed to and nurture.
\n","showOnHomepage":true,"author":{"title":"James McArthur, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_McArthur_PepGen.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/james-mcarthur-b562a34","email":null,"company":{"title":"PepGen"}}}},{"answer":"To be a leader in the industry, we believe that your philosophy must be patient-centered. The entire field is driven by the opportunity to offer patients hope for more effective therapeutics through innovation. True innovation requires leaders to relentlessly push the boundaries of what is possible and be comfortable with the uncertainty that comes with every calculated risk.
\nAs leaders, we are often pioneering uncharted territory. Quickly recognizing the underpinnings of a problem and remaining flexible will allow you to pivot when needed to create the best chance for success. The biopharma industry is rapidly evolving, and, as leaders, we must be able to adapt. Being agile allows you to make smart decisions that maximize future success for both the company and patients.
\nThe final key to impactful leadership in this industry is flawless execution. As research progresses, businesses develop, and clinical trials are carried out, it is important to execute on each aspect over which you have control. To be successful, you need to build an experienced team with diverse perspectives that is comfortable with the challenges of drug development. While anyone can set goals, only the right team can make all the difference in executing on them seamlessly for patient benefit.
\n","showOnHomepage":true,"author":{"title":"Mahesh Karande","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Karanda_Omega.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/mahesh-karande/","email":null,"company":{"title":"Omega Therapeutics"}}}},{"answer":"There are several important factors that contribute to leadership in this industry — building a great team, prosecuting great science, and keeping the end goal top of mind — developing life-changing medicines for patients.
\nDrug development is a team endeavor, and it is critical to build a multidisciplinary team of individuals who bring different experiences and backgrounds and can work collaboratively toward a shared goal. This is what we have worked to build throughout the organization at Nurix.
\nAt Nurix, prosecuting great science means always striving to push the frontiers of molecular biology and genetics while combining such approaches with the latest in structural, computational, and medicinal chemistry. Based on a great scientific foundation, we have developed our proprietary DELigase platform, which combines our deep knowledge of the E3 ligase class of proteins with the powerful technology of DNA-encoded libraries (DEL). We are leaders in the field in this exciting new application of massive combinatorial DEL chemistry. Our DEL collection now includes over five billion compounds and fuels our pipeline, enabling us to rapidly build and screen drugs that can address therapeutic targets that were once thought to be undruggable. We advanced four wholly owned programs to clinical studies in the last year, as well as making progress in significant strategic partnerships with both Sanofi and Gilead Sciences.
\nGreat science and a great team are what power Nurix as we work toward our goal of bringing novel, first-in-class, life-changing medicines to patients.
\n","showOnHomepage":true,"author":{"title":"Arthur T. Sands, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Sands_Nurix.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President, Chief Executive Officer, and Board Director","linkedin":"https://www.linkedin.com/in/arthur-t-sands-m-d-ph-d-5392308b/","email":null,"company":{"title":"Nurix Therapeutics"}}}},{"answer":"To be a leader in this industry, you must genuinely care and have empathy for the people you are intending to help. With over 50 million American adults suffering from mental illness and 250 dying per day due to substance abuse disorders, we are all impacted directly or indirectly by this.
\nLeadership takes courage and an ability to persuade others to believe in an alternative approach. Amid a renewed interest in psychedelic-assisted therapy for mental health, MindMed is leading with science, conducting clinical trials, and building on the extensive existing data to prove the therapeutic potential of psychedelics while changing the surrounding narrative.
\nBuilding a team with expertise in areas beyond your own with a shared goal and with people you can trust is key. We’re expanding our team with not only psychedelic and mental health experts but scientists in other areas of drug development who believe in the potential of psychedelic-inspired medicines and experiential therapies to provide patients sustained mental healing.
\nBeing open to strategic collaborations is also critical. I believe that, in our industry, a rising tide will lift all boats, so our ethos is to cheer on others making genuine, lasting innovations in this space. With many psychedelic compounds and derivatives being studied for a range of indications, collaboration is the way forward. This will not be a winner-take-all market. We are taking a collaborative approach to advancing our pipeline through partnerships with all who share our mission to revolutionize the treatment of brain health disorders.
\n","showOnHomepage":true,"author":{"title":"Rob Barrow","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Barrow_MindMed.png","mediaDetails":{"height":279,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/robert-barrow-b50836a","email":null,"company":{"title":"MindMed"}}}},{"answer":"In this industry, we believe that the key element to being a leader is placing patients and their quality of life at the center of your strategy. We are committed to pushing the boundaries of our immunotherapeutic platform to offer potentially better treatments for hematologic and solid cancers. Current therapy options for many cancers are inadequate, and some can cause devastating side effects and can be difficult to administer, and, over time, many patients become resistant to treatment or relapse. We are keeping patients’ quality of life at the forefront of our work, and we are motivated every day by providing new therapeutic options to fulfill unmet medical needs.
\nContinuous innovation is necessary in this entire industry, but a vital driver in the oncology landscape in creating novel therapies for patients with limited treatment options and changing the current standard of care. At IMV, we are working to develop partnerships to build on the expertise of all stakeholders in the industry (institutes, researchers, biotechs, and pharmaceutical companies) and creating new and better immunotherapies to fight cancer. Through our science, the passion of our team, and continued collaborations, we look to move drugs to market, but most importantly to make a difference in the lives of patients.
\n","showOnHomepage":true,"author":{"title":"Andrew Hall","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Hall_IMV.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/andrewhall29/","email":null,"company":{"title":"IMV"}}}},{"answer":"Two factors that stand out as differentiators for leaders (and their companies) are being proactive and innovative. Staying in tune with the continued development of trending therapies in the space is essential to making progress and continuing to develop cutting-edge treatments. Take my company, Immunome, as an example. Our goal is to become a leader in redefining drug discovery by leveraging the information provided by the most educated components of the human immune system (memory B cells) to develop new therapeutics, beginning with oncology and infectious diseases. Guided by that innovative mindset and ambitious strategy, we quickly adapted after the start of the COVID-19 pandemic to develop an antibody cocktail against SARS-CoV-2, which we believe could provide a novel and powerful approach to combat the virus, despite its rapid mutational drift. We have been proactive in testing our cocktail’s efficacy against new variants as they emerge, and the rapid response nature of our platform allows us to introduce new therapeutics should the need arise.
\nThis innovation and proactivity is important not only for Immunome as a company, but for the patient communities that could benefit from our treatments. We have seen with immune checkpoint inhibitors how powerful harnessing the PD-L1 pathway can be in treating cancer. We believe the immune system can be a tremendous source of new innovation in new drugs, and we intend to lead this effort.
\n","showOnHomepage":true,"author":{"title":"Purnanand Sarma, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Sarma_Immunome.png","mediaDetails":{"height":267,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/purnanand-sarma-6412444/","email":null,"company":{"title":"Immunome"}}}},{"answer":"As an executive in the emerging life sciences space, it’s critical that we stay ahead of the ever-changing landscape to anticipate potential risks and opportunities and take actions to mitigate them or be in a position to create options for the company. As a retired military veteran, I was trained to identify potential threats and then plan contingencies and alternate actions around those issues. By applying these principles, I have found that our team has been able to remain highly flexible and to maintain progress, often thinking creatively and differently to overcome the obstacles we’ve faced and quickly pivoting to potential solutions.
\nIn addition to remaining agile, it’s also critical to identify the right talent to help your company achieve its overarching objectives. In small companies, each person and position is critical. After hiring the right individuals in terms of experience and disposition for small companies, putting in place a culture of collaboration and joint accountability leverages the strengths of your team. By encouraging them to be empowered in their respective areas of expertise, I have found that people truly feel themselves becoming a part of something much bigger. That is the environment we have seen generate the best results. At Windtree, I am very proud of the team we’ve assembled, which has demonstrated an overwhelming passion for helping advance the multiple programs in our pipeline, despite significant headwinds associated with the pandemic and executing complex programs. Through our work, we hope to bring transformative solutions for significantly underserved patient populations that face critical health situations.
\n","showOnHomepage":true,"author":{"title":"Craig Fraser","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Fraser_Windtree_Therapeutics.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Chief Executive Officer, President, and Director","linkedin":"https://www.linkedin.com/in/craigfraser/","email":null,"company":{"title":"Windtree Therapeutics"}}}},{"answer":"A leader is only as strong as their team. At TFF Pharma, we rely on the expertise and dedication of our management, our advisory boards, and our many collaborators who impart a wealth of invaluable scientific, medical, and technical knowledge to propel our programs from early-stage development to advanced clinical testing. This level of integrated and consistent collaboration requires transparency and communication with all of TFF’s partners and stakeholders. In an industry where timelines are consistently shifting, especially during the ongoing COVID-19 pandemic, we prioritize maintaining consistent discussions with our collaborators on progress to ensure alignment and ability to shift or reassess if challenges arise.
\nWith so many moving parts involved — including in TFF’s partnerships and our in-house programs — it’s also my responsibility as a leader to remind my team to remain steadfast in our focus, which is to use our Thin Film Freezing technology to improve efficacy and administration of medicines and improve health outcomes for patients. This synergy of maintaining communication and awareness across ongoing projects while still staying focused on your company’s core goal is essential to successful leadership in the biotech industry.
\n","showOnHomepage":true,"author":{"title":"Glenn Mattes","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/G_Mattes_TFF.png","mediaDetails":{"height":239,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"http://www.linkedin.com/in/glenn-mattes-78617349/","email":null,"company":{"title":"TFF Pharmaceuticals, Inc."}}}},{"answer":"To be a leader, you must have a mission — a driving force. For me personally, and for SCYNEXIS, our primary mission as a leader in the antifungal space is to positively impact patients by bringing truly innovative medicines to market. With this in mind, our scientists are developing the company’s lead asset, ibrexafungerp, as a broad-spectrum, systemic antifungal for multiple indications in both the community and hospital settings. Years of dedicated work led to the development and commercialization of our first product, which is in the area of women’s health and which represents the first new antifungal class approved in more than 20 years.
\nTenacity, commitment, and purposeful collaboration are key components that lead us to be successful. With this ongoing work and collaboration, we can align ways not only to best diagnose, contain, and treat infected patients, but to appropriately support and fund the development of specific and targeted antifungals. Encouraging a sense of collaboration and teamwork is important. We can accomplish a lot more together than individually with our “never give up” attitude in the fight against serious and often deadly infectious diseases. Ultimately, SCYNEXIS has a robust pipeline that speaks for itself, but having a clear and distinct mission with open ears as a leader is what makes the real difference.
\n","showOnHomepage":true,"author":{"title":"Marco Taglietti, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Taglietti_SCYNEXIS.png","mediaDetails":{"height":246,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/marco-taglietti-md/","email":null,"company":{"title":"SCYNEXIS, Inc."}}}},{"answer":"The key to being a leader in the biotech industry is relationships both externally and internally. Building a complementary team with individuals from different backgrounds leads to an invigorating work environment that allows individuals to think beyond conventional boundaries and take what they learned from their own unique experiences and challenges to efficiently solve problems. Utilizing these various perspectives from different walks of life allows our team to develop creative and innovative ideas that can better serve patients and the organization. As a CEO, this pushes me to think outside of the box and continuously look through a different lens that ultimately strengthens the company’s vision and approach in a fast-paced, constantly evolving industry. Additionally, cultivating relationships within your team and professional network is an essential part of the learning process for any leader that helps to identify opportunities for growth. Maintaining these relationships is even more important as your company grows and you are challenged to navigate the industry. Being open to different ways of thinking and gaining insight from external perspectives has allowed me to build a strong foundation for long-term success and growth.
\n","showOnHomepage":true,"author":{"title":"Avanish Vellanki","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Vellanki_Rain_Therapeutics.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/avellanki/","email":null,"company":{"title":"Rain Therapeutics"}}}},{"answer":"Over the past ten years, we have witnessed the unprecedented evolution of the life sciences, exploding to a $190 billion market. At MilliporeSigma, through an innovative and customer-first mindset, we have catalyzed this change in what continues to be a highly competitive and dynamic industry. Today, we are a top-tier player with a broad portfolio of products and a complementary range of services, including CDMO and contract testing, supporting our customers’ ambitions to deliver traditional and novel therapies. Several key factors contribute to our strong position.
\nFirst, we can serve our customers’ full spectrum of needs with solutions rather than stand-alone products. For example, we are moving beyond specific products for the R&D and Quality Control labs to complete workflow solutions, including digital data capture and management. Another example is leveraging synergies between our best-in-class products for our bioprocessing customers with service offerings and collaborating with our customers on designing robust, efficient processes to enable them to get therapies to patients faster.
\nSecond, we constantly scan for emerging trends — scientific, customer, and societal expectations — and proactively invest to capture the key ones to stay ahead of the curve. We aim to ensure that we have the right technologies mature enough to serve rising demand as the market evolves. For example, our capabilities in lipids for nonviral delivery positioned us at the right time and place to support the delivery of the breakthrough mRNA vaccine. We have since augmented this by building capabilities in services to provide our customers with a unique end-to-end offering to support the pipeline of future mRNA vaccines and therapeutics, ultimately bringing them to patients.
\nThird, we define leadership not just in terms of products or services but also in societal impact. The ability to holistically address sustainability, environmentally and socially, whether it is helping customers understand the CO2 footprint with a transparent, data-driven approach, having a clear roadmap to decarbonizing your business, or proactively engaging the supply chain to be prepared for the new green economy, is now a key decision-making criterion. While we have much to do here, it is central to our plan going forward.
\n","showOnHomepage":true,"author":{"title":"Meeta Gulyani","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Gulyani_MilliporeSigma.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Head of Strategy, Business Developments, and Sustainability","linkedin":"https://www.linkedin.com/in/meeta-gulyani-3bb60b10","email":null,"company":{"title":"MilliporeSigma"}}}},{"answer":"For contract development and manufacturing organizations (CDMOs), customer service excellence is crucial to forging successful long-term partnerships and collaborations. At the core of this is investment in technology, capabilities, capacity, and people. At Sterling, we have strategic plans to ensure that we look forward and stay ahead of the competition by constantly evaluating the market and industry in order to better understand existing and future needs. This allows us to identify opportunities to continuously improve and invest, both in manufacturing assets and in our employees’ skills and training.
\nEvery manufacturing process involves on-time delivery of product, in full, and to the correct specification. For the manufacturer, this means that the process must be optimized and executed with all safety and quality compliances adhered to. Behind every process are countless hours of development, in both the chemistry and analysis, as well as investments in, and qualification of, laboratory and production equipment. There are also the crucial systems such as maintenance, as well as secure data capture and handling.
\nCustomer audits now look beyond whether a company can simply make a product and include assessments on environmental and employment procedures, as well as long-term security of supply chains and overall business practices. Evaluation of processes and capabilities — and investments made where necessary — are crucial to maintaining a leadership position and meeting customers’ demands.
\n","showOnHomepage":true,"author":{"title":"Andrew Henderson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Henderson_Sterling_Pharma-1.png","mediaDetails":{"height":249,"width":211}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://uk.linkedin.com/in/andrew-henderson-7464278","email":null,"company":{"title":"Sterling Pharma Solutions"}}}},{"answer":"Experience. Future orientation. Customer focus. Extensive know-how with numerous technologies — that doesn't happen overnight. Syntegon has built this up over 160 years. It is important not only to face market trends like digitalization, efficiency, and flexibility, but to actively shape them. Sustainability is also becoming increasingly important for the pharma industry. We can use our broad experience from the food business to support our customers in achieving their sustainability goals. An industry leader also works closely with its customer. Besides a global presence, this means knowing customer needs and being able to offer complete solutions: from consulting and services to machines and systems.
\n","showOnHomepage":true,"author":{"title":"Uwe Harbauer","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/U_Harbauer_Bosch.png","mediaDetails":{"height":235,"width":211}}},"authorFields":{"title":"Member of the Executive Board","linkedin":"http://www.linkedin.com/in/uwe-harbauer-23b08244","email":"PA-PH.Management@bosch.com","company":{"title":"Syntegon"}}}},{"answer":"To be a successful leader in the bioreagents and CRO services industry, one must have a broad depth of understanding regarding client needs in basic research, as well as vaccine, therapeutic, and diagnostic platform development. Forward vision as to what clients in industry and academia will desire, both in the short and long term, is critical. In addition, a leader must always surround him or herself with talented and driven individuals and not be afraid to aggressively draw on those talents and that ambition to grow the company at every level.
\n","showOnHomepage":true,"author":{"title":"Rob Burgess, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Burgess_Sino_Biological.png","mediaDetails":{"height":295,"width":211}}},"authorFields":{"title":"Chief Business Officer","linkedin":"https://www.linkedin.com/in/rob-burgess-074a8023/","email":null,"company":{"title":"Sino Biological"}}}},{"answer":"When I think about being a leader in our industry, I think about being a role model — one that inspires others to focus on the greater purpose that we serve and one who drives positive change. Developing new medicines with the potential to improve the quality of life for patients in need is an incredibly rewarding purpose and an important responsibility. This is why Quotient’s manifesto is focused on exactly that: “Molecule to Cure. FAST.”
\nThe leaders that I admire have consistently had this focus at the front and center of their vision as their North Star. I’m fortunate to be surrounded every day by great leaders in Quotient and at our customers. Importantly, such leaders are not dictated by their position in an organizational hierarchy. They are colleagues that come from anywhere in the business and have the vision to deliver a real positive impact that is so powerful that it inspires those around them to mobilize and support. Strong leaders maintain that passion when things don’t always work out, which, unfortunately, we know happens all too frequently in drug development. But when it does work out, it’s an incredibly fulfilling experience.
\n","showOnHomepage":true,"author":{"title":"Mark Egerton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Egerton_Quotient_Sciences.png","mediaDetails":{"height":240,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/markegerton/","email":null,"company":{"title":"Quotient Sciences"}}}},{"answer":"I think one of the things that has kept Corning Life Sciences relevant over time is our ability to innovate — while working closely with our customers on these innovations. Each recent innovation we have launched has one thing in common: we worked closely with customers to understand their research or bioproduction processing challenges, and we worked to address and alleviate these constraints. Staying in touch with the pulse of where industry trends are going and what it will take to drive widespread adoption and cost-effective solutions for these trends is another key factor.
\n","showOnHomepage":true,"author":{"title":"Kim Titus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Titus_Corning_Life_Sciences.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Director of Business Operations","linkedin":"https://www.linkedin.com/in/kim-titus-bb481a9/","email":null,"company":{"title":"Corning Life Sciences"}}}},{"answer":"A key trait for any leader is offering the best service to customers possible, and I am no exception. This means that customer centricity is essential — treating your customers’ products like they are your products. It also means making yourself easily accessible as a leader and providing counsel to customers that need it. My goal is always to work with them to find solutions, define clear timelines, and create fair pricing policies that bring their products to market and ensure the supply of drug substances for the patients who need them.
\nCustomer centricity is also important for our most important stakeholders — our employees. A service provider is only as good as their staff enables them to be, and that’s why being a leader starts at home. It starts with treating employees respectfully, enabling them to bring new ideas to the table for consideration, and providing them with the training and support they need. It also means investing in your employees.
\nWe are proud to be developing new training opportunities for our teams across the globe this year that will allow them to advance their careers and better serve our customers.
\n","showOnHomepage":true,"author":{"title":"Patricio E. Massera","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Patricio E. Masser_AGC_web.png","mediaDetails":{"height":264,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/pmassera/","email":null,"company":{"title":"AGC Biologics"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-what-important-company-milestone-do-you-anticipate-reaching-in-2022/","uri":"/roundtable/articles-q-what-important-company-milestone-do-you-anticipate-reaching-in-2022/","slug":"articles-q-what-important-company-milestone-do-you-anticipate-reaching-in-2022","title":"Q: What important company milestone do you anticipate reaching in 2022?","roundtable":{"topic":"2022 Milestones","question":"What important company milestone do you anticipate reaching in 2022?","roundtable":[{"answer":"In 2022, the Pharma Business group will be putting more choices, solutions, and resources directly in the hands of customers through an innovative approach to our website. We have gone through an extensive digitalization process that we think will bring expertise and capabilities much closer to our customers. One thing all pharma companies seek is the effective treatment or product brought to market as quickly as possible. We can bring value and support to virtually every part of the development, production, and future of pharmaceutical products. The key in our digital age is to get the right balance between direct person-to-person expertise and accessibility for the customer at a time they choose or need. People have finite time to deliver top-quality service, and I think many developers and formulators accept this very well, but I know that IMCD Pharma group and the people we serve have a lot of common ground on what should be readily available. For this reason, our increasingly digitized and collaborative laboratory network will bring enhanced capabilities more seamlessly to our customers through the website-based Solution Centre. This will achieve the milestone of putting the IMCD Pharma group next to the customer as they create solutions for their challenges.
\n","showOnHomepage":true,"author":{"title":"Alen Guy, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Guy_IMCD.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Technical Director, the Pharmaceutical Business Group","linkedin":"https://www.linkedin.com/in/alen-guy-07a4444/?originalSubdomain=de","email":null,"company":{"title":"IMCD"}}}},{"answer":"Arising from an increasing number of small and medium-sized pharmaceutical and biotech companies without their own production and/or testing facilities, heightened need for sterile injectable formulations, and growing demand for biopharma products, Alcami is undergoing significant growth.
\nIn 2022, our Morrisville, North Carolina, and Charleston, South Carolina, sites are expected to double in number of aseptic fill lines with lyophilization capabilities in support of sterile manufacturing from clinical to commercial scale.
\nImplementing new operational approaches, including isolator technology, low-loss fill lines, single-use equipment, and terminal sterilizations allows us to increase manufacturing process efficiencies, minimize waste, and reduce costs.
\nActivities related to the development of COVID-19 therapeutics and vaccines, combined with the continued advancement of other biologic candidates, created deepened demand for bioanalytical testing. 2022 will bring significant enhancement to Alcami bio testing at our 16,000–square foot laboratory in the Durham, NC, site, which is being equipped with new tandem quadrupole and QTOF systems, variable pathlength UV, and ultracentrifugation.
\nAdditionally, a solid-state chemistry center of excellence will occupy our newly built 12,000–square foot laboratory in Morrisville. This space will host thermal analysis with DSC and TGA, along with polymorph, crystallization, and salt form screenings using laser particle size, polarizing light microscopy, X-ray powder diffraction, and ion chromatography.
\n2022 also brings advancement in our cleanroom services. The acquisition of Masy BioServices expands Alcami's external environmental monitoring program with room and chambers mapping and the SenseAnywhere monitoring system.
\nWe are also strengthening our internal systems by installing NuGenesis by Waters for next-generation, integrated laboratory information-management systems (LIMS).
\n","showOnHomepage":true,"author":{"title":"Anna Dormady","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Dormady_Alcami.png","mediaDetails":{"height":289,"width":211}}},"authorFields":{"title":"Director of Laboratory Operation, Morrisville, NC","linkedin":"https://www.linkedin.com/in/anna-dormady-b8a2067/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"This year begins a new chapter for Vector Laboratories as we move to expand our portfolio and capabilities. Thankfully, we’re not starting from scratch. Following a historic 2021 that saw Vector Laboratories become a standalone company, we now have in place the people, systems, and processes to capitalize on our inherent value.
\nWith everything under one roof, we are planning an ambitious mergers and acquisitions strategy. We’re actively identifying complementary companies to further accelerate our growth strategy. Our goal is to complete one major acquisition, as well as multiple small, large, and transformative add-ons, starting this year.
\nM&A will be a key driver in our two-pronged product strategy. The first involves expanding our capabilities to better serve customers, not only with catalog products and customizations, but also custom services that result in high-value, bespoke products. The second prong hinges on serving the needs of customers as they move into applied uses, such as diagnostics. We want to broaden Vector’s presence in our existing sectors by continuing to invest in cutting-edge tools that can help our customers accelerate their innovations. We are planning to become market leaders in one new vertical, build out our custom product manufacturing capabilities, and grow commercial supply relationships in 2022.
\n","showOnHomepage":true,"author":{"title":"Lisa Sellers, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/L_Sellers_Vector.png","mediaDetails":{"height":244,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/lisavsellers/","email":null,"company":{"title":"Vector Laboratories"}}}},{"answer":"This year, IFF’s Pharma Solutions is looking forward to the 60th anniversary of our flagship brand Avicel®, which pioneered the use of microcrystalline cellulose as a strategic excipient in the formulation of high-quality pharmaceutical products. As the originator and leader in this space, we have the responsibility to continue to supply the highest possible quality to the industry to grow and evolve with our customers. It’s remarkable how we’ve been able to shape and support the pharmaceutical industry with this critical product in the last six decades. Our journey is marked by continuous innovation, starting with our gold standard grades of Avicel® PH-101 and Avicel® PH-102 and then enabling customization to produce a wide range of solutions that are widely used by customers today. Due to our polymer science expertise and deep application know-how, we’ve also been able to create multiple co-processed materials that have enabled the production of more robust and reliable formulations.
\nMoving forward, we’ll continue to invest and support this product line. We are actively using cutting-edge digital tools like advanced analytics and predictive modeling to further improve the reliability, consistency, and quality of our entire product offering.
\n","showOnHomepage":true,"author":{"title":"Dago Caceres","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Caceres_DOW.png","mediaDetails":{"height":238,"width":211}}},"authorFields":{"title":"Global Strategy Director","linkedin":"https://www.linkedin.com/in/dago-caceres-6491a4/","email":null,"company":{"title":"IFF"}}}},{"answer":"We have several important milestones on the horizon. One is the continued release of new modules for our digital tools within our industry-leading Virtual Pharma Assistants (VPAs) platform. We continue to focus on improving the customer experience, whether that customer is seeking technical, quality, regulatory, or purchasing information and services. New modules will build on our success and offer a seamless and unique experience to customers large and small.
\nNext, we are integrating digitalization into our core manufacturing sites; for example, in 2022, we will launch a truly virtual audit experience at our flagship Bishop, Texas, ibuprofen plant — offering all customers an intimate experience with the facility despite lingering travel restrictions from COVID.
\nI want to also highlight the increasing momentum in the area of sustainability. Customers in 2022 are demanding far more transparency into product carbon footprint (PCF) than in any years in the past, and, as a direct result, we have fully validated the specific PCFs for our ibuprofen portfolio and are actively expanding this initiative for other product lines this year.
\nFinally, we continue to expand our footprint in the fast-growing biopharma industry, where portfolio expansions and investments will continue to increase our capacity and unique capabilities in the market.
\n","showOnHomepage":true,"author":{"title":"David Freidinger","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Freidinger_BASF.png","mediaDetails":{"height":253,"width":211}}},"authorFields":{"title":"Vice President of Global Business Management","linkedin":"https://www.linkedin.com/in/david-freidinger-a8a49814/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"2022 is the first full year after the preliminary FDA guidance for real-world data (RWD) supporting real-world evidence (RWE) for regulatory decisions was released in the fourth quarter of 2021. This is one of those rare inflection points where study designs can now be fundamentally reconsidered and where data from retrospective and prospective approaches can be integrated into a single coherent evidence-generation plan, by study and over the life cycle of a therapeutic program. There’s an emerging “System of Evidence” that offers the potential of accelerating therapeutic programs, allowing more confidence in earlier decisions, and ongoing studies confirming efficacy and safety.
\nConcertAI was founded to advance the next generation of RWD and artificial intelligence software-as-a-service (AI SaaS) solutions to bring RWE generation in oncology, hematology, and urological cancers more broadly into practice with new standards of precision, representativeness, and utility across a range of study types. Our 2021 integration of TeraRecon, a leading radiological imaging company, and our partnership with ASCO’s ConcerLinQ program have set us up to bring a multitude of pieces together this year. Our retrospective RWE work will be complemented by our Digital Clinical Trial solution to enable biopharma-sponsored and investigator-initiated clinical trials within their workflows — using clinical data sources throughout. This will bring the entire “System to Evidence” to reality by offering biopharma innovators more options to accelerate needed new medicines and additional evidence guiding treatment decisions to patients and their care providers.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"This year, the first patients in two critical clinical trials further examining investigational EYP-1901 will be dosed, respectively — in our phase II Durasert and Vorolanib in Ophthalmology (DAVIO) study of EYP-1901 for wet age-related macular degeneration (AMD), and in our phase II study of EYP-1901 for diabetic retinopathy.
\nIn 2021, we shared promising findings observed in our phase I DAVIO study of EYP-1901 for wet AMD — interim six-month results demonstrated a positive safety profile, with 53% of patients remaining rescue-free following a single injection of EYP-1901. We hope the forthcoming studies commencing this year will continue to affirm and reinforce these data and the potential of EYP-1901.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"Possibly the only milestone that matters in 2022 is ensuring that cancer centers of all dimensions can be included in the clinical trial process and, in doing so, offering more trials to more patients as a clinical care option.
\nIn particular, our team’s goal is to reduce the myriad administrative burdens and costs holding all cancer centers back from joining the ranks of academic centers in clinical trial participation.
\nThis is a massively ambitious industry and corporate goal because the real milestone is not necessarily showing that reducing the administrative burdens matters,, but that it can be done significantly and across many cancer centers uniformly. We have proved this somewhat quietly within the consortium we serve. But 2022 demands that we and others like us be more vocal in allowing more healthcare organizations and stakeholders to see it, to test it, and to make it easier for this model to be accepted and adopted.
\nSo, it’s not just having accomplished material success, but doing it visibly so that others can readily adopt the best standardized methods.
\nThere is tremendous urgency, because this year is so unique. The ongoing impact of the pandemic and challenges in staffing and retaining necessary talent are denying all of us the benefits of clinical research that should be further along today than they are. We can, however, change things permanently for the better.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"We expect to announce a series of key partnerships to further streamline and automate the use of molecular diagnostics in clinical workflows across the United States using a digital platform solution for comprehensive cancer management. Our objective is to illustrate how a digital healthcare platform can unify EMRs, lab information systems, and molecular diagnostics to digitally reflect what the best comprehensive cancer care centers deliver to their patients.
\nIn particular, we want to establish that automating referral management, tumor boards, molecular test results, and prior authorization with revenue cycle management removes significant friction from health systems. We believe that this is the year we will break down therapeutic silos by providing a unified health record, allowing healthcare providers to ensure patients receive precision treatments and opportunities to enroll in clinical trials.
\n","showOnHomepage":true,"author":{"title":"Carla Balch","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Balch_Spesana.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/carla-balch-hates-cancer/","email":null,"company":{"title":"Spesana"}}}},{"answer":"Going into 2022, we continue to see high demands in large-scale manufacturing for the delivery of treatments and vaccines involving not just traditional antibodies but also novel technologies, such as mRNA and cell and gene therapies. As a result, we as a CDMO face a challenge to be well-equipped with sufficient capacity and the right facilities to accommodate the increasing needs.
\nThis year, we have announced plans to expand our biopharmaceutical business within our three core drivers: capacity, portfolio, and global expansion. As part of this growth plan at Samsung Biologics, we are currently building Plant 4, which is expected to start cGMP manufacturing in October 2022, and are also scaling up our mRNA drug substance (DS) manufacturing capacity at our current facility, ready for cGMP operations within the earlier part of this year.
\nThe construction of another new facility, Plant 5, is planned to start within this year, where we will offer multimodal products including cell and gene therapies and next-gen vaccines utilizing mRNA, pDNA, and viral vectors, all at a single site.
\nWe are further venturing into securing additional sites within Songdo, for the construction of Plant 6 and Open Innovation Center, and also overseas in multiple locations to maximize both our manufacturing capacity to produce large-scale biologics and to be in close proximity to its global clients.
\n","showOnHomepage":true,"author":{"title":"Kevin Sharp","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Sharp_Samsung_Biologics.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Vice President of Global Sales and Head of Strategic Operations Team","linkedin":"https://www.linkedin.com/in/kevintsharp/","email":null,"company":{"title":"Durbin"}}}},{"answer":"2022 represents the first year Lonza is entirely focused on supporting the needs of the healthcare industry. This newly defined clarity allows us to concentrate on meeting the needs of our customers irrespective of their size, location, or modality type. We will continue to anticipate challenges related to the ongoing global pandemic and monitor the evolving market needs to remain firmly positioned to deliver solutions for our customers, partners, and investors.
\nIn the past few months, we have continued to focus on our long-term success and responded to the evolving needs of the pharmaceutical industry. We progressed our growth investment strategy and, in 2022, expect to increase our total capital expenditures (CAPEX) to reach 30% of sales. We are committed to furthering our ongoing expansions in manufacturing capacity and capabilities spanning drug substance and drug product development and manufacturing across our existing production bases in China, the rest of Asia, the United States, and Switzerland.
\nWith the biopharmaceutical industry undergoing significant transformation, CDMOs must evolve to meet their clients' changing needs and growth. At Lonza, we understand that our innovation delivers essential advantages for our customers. In 2022, we will continue to focus on finding new manufacturing solutions, such as Ibex®, which allowed the build-out of mRNA facilities in record time to produce Moderna’s Spikevax vaccine. We will further develop offerings spanning novel modalities, such as exosomes, and technologies, including the Cocoon® Platform for automated cell and gene therapy manufacturing and robotic solutions for endotoxin testing.
\n","showOnHomepage":true,"author":{"title":"Jean-Christophe Hyvert","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_C_Hyvert_Lonza.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President, Biologics and Cell & Gene","linkedin":null,"email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"In terms of parenteral drug delivery solutions at Evonik, I think we are in for an exciting time in 2022. We are committed to further fueling the growth of nucleic acid therapies with the supply of lipids, formulation technologies, and manufacturing. Alongside lipids, we are also working with Stanford University on a polymer platform known as CARTs (charge-altering releasable transporters). These synthetic polymers can safely deliver mRNA to cells. A benefit of this platform is that it enables the delivery of mRNA to tissues and organs that are difficult to target with current lipid nanoparticle delivery. This year, we will start to offer formulation services with CARTs — expanding our toolbox of drug delivery technologies for mRNA and other nucleic acids.
\nAnother highlight is the continued roll-out of the new version of our well-known liposome extruder called LIPEX® Flow, which we launched last year. This enhanced extruder enables higher throughput, faster batch processing times, and a broader operating range, thus expanding application opportunities.
\nA final highlight for this year is an important addition to the VarioSys® Aseptic Fill Line, which was built and integrated by Bausch + Ströbel in 2020 at our parenteral drug manufacturing facility in Birmingham, Alabama. This year we will install an L-flange, which will add even more flexibility to our VarioSys® fill line, allowing us to do double fills, including for aseptic suspension drug products.
\n","showOnHomepage":true,"author":{"title":"Jane Meyer","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Meyer_Evonik.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":", Global Head, Parenteral Drug Delivery Solutions","linkedin":"https://www.linkedin.com/in/janemmeyer/","email":null,"company":{"title":"Evonik"}}}},{"answer":"For WuXi Biologics, the most significant milestones in 2022 will be the official operation and GMP release of both our U.S. site in Cranbury, New Jersey, and our European site in Dundalk, Ireland. With these locations, we will be closer to existing and prospective clients, given the fact that over 50% of our clients are headquartered in the United States or Europe. These milestones will also reinforce our “Global Dual Source” strategy — a commitment to clients that materials can be sourced and products can be manufactured at multiple WuXi Biologics locations across the globe.
\nAs a global contract research, development, and manufacturing organization (CRDMO), we have continually expanded our capacities and capabilities in the United States, Europe, and Asia in response to growing customer demand around the world. With the COVID-19 pandemic, our reach and diversified capacity meant that we could help enable clients' response without being restricted to any particular region.
\nIn 2022, WuXi Biologics will also further establish full, parallel capabilities in our sites across the United States and Europe, so they can provide true one-stop service — from process development to drug substance and drug product manufacturing. Our total cumulative CapEx in the U.S. and European markets is expected to reach USD $1.5 billion this year.
\n","showOnHomepage":true,"author":{"title":"Chris Chen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Chen_WuXi_Biologics.png","mediaDetails":{"height":254,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":null,"email":null,"company":{"title":"WuXi Biologics"}}}},{"answer":"In 2022, PCI will continue to expand our sterile fill/finish capabilities, improving the global capacity shortage for sterile drug manufacturing and packaging that began during the pandemic. Through our acquisition of Lyophilization Services of New England, Inc. (LSNE) and the recent addition of three new automated, isolator technology sterile fill/finish lines at two key clinical trial facilities (San Diego, California, and Melbourne, Australia), we are continuing to meet the demand of the ever-growing biologics market and bringing life-changing therapies to patients faster. PCI is already perceived as a pioneer in biologics packaging; with the addition of LSNE, we will cement our reputation as a leading global CDMO that provides an integrated experience to our clients across the entire drug product life cycle.
\n","showOnHomepage":true,"author":{"title":"Tim Roberts","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Roberts_PCI.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://linkedin.com/in/tim-roberts-a83a775","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"We look forward to the upcoming launch of our SOPHiA Homologous Recombination Deficiency (HRD) Solution, opening new doors for cancer research. HRD is a complex biomarker, important for PARP inhibitors, that helps identify whether cancer patients may respond better to specific treatments. HRD is caused by a cell’s inability to repair double-stranded DNA breaks through the homologous recombination repair (HRR) pathway, causing mutations that lead to the development of certain cancers. One method for quantifying these genomic aberrations is with whole-genome sequencing (WGS). More specifically, the SOPHiA GENETICS method uses a deep learning algorithm that has been specifically trained to recognize patterns of homologous repair deficiency in the genome of cancer samples. The algorithm is designed to produce a quantitative measurement of the level of genomic aberrations present in the sample being tested. Prior to HRD testing, PARP inhibitors — which keep cancer cells from repairing — were among the biggest breakthroughs in oncology in the last 10 years. SOPHiA GENETICS has also partnered with Friends of Cancer Research and others to develop strategies for assessing assay performance and aligning methods for measuring homologous recombination status and its use as a biomarker in clinical care.
\n","showOnHomepage":true,"author":{"title":"Jurgi Camblong, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Camblong_Sophia_Genetics.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/jurgicamblong/","email":null,"company":{"title":"SOPHiA Genetics"}}}},{"answer":"The Specialty & Custom Chemicals Show: SOCMA recently acquired a trade show, enhancing our mission to support the growth of the specialty chemical sector in North America. Our return to the trade show arena underpins SOCMA’s strategic focus to deliver commercial growth opportunities and maximize business development partnerships for the specialty and fine chemicals industry, which thrives on these connections. As companies work to reconstruct value chains and rethink CapEx projects and other business strategies, it has never been more important for them to come together — in a way that hasn’t been possible in almost two years. In 2021, we celebrated SOCMA’s 100th anniversary, and we are excited to solidify our position as a leader and connector for this innovative industry by delivering this critical avenue for companies to do business in 2022 and beyond.
\nChemOps Training: With the lingering effects of the pandemic remaining, SOCMA accelerated the launch of the ChemOps Training program, answering a call for industry-specific, specialized training resources for chemical manufacturing facilities. A solution to many of our members’ top concerns around chemical operator training and onboarding, the program is quickly becoming the go-to source for the specialty chemical industry to safely and effectively train operators. Companies and industry associations alike are implementing ChemOps Training to improve efficiencies in onboarding as sites fill critical production openings.
\n","showOnHomepage":true,"author":{"title":"Paul Hirsh","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Hirsh_SOCMA.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Senior Vice President, Industry Relations","linkedin":"http://www.linkedin.com/in/paul-hirsh-b4148185","email":null,"company":{"title":"SOCMA"}}}},{"answer":"2022 will be a cornerstone year for Skye Bioscience, as we transition from a preclinical to a clinical-stage company. We are fast approaching the initiation of our first-in-human phase I study in the first half of the year, with topline data expected in the third quarter and the full data readout in the fourth quarter of 2022.
\nOur phase I study will evaluate the safety and tolerability of SBI-100 in healthy volunteers. Our objective is to check an important box for regulatory authorities by demonstrating that our drug has minimal to no side effects in the eye and no unwanted systemic side effects from THC.
\nWhat is more significant, of course, is potentially demonstrating the intraocular pressure–reducing effects of SBI-100 in patients with glaucoma, thus leading to our planned phase II study in the United States At this time, we have completed our pre-IND meeting, which has resulted in valuable guidance from the FDA, providing Skye with a clear path to move forward with an IND submission. Subject to approval, the initiation of its phase II study will follow, with an expected start date in Q4 2022.
\n","showOnHomepage":true,"author":{"title":"Punit Dhillon","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Dhillon_Skye_Bioscience.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Chair","linkedin":"https://www.linkedin.com/in/punit-dhillon/","email":null,"company":{"title":"Skye Bioscience"}}}},{"answer":"Last year, we announced our dedicated global pharmaceutical ingredients organizational structure, leveraging our regional teams, international footprint, and strategic relationships with industry-leading suppliers to serve our customers better worldwide.
\nThis year is about achieving a new level of intimacy with our customers and suppliers. We continuously expand our offering — from infrastructure investments to biopharmaceutical portfolio growth, to strengthen our value and service level. We will continue investing in our distribution facilities, upgrading several more of our locations to meet API handling requirements, FDA registration, and ISO 9001 certification. We will also expand our high-purity solvents distribution capability beyond North America to Europe and Latin America by installing filtration lines, purified tank farms, and equipment essential to maintaining product integrity and quality from origin to destination.
\nAs the fast-evolving biopharma medicinal sector grows, we have already onboarded several suppliers to expand our offering with the novel ingredients used by this sector. We will continue expanding our portfolio with the bio-grade excipients and actives that this market uses.
\nBeyond our product offering, we plan to expand our technical capabilities by opening several Pharmaceutical Ingredient Solution Centers across the United States, Europe, and Latin America. These facilities and the scientists and professionals who lead them will allow us to deliver development solutions, regulatory assistance, and technical application testing. Whether it’s comparative analysis, formulation troubleshooting, or ingredient testing, customers and suppliers will have our labs and experts at their disposal for their innovation needs.
\nFinally, we take our Environment, Social and Governance (ESG) responsibilities very seriously as a global organization. We've outlined aggressive ESG goals for 2022 and will continue the rollout and investment across our business in low-carbon and resource-efficient technologies.
\n","showOnHomepage":true,"author":{"title":"James Park","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Park_Samsung.png","mediaDetails":{"height":261,"width":211}}},"authorFields":{"title":"Senior Vice President and Global Head, Business Development Center","linkedin":"https://www.linkedin.com/in/park73/","email":null,"company":{"title":"Durbin"}}}},{"answer":"Collaboration is the catalyst for scientific innovation. As such, leaders need to be focused on how they can make the world a better place, together. Think about what your products, solutions, and research bring to the table, as well as what other players in the industry can bring. You may have a gap that another company’s product or research can fill, and vice versa. Each of us have different strengths and weaknesses, and to identify those within ourselves and others will result in strategic partnerships that highlight our strong suits and solve important problems. By promoting industry-wide collaboration, we can all focus on the overall mission of making the world a better place.
\n","showOnHomepage":true,"author":{"title":"Jeff Mazzeo","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Mazzeo_Waters.png","mediaDetails":{"height":254,"width":211}}},"authorFields":{"title":"Vice President of Scientific Operations and Marketing","linkedin":"https://www.linkedin.com/in/jeff-mazzeo-8651587","email":null,"company":{"title":"Waters Corporation"}}}},{"answer":"2022 marks our 10th year as a company. Looking back at our early days, we had this vision to create simple tools that could provide a robust answer in a field setting to someone who is not an expert in mass spectrometry. Our life sciences and forensics customers have a job to do, and if we can make that job faster, easier, and more economical, then that’s a huge win for them. And it’s exciting to see, on a daily basis, the impact our customers are making in very critical-to-life applications. For example, first responders are using our handheld devices to detect and identify illicit synthetic opioids, reducing the number of fatal overdoses. Researchers are using our desktop devices to help bring new biotherapeutics to market faster in a quest to save lives from debilitating diseases.
\nWhile we’re proud of what we’ve accomplished, we’re excited about the next stage of our journey. We went public in December 2020, which has given us an infusion of capital to increase our technology and product investments. We look forward to the next 10 years, helping customers transform the way they’re doing things and making a difference in people’s lives.
\n","showOnHomepage":true,"author":{"title":"Kevin J. Knopp, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_J_Knopp_908_Devices.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/kjknopp","email":null,"company":{"title":"908 Devices"}}}},{"answer":"In 2022, Reify Health is focused on scaling the capabilities we have developed to a large, global customer base and systematically working to increase patient representation in clinical trials along the way.
\nWith our StudyTeam platform, this means continuing to increase adoption among sites, sponsors, and recruitment partners, especially in global markets. We already support clinical research in more than 75 countries, but we can do more to provide research teams in these countries with tools to run clinical trials more efficiently and more effectively.
\nThis year, we will also be working closely with our enterprise sponsor partners to scale utilization of StudyTeam’s Diversity Reporting functionality. Sponsors and sites are limited in the ability to understand how a trial’s inclusion/exclusion criteria and protocol design impact people from diverse demographics through the recruitment process. We recently found that, out of every 100 Black trial candidates, only 23 will eventually enroll — compared to 40 out of 100 white candidates. In 2022, we are digging deeper into data like those to help our partners understand why the industry is failing to engage a more diverse group of people, and, most importantly, what they can do to develop real, nuanced strategies to improve.
\n","showOnHomepage":true,"author":{"title":"Ralph Passarella","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Passarella_Reify_Health.png","mediaDetails":{"height":279,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/ralphpassarella/","email":null,"company":{"title":"Reify Health"}}}},{"answer":"In 2022, eClinical Solutions will celebrate its 10-year anniversary, marking a decade of helping modernize an industry that looked very different 10 years ago. The industry changes we anticipated have accelerated exponentially in recent years. Clinical trials have become much more complex, incorporating many new types of data, all of which have the opportunity to bring faster and richer insights to the development process.
\nToday, an average phase III trial includes data from 10 different systems, double the average from 2012. The impacts of working with a much higher volume of data in trials, including those from decentralized trial designs and systems, are numerous and have put stress on the people, processes, and technology associated with data review, integration, and analysis. The current processes and tools in the middle of clinical development have not kept pace with the type of data required to develop personalized medicines. In 2022, the trend to modernize all aspects of the end-to-end clinical data life cycle has hit an inflection point as technology investment in this space continues to grow. More life sciences companies of all sizes will adopt a modern data infrastructure and analytics platform, such as the elluminate Clinical Data Cloud, to liberate data from silos, automate manual processes, and make the work of drug development experts easier, faster, and more efficient.
\n","showOnHomepage":true,"author":{"title":"Raj Indupuri","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Indupuri_eClinicalSolutions.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/rajindupuri/","email":null,"company":{"title":"eClinical Solutions"}}}},{"answer":"As we begin 2022, we look forward to an exciting year for 9 Meters. We anticipate topline data from our phase II trial of vurolenatide for the treatment of short bowel syndrome (SBS), a rare and debilitating disease resulting in poor absorption of nutrients as a result of losing a significant length of the intestine. Patients suffering with this disorder can face serious nutrient deficiencies and life-altering GI symptoms. We believe that vurolenatide has the potential to address a number of these symptoms and may provide advantages over current treatment approaches, which aren’t appropriate for all types of SBS patients.
\nWe are also anticipating an interim analysis in Q2 for our phase III trial of larazotide, the most advanced drug in development for celiac disease. Currently, there are no treatment options for the disease outside of a strict gluten-free diet, which doesn’t alleviate symptoms for all patients. We expect the results of our trial by the end of this year, and positive data at that stage could represent a breakthrough milestone for celiac disease care.
\n","showOnHomepage":true,"author":{"title":"John Temperato","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Temperato_9Meters.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President, Chief Executive Officer, and Director","linkedin":"https://www.linkedin.com/in/john-temperato-62aba52/","email":null,"company":{"title":"9 Meters Biopharma"}}}},{"answer":"This year, we’re anticipating several milestones for our proprietary technologies that have the capabilities to unlock the potential of personalized TCR T cell therapy for cancer treatments. Within the first half of this year, we will launch the production version of our TCXpress™ platform, which is capable of processing thousands of single T cells directly into functionally expressed T cell receptors (TCRs) within a matter of days, thereby creating extensive libraries for rapid candidate selection. We will use the TCXPress™ production platform to support our discovery work for our internal clinical programs and for strategic discovery partnerships with other immuno-oncology companies.
\nAlongside this platform, we’ll continue to build upon our virtual patient data with our NEOXpress™ platform to further our personalized solid tumor program. Both TCXpress™ and NEOXpress™ work together to quickly identify the matching TCR/neoantigen pairs from the captured TCR and tumor-specific neoantigen repertoires obtained from patient tumors — a process we refer to as multiplexing.
\nIn Q4 of 2022, we plan on filing an IND with the U.S. FDA for our lead TCR T cell therapy clinical candidate in our TCX-101 pipeline platform. This TCR T cell therapy, directed against HA-1, a minor histocompatibility antigen, will be given to high-risk leukemia patients in the context of allogeneic stem cell transplant to target their leukemia with a lower risk for graft-versus-host-disease.
\nOverall, we’re excited for our continued growth this year and remain committed to making personalized cancer therapy treatments a reality.
\n","showOnHomepage":true,"author":{"title":"David Apelian, Ph.D., M.D.,","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Apelian_BlueSphereBio.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/david-apelian-64a7662/","email":null,"company":{"title":"BlueSphere Bio"}}}},{"answer":"This year, we anticipate achieving a critical milestone for the company with the initiation of our pivotal study in the United States to evaluate the safety and performance of the C-Scan® System, our preparation-free, capsule-based colorectal cancer screening test in development to detect precancerous polyps.
\nC-Scan is designed to address a relevant unmet medical need: the low colorectal cancer screening rates observed globally, which result in almost 1 million deaths annually. Only about two in three adults among the targeted screening population undergo a colonoscopy in the U.S., and lower rates are found in other regions of the world, such as Europe and Asia.
\nMain barriers to screening include the invasiveness of the colonoscopy procedure and bowel preparation. Low invasiveness tests available or in development, such as fecal tests or liquid biopsy, are primarily designed to detect cancer and demonstrate low sensitivity in detecting pre-cancerous polyps. As such, they do not necessarily provide patients with the time window to pre-empt the disease. We believe there is a large unmet need for a patient-friendly colorectal cancer screening option, such as C-Scan, that can overcome barriers to colonoscopy screening while also enabling detection of polyps before they turn into cancer, versus detecting cancer once it has already appeared.
\nWe look forward to bringing a much-needed colorectal cancer prep-less screening modality to the market in the upcoming years to enable early intervention, cancer prevention, and improved screening adherence worldwide.
\n","showOnHomepage":true,"author":{"title":"Alex Ovadia","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Alex Ovadia_Check-Cap_web.png","mediaDetails":{"height":264,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/alex-ovadia-7b471b4/","email":null,"company":{"title":"Check-Cap"}}}},{"answer":"Last year, we began the phase I/II AMPLIFY-201 trial of ELI-002, a lymph node–targeted therapeutic cancer vaccine. This year, we anticipate sharing data from all three cohorts evaluating a low, medium, and high dose of the vaccine. ELI-002 was developed with the company’s proprietary Amphiphile (AMP) technology that allows delivery of a therapeutic payload directly to the “brain center” of the immune system — the lymph nodes. The payload in ELI-002 includes AMP mKRAS peptides and ELI-004, a proprietary AMP CpG adjuvant. These components “teach” the immune cells in the lymph nodes how to identify specific cancer cells and target them for degradation.
\nOne quarter of solid tumors harbors KRAS mutations, and AMPLIFY-201 is evaluating the safety and efficacy of ELI-002 as a potential treatment for patients with KRAS-driven tumors who have minimal residual tumor cells following surgery to remove the tumor. An investigational in vitro diagnostic device (IVD) is used to detect circulating tumor DNA (ctDNA) to identify patients who show signs of minimal residual disease in their blood before relapse is detected in traditional radiographic scans.
\nIn addition to announcing data on the ELI-002 program, we plan to continue to advance our other pipeline programs, which include another therapeutic vaccine, the clinical stage ELI-004 AMP CpG adjuvant, cell therapy AMPlifiers, and infectious disease vaccines.
\nWe have an exciting year ahead of us and look forward to continuing to unlock the potential of our AMP platform to make a difference in the lives of patients.
\n","showOnHomepage":true,"author":{"title":"Robert Connelly","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Connelly_Elicio_Therapeutics.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/robert-connelly-b0445516/","email":null,"company":{"title":"Elicio Therapeutics"}}}},{"answer":"We have an exciting year ahead of us at Anixa Biosciences, with key milestones for our pipeline of oncology and infectious disease assets. Toward the end of 2021, our prophylactic cancer vaccine targeting triple-negative breast cancer entered a phase I clinical trial at the Cleveland Clinic. Long-term, this vaccine holds the potential to prevent women from developing breast cancer in the first place. We look forward to monitoring progress and sharing further updates on the program later in 2022.
\nIn addition, in the first quarter of this year, we expect to initiate a phase I clinical trial for our CAR-T therapy being developed in partnership with the Moffitt Cancer Center to treat ovarian cancer. If successful, this treatment could be the first effective CAR-T therapy for a solid tumor and a model for how other CAR-T therapies can be developed to better address difficult-to-treat cancers.
\nWe also plan to continue preclinical work for our COVID-19 therapeutic with our partners at MolGenie. Our aim with this program is to design an inexpensive, room temperature–stable oral therapy that is both convenient and highly effective against multiple variants of the virus.
\nWe’re proud of the foundational work that we’ve accomplished in 2021 and look forward to continuing to bring our therapies forward to meet persistent unmet needs in cancer and COVID-19.
\n","showOnHomepage":true,"author":{"title":"Amit Kumar, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Kumar_Anixa_Biosciences.png","mediaDetails":{"height":281,"width":211}}},"authorFields":{"title":"President, and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/amit-kumar-9851b521/","email":null,"company":{"title":"Anixa Biosciences"}}}},{"answer":"We anticipate completing the phase Ib clinical trial evaluating our lead drug candidate neihulizumab (AbGn-168H), a novel immune checkpoint agonist antibody targeting PSGL-1, in steroid-refractory acute graft-versus-host disease. Supported by the U.S. FDA with Orphan Drug and Fast Track Designation, we look forward to developing a safer and more durable drug in this population of high unmet medical need where patients suffer and fail previous lines of therapy safety.
\nWe will be performing toxicology studies which will enable us to file an IND for our next-generation PSGL-1–targeting asset, leiolizumab (AbGn-268), which uses the same binding domain as neihulizumab but is engineered to provide convenient, patient-friendly subcutaneous dosing with higher efficacy. We will continue to progress our ongoing studies of leiolizumab (AbGn-268) in other indications, such as ulcerative colitis, Crohn’s disease, alopecia areata, vitiligo, and beyond.
\nAdditionally, we will be focusing on generating additional follow-on molecules in our research and development work, as well as business development and licensing in complementary immune-modulating candidates.
\n","showOnHomepage":true,"author":{"title":"Judy Chou, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Chou_AltruBio.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":null,"email":null,"company":{"title":"AltruBio, Inc."}}}},{"answer":"In 2022, we look forward to a historic year for Omega Therapeutics and the industry, where we will bring programmable epigenetic medicines into human trials for the first time. Additionally, we have several key milestones that highlight the precision and flexibility of our OMEGA Epigenomic Programing™ platform and its potential to address a broad range of indications.
\nWe anticipate filing an IND for the industry’s first epigenomic controller, OTX-2002, for the treatment of hepatocellular carcinoma (HCC) in the first half of the year. OTX-2002 is a modular and programmable mRNA therapeutic that targets a historically undruggable gene, MYC, through epigenetic modulation. As background, MYC is an oncogene found in >50% of cancers, including HCC. Despite its ubiquity among cancers, current approaches have failed to target this gene effectively. We believe, that through our epigenetic programming platform, we could offer new solutions to the challenges that have limited our industry’s ability to target the biological root of a disease.
\nBeyond OTX-2002, we are planning to select additional development candidates in the first half of 2022 to expand our clinical portfolio in oncology and beyond. We also expect to unveil exciting new preclinical data through multiple conference presentations that highlight the flexibility and therapeutic potential of our approach.
\nCumulatively, 2022 represents a major transition for the company to the next stage of its evolution. We’re excited to be able to share the progress we’ve made and showcase the broad applicability of our platform in oncology, immunology, regenerative medicine, and multigenic diseases.
\n","showOnHomepage":true,"author":{"title":"Mahesh Karande","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Karanda_Omega.png","mediaDetails":{"height":268,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/mahesh-karande/","email":null,"company":{"title":"Omega Therapeutics"}}}},{"answer":"We expect 2022 to be a year rich with clinical data as we advance our four wholly owned and internally developed drug candidates in phase I clinical trials in hematologic malignancies and solid tumors. Nurix’s drug candidates are designed to modulate proteins by either harnessing or inhibiting a class of enzymes known as E3 ligases that orchestrate the body’s natural process of protein degradation within the cell.
\nNX-2127, the lead drug candidate in our protein degradation portfolio, is being evaluated in a phase Ia/Ib clinical trial in adults with relapsed or refractory B cell malignancies. We have demonstrated its ability to rapidly degrade Bruton’s tyrosine kinase (BTK) in the initial patients treated in the dose-escalation phase Ia trial and expect to report additional data from this first-in-human trial in the second half of 2022.
\nNX-1607, the lead drug candidate in our E3 ligase inhibitor portfolio, is a first-in-class inhibitor of the ligase known as Casitas B-lineage lymphoma proto-oncogene-B (CBL-B), which is being evaluated in an ongoing phase I trial in multiple solid tumor indications. We expect to have initial safety and PK/PD data from the dose-escalation portion of the phase I trial in mid-2022.
\nFinally, Nurix is the first company to combine targeted protein modulation with cell therapy in DeTIL-2055, an autologous T cell product stimulated and enhanced with the addition of a novel CBL-B inhibitor, NX-0255. We anticipate reporting initial findings from the ongoing phase I trial in the second half of 2022.
\n","showOnHomepage":true,"author":{"title":"Arthur T. Sands, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Sands_Nurix.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President, Chief Executive Officer, and Board Director","linkedin":"https://www.linkedin.com/in/arthur-t-sands-m-d-ph-d-5392308b/","email":null,"company":{"title":"Nurix Therapeutics"}}}},{"answer":"In 2022, we anticipate several company milestones, including clinical trial initiations and data readouts, digital medicine studies, and corporate growth. We kicked off 2022 with U.S. FDA clearance of a phase IIb trial, expected to start early this year, evaluating our pharmacologically optimized form of LSD, MM-120, as a treatment for general anxiety disorder. This is an industry milestone, as it marks the first commercial study of LSD in over 40 years. We expect to announce topline results from our phase I trial and initiate phase IIa for our 18-MC compound, an ibogaine derivative used to treat opioid withdrawal. We also plan to initiate phase IIa trials of our optimized form of LSD for acute and chronic pain indications, as well as a phase I trial of R(–)-MDMA for autism spectrum disorder.
\nAlongside our drug development milestones, we are looking to complete our first study of MindMed’s Session Monitoring System, a digital platform that supports the passive collection of sensory data during a consciousness-altering therapeutic session. We more than quadrupled our head count in 2021 and anticipate at least doubling in size in 2022 as we advance our drug development and digital medicine pipelines. To do so, we hope to secure additional equity funding from institutional investors with a shared long-term vision and belief in MindMed’s mission, leadership team, and execution strategy.
\n","showOnHomepage":true,"author":{"title":"Rob Barrow","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Barrow_MindMed.png","mediaDetails":{"height":279,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/robert-barrow-b50836a","email":null,"company":{"title":"MindMed"}}}},{"answer":"In 2022, we will continue demonstrating the power and versatility of our immune-educating delivery platform, the DPX® technology, to create novel immunotherapies. DPX is being developed for a variety of therapeutic areas (e.g., oncology) where generation of a long-lasting, target-specific immune response is expected to mitigate disease. Recently, we obtained promising clinical results with our lead compound, maveropepimut-S (MVP-S), in several hard-to-treat cancers. This year, we look forward to confirming these results in larger cohorts while expanding our clinical pipeline.
\nLater this year, we anticipate communicating preliminary results from our phase IIb clinical trial, VITALIZE, evaluating the benefit of MVP-S and intermittent, low-dose cyclophosphamide (CPA) in combination with KEYTRUDA® in relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL).
\nWe also predict sharing topline data from our phase II basket trial showing clinical benefit in patients with advanced, metastatic bladder cancer and treated with MVP-S, intermittent low-dose CPA in combination with KEYTRUDA at an upcoming scientific conference. MVP-S is also being evaluated for the first time in a neoadjuvant setting in a phase Ib study in women with HR+/HER2– breast cancer, where topline results will be collected in the second half of 2022.
\nIn 2022, we are initiating two new clinical trials: AVALON, a phase IIb trial in ovarian cancer evaluating MVP-S to confirm results observed in a previous study (DeCidE1); and a phase Ib trial in bladder cancer evaluating our dual antigen–targeted T cell immunotherapeutic compound, DPX-SurMAGE. Through these milestones, we aim to continue moving MVP-S forward to registration.
\n","showOnHomepage":true,"author":{"title":"Andrew Hall","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Hall_IMV.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/andrewhall29/","email":null,"company":{"title":"IMV"}}}},{"answer":"This year holds significant momentum for Immunome as we continue to advance the discovery and development of antibody-based therapies for areas of high unmet need, with a focus on oncology and infectious diseases. As new COVID-19 variants emerge and we continue to grapple with the potential of COVID-19 becoming an endemic disease, it is a top priority for us to leverage our discovery engine to develop cutting-edge antibody therapies that can fight this virus. We recently submitted our first investigational new drug (IND) application to advance our three-antibody cocktail. In preclinical testing conducted to date, our cocktail demonstrates an ability to neutralize SARS-CoV-2 variants of concern, including Omicron. We look forward to communicating additional data as it becomes available.
\nIn addition to our expected milestones in our infectious disease program, Immunome is also making substantial progress in our lead oncology program, IMM-ONC-01, an antibody targeting the novel, innate immune checkpoint IL-38. We believe, based on IL-38 expression in multiple solid tumors of high unmet clinical need, that this checkpoint may have a significant therapeutic role in oncology. We are actively working toward filing an IND in the second half of 2022. In parallel, we are advancing new oncology preclinical candidates and look forward to further demonstrating the potential of our platform in harnessing the power of human immune response.
\n","showOnHomepage":true,"author":{"title":"Purnanand Sarma, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Sarma_Immunome.png","mediaDetails":{"height":267,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/purnanand-sarma-6412444/","email":null,"company":{"title":"Immunome"}}}},{"answer":"This is an exciting year for X4, as we are anticipating topline data from our fully enrolled phase III trial evaluating our lead drug candidate, mavorixafor, in people with the rare immunodeficiency WHIM syndrome. As a first-in-class oral antagonist of the chemokine receptor CXCR4, mavorixafor has the potential to become the first disease-modifying therapy for these patients, given its ability to mobilize white blood cells from the bone marrow into the blood. Data from our ongoing phase II trial to date continue to show positive safety and efficacy, including durable increases in multiple white blood cell counts and improvements in infections and warts, characteristic symptoms of WHIM patients. Data from both trials will support a later NDA submission to the U.S. FDA.
\nOn the primary immunodeficiency front, we also anticipate releasing additional data from our ongoing phase Ib trial in chronic neutropenia, in addition to continuing to explore other indications to target the broader chronic neutropenia landscape, given recent data that showed the potential of mavorixafor to increase white blood cell counts across multiple disease states, independently of CXCR4mutation status.
\nFinally, we anticipate releasing additional interim data from our ongoing phase Ib study of mavorixafor for the treatment of people with the rare non-Hodgkin’s lymphoma, Waldenstrom’s macroglobulinemia, who carry the CXCR4 mutation. These patients have more severe disease than those without the mutation and respond worse to the currently approved drug, ibrutinib. Data so far have shown the potential of mavorixafor–ibrutinib combination to improve clinical responses of these patients.
\n","showOnHomepage":true,"author":{"title":"Paula Ragan, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Ragan_X4_Pharmaceuticals.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Chief Executive Officer and President","linkedin":"https://www.linkedin.com/in/paula-ragan-ph-d-a4111a2/","email":null,"company":{"title":"X4 Pharmaceuticals"}}}},{"answer":"We look forward to another year of advancing TFF Pharma’s mission to leverage our Thin Film Freezing technology and transform medicines for better efficacy, safety, and stability.
\nWe are entering phase II studies for our Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder programs, which could improve standard of care for invasive pulmonary aspergillosis and immune rejection from lung transplant, respectively. In the near term, we are focusing on our internal programs, including Inhaled Voriconazole Powder, Inhaled Tacrolimus Powder, and our Inhaled Niclosamide Powder, an antiviral which is a potent inhibitor of multiple infections, including SARS-CoV-2, and is moving quickly toward phase II studies. We also expect to share updates on our inhalable COVID-19 antibody treatment, AUG-3387, which is being developed in collaboration with Augmenta Bioworks.
\nBeyond our internal pipeline, we are continuing to pursue our many R&D collaborations with academia, pharmaceutical companies, and the government, where our technology has potential to provide a differentiating impact for patients. Our Thin Film Freezing technology is versatile and is differentiated by the applicability to convert a broad array of molecules, including biologics, such as mRNA vaccines, to a dry powder that remains shelf-stable and can be administered through a standard inhaler, intranasally, or intra-ocularly to target affected organs more directly. This broad potential has garnered ongoing interest from companies, the government, and academic organizations alike, and we will continue to identify licensing partners to ultimately commercialize our assets.
\n","showOnHomepage":true,"author":{"title":"Glenn Mattes","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/G_Mattes_TFF.png","mediaDetails":{"height":239,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"http://www.linkedin.com/in/glenn-mattes-78617349/","email":null,"company":{"title":"TFF Pharmaceuticals, Inc."}}}},{"answer":"Selecta had a productive 2021 with the release of human data showing ImmTOR’s potential to enable redosing and change gene therapy’s “once and done” treatment paradigm, the submission of our first gene therapy IND to treat Methylmalonic Acidemia, the enrollment completion of our DISSOLVE I clinical study, and numerous business development transactions.
\nBuilding on this momentum, we anticipate several exciting and important clinical milestones in 2022, including: topline data from the phase III DISSOLVE program, our partnered program in chronic refractory gout, a severe form of inflammatory arthritis; the initiation of our SEL-302 gene therapy trial in methylmalonic acidemia, a rare metabolic disease that affects the body’s ability to metabolize certain amino acids and fats; and the advancement of our IgG protease (Xork) toward the clinic with the hope of making those with pre-existing immunity eligible for treatment with AAV gene therapies.
\nAdditionally, with the exciting preclinical data we released in January showing strong synergistic effects when ImmTOR is combined with an IL-2 agonist, one of Selecta’s top priorities is the rapid advancement of our next-generation ImmTOR platform toward the clinic. This combination, with its potential to induce and expand both regulatory T cells and antigen-specific regulatory T cells, has the potential to improve the ImmTOR platform across our three product pillars: Tolerogenic Therapies for Autoimmune Disease, Gene Therapies, and Enzyme Therapies.
\nWith our expected milestones in 2022, we believe that this will be the year that we solidify our position as the leader in Precision Immune Tolerance.
\n","showOnHomepage":true,"author":{"title":"Carsten Brunn, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Brunn_Selecta.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/carsten-brunn-a8b287a","email":null,"company":{"title":"Selecta Biosciences"}}}},{"answer":"Last year was a landmark year for SCYNEXIS. We received U.S. FDA approval for our first commercial product to treat vulvovaginal candidiasis (vaginal yeast infection) in the second quarter of 2021. I anticipate a similarly exciting year in 2022. In February, we announced positive topline data from CANDLE, a phase III study evaluating oral ibrexafungerp for the prevention of recurrent vaginal yeast infections. With these data, we plan to file a supplemental NDA by the end of Q2 and anticipate possible approval by the end of the year to give doctors a new option when treating their patients. Additionally, we will have the opportunity to showcase new data for ibrexafungerp as a versatile antifungal for a broad range of infections with interim analysis of FURI and CARES — two studies that are evaluating oral ibrexafungerp for patients with difficult-to-treat fungal infections, including those caused by resistant strains. We also plan to enroll our first patient in MARIO, a phase III study to evaluate oral ibrexafungerp in patients suffering from invasive candidiasis. Oral ibrexafungerp would serve as a step-down from IV therapy, with the goal of allowing patients to leave the hospital earlier and continue treatment with a potent oral fungicidal therapy. These milestones highlight our efforts to bring to market meaningful and innovative solutions in the fight against a broad range of fungal infections.
\n","showOnHomepage":true,"author":{"title":"Marco Taglietti, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Taglietti_SCYNEXIS.png","mediaDetails":{"height":246,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/marco-taglietti-md/","email":null,"company":{"title":"SCYNEXIS, Inc."}}}},{"answer":"2022 will be another productive year for Revolo as we continue our efforts to revolutionize autoimmune and allergic disease treatment with drug product candidates that reset the immune system to achieve superior long-term disease remission without immunosuppression.
\nOn the clinical front, we anticipate clinical readouts from two ongoing phase II clinical trials evaluating our lead immune-resetting drug candidate, ‘1104, in eosinophilic esophagitis (EoE), and allergen sensitivity. EoE is a chronic rare allergic inflammatory disease that results in thickening of the esophageal walls and difficulty swallowing, which has really impactful consequences to daily life for these suffering patients. Currently, there are no approved treatments available, and we believe ‘1104 has the potential to offer a truly life-changing option.
\nWe also plan to begin two phase II trials to explore the potential of our second immune-resetting drug candidate, ‘1805, for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA) and non-infectious uveitis (NIU), a chronic inflammatory condition of the eye that is the leading cause of adult blindness in Western countries. Data from a previous phase IIa trial in RA demonstrated ‘1805’s potential as a safe and effective treatment for these patients, with sustained remission for 12 weeks following a single intravenous dose, and without immune suppression. We look forward to continuing to advance our candidates to bring what could be revolutionary therapies to those in great need.
\n","showOnHomepage":true,"author":{"title":"Jonathan Rigby","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Rigby_Revolo.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jonathanmnrigby/","email":null,"company":{"title":"Revolo Biotherapeutics"}}}},{"answer":"The milestones that Recce Pharmaceuticals achieved in the last year have given us significant momentum heading into 2022 as we continue to advance the research and development of our new class of synthetic anti-infectives against a variety of bacterial pathogens, including their antimicrobial-resistant forms. After receiving ethics approval to start a phase I intravenous (IV) clinical trial of our lead synthetic polymer compound, RECCE® 327 (R327), we kicked off the new year with positive safety data, demonstrating R327 to be safe and well tolerated in healthy subjects up to 150 mg. Based on these results, we look forward to sharing further clinical updates regarding the remaining cohorts and testing subjects with ascending doses of R327, which is on track for Q2 2022. We are also making substantial progress in our phase I/II clinical trial designed to assess the safety and efficacy of the topical application of R327 for patients with burn wound infections. Visible infection reduction has occurred in all patients to date within the first 24 hours of treatment, including efficacy against a range of both gram-positive and gram-negative bacteria. With further clinical data expected to be available early this year, 2022 will see R327 continue to advance in ongoing in-human trials while also developing throughout preclinical studies. We look forward to further demonstrating the exciting potential of our anti-infective pipeline to assist in the fight against deadly drug-resistant pathogens.
\n","showOnHomepage":true,"author":{"title":"James Graham","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Graham_ Recce_Pharmaceuticals.png","mediaDetails":{"height":260,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Managing Director","linkedin":"http://www.linkedin.com/in/james-graham-6839533a/","email":null,"company":{"title":"Recce Pharmaceuticals Ltd."}}}},{"answer":"2022 marks an important year for Rain as we continue to evaluate our lead product candidate, milademetan, in multiple clinical trials and explore its therapeutic potential in new, broader indications alone and in combination with validated treatment strategies. Our initial approach was to commence and evaluate milademetan in a registrational de-differentiated liposarcoma clinical study based on strong prior clinical data. However, we see immense potential for milademetan to help a wide range of patients suffering from cancer. We expect to report interim analysis from our second trial, the MDM2-amplified phase II basket trial (MANTRA-2) later in 2022, evaluating milademetan in patients that exhibit wild-type p53 and MDM2-amplified advanced solid tumors. This year, we also plan to dose the first patient in our phase II MANTRA-3 trial evaluating milademetan as a monotherapy for the treatment of patients with Merkel cell carcinoma that are refractory to immune checkpoint inhibition. Finally, we recently formed a collaboration with Roche to evaluate milademetan in combination with Roche’s anti-PD-L1 antibody, atezolizumab, for the treatment of patients in a specific genetically selected population — patients that have lost function of CDKN2A — in a phase I trial. We expect 2022 to be the year when Rain begins to release milademetan clinical data, from which a multitude of clinical data will be represented over multiple quarters. Overall, we are excited for what 2022 holds for Rain as we continue to make progress toward bringing new therapeutics to patients with cancer.
\n","showOnHomepage":true,"author":{"title":"Avanish Vellanki","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Vellanki_Rain_Therapeutics.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/avellanki/","email":null,"company":{"title":"Rain Therapeutics"}}}},{"answer":"At MilliporeSigma, we have set critical milestones to address our customers’ needs. We are committed to innovating and acting on trends impacting life and health with science. Let me highlight three key areas.
\nFirst, given the increasing trend in outsourcing services and the rising demand for both traditional and novel modalities, we have set up a global, fully integrated multi-modality CDMO services business. This year, we expect to take significant steps to scale our businesses and provide an end-to-end offering across modalities to help customers accelerate their lifesaving therapies to and through the clinic.
\nSecond, our customer expectations are shifting, as shaped by their own digital experience. We are moving to provide a more seamless experience across labs, including academic, pharma, biotech, testing, and other labs, through innovation in our industry-leading eCommerce platform, sigmaaldrich.com. We expect that these changes for desktop and mobile platforms will provide a best-in-class customer experience. In addition, we will broaden our eCommerce offering to include select, high-value third-party suppliers that complement our leading portfolio to build a seamless experience for customers.
\nThird, we will continue to focus on delivering the company’s leading product offering for pharmaceutical development and manufacturing, including filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals, and excipients. Significant investment in our manufacturing capacity across our portfolio will become operational this year; one example is the production of Mobius® Single-Use Assemblies in Molsheim, France, a critical product used to manufacture vaccines, including for COVID-19, and other lifesaving therapies. Bringing additional single-use capacity online in the United States, at our single-use Center of Excellence in Danvers, Massachusetts, and establishing single-use at our Molsheim site will shorten the lead time for custom assemblies for global customers. We recognize that innovation is also accelerating across the life science ecosystem in APAC, and we are continuing our commitment to ensure that our leading portfolio is available to customers where and when they need it.
\n","showOnHomepage":true,"author":{"title":"Meeta Gulyani","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Gulyani_MilliporeSigma.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Head of Strategy, Business Developments, and Sustainability","linkedin":"https://www.linkedin.com/in/meeta-gulyani-3bb60b10","email":null,"company":{"title":"MilliporeSigma"}}}},{"answer":"Despite the unexpected nature of the past two years during the pandemic, Sterling’s strategic plan to grow its business saw us undertake a number of investments in areas that will either come online or reach a milestone this year.
\nFirst, we acquired ADC Biotechnology, a UK-based bioconjugation development services business specializing in antibody–drug conjugates (ADCs). Since the acquisition, we have invested to grow and develop the technical services team and expanded the analytical services team at the site in Deeside, Wales. This year, we will complete a project to establish cGMP bioconjugation and ADC manufacturing at Deeside, allowing us to offer end-to-end development services in this fast-expanding area of the industry.
\nAdditionally, we have made a number of investments in other key technologies, such as flow chemistry and biocatalysis, but most importantly in capacity, to support what is a growing need of high-quality, small molecule API manufacturing. This year will see further capacity being added to our manufacturing network, potentially through a combination of strategic capital projects and/or additional acquisitions.
\nSterling has also undertaken an initiative to increase the sustainability of our Dudley, UK, facility, with a goal of reducing carbon emissions by 50%. This year, an anaerobic digestion plant will be commissioned that will convert waste into a usable energy source and aims to reduce waste treatment emissions by 65% and carbon dioxide emissions by over 7,000 tons.
\nWe also continue to align our culture, processes, and systems across our four sites, ensuring our continued commitment to service excellence for customers, as well as investing in our people and the opportunities we provide for them to grow with the organization.
\n","showOnHomepage":true,"author":{"title":"Kevin Cook","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Cook_Sterling_Pharma.png","mediaDetails":{"height":245,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://uk.linkedin.com/in/kevin-cook-54398013","email":null,"company":{"title":"Sterling Pharma Solutions"}}}},{"answer":"Following a strong 2021, SOTIO anticipates several key milestones to continue building out our robust clinical pipeline. This year, we are advancing three novel programs through phase I. BOXR1030 is our lead CAR-T program for the treatment of various solid tumors expressing GPC3. It’s based on the proprietary BOXR platform that aims to enhance the fitness of T cells in the hostile tumor microenvironment, a long-standing challenge for traditional CAR-T therapies. The study is scheduled to start early 2022. SOT102 is a novel antibody–drug conjugate (ADC) with a best-in-class potential for Claudin 18.2–targeting therapies. We expect to start a phase I dose escalation in patients with gastric and pancreatic cancer in April 2022. Finally, we plan to initiate a phase I study with our first IL-15–based immunocytokine using a PD-1 inhibitor as the targeting arm by the end of 2022.
\nIn parallel with the initiation of these three clinical trials, we are also initiating our phase II AURELIO-04 study in collaboration with Merck. The study will evaluate the combination of our IL-15 superagonist, SOT101 and MSD’s KEYTRUDA® (pembrolizumab) in patients with selected advanced/refractory solid tumors. The study is expected to treat up to 300 patients with a combination of SOT101 and a standard dose of KEYTRUDA and will enroll patients in the United States and selected European countries across six different indications.
\nI’m looking forward to another strong year from SOTIO as we continue to develop the next generation of potent immunotherapies for patients with cancer.
\n","showOnHomepage":true,"author":{"title":"Radek Spisek, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Spisek_Sotio.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/radek-spisek-74003924/","email":null,"company":{"title":"SOTIO"}}}},{"answer":"We will continue to support our customers in the context of the COVID-19 pandemic. Every second production site for COVID-19 vaccines worldwide now has process and packaging technology from Syntegon. We are currently seeing a change in vaccine production from vials to syringes and have already supplied first solutions to customers in China. An important highlight is definitely Achema 2022. It is the first major pharma trade show where customers can experience the new Syntegon brand live. We will introduce our Versynta FFP for small-batch applications, as well as Versynta microBatch here for the first time.
\n","showOnHomepage":true,"author":{"title":"Uwe Harbauer","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/U_Harbauer_Bosch.png","mediaDetails":{"height":235,"width":211}}},"authorFields":{"title":"Member of the Executive Board","linkedin":"http://www.linkedin.com/in/uwe-harbauer-23b08244","email":"PA-PH.Management@bosch.com","company":{"title":"Syntegon"}}}},{"answer":"At Sino Biological, we have numerous milestones we intend to reach in 2022. Our main efforts will focus on product line availability and expansion and include the initiation of research and development in Taizhou and Suzhou, China, and product manufacturing/assembly in the United States. In addition, we will increase our infectious disease product offering as well as warehousing capacity and inventory levels in the United States and Europe for more efficient delivery to our clients in these regions. We will also expand our direct sales force in the United States, Europe, and China and complete at least one company acquisition, allowing for access to new technologies and talent.
\n","showOnHomepage":true,"author":{"title":"Rob Burgess, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Burgess_Sino_Biological.png","mediaDetails":{"height":295,"width":211}}},"authorFields":{"title":"Chief Business Officer","linkedin":"https://www.linkedin.com/in/rob-burgess-074a8023/","email":null,"company":{"title":"Sino Biological"}}}},{"answer":"As an organization, it is starting to feel like we have overcome the disruption that arose from the COVID-19 pandemic these past two years, and we are looking forward to maintaining our growth momentum during 2022. We continue to win new customers and broaden the portfolio of exciting new molecules that we are helping to develop. In response to this increasing demand, we will conclude major facility expansion programs at our key operating sites in both the U.S. and U.K. in the next 12 months. These expansions will deliver new capabilities that can be fully integrated into our services portfolio and increase capacity for our existing services — all of which are part of our continued commitment to expand and innovate our offering to support our customer’s drug programs.
\nThis year also marks the 15th anniversary of our flagship Translational Pharmaceutics™ platform, arguably our most impactful innovation to date. In the intervening years, we have delivered hundreds of integrated drug development programs for our customers, proving that the acceleration of development timelines can be achieved with our unique approach. We’ve replicated the platform in the U.S., providing our customers with a choice of which territory they would like their work to be undertaken. During this year, we are focused on demonstrating how we can integrate drug substance synthesis and manufacturing into the Translational Pharmaceutics platform, which will represent another significant achievement in our mission to accelerate the development of new medicines for patients in need.
\n","showOnHomepage":true,"author":{"title":"Mark Egerton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Egerton_Quotient_Sciences.png","mediaDetails":{"height":240,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/markegerton/","email":null,"company":{"title":"Quotient Sciences"}}}},{"answer":"There are a few key milestones that Corning has on our 2022 roadmap to support our customers. As a leader at the forefront of 3D cell culture, we are continuing to evolve our product offerings for these advanced techniques in semi-automated and automated ways to allow for more widespread adoption, including in areas like high throughput screening applications. New tools like the Corning Matribot Bioprinter, Elplasia plates, Cell Counter, and Matrigel Matrix-3D plates help scientists reduce manual steps, improve consistency, and support more physiologically relevant models.
\nCell and gene therapies continue to be a growing area in life sciences, and, to accelerate the path from the research bench to clinical treatments, Corning is continuing to develop and launch new solutions to support bioproduction. Our latest addition is the Ascent® Fixed Bed Reactor (FBR) System, which is designed to combine the greater yield efficiency, flexibility, and viable cell harvest capability of adherent bioproduction platforms with the scale, automation, and control of suspension manufacturing systems. The Ascent FBR System joins the full upstream workflow that Corning offers, which can support customers from vial thaw to seed-train scale-up and now to production scale across several advanced therapy applications.
\n","showOnHomepage":true,"author":{"title":"Kim Titus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Titus_Corning_Life_Sciences.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Director of Business Operations","linkedin":"https://www.linkedin.com/in/kim-titus-bb481a9/","email":null,"company":{"title":"Corning Life Sciences"}}}},{"answer":"The themes of 2022 for AGC Biologics are investment and ingenuity.
\nThrough our investments and ingenuity, we are laser-focused on three key milestones as a company. First is enhancing and growing our cell and gene therapy services and capacities. The second is building upon our reputation in the protein biologics space. And the third is adopting and developing new processes and technologies to bring products to market even faster and more effectively.
\nFor cell and gene therapy specifically, we are one of the fast-growing CDMOs, with some of the brightest minds in the industry, thanks to facility acquisitions in Longmont, Colorado, in 2021 and Milan, Italy, in 2020. The Longmont site coming online gives us even more global capacity to offer immediately to developers, at a time when there are industry-wide shortages. Our Milan site is also expanding its capacity and developing a new revolutionary viral vector suspension system.
\nThough we are expanding in those areas, we aren’t slowing down in our biologics protein work. We are expanding capacity at our largescale Boulder, Colorado, mammalian facility, our mammalian and plasmid facility in Heidelberg, Germany, and the Seattle, Washington facility’s mammalian and microbial capabilities. We are on a mission to grow our knowledge and services within this area to ensure we utilize the latest technology and processes to develop and manufacture substances.
\nFor the underlying support of both these service areas, we are building new technology platforms and procedures that will improve every aspect of how we bring a product to market in 2022.
\n","showOnHomepage":true,"author":{"title":"Patricio E. Massera","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Patricio E. Masser_AGC_web.png","mediaDetails":{"height":264,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/pmassera/","email":null,"company":{"title":"AGC Biologics"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-what-do-you-see-as-the-key-innovations-or-technologies-that-will-make-personalized-precision-medicine-a-reality/","uri":"/roundtable/articles-q-what-do-you-see-as-the-key-innovations-or-technologies-that-will-make-personalized-precision-medicine-a-reality/","slug":"articles-q-what-do-you-see-as-the-key-innovations-or-technologies-that-will-make-personalized-precision-medicine-a-reality","title":"Q: What do you see as the key innovations or technologies that will make personalized/precision medicine a reality?","roundtable":{"topic":"Personalized/Precision Medicine","question":"What do you see as the key innovations or technologies that will make personalized/precision medicine a reality?","roundtable":[{"answer":"One of the major limitations of drug development efforts has been the lack of laboratory models that capture the complex biology of cells in our bodies. With the advent of technologies that allow the growth of cells in three dimensions, such as Corning® Matrigel® matrix, Corning spheroid microplates, and Corning Elplasia® plates, it is now possible to culture patient-derived mini-organs, or organoids. The ability to grow mini-organs in a laboratory allows researchers to build robust disease models that are tailored to the individual. Toxicity studies and drug screening can then be completed to confirm that the treatments are personalized and appropriate for the unique patient. Right now, two emerging areas of innovation include adding complexity to the organoid model and increasing throughput. A solution to both of these challenges is the Corning Matribot® Bioprinter, which allows for bioprinting of more complex disease models and automated dispensing of organoid droplets.
\n","showOnHomepage":true,"author":{"title":"Austin Mogen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Mogen_Corning.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Senior Field Application Scientist","linkedin":"https://www.linkedin.com/in/austinmogen/","email":null,"company":{"title":"Corning Life Sciences"}}}},{"answer":"At the heart of personalized and precision medicine is data. The ability to diagnose a condition and prescribe a therapy has been at the core of medicine dating back to Imhotep, who lived in the 27th century BCE (nearly 5000 years ago) and prescribed courses of treatment for a range of maladies. Today, we can map the human genome, as well as the genomes of various cancers; we are also developing an understanding of epigenetics and how that translates into conditions such as disease and aging.
\nOur understanding of the biological processes unfolding within our bodies continues to grow, and our ability to make use of this immense set of data through AI and advanced data analytics will be a driving force behind the development of personalized therapies. It will lead to accelerated advancement of complex and novel therapies, such as gene editing and RNA medicines, and the ability to treat conditions, such as cystic fibrosis, muscular dystrophy, forms of blindness and sickle cell anemia, at the genetic level.
\nThe use of AI and data analytics to determine whether previously developed therapies can be used for other conditions or whether more traditional types of therapies, such as a small molecule drug, can be applied to what have been thought to be “large molecule” problems has the potential for great impact. These “innovations” could touch far more lives in the near term than advanced treatments that may be available to a relatively small portion of the worldwide population.
\n","showOnHomepage":true,"author":{"title":"Brian Graves","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/B_Graves_Grace_Materials_Technologies.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Business Manager, Grace Materials Technologies","linkedin":"https://www.linkedin.com/in/brian-graves-8121255/","email":null,"company":{"title":"W.R. Grace"}}}},{"answer":"Traditionally, the goal for drug developers has been to create therapies that would be the drug of choice for all, thus capturing a large market. However, we now realize a one-size-fits-all approach is not always realistic, especially with cancer indications where, even within tumors, the individual cancer cells may harbor unique combinations of genomic and epigenomic events. Identifying “driver” mutations and targeting the proteins derived from these genomic events has been the route followed most often, and we now have therapeutics that target many mutated kinases and translocation fusion proteins.
\nThere are many therapeutic approaches emerging that differ in their approach. Examples include immunotherapies; targeted degraders, such as PROTACs; and even synthetic lethal drugs. Key innovations for personalized/precision medicine may come from advances in biomarker discovery and monitoring technologies. This includes new experimental modalities in the detection of markers in serum samples but may also involve completely novel screening approaches that enable us to determine when to use a targeted drug, how patients are responding, when to adjust the dose, and when to switch to an alternative therapeutic approach. I feel that personalized medicine will truly be the norm when we have the knowledge base, technology, and willingness for rapid and periodic monitoring of biomarkers for each patient.
\n","showOnHomepage":true,"author":{"title":"Thaddeus Allen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Allen_Anticancer_Bioscience.png","mediaDetails":{"height":284,"width":211}}},"authorFields":{"title":"Vice President of Translational Biology and Business Development, San Francisco","linkedin":"https://www.linkedin.com/in/thaddeus-allen-1a80466/","email":null,"company":{"title":"Anticancer Bioscience"}}}},{"answer":"Personalized medicine allows patients to receive treatments tailored to their genome. A prerequisite of personalized medicine is therefore being able to sequence a patient’s genome rapidly and affordably, which is becoming more of a reality every passing day. By examining an individual’s genome, we can look for patterns that might indicate risk of disease and identify tailored treatment solutions. mRNA therapeutics are one of the key tools for providing tailored treatment solutions for patients. Developing mRNA–LNP platforms where the information encoded in the platform can be rapidly exchanged more easily will be critical for personalized medicine. Once the mRNA therapeutic has been adapted and fine-tuned for a patient or group of patients, being able to manufacture these at the appropriate scale will be essential. Evonik, for example, is fully integrated across the value chain and can provide clinical to commercial drug product manufacturing capability at the smaller scales compatible with personalized medicine.
\n","showOnHomepage":true,"author":{"title":"Maaike Everts, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Everts_Evonik.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Director of Strategic Marketing, Parenteral Drug Delivery Solutions","linkedin":"https://www.linkedin.com/in/maaike-everts/","email":null,"company":{"title":"Evonik"}}}},{"answer":"Right now, the frontrunner for cell and gene therapy treatments is CAR-T, which works well for hematological cancers, but to date has had limited success with solid tumors. CAR-NK offers potential for an allogeneic product, as solid tumors are a frontier yet to be reached.
\nAnother consideration would be advancing CAR-NK therapies, which take natural killer cells that are allogenic from patients or donors. This means that one CAR-NK therapy can be used for many patients off the shelf, rather than the need for autologous treatment, such as CAR-T therapies that require a custom CAR-T product produced for each patient. With an allogeneic therapy, you get the benefits of scale and consistency, as well as less challenging regulatory compliance with increased safety for the patients. There's a lot of opportunity in that space.
\n","showOnHomepage":true,"author":{"title":"Andrew Bulpin, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Bulpin_MilliporeSigma.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Head of Process Solutions Strategic, Marketing and Innovation","linkedin":"https://www.linkedin.com/in/andrew-bulpin-49298b3","email":null,"company":{"title":"MilliporeSigma"}}}},{"answer":"At SOPHiA GENETICS, we continue to rapidly evolve the landscape of precision medicine, and our platform users have already experienced tremendous growth in what they can accomplish through more comprehensive next-generation sequencing aided by elite machine learning. A determining factor is our ability to expand the scope of what clinical researchers can discover in a single assay while also maintaining and advancing the levels of accuracy and meaningful insights for those tests. But this is only one piece of the puzzle when it comes to precision medicine. Combining various types of health data from a patient’s genomic data, medical imaging, clinical trials, or even personal wearable devices with real-time health monitoring will bring a truly multimodal approach to the landscape that will allow physicians to get a comprehensive 360° view of an individual.
\n","showOnHomepage":true,"author":{"title":"Jurgi Camblong, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Camblong_Sophia_Genetics.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/jurgicamblong/","email":null,"company":{"title":"SOPHiA Genetics"}}}},{"answer":"There have been tremendous leaps in recent years related to precision medicines. Advances in our understanding of biomarkers and cell therapy applications are helping to radically redefine what is possible for patients; however, for all of the advancements, many of these technologies are only useful for a small subset of patients. As we look to the next wave of precision medicine, researchers must explore mechanisms for expanding the impact of these technologies to larger patient populations. It will take bold new ideas to advance the science, and that is a key reason why we at Double Rainbow are focused on developing platform technologies that can help deliver a new era of medicine.
\nWhen you explore the history of medicine over the past 50 years, most major advancements have resulted from platform technologies that were previously thought impossible. Our team is working to provide the next step in that innovation journey by harnessing the full potential of synthetic biology to create precision glycosylated therapeutics with enhanced targeting, safety, and bioavailability. By combining the progress of precision medicine to date with previously underexplored sugar chemistry, we are taking a well-established natural process in glycosylation and leveraging it with unprecedented precision to affect human health.
\nOur goal is to leverage the vast presence of glycans on cells and proteins to enable a new field of targeted drug development and discovery. As our team continues to push the limits of our technologies, we believe that the advancement of our PRISM platform could create new targets for immuno-oncology, improve drug delivery across the blood–brain barrier, and even manipulate the microbiome for drug absorption. Work is underway to further validate glycosylation as a novel therapeutic modality, and our team remains focused on our goal of delivering safer, more effective medicines to the patients we serve.
\n","showOnHomepage":true,"author":{"title":"Holly Schachner, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/H_Schachner_Double_Rainbow_Bioscience.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Medical Officer","linkedin":null,"email":null,"company":{"title":"DoubleRainbow Biosciences"}}}},{"answer":"Autologous cell therapy, which involves manipulating cells outside a person’s body and then readministering them to the patient, is one of the most exciting innovations in personalized/precision medicine. The process involves augmenting the cells taken out with a stronger missing gene and then reinforcing the patient’s immune system with this improved cell. Autologous therapies can help combat immunological reactions or bio-incompatibilities, such as when a substance produces a toxic response in the body. They can also serve as skin substitutes, treating burns, wounds, and chronic inflammation. This method relies on the intrinsic ability of blood stem cells to reproduce and create this new and improved form of a cell. In the last year and a half, we have seen a lot of attention around mRNA vaccine techniques, which have become mainstream for producing antibodies, but autologous cell therapies could be the next medical innovation we bring to the masses.
\n","showOnHomepage":true,"author":{"title":"Tim Roberts","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Roberts_PCI.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://linkedin.com/in/tim-roberts-a83a775","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"Disease characterization and therapeutics development are obviously crucial components of personalized medicine, but the real gatekeeper will be scalable manufacturing — it already is. The few autologous cell therapies on the market today are struggling to meet patient demand. These therapies are made from a patient’s own cells using techniques not well standardized to develop bespoke living drugs. As a result, they come at a high cost for patients in desperate need who have typically stopped responding to all other treatments.
\nThe pharmaceutical industry has been built to scale identical therapeutics to treat many people with similar disease profiles, but potential curative treatments like cell therapies are customized for both the subtype of disease and the traits of the individual patients. In other words, the trend of mass customization has reached healthcare. To meet the challenges of this new healthcare paradigm at large scale and modest per-patient cost, we need true end-to-end automation and software-defined manufacturing.
\nThere are several pain points where automation is able to accelerate manufacturing, improving reproducibility and decreasing reliance on limited human technical expertise. These include cell activation, in-process sampling, media exchanges, quality check, cell processing, and more. Our approach at Cellares is to create true end-to-end process automation within a customizable enclosed system that can manufacture up to 10 different therapeutic products simultaneously. This agile and automated approach will ultimately make truly personalized therapies accessible to everyone who needs them.
\n","showOnHomepage":true,"author":{"title":"Fabian Gerlinghaus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/F_Gerlinghaus_Cellares.png","mediaDetails":{"height":287,"width":211}}},"authorFields":{"title":"Co-founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/fabian-gerlinghaus/","email":null,"company":{"title":"Cellares"}}}},{"answer":"Advanced molecular diagnostics have had a huge impact on precision medicine in areas like prenatal care, transplant medicine, and oncology. But the future of precision medicine lies in other areas of medicine as well, like infectious diseases.
\nIn the past, cancer has been a major focus of the precision medicine initiative. People get very excited about advancements in treating cancer, because we’ve all been touched by it; everybody has someone they know who’s struggling with cancer. But now is the time where we need to take these advanced diagnostics technologies and move them into other areas of medicine — for example, mental health, infectious disease, and other conditions where genomics can have a dramatic impact on the care and outcomes of patients.
\nRight now, there’s a lot of conversation about making sure that we’re leveraging technology so that people get the best therapies based on the best information possible and in the most targeted way. A “one-size-fits-all” approach to medicine won’t give us the best results anymore, whether it’s for cancer or infections. We have fewer new drugs in infectious disease, drugs that work less well over time, and a threat is increasing relative to our ability to treat patients effectively. The diagnostics we use are also decades old.
\nThe start of precision medicine for infectious diseases has been spurred with molecular diagnostics like the Karius test — the first liquid biopsy for infectious diseases that can detect >1000 pathogens from a single blood sample for infections located throughout the body.
\n","showOnHomepage":true,"author":{"title":"Alec Ford","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Ford_Karius_Inc.png","mediaDetails":{"height":294,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/alec-ford-b578003/","email":null,"company":{"title":"Karius Inc."}}}},{"answer":"We’ve seen tremendous biomedical progress in recent years that has introduced us to this concept of precision medicine that would replace the “one-size-fits-all” treatment approach for cancer and many other diseases. But the future of these advanced personalized medicines relies on technologies that provide deeper access to in vivo biology to create durable, curative impacts on health. By gaining this type of cellular and molecular access, I believe that we can shift paradigms in cell and gene therapy, cancer immunology, and infectious disease toward more patient-specific, long-lasting treatments.
\nThe technologies we are advancing at IsoPlexis give insight into single-cell biology and functional proteomics. In other words, we are probing the immune system to reveal unique immune biomarkers in small subsets of “superhero cells.” These superhero cells are essentially turbocharged immune cells that orchestrate how an individual responds to treatment. Now, for the first time, we can identify and predict how these superhero cells communicate and respond much earlier in the clinical process, by way of a variety of molecules like proteins and cytokines. In this manner, we can “tune” immunotherapies and targeted therapies at the cellular behavior level so that they are more highly precise and personalized.
\nNot only that, but I also think it’s incredibly important to be able to leverage the same cell to produce protein maps and genetic maps. Our technologies are finally connecting one to the other to reveal direct pathways that would be missed if you were averaging across a large group of cells.
\n","showOnHomepage":true,"author":{"title":"Sean Mackay","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Mackay_IsoPlexis.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/sean-mackay-0288a511","email":null,"company":{"title":"IsoPlexis"}}}},{"answer":"Key innovations and technologies that have the potential to significantly impact personalized/precision medicine address the following:
\nEfficient, consistent, and scalable manufacturing;
\nThe number of personalized and custom-engineered therapies in R&D and preclinical stages has grown exponentially. However, even for the most advanced initiatives, a major bottleneck is still the transition to clinical-scale production. Developing fully automated systems able to sustain the scale-up and scale-out needs and to yield a consistent product for every patient will represent a major step in advancing the field.
Greater depth of understanding of disease through high-content single-cell resolution investigations (especially for immuno-oncology indications);
\nHaving a more thorough understanding of underlying disease initiation and progression will help to identify critical biomarkers that are relevant to therapy. In turn, this will have a tremendous impact on: (a) tailoring therapies to specifically target critical aspects of the disease and (b) selecting and stratifying patients more accurately in clinical studies, thereby increasing the effectiveness and success of a therapeutic intervention.
In-depth characterization of therapeutic products during development and post-infusion;
\nThis is especially relevant for cell therapy products, which are “living drugs” that evolve in the course of treatment. With advancements in technologies that expand analytical capacity and accommodate small sample sizes, we will gain better insights into critical aspects associated with function, fitness, toxicity, and longevity of therapeutic products. This information, in turn, will help to inform on therapy strategy and will guide appropriate clinical trial designs for each indication and patient population.
We have to acknowledge analytical innovations’ ongoing contributions in target and lead discovery. Next-generation sequencing (NGS) and RNA-Seq technologies have enabled a much deeper understanding of disease biology at the genomic and transcriptomic levels. Innovations in mass spectrometry (MS) (tandem-MS and high-resolution MS) have delivered insights into the expression (proteomics) and activity (metabolomics) of proteins in relation to disease.
\nA deeper understanding of biology has delivered innovative new drugs and therapeutic approaches that, to us, signal precision medicine’s rising presence in the clinic. Multispecific drugs are a great example. The drug modalities within this category exploit biological processes — “normal” and pathogenic — to deliver impressive levels of therapeutic target specificity. We applaud antibody–drug conjugates (ADCs) as one of the most mature multispecific drug innovations. We are excited to see and support the further induced proximity innovations emerging — for example, chimeras that harness cells’ endogenous protein degradation machinery to eliminate known or suspected disease-related proteins (e.g., PROTACs, LYTACS).
\nWe believe that the impact of innovative drug delivery technologies on the future of precision medicine cannot be understated. Highly engineered lipid nanoparticle delivery systems, designed for the pH-triggered release of nucleic acid–based vaccines in the cytosol, have proven very effective in the fight against SARS-CoV-2. These and other delivery innovations, such as synthetic exosomes, allow us to imagine a future in which medicines can access protein or gene targets within the cell, with payloads ranging from small molecules to mRNA. We are extremely encouraged about precision medicine’s near-term prospects. We feel privileged to support innovators who are bringing them to life.
\n","showOnHomepage":true,"author":{"title":"David Vodak, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Vodak_Lonza.png","mediaDetails":{"height":242,"width":211}}},"authorFields":{"title":"Senior Director, Head of Small Molecules R&D","linkedin":"https://www.linkedin.com/in/david-vodak-10583054/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"One of the primary challenges for effective personalized/precision medicine is the stabilization and delivery of RNA. So, we see our silicon-stabilized hybrid lipid nanoparticles (sshLNP) technology as the key innovation that will make precision medicines a reality.
\n","showOnHomepage":true,"author":{"title":"Suzanne Saffie-Siebert, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Saffie-Siebert_SiSaf.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/dr-suzanne-saffie-siebert-695b124/","email":null,"company":{"title":"SiSaf"}}}},{"answer":"Historically, traditional therapeutics aim at developing the same drug (e.g., aspirin) for everybody. Personalized medicine, on the other hand, pursues development of targeted drugs for a specific group of patients. This new therapeutic approach uses companion diagnostics to see which patient would benefit from the treatment. Companion diagnostics simply test patients for a predictive biomarker, classifying them into responders and non-responders. An example of this approach is the development of a therapeutic antibody that is specific for a molecular target within the patient.
\nWith widespread growth in predictive technologies, personalized therapeutics has advanced into manufacturing individualized medicine so that each patient receives their own unique treatment. This approach is contingent upon having access to high-quality data on the genome of a large group of patients. This would enable us to couple a patient’s biological sample to comprehensive clinical data, leading to the most effective individualized therapy. Given that the human genome contains about 3 billion DNA base pairs and about 25,000 genes, advanced computational methods in genome sequence analysis serve as the foundation for producing individualized therapeutics.
\n","showOnHomepage":true,"author":{"title":"Mahsa Mohiti-Asli, Ph.D.,","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Mohiti-Asli_BASF_Pharma_Solutions.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"Technical Manager, BASF Pharma Solutions","linkedin":"https://www.linkedin.com/mahsa-mohiti-asli-phd/7b845b51/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Across the globe, we’re witnessing the rapid transformation of healthcare and medicine driven in part by biopharmaceutical product advances and aggressive biotechnology research. One of the best examples of this is genomics, a term I hear often from our life sciences suppliers and customers. Genomic medicine involves scientists studying genes, helping them predict, diagnose, and treat diseases with greater precision and personalization. When it comes to treatment, genomics is driving another vital element of precision medicine — pharmacogenomics, which determines how a person’s unique genetic makeup influences their response to medications.
\nIt’s no secret that a drug in the same form and dosage can affect people differently. That’s because our genes influence the enzymes that metabolize drugs and differ from person to person. Pharmacogenomics means we can test for these gene variations and potentially compensate with alternative medications. What’s making this level of personalized medicine possible? In a word: data. Today, more than 250 drugs labeled with pharmacogenomic information can be prescribed on the basis of a person’s genetics. As this number grows and DNA sequencing becomes more standard, we will likely see more medicines developed and prescribed based on our genes — helping minimize side effects and improving treatments. With genome data, predicting disease and identifying a specific treatment based on an individual’s genetic material is now real.
\nUnivar Solutions supports this fast-evolving industry’s supply chain with compounds, chemicals, and ingredients used in developing and producing finished forms of personalized medicine treatments. Our product line includes buffers, stabilizers, and substances used in protein purification and DNA sequencing. As the discipline advances, so do we, bringing on new suppliers and adding to our offering. With an entire team of professionals dedicated to life sciences, we are keeping a close eye on the unique supply chain needs of this segment and helping deliver the solutions to meet those needs.
\n","showOnHomepage":true,"author":{"title":"James Peterson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Peterson_Univar_Solutions.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Vice President, Pharmaceutical Ingredients","linkedin":"https://www.linkedin.com/in/james-paterson/8597b749/","email":null,"company":{"title":"Univar"}}}},{"answer":"Advancements in next-generation cell and gene therapies (C>) are bringing us one step closer to the promise of personalized medicine, leading to rapid growth in the C> market. However, this promise is still hindered by the challenges associated with developing them. Due to the complexity of C> therapies, they require a flexible discovery and manufacturing process, and manufacturing must be considered early in process development. No single organization has the complete solution to bringing these transformative therapies to market on their own.
\nBiopharma companies crave partners who understand the significance of manufacturing in the overall timeline and the potential challenges and also offer the expertise to provide counsel throughout the development process. CROs offer a multidisciplinary bench of expertise and access to innovative technologies to serve as a trusted partner throughout the development journey, creating a streamlined approach for coordination, operationalization, and efficiency.
\nFurther streamlining development activities requires innovative technologies, such as advanced analytics, which are likely to occupy at least two spaces within cell therapy. The first is for profiling patient starting material to assess whether a patient’s cells are sufficient for manufacturing. Analytics can also help identify cell therapy product critical quality attributes (CQAs), which are predictive of clinical efficacy. The second area is intelligent therapeutic target identification and design. As therapeutic candidates make their way into clinical development, these analytical technologies can help predict adverse events. A more complete understanding of the pathways being targeted will enable us to design better, more personalized therapies.
\n","showOnHomepage":true,"author":{"title":"Matthew Hewitt, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Hewitt_Charles_River.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Executive Director, Scientific Services, Cell and Gene Therapy (CGT)","linkedin":"https://www.linkedin.com/in/matthewmhewitt/","email":null,"company":{"title":"Stilmas"}}}},{"answer":"The key innovations and technology that we frankly should be expecting and supporting around precision medicine are those that reduce the administrative burden for healthcare systems and staff who provide care delivery and clinical trials as a care option. Personalized medicine requires the data and technology that allow those data to be rapidly synthesized to pinpoint interventional treatment(s) or clinical trial(s) that would best meet a patient’s need. Current infrastructure and technology are not sufficient to address the ever-evolving genomic/molecular data in a sustainable, structured way. Significant manual effort continues around the globe in the healthcare arena, even while genome sequencing is evolving the standard of care, and new novel therapeutics continue to move through discovery to commercialization. The use of electronic health records and associated systems not originally designed for our current expectations has not kept pace with the way data must be structured and used for precision medicine. This exacerbates the manual workload for a highly educated and skilled workforce and takes the time away from patients, and the costs of the manual efforts reduce the margins of the healthcare institutions. Using technology for data and imaging to bring forth those patients who would benefit from personalized medicine, either approved or in trials, will have significant impact on patient lives and will evolve precision medicine faster along the continuum to reality.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"Several years into the future, we will look back to 2020 and 2021 as the years that the COVID-19 pandemic accelerated the creation of confederated data solutions and brought greater velocity to data use and where decisions were made with greater speed and confidence as a consequence of the combination of real-world evidence (RWE) and randomized control trials — all of which are key to making personalized medicine a reality.
\nRWE is critical here. The preliminary guidance published by the U.S. FDA on September 30, 2021 was a watershed moment that has brought real-world data–driven evidence generation to the forefront for both registrational and post-approval uses.
\nInherent in the words personalized and precision is the ability to (a) access data, (b) contextualize data, (c) bring insights from those data that are meaningful and actionable, and (d) process the data, apply those insights, and take beneficial actions in a timely and relevant way.
\nRWE supports progress in all of these areas. It accelerates evidence generation with lower costs and time commitments; increases the reliability of data sources and methods; and brings evidence and research to the narrowest and most immediate point of treatment or trial decision.
\nWe also have to look at AI, machine learning, and deep learning. In the FDA’s preliminary guidance, there was a subtle but significant reference to AI. This was auspicious and intentional in being located within the RWE guidance. We are entering the phase where AI will be integrated across the continuum of evidence-generation approaches and clinical decisions. We’re starting to see the broader use of AI for advancing biomedical innovations and as a complementary technology in clinical care — becoming a catalyst for greater value in both.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"Across therapeutic areas, we’re learning more and more about how and why different patients may have different responses to a given therapy. With that, we know that genetics can play a significant role. As technological innovations allow for deeper exploration into individual phenotypes and genotypes, potentially drawing connections between specific genetic markers and therapeutic response through clinical investigation, the impact could be transformative.
\nThe more we understand about an individual patient’s genetics, and as we have an increasingly enhanced ability to evaluate clinical response based on genetic factors, physicians will be able to better anticipate which of their patients might best respond to a particular therapy — and potentially tailor treatment plans for the benefit of each patient.
\nLooking even further ahead, the advent and commercial launch of advanced home monitoring devices will offer physicians an unprecedented view into patients’ real-world response to therapies in near real time. The more precise we can get with such tools and insights, the better we can develop and calibrate truly personalized treatment plans for patients that depend on combined critical factors — including genetics, disease activity, and real-time response.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"Cancer treatment has evolved significantly in recent years, creating new opportunities for people with devastating cancers to find the therapies they need. However, existing drugs target only the most common cancer-triggering mutations, and most mutations are infrequent and remain understudied and unaddressed, even for well-known oncogenes. Fortunately, evolving technological approaches, like functional genomics, are enabling a new future for people who are living with cancer caused by rare mutations and currently have limited treatment options.
\nAt Fore Bio, we aim to develop the targeted therapies desperately needed by patient populations with unaddressed tumor mutations by leveraging our fast-acting, innovative, and powerful genomics capabilities. Our proprietary functional genomics platform, known as Foresight, elucidates disease biology to develop hyper-targeted therapies to patients with rare or unaddressed mutations by identifying candidates that have potential to address patient populations that might otherwise never have found a treatment option. We are building upon decades of expertise in precision oncology to continually refine our scientific and clinical approach to identify and advance potentially impactful therapies by uncovering a detailed understanding of mutation-driven cancers.
\n","showOnHomepage":true,"author":{"title":"Gabi Tarcic, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/G_Tarcic_Fore_Biotherapeutics.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Technology Officer","linkedin":"https://www.linkedin.com/in/gabi-tarcic-4395aa28/","email":null,"company":{"title":"Fore Biotherapeutics"}}}},{"answer":"The growing wealth of knowledge in the drug discovery industry has significantly expanded the potential for specific, targeted cancer treatments. With the deeper understanding of cancer pathways, new drug modalities, and further implementation of patient selection biomarkers that can identify genetic and signaling dependencies, the toolbox for developing targeted cancer therapies has never been so broad. I am hopeful that these technological advancements, which continue to evolve in real time, will allow researchers and physicians to reach what we have been striving for: a tailored, personalized approach to cancer treatment.
\nThese advancements have also allowed scientists and physicians to develop combinations as cancer therapies. My team at Ikena Oncology is developing agents to be used as monotherapies that directly target the underlying mechanisms driving cancer survival and growth, which are also being developed to work in combination with one another or with other existing treatments. We leverage both novel and existing biomarkers in our clinical trials to identify patient subpopulations who we believe have the best chance to benefit from our therapies. Our strategy is a culmination of — and an addition to — the significant progress that has been made in identifying druggable pathways and targets for specific cancer patient populations. Hopefully, it is also a step in the right direction toward personalizing treatment for every person living with cancer. We look forward to exploring the application of these monotherapies and combinations in multiple indications and to working with others who share our mission of making patient-tailored cancer treatments a reality.
\n","showOnHomepage":true,"author":{"title":"Mark Manfredi, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Manfredi_Ikena_Oncology.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/mark-manfredi-50923a10/","email":null,"company":{"title":"Ikena Oncology"}}}},{"answer":"Once a patient is diagnosed with cancer, the first question usually asked is, “What are my options?” Perhaps a better question to ask is, “What kind of cancer do I have?” In determining therapies that offer the best chance of success, genomic testing may hold the answer. Genomic testing, which identifies mutations in cancer cells, can help provide a more precise understanding of the underlying drivers of the cancer and hence provide insights into the optimal treatment strategy.
\nIncreasing the reach of next-generation sequencing more broadly to community hospitals will allow doctors to make informed decisions that can improve treatment outcomes and the quality of life for patients.
\nCancer is fundamentally driven by mutations in DNA. However, these types of mutations are not always the same, even within similar cancer types. This poses a significant problem for new precision approaches targeting specific pathways or molecules only present within certain subsets of cancers.
\nNext-generation sequencing can identify these mutations and allow doctors to develop tailored treatment strategies that have demonstrated success in cancers that harbor the same or similar mutations. By using a biomarker-informed approach, we can get away from treatment strategies based on the location of the cancer and move toward a tumor-agnostic approach driven by the underlying biology of the disease.
\nIf community hospitals everywhere could follow in the footsteps of academic hospitals and use genomic testing for all cancers, patient outcomes, including both the quality and duration of life, may be vastly improved.
\n","showOnHomepage":true,"author":{"title":"Avanish Vellanki","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Vellanki_Rain_Therapeutics.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/avellanki/","email":null,"company":{"title":"Rain Therapeutics"}}}},{"answer":"While cell therapies offer new opportunities for personalized medicine that we haven’t seen before, autologous-based treatments are expensive to produce and harder for patients to afford. They involve complex processes with short hold times and geographical limitations. These factors create economic issues for developers, medical providers, and, of course, the patients in need, limiting the impact these personalized treatments can have today.
\nResearch shows that a similar type of cell therapy–based personalized medicine — allogeneic treatments — holds the potential for quicker, more efficacious, and more accessible therapies that meet a patient’s individual needs.
\nAllogeneic therapies offer an economically feasible approach to cell therapy–based personalized medicine. These treatments are simpler to produce, because they do not rely on the logistical challenges of getting cells from the patient to the processing facilities. Furthermore, they offer a standardized and cost-effective approach, which makes creating larger batches more feasible and reduces the risk of contamination. These factors make this treatment type easier to implement than its autologous alternative, creating an opportunity to offer cell therapies for personalized care on a larger, global scale.
\nWith enhancements to our global facilities and capabilities, AGC Biologics is prepared to meet the increasing demand for both autologous and allogeneic therapies and to help find the best ways to produce affordable cell therapy treatments. Further, with recent investments in a new cell and gene therapy facility in Longmont, Colorado, we have untapped resources to bring these more personalized and economical life-changing treatments to market.
\n","showOnHomepage":true,"author":{"title":"Patricio E. Massera","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Patricio E. Masser_AGC_web.png","mediaDetails":{"height":264,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/pmassera/","email":null,"company":{"title":"AGC Biologics"}}}},{"answer":"As evidenced by the number of new gene-modified cell therapies approved in recent years, personalized/precision medicine has arrived. That said, the complexity and cost to manufacture these medicines may make them difficult to expand their use to a larger patient population. It will take breakthroughs in manufacturing and testing to reduce facility/labor/material costs and standardization of safety and release testing to increase availability of these medicines. One example is the standardization of a manufacturing platform to make viral vectors to increase yield and drive down the cost of materials. Also, a switch to allogeneic cell lines will reduce the complexity and cost of gene-modified cell therapies and increase patient access. Finally, improvements in delivery of the medicine to the patient will increase efficacy and reduce dosing requirements, driving down costs and increasing patient access.
\nI expect you will see great progress in the use of viral vectors for rare disease. Production processes will improve, increasing yield and lowering cost, and innovators will improve administration/re-administration to ensure durable effectiveness. I would also expect that allogeneic cell therapies will be approved to treat a broad array of cancers.
\n","showOnHomepage":true,"author":{"title":"Christopher K. Murphy","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Murphy_Brammer.png","mediaDetails":{"height":277,"width":211}}},"authorFields":{"title":"Vice President and General Manager, Viral Vector Services North America, Pharma Services","linkedin":"https://www.linkedin.com/in/chriskmurphy/","email":null,"company":{"title":"Thermo Fisher Scientific"}}}},{"answer":"For personalized medicine to become truly impactful, it will be critical to gain a picture of inherently heterogeneous diseases down to individual cells, since this is the only path to fully understanding their biology.
\nToday, cancer progression, treatment resistance, and disease recurrence are commonplace because we do not fully understand clonal evolution or heterogeneity, missed by bulk analysis. But single-cell DNA and multi-omic sequencing technologies allow us to see into individual cells.
\nThese transformative analytical technologies will enable the development of cutting-edge therapies that can truly address cancer drug resistance, as well as devastating genetic diseases. Mission Bio’s partners have already made discoveries with our Tapestri platform that can change the way we understand and treat diseases like acute myeloid leukemia, pediatric myelodysplastic syndrome treatment, and solid tumors, to name a few.
\nIn parallel, hundreds of personalized cell and gene therapies that rely on changes made to DNA in human cells are in clinical development but dogged by safety and efficacy concerns and regulatory delays. Here again, single-cell multi-omic technologies will be crucial for getting personalized therapies to patients by providing incredible insight into the heterogeneity of the engineered cells and therapies, allowing drug companies to fully characterize their therapeutics early in development, with implications for trials and ongoing patient monitoring.
\nSoon, we expect these same single-cell analytical technologies will play a recurring role in accelerating therapeutic development, improving cancer diagnosis, and identifying clonal progression, taking precision medicine to new heights.
\n","showOnHomepage":true,"author":{"title":"Yan Zhang, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Y_Zhang_Mission Bio.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/yan-zhang-6983911/","email":null,"company":{"title":"Mission Bio"}}}},{"answer":"At a macro level, I believe that personalized medicine can only become a reality upon adoption of a suitable social, regulatory, and economic framework. This will require innovation in the education of both staff and patients, reimbursement and regulatory practices, knowledge and data sharing policies, and practice management strategies.
\nThe implementation of personalized medicine will also require updated manufacturing methods that allow for tuning of drug release kinetics based on an individual’s ideal dosage. One proof point is the emerging field of high-throughput screening of excipient and drug combinations, a market where we see increasing start-up activity. Another example are additive manufacturing technologies, such as 3D printing, for the oral delivery of tailored-dosage or multi-API pills. Aprecia Pharmaceuticals’ Spritam tablet for epilepsy treatment was the first 3D-printed pill to be approved by the FDA back in 2015. Now, leading science companies, such as Merck, are investing in drug manufacturing via 3D printing technology. Polymer science and expertise to engineer excipients that enable tailored drug release will be a critical success factor in this field.
\nThird, I observe strong growth in the 3D-culture market for rapid in vitro testing of niche therapies, for example in the field of oncology. Functional drug testing with culture systems, such as organoids or cell-impregnated matrices, might accelerate clinical screening to bring personalized therapies into reality. As an example, our NovaMatrix® business offers innovative ultrapure alginates that can be utilized as an extracellular matrix in this field.
\n","showOnHomepage":true,"author":{"title":"Caroline Cooreman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Cooreman_Iff.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Business Development Manager, Biotechnology","linkedin":null,"email":null,"company":{"title":"IFF"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-for-what-therapeutic-area-do-you-think-we-will-see-the-greatest-progress-in-the-coming-years/","uri":"/roundtable/articles-q-for-what-therapeutic-area-do-you-think-we-will-see-the-greatest-progress-in-the-coming-years/","slug":"articles-q-for-what-therapeutic-area-do-you-think-we-will-see-the-greatest-progress-in-the-coming-years","title":"Q: For what therapeutic area do you think we will see the greatest progress in the coming years?","roundtable":{"topic":"Progress in Therapeutics","question":"For what therapeutic area do you think we will see the greatest progress in the coming years?","roundtable":[{"answer":"With the approval of Zolgensma in 2019, a gene therapy for treatment of spinal muscular atrophy that impacts infants, we are ushering in an age where many difficult-to-treat genetic disorders have the potential to be cured. Two therapeutic areas where I expect to see great progress are for neurologic disorders and rare genetic diseases. Many technological developments have recently been made to enable the scalability of gene therapy manufacturing, such as the Corning HYPERStack® cell culture vessel and the Ascent Fixed Bed Reactor System. Improvements in both viral vector design and systems for gene therapy production are making commercialization of gene therapies a reality.
\n","showOnHomepage":true,"author":{"title":"Austin Mogen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Mogen_Corning.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Senior Field Application Scientist","linkedin":"https://www.linkedin.com/in/austinmogen/","email":null,"company":{"title":"Corning Life Sciences"}}}},{"answer":"Therapeutic areas offer a convenient demarcation allowing us to focus areas of research to better understand and address disease. We look at solving problems by the conditions and areas of the body in which they manifest themselves: cardiology, the heart; dermatology, the skin; neurology, the brain; and the central nervous system. Oncology/cancer is different; it has always been a scary illness, stigmatized and, for much of history, too scary to name. Cancer is the body’s own cellular system gone awry.
\nCancer is a genetic condition. It is not a foreign invader (although it might be triggered by one) but is caused by genetic mutations in our own tissues, possibly influenced by epigenetic factors, that manifest in uncontrolled cell division and disrupted biological processes. Many of the most advanced cancer therapies currently target a cancer’s genome to suppress its growth and spread.
\nBut what about other genetic conditions: congenital ones like sickle cell anemia, muscular dystrophy, cystic fibrosis? Many of the same technologies employed to target cancer are also being brought to bear on congenital conditions.
\nGoing back to the previously named therapeutic areas of neurology, cardiology, and dermatology, many diseases in these areas (Parkinson’s, Alzheimer’s, hyperlipidemia, plaque psoriasis) are being linked to genetic traits and epigenetic factors.
\nPerhaps the “therapeutic area” that could see the greatest progress will not be an existing area at all, but a convergence of the understanding of disease at a more fundamental level, allowing us to make advancements in many areas of therapeutic interest, all at the same time.
\n","showOnHomepage":true,"author":{"title":"Brian Graves","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/B_Graves_Grace_Materials_Technologies.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Business Manager, Grace Materials Technologies","linkedin":"https://www.linkedin.com/in/brian-graves-8121255/","email":null,"company":{"title":"W.R. Grace"}}}},{"answer":"The pandemic has stimulated a renewed interest in all areas of therapeutic and biotechnology development, so this is a difficult question to answer. The area of expertise for our company is in the development of synthetic lethal cancer drugs. We would not be engaged in this field if we did not foresee this to be a therapeutic area in which we could make great progress within the near future. Synthetic lethal drug development is possible when the same cancer-associated changes that enable carcinogenesis also introduce an overdependence on specific proteins or pathways. Of course, finding these dependencies and targeting them with a drug is difficult. The most recognizable synthetic lethal cancer therapeutics in use are the PARP inhibitors, which have found use in cancers with DNA-repair deficiencies, such as those associated with BRCA mutations. Given the enormous success of PARP inhibitors and thus the synthetic lethal approach in general, we expect many more synthetic lethal cancer drugs to emerge in the coming years. This includes targeting newly uncovered dependencies that we have thus far not fully appreciated.
\n","showOnHomepage":true,"author":{"title":"Thaddeus Allen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Allen_Anticancer_Bioscience.png","mediaDetails":{"height":284,"width":211}}},"authorFields":{"title":"Vice President of Translational Biology and Business Development, San Francisco","linkedin":"https://www.linkedin.com/in/thaddeus-allen-1a80466/","email":null,"company":{"title":"Anticancer Bioscience"}}}},{"answer":"Respiratory diseases, such as asthma and COPD, continue to dominate the inhaled space, with COPD the third leading cause of death worldwide in 2019. These represent the majority of the inhaled targets for drug development, but, with the rise of biologics, we are seeing new classes of treatment emerge to tackle these diseases. With 80% of COPD deaths coming from low- or middle-income countries, further development of generic and lower-cost treatments will also be vitally important, and we hope to see continued progress in what can be a challenging area of development.
\nBeyond the traditional targets, we are seeing a rise in interest for other indications. Antiviral and antibiotic treatments for the lung are increasing in number, and we are seeing a lot of interest in nasal delivery of materials for systemic treatment of conditions like Alzheimer’s, depression, migraine, etc., with some exploring the potential for delivery to the brain through the olfactory regions in the nose. For example, the recent launch of a single-dose nasal DPI product that delivers emergency glucagon treatments illustrates the types of products that we may see more of as innovation and development in the area continues.
\nVaccine delivery by inhaled and nasal routes has already been proven for flu vaccination, is an active research area, and has taken on new significance with the current COVID-19 situation. There has been an increased interest in nasal delivery, targeting an immune response within the mucosal regions of the respiratory system where the initial COVID-19 infection occurs. Having an effective local immune response in addition to a systemic response can significantly boost the potential efficacy of a vaccine. Nasal vaccines can provide other advantages, such as easier administration by people other than traditional healthcare workers as part of a widespread, needle-free, mass vaccination strategy.
\n","showOnHomepage":true,"author":{"title":"Mark Parry","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Parry_Intertek.png","mediaDetails":{"height":274,"width":211}}},"authorFields":{"title":"Technical Director","linkedin":"https://www.linkedin.com/in/mark-parry-40130627/","email":null,"company":{"title":"Intertek"}}}},{"answer":"The success of the COVID-19 vaccines has shown the potential of mRNA vaccines for prophylactic purposes. In coming years, I think that we will see rapid developments in mRNA to tackle other infectious diseases. In addition, we will also see the platform’s therapeutic use in oncology, for example, in combination with other therapeutic strategies, such as the use of checkpoint inhibitors. Another area of great interest for mRNA therapeutics is in gene therapy applications for treating genetic diseases like lysosomal storage disorders with a “protein replacement” approach. In these situations, the liver or another organ can be used as a “bioreactor” to supplement a critical protein that the patient is either not making correctly or not making in the necessary quantities.
\nTo make full use of these technologies, we will need to ensure that the mRNA can be effectively and safely delivered into the cell. Lipid nanoparticles (LNPs) are crucial to the successful delivery of nucleic acid therapeutics, although other formulation platforms are currently being investigated as well, which will be complementary to LNPs, for example, by being able to target organs other than the liver.
\n","showOnHomepage":true,"author":{"title":"Maaike Everts, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Everts_Evonik.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Director of Strategic Marketing, Parenteral Drug Delivery Solutions","linkedin":"https://www.linkedin.com/in/maaike-everts/","email":null,"company":{"title":"Evonik"}}}},{"answer":"Particularly for the treatment of cancer, both mRNA-based therapies and antibody–drug conjugates (ADCs) have potential for tremendous progress.
\nWe've seen the noteworthy success of mRNA against infectious diseases over the last 18 months of the pandemic as a part of the COVID-19 vaccine, but applications in the field of oncology are still developing. As a modality, it's simple, elegant, and incredibly precise with the genetic sequence. As we've seen, because of the simplicity, it's incredibly quick to market. There will be significant investments and advances in mRNA as a modality moving forward. It will continue to go from strength to strength, especially given the proof of principle that it's safe and can be deployed on a huge global scale.
\nWhen it comes to an ADC as a therapy, it has the potency of a small molecule. Yet, with the delivery system, when it's attached to a monoclonal antibody (mAb), you have an antibody's precision and cellular focus. It offers the best of both worlds. You have the magic bullet effect of the mAbs and the potency of a small molecule API, so it will continue to be a very strong tool in our pharmaceutical armory.
\n","showOnHomepage":true,"author":{"title":"Andrew Bulpin, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Bulpin_MilliporeSigma.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Head of Process Solutions Strategic, Marketing and Innovation","linkedin":"https://www.linkedin.com/in/andrew-bulpin-49298b3","email":null,"company":{"title":"MilliporeSigma"}}}},{"answer":"Undoubtedly oncology. It is currently changing and evolving, thanks to tech platforms that record and combine data longitudinally with treatment information and outcomes as the cancer is being treated. The next step is to leverage the data to get insights, improve disease prevention, and add quicker, more effective drugs in the market. At SOPHiA GENETICS, we’ve recently highlighted two biomolecular approaches already being implemented within our technology that show great promise in aiding research for new therapies. These include the detection of homologous recombination deficiency (HRD) and RNA fusions (RNA targeting). Clinical studies are revealing how effective these types of biomarkers can be in not only identifying but also tracking the effectiveness of treatment for cancers associated with these molecular abnormalities. Precision medicine is all about further impacting clinical discoveries by fine-tuning the complicated process, something I believe will be accomplished with a data-driven medicine approach. At SOPHiA GENETICS, we supply researchers with the advanced data-driven tools they’ll need to support their drug, treatment, and research development.
\n","showOnHomepage":true,"author":{"title":"Jurgi Camblong, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Camblong_Sophia_Genetics.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Founder","linkedin":"https://www.linkedin.com/in/jurgicamblong/","email":null,"company":{"title":"SOPHiA Genetics"}}}},{"answer":"One of the reasons I was drawn to Double Rainbow is that we take a disease-agnostic approach to our scientific platforms. As we look at the standard of care across many therapeutic areas, we unfortunately see that, for many diseases, patients are left with underwhelming options. While we hope to apply our technology through partnership to a wide range of therapeutic areas, what we see in the near term is a continued prioritization of oncology by much of the industry. Given the scale and devastating nature of many cancer diagnoses, it is reasonable to see significant investment in this area, and I believe the collective efforts of researchers and applications of novel technologies — like those being explored within Double Rainbow — will continue to revolutionize care for these patients.
\nIn addition to oncology, there is a significant opportunity to advance the standard of care for people suffering from neurologic disorders, particularly neurodegenerative diseases such as Alzheimer’s, Huntington’s, or Parkinson’s. In recent years, we have seen several incremental steps toward improved care for these patients, but as our knowledge of biomarkers and mechanistic pathways continues to grow in combination with emerging technologies and novel modalities, researchers have an opportunity to push for meaningful, disease-modifying treatments for these patients. That is why our team at Double Rainbow is exploring multiple opportunities to advance the standard of care in this space through either enhanced drug delivery and targeting via our PRISM platform, or through novel asset origination via our HARMONY platform. Ultimately, our team is dedicated to doing whatever it takes to maximize our technologies for the benefit of human health.
\n","showOnHomepage":true,"author":{"title":"Holly Schachner, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/H_Schachner_Double_Rainbow_Bioscience.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Medical Officer","linkedin":null,"email":null,"company":{"title":"DoubleRainbow Biosciences"}}}},{"answer":"Pinpointing one therapeutic area is nearly impossible, as there is and will continue to be a tremendous surge of breakthrough therapies across oncology, vaccine, immunosuppressant, and other high-growth therapeutic areas. What is certain is the need for effective and efficient drug development cycles to maintain this extraordinary momentum. Alcami finds its niche here in our ability to foresee the needs of our customers, both in timeliness and capabilities to facilitate the progress of these advanced therapeutics.
\nAs an established CDMO with a versatile service offering, we provide high-throughput method development, efficient protocols for method onboarding, and industry-leading performance metrics for GMP analysis. This platform allows us to select optimal parameters quickly and develop robust and QC-friendly methods that are established for testing in much shorter timeframes.
\nWith great progress also comes the need for innovative technology to turn concepts into reality. Alcami continuously assesses and acts on what investments will deliver best-in-class drug development cycles. For example, we recently acquired analytical ultracentrifugation, variable pathlength UV for A260/A280 determinations, and new tandem quadrupole and QTOF instruments, as part of a 16,000-ft2 renovation in our Durham, North Carolina, laboratory to be commissioned in Q1 2022.
\n","showOnHomepage":true,"author":{"title":"Elliott Franco, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/E_Franco_Alcami.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Vice President, Laboratory Operations","linkedin":"https://www.linkedin.com/in/elliottfranco/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"In the coming years, I believe we could see innovation in the treatment of diabetes via emerging technologies and therapies. Thirty-four million Americans — about one in 10 — suffer from diabetes, and it’s the nation’s seventh leading cause of death, with about 79,000 deaths attributed to the disease annually. I’ve witnessed firsthand through my wife, who has type 1 diabetes, how difficult it is to handle. Outside of insulin injections or eating candies and other foods high in glucose, it’s not easy to regulate one’s blood sugar. We must create a technology with a better closed-loop management system that can share feedback, manage these levels, and provide insulin or sugar when needed. Currently, no device gives sugar to those with diabetes, only insulin.
\nWhile significant progress still needs to be made in the treatment of diabetes, Vertex Pharmaceuticals’ stem cell–derived diabetes therapy, VX-880, has the potential to create substantial change for those living with the disease. When the body’s blood sugar is too high, this system can deliver insulin to lower it, but when it drops too low, it offers glucose to raise it to a normal level. The therapy has already seen impressive results from its phase I/II clinical trial. The first patient who received the therapy saw their need for insulin disappear, providing hope of finding a sustainable treatment for the currently incurable disease.
\n","showOnHomepage":true,"author":{"title":"Tim Roberts","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Roberts_PCI.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Commercial Officer","linkedin":"https://linkedin.com/in/tim-roberts-a83a775","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"I believe that we will see great progress in cell-based immunotherapies for oncology indications in the coming years. With the deployment of five CAR-T cell therapies approved for clinical use, the field has now developed a path for clinical translation and commercialization of this new class of therapeutics. Motivated by these successes, there has been a great expansion in preclinical programs that are quickly advancing to the clinical track. Many of these are aimed at addressing the vast unmet need for treatments against solid tumors, and we hope to see these initiatives translate into improved outcomes and cures for this critical patient population.
\n","showOnHomepage":true,"author":{"title":"Tamara Laskowski, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Laskowski_Lonza.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Head of Clinical Development, Lonza Personalized Medicine","linkedin":"https://www.linkedin.com/in/tamara-j-laskowski/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"Historically, the best metric for advances in a therapeutic area follows either advancement in the understanding of the biology of the disease state, a large unmet need in public health, or both. In tracking with recent advancements, the area of inflammation has shown great strides in understanding the underlying causes of physiological responses that then trigger inflammatory cascades and ultimately symptomatic disease states. Conventional therapies have targeted these symptomatic responses to inflammation, but, with this new understanding, we can expect to see great progress in the treatment of the causes of inflammation response, hopefully even before symptoms become problematic. This will lead to new therapies targeted to change how asthma/COPD, arthritis, and autoimmune diseases are treated and a call to design and develop more targeted large and small molecule therapeutics. The advent of new therapeutics will require innovation in the synthesis and route design of these more complicated medicines as well as integrated development with new drug delivery technologies.
\nThe COVID-19 pandemic has exemplified how extreme public health needs will drive rapid and innovative progress as well. We have already observed new therapeutic approaches to vaccines in the design of the therapy as well as the integrated drug delivery system. This will continue to drive innovation and change, and we will be ready to meet these challenges as we see them on the horizon.
\n","showOnHomepage":true,"author":{"title":"David Vodak, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Vodak_Lonza.png","mediaDetails":{"height":242,"width":211}}},"authorFields":{"title":"Senior Director, Head of Small Molecules R&D","linkedin":"https://www.linkedin.com/in/david-vodak-10583054/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"Cancer immunotherapy with mRNA-based vaccines. Multiple clinical trials for such therapies are currently being conducted, and the successful use of mRNA vaccines for COVID-19 has given the development of mRNA-based cancer vaccines a significant boost.
\n","showOnHomepage":true,"author":{"title":"Suzanne Saffie-Siebert, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Saffie-Siebert_SiSaf.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/dr-suzanne-saffie-siebert-695b124/","email":null,"company":{"title":"SiSaf"}}}},{"answer":"The first wave of personalized medicine caught oncologists’ attention to use this technology in cancer therapeutics. The complexity of cancer cells, along with different somatic mutations, complicates the diagnostic and treatment plans. Historically, cancer patients have been treated with radiation and some cytotoxic agents that kill tumorous cells and healthy cells at the same time. This approach results in known severe side effects, such as hair loss, nausea, and fatigue. It is also often not very effective.
\nMore recently, immunotherapy has shown great promise for cancer treatment. This therapeutic approach attempts to give a patient’s immune system information that enables them to recognize and destroy cancer cells in a selective manner. In other words, your immune system is trained to be selective and not attack normal tissue and cause side effects. Individualized therapy in cancer treatment can be used to understand all the mutations that are present in a patient’s tumor, to forecast which of those tumor-specific mutations are going to be important in the generation of an immune response, and to predict the immunogenic neoantigen as part of the patient’s therapy.
\nThese days, modern genomics techniques let us map a patient’s tumor mutation profile. These analog data can be converted to digital data and used in predictions of the mutation profile of a specific patient using artificial intelligence (AI). The scientific advances in individualized cancer therapies bring enormous hope for more effective therapies with less severe side effects in this area. The digital methods also offer a more reproducible — and thus scalable for production — workflow.
\n","showOnHomepage":true,"author":{"title":"Mahsa Mohiti-Asli, Ph.D.,","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Mohiti-Asli_BASF_Pharma_Solutions.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"Technical Manager, BASF Pharma Solutions","linkedin":"https://www.linkedin.com/mahsa-mohiti-asli-phd/7b845b51/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Innovation is accelerating in therapeutic areas that traditionally receive significant funding. Not surprisingly, these areas — oncology, cardiovascular disease, diabetes, and infectious diseases — will likely see great progress.
\nWhen we consider advancements in treatments for infectious diseases, we think about the progress in biopharmaceutical treatments linked to the pandemic. We’re witnessing a propelled focus in this space — the point where biotechnology and pharmaceutical manufacturing meet — as scientists seek answers to quickly treat and even prevent deadly infectious diseases like coronavirus disease (COVID-19). Rather than synthesizing chemical compounds to produce an active pharmaceutical ingredient that treats a symptom, biotechnology uses living organisms or components of living organisms to help an individual’s own genetic makeup fight or prevent disease. This technology isn’t exclusive to COVID-19 vaccines and therapies. Biopharmaceutical organizations are using biotechnology to treat therapeutic areas such as cancer, cardiovascular disease, and other illnesses.
\nServing the biopharmaceutical industry has offered Univar Solutions the opportunity to demonstrate the value of our robust distribution capabilities, including supplying ingredients used in COVID-19 vaccine production. As biopharmaceutical treatments continue revolutionizing medicine for other therapeutic areas, we’re supporting customers with our expansive and diversified portfolio, building out our infrastructure, and providing manufacturers ready accessibility to the high-purity solvents, excipients, and other ingredients they use to produce treatments aimed at keeping our communities healthy and safe.
\n","showOnHomepage":true,"author":{"title":"James Peterson","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Peterson_Univar_Solutions.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Vice President, Pharmaceutical Ingredients","linkedin":"https://www.linkedin.com/in/james-paterson/8597b749/","email":null,"company":{"title":"Univar"}}}},{"answer":"Oncology and rare diseases are the therapeutic areas where I believe we’ll see the fastest and greatest adoption of precision medicine. For rare diseases, the need is so great, with long research discovery cycles but precise due to molecular/genetic testing (e.g., genotype and phenotype). In oncology, the adoption will be driven by the very rapid understanding of biomarker impact on disease progression and therapeutic options for treatment.
\nHowever, we do need to (a) incorporate clinical trials as a care option to provide more choices to treating physicians and their patients and (b) expand clinical trials from being limited to a small set of healthcare organizations as trial sites to a broader range of sites in all communities and geographies. By doing this, more diverse populations will be served, the movement to precision medicine will continue at a rapid pace, and we can better support studies which are challenged today, because limited patient recruitment is stalling research.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"There are two areas where we’ll likely see the greatest progress: oncology and vaccines.
\nThere are going to be major advances in some of the hardest-to-treat cancers. For example, bladder cancers will be beneficiaries of both broader use of immuno-oncological therapy and more targeted therapeutics. They’ll be treated with the precision and narrow patient stratifications based on genomics now standard in non-small cell lung cancer (NSCLC). We’ll also see substantial improvements in outcomes, treatment durability, and quality of life.
\nMultiple myeloma and other hematological malignancies will also move into a new era of options. More effective treatments will be available earlier, and late-stage (e.g., triple class refractory) treatments, such as CAR-T and other engineered cells, will assure longer survival and far great quality of life for broader groups of patients.
\nLooking at vaccines, the COVID-19 vaccine development process validated mRNA approaches as safe and precise for vaccines. This has the potential of revolutionizing where and how vaccines can be deployed economically, with speed and precision.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"It’s inspiring to see notable progress across the healthcare industry and its many therapeutic areas. I’m particularly excited about current advances and what’s to come in ophthalmology, as innovations in drug delivery — most notably those offering extended therapeutic delivery — have the potential to shift treatment paradigms toward greater efficiency, improve patient adherence and compliance, and continue to maximize safety and effectiveness.
\nExtended-release drug delivery options that require less frequent administration — be it at the doctor’s office or at home — may offer a comparatively longer duration of effect in addition to more consistent and balanced therapeutic delivery. This sort of optimization will serve to benefit the patient, caregiver, and healthcare provider alike in meaningful ways — for example, patients may not need to see their doctor as frequently for an injection or be required to administer as many eyedrops in a given timeframe.
\nCollectively, all of these factors — minimizing invasive procedures and offering more convenience, coupled with safe and efficacious therapeutics delivered over a longer period that maintain a stable level of vision and less deterioration of eyesight — hold the power to help reduce treatment and disease burden on the patient and further improve outcomes. Promising headway in this space is already being made, and I’m extremely optimistic about the transformative advances we’ll see in the next few years.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"Monoclonal antibodies will be the therapeutic area with the greatest progress throughout the coming years. Antibodies are proteins created by the human immune system to fight against disease. Recent advances in our understanding of biology have led to great therapies in oncology, such as checkpoint inhibitors, and, more recently, neutralizing antibodies against COVID. There are now multiple novel ways of using monoclonals, including in cocktails, combinations, and against novel targets to create therapies that are safe and highly effective.
\nHistorically, monoclonal antibodies have been utilized in the treatment of cancer. While cancer will continue to be a target of antibody therapeutics, the emergence of COVID-19 has shown that monoclonal antibodies are highly advantageous in the fight against infectious diseases as neutralizing antibodies (nAbs). This is due to their ability to home in on specific epitopes on the virus, such as the spike protein, to neutralize the virus directly. The net effect is much higher efficacy and safety compared with other treatment methods.
\nAt Abpro, we have developed an entire program for COVID-19 based on neutralizing antibodies. ABP310, which has the advantage of being future-proofed against variants yet to come and has superior binding to the SARS-CoV-2 spike protein than currently approved nAbs, which enables it to be used very effectively as a therapy and also as a prophylactic for immuno-compromised individuals who can't generate a response to vaccines. Our antibody treatment binds to areas of the spike protein that have not changed over multiple generations of viruses so that it will remain effective against future variants.
\nAs the pandemic continues into 2022, vaccines will be critical in quelling the effects of the pandemic. However, a one–two punch will be required in order to complete the puzzle as a treatment for breakthrough cases, immunocompromised patients who cannot develop their own antibodies in response to the vaccine, and other non-responders or non-adopters of the vaccine.
\n","showOnHomepage":true,"author":{"title":"Ian Chan","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/I_Chan_Abpro.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/ian-chan-b053aa45/","email":null,"company":{"title":"Abpro"}}}},{"answer":"Our greatest impact will be in the field of psychiatry, due to our bringing a precision medicine approach to the field for the first time. Today, psychiatric treatment only works for roughly one in three patients. Core to this problem is the challenge that we can’t identify who those one in three will be. Current diagnoses are based on clinical symptoms only, without biological biomarker tests that direct any aspect of diagnosis, prognosis, or treatment selection in psychiatry. Consequently, medications and devices are developed using a one-size-fits-all approach. By contrast, other therapeutic areas have leveraged precision approaches and generated far better results for patients. As a consequence, the total investment in precision medicines has risen rapidly in recent years. Now is the time for a precision approach in psychiatry. Doing so would generate rapid progress in a space that hasn’t seen innovation in decades. We are poised to rethink how we diagnose mental health conditions and to begin developing personalized treatments that are geared toward likely drug responders, taking the guesswork out of psychiatric treatment. In the coming years, the expansion of precision psychiatry, an emerging field that takes an individual’s brain biology into consideration, will likely see tremendous progress, because the current global state of mental health demands this progress. By combining artificial intelligence with data from behavioral tests; brain function measures, including electroencephalography activity; and wearables, we will be able to optimize treatments for patients that actually work for them because of their targeted nature. Consequently, by moving away from the trial-and-error approach that pervades psychiatric drug development and clinical practice today, the lives of those with mental health conditions will dramatically improve.
\n","showOnHomepage":true,"author":{"title":"Amit Etkin, M.D., Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Etkin_Stanford_University.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/amit-etkin-783a04158/","email":null,"company":{"title":"Alto Neuroscience"}}}},{"answer":"Technological innovation, and particularly fields like artificial intelligence, have opened up new potential in cancer treatment. The emergence of immunotherapies, small molecules, and other therapies has increased overall survival and made it possible to address more cancers that are not responsive to chemotherapy or radiation. The next step in oncology research is to identify new solutions for the patients that are still being left behind — that is, the many patients who have cancer driven by less common mutations that are more difficult to treat. I am encouraged by the motivation and growing capabilities of the scientists whose aim is to address these rare cancers, including our team at Fore Bio, and am optimistic that within the coming years we will see the beginnings of a new model of precision oncology where treatments are hyper-targeted and therapeutic strategies are personalized for every cancer patient.
\n","showOnHomepage":true,"author":{"title":"Gabi Tarcic, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/G_Tarcic_Fore_Biotherapeutics.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Chief Technology Officer","linkedin":"https://www.linkedin.com/in/gabi-tarcic-4395aa28/","email":null,"company":{"title":"Fore Biotherapeutics"}}}},{"answer":"Technology that enables us to reach a new future of precision medicine expands across many therapeutic areas, but, as CEO of an oncology company, I am particularly excited about our industry’s potential to make additional progress in cancer treatment in the coming years. The scientific community has continued to rally behind the discovery of new ways to drug important pathways and new insights into mechanisms of drug resistance that can lead to next-generation therapies or unique combination strategies. This has sped up our ability to pursue hypothesis-driven therapeutic approaches and thus expanded the total treatments in development.
\nThe sheer amount of ongoing innovative cancer research right now is incredible and will hopefully have a positive impact on patients who do not respond to or become resistant to current therapies. Each new mechanism identified is a new potential pathway for a cancer patient to find a cure. Personally, I am optimistic for a future where cancer treatment is more tailored to each individual, guided by the continual knowledge-building across the oncology research community and our shared passion to find viable treatment avenues for every person living with cancer.
\n","showOnHomepage":true,"author":{"title":"Mark Manfredi, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Manfredi_Ikena_Oncology.png","mediaDetails":{"height":309,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/mark-manfredi-50923a10/","email":null,"company":{"title":"Ikena Oncology"}}}},{"answer":"Among experts, the conversation is not about if there will be another pandemic, but when it will occur. The focus of these conversations surrounds the global emergence of antimicrobial resistance (AMR). Notably, no new classes of antibiotics have been brought to market in decades, and, with a long history of overuse and misuse of existing antibiotics, physicians are left with limited therapeutic options for patients when faced with AMR. The World Health Organization has recognized AMR as the cause of over 700,000 deaths worldwide and estimates that this figure will likely increase to 10 million by 2050. This urgent need has sparked significant investment and research in the space. New classes of anti-infectives have shown efficacy in clinical trials against some of the most resistant bacteria, including a designated group of nosocomial pathogens commonly associated with AMR, acronymically dubbed “ESKAPE” pathogens due to their propensity for “escaping” the biocidal action of antibiotics. ESKAPE pathogens, which include both Gram-positive and Gram-negative bacteria, make up the majority of multidrug resistant infections. The research and development of new classes of anti-infectives will no doubt see extensive progress in the coming years as the world continues to advance the fight against deadly drug-resistant pathogens.
\n","showOnHomepage":true,"author":{"title":"James Graham","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Graham_ Recce_Pharmaceuticals.png","mediaDetails":{"height":260,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Managing Director","linkedin":"http://www.linkedin.com/in/james-graham-6839533a/","email":null,"company":{"title":"Recce Pharmaceuticals Ltd."}}}},{"answer":"I believe that we’re entering an incredibly exciting time in the field of precision therapy for genetic cardiovascular diseases. We’ve known the genetic causes of several major inherited heart diseases for decades, but the field has been limited in the therapeutic tools at our disposal to correct the underlying disease biology. For instance, the first genes implicated in long QT syndrome and hypertrophic cardiomyopathy were identified in the 1990s, but precision therapies for these types of disorders have only recently become feasible.
\nToday, we’re getting closer than ever to having the right set of technologies to address the underlying disease biology of many different genetic heart diseases. As clinical, genetic, and disease biology insights for many of these diseases continue to advance and become more sophisticated, we’re able to pair these insights with emerging therapeutic modalities that have tremendous potential.
\nAAV-based gene transfer is an excellent example of how far this field has come. With AAV-based gene transfer, we now have the potential to bridge the gap between knowing how several genetic heart diseases unfold and knowing how we could effectively treat them to address their mechanistic underpinnings. These advances in precision therapy could allow us to help patients living with chronic and devasting genetic heart diseases, such as dilated cardiomyopathy, like never before. I’m hopeful that, in the coming years, we’ll continue to witness some profound advances in this field.
\n","showOnHomepage":true,"author":{"title":"Matt Killeen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Killeen_Renovacor.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Scientific Officer","linkedin":"https://www.linkedin.com/in/matthewkilleen/","email":null,"company":{"title":"Renovacor"}}}},{"answer":"Biotechnology-based treatments are helping fight some of today’s most life-threatening diseases and are bringing promise to several areas of therapeutics, so it is hard to pick just one.
\nThe advances we have seen in immuno-oncology are impressive, and I anticipate that this therapeutic area will continue to see a great deal of progress. With another treatment area, cell and gene therapies, any genetic disorder can potentially be treated. Both of these treatment areas have the potential to collide and produce fantastic results.
\nFor example, today’s typical recombinant protein–based treatments (like monoclonal antibodies) are helping turn cancer into a chronic disease that doesn’t end life prematurely. We have seen tremendous progress here and will continue to see more in the coming years. In addition to these advances, there are cell and gene therapy oncology treatments being developed that have the potential to cure patients altogether.
\nWe are still at the beginning of the cell and gene therapy revolution, and some of the treatments require early detection to make an impact on patient lives. Therefore, diagnostics is a third area we cannot forget. It is necessary to advance rapid and cheap genetic diagnostic testing in newborns and young children to avoid the development of some pathologies.
\nAGC Biologics is currently working with more than 100 processes that will treat or cure multiple diseases, and we anticipate exponential growth in treatments of life-threatening diseases coming to market that will improve the lives of millions of people.
\n","showOnHomepage":true,"author":{"title":"Patricio E. Massera","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Patricio E. Masser_AGC_web.png","mediaDetails":{"height":264,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/pmassera/","email":null,"company":{"title":"AGC Biologics"}}}},{"answer":"I think that precision medicine will be spearheaded by the field of oncology, where the need for accurate diagnosis, therapy optimization to unique pathophysiological factors, and disease progression monitoring are indispensable for successful treatment. We see that the industry is making significant investments in the relatively small,but rapidly growing fields of cellular therapies and regenerative medicine. To illustrate, cellular immunotherapies based on T cell receptor, CAR-T cell, and NK cell platforms show potential for differentiated cancer treatments. The Alliance for Regenerative Medicine reported a surge in investment in this field, reaching $6.6 billion in the first half of 2021.
\nOn the other hand, I would recognize the significant challenges that the industry is still facing to implement precision medicine in large therapeutic fields, such as diabetes. With a large patient pool available for data analysis, treatments are already tailored to the patient on the basis of population averages. However, treatment at the individual level is still challenged by factors such as data-collection and data-sharing restrictions and by the implementation of a flexible and decentralized supply chain. In addition, one can question the balance between new healthcare delivery practices and patient empowerment.
\n","showOnHomepage":true,"author":{"title":"Caroline Cooreman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Cooreman_Iff.png","mediaDetails":{"height":288,"width":211}}},"authorFields":{"title":"Global Business Development Manager, Biotechnology","linkedin":null,"email":null,"company":{"title":"IFF"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-whats-the-next-big-thing-on-the-horizon-that-will-significantly-alter-the-pharma-biopharma-market-your-operations-or-the-way-you-do-business/","uri":"/roundtable/articles-q-whats-the-next-big-thing-on-the-horizon-that-will-significantly-alter-the-pharma-biopharma-market-your-operations-or-the-way-you-do-business/","slug":"articles-q-whats-the-next-big-thing-on-the-horizon-that-will-significantly-alter-the-pharma-biopharma-market-your-operations-or-the-way-you-do-business","title":"Q: What’s the next “big thing” on the horizon that will significantly alter the pharma/biopharma market, your operations, or the way you do business?","roundtable":{"topic":"The Next \"Big Thing\" in the Pharma/Biopharma Market","question":"What’s the next “big thing” on the horizon that will significantly alter the pharma/biopharma market, your operations, or the way you do business?","roundtable":[{"answer":"The digitalization of the pharma market is advancing at a speed and scale that has exceeded my expectations. It has reached just about every critical element of the industry — from the way pharma companies conduct clinical trials and R&D work to improvements in quality management and post-marketing monitoring. I’m also seeing more companies implement artificial intelligence–based technology platforms regardless of their size, business model, or position in the value chain.
\nAn important digital trend — that has been exacerbated by the pandemic — is using advanced tools to increase the resilience and predictability of the complex pharma supply chain. For the Pharma Solutions division at IFF, we’re diving right into the digital era with our manufacturing facilities to increase the robustness and consistency of our products. Digitalization not only helps us to optimize production processes but also enhances our product offerings overall. We’re utilizing innovative technologies and advanced statistical techniques for data mining, predictive modeling, and process optimization. With advanced analytical tools, we can tap into the robust data generated during production processes. This data offers new insights to address variability in the manufacturing chain — resulting in more stable processes, fewer supply disruptions ,and greater batch-to-batch consistency, all within strict validated parameters.
\n","showOnHomepage":true,"author":{"title":"Dago Caceres","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Caceres_DOW.png","mediaDetails":{"height":238,"width":211}}},"authorFields":{"title":"Global Strategy Director","linkedin":"https://www.linkedin.com/in/dago-caceres-6491a4/","email":null,"company":{"title":"IFF"}}}},{"answer":"From the perspective of some of our pharma customers, mRNA will be the biggest focus for the next generation vaccines for influenza, yellow fever, HIV, etc.; and new therapies for cystic fibrosis, multiple sclerosis, and different types of cancer. Of course, mRNA technology cannot work without lipids, which stabilize and ensure delivery of the nucleic acid molecules within human cells. Grace chromatographic silicas will become increasingly important for the purification of the key lipids.
\nWith major investment in our manufacturing facilities, Grace is well prepared to meet an increased demand for silica gel. Grace also is working on technologies for the purification of mRNA, and we are committed to bolstering collaborations with pharma companies.
\n","showOnHomepage":true,"author":{"title":"Sandra Wisniewski","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Wisniewski_W.R.Grace_Co.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"President, Materials Technologies","linkedin":"https://www.linkedin.com/in/sandra-wisniewski-0b25a329/","email":null,"company":{"title":"W.R. Grace"}}}},{"answer":"Another “big thing” that is happing in the industry is the prioritization of investments into new drug modalities, focusing on disease prevention and curative therapies. For example, the novel mRNA technology platform that enabled the industry to pass the test of rapid pandemic response with flying colors is now being investigated for use in the potential prevention of diseases ranging from difficult-to-eradicate pathogens to cancer. This new mRNA technology platform will likely lead to breakthroughs in gene therapy offering a once-in-a-lifetime correction of defective genes by delivering CRISPR-Cas9 coding mRNA and guide RNA packaged into lipid nanoparticles to target organs.
\nAt the enterprise level, pharma/biopharma companies will also need to continue to invest in programs targeting increased productivity and reduced costs, with digital transformation programs taking central stage. These programs will range from broader adoption of artificial intelligence and machine learning in novel drug design to investments into lab automation and instrument connectivity leading to intelligent end-to-end workflow solutions. The digital transformation of pharma/biopharma lab will improve R&D, operations, business processes, and other enterprise functions.
\n","showOnHomepage":true,"author":{"title":"Sergey Vlasenko, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Vlasenko_Agilent.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Associate Vice President Pharma and Biopharma End Markets","linkedin":"https://www.linkedin.com/in/sergey-vlasenko-645a477/","email":null,"company":{"title":"Agilent Technologies, Inc"}}}},{"answer":"I think the next big thing in healthcare is the integration of the normalization of digital tools to analyze and share ever increasing amounts of data. Not only from integrated and connected be electronic health records, but also digital delivery of care like telemedicine. In U.S. healthcare, the next big thing is a quantum leap in accessibility to healthcare that is driven by these digital breakthroughs. The digitization of data and the pervasive use of mobile devices, including video calls, makes it easier for people to get the advice and information they need when they need it to take care of themselves better and ultimately prevent disease from impacting their lives — not just providing treatments when needed.
\nThe next big thing for Pii is contributing to the COVID-19 supply chain. This is a massive global health challenge and, given the transmission rates and frequency of new variants emerging, it’s going to be around for a long time. Vaccination rates outside the U.S. are woefully small — less than 1% — which adds to the challenges ahead for the global community. There are 11 billion doses of vaccine needed outside the United States. Pii has an opportunity to be part of that global supply chain to provide initial and booster vaccinations to millions of people.
\nThe other “next big thing” for Pii is onshoring of the pharmaceutical supply chain back to the U.S. It’s been moving east for over 40 years: Europe to India to China. The COVID pandemic has highlighted the need for governments across the globe, including the U.S., to re-evaluate the long, complex supply chains that were put in place to take cost out of the system. That strategy worked when the increasingly globalizing supply chain was serving near-term profit demands in the retail and institutional distribution channels. However, with the rise of populism globally and in the U.S., as well as the democratization of healthcare in the U.S., the U.S. Government has stepped in to provide grants, loans, and contracts to many healthcare businesses to build and revitalize infrastructure in the U.S. But when you talk about providing care to larger numbers of people, it’s a different motive than simply profit. In order to further democratize healthcare, infrastructure is needed onshore: accessible, modern, adaptable, flexible, and ready to perform here in the U.S.
\n","showOnHomepage":true,"author":{"title":"Kurt R. Nielsen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Nielsen_Pii.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"President and CEO","linkedin":"https://www.linkedin.com/in/kurt-nielsen-ph-d-0013217/","email":null,"company":{"title":"Pii (Pharmaceutics International, Inc.)"}}}},{"answer":"One of the next big things which is pertinent to us is the increased momentum of inhaled or nasal drug development for delivery of vaccines and complex drugs, including peptides, monoclonal antibodies, oligonucleotides, mRNA, and gene therapies. The potential for patient-friendly drug delivery and new therapeutic pathways for diseases such as cystic fibrosis, asthma and lung cancer, coupled with the advantages presented both by targeted delivery to the lung and systemic delivery for other diseases or treatment pathways, are driving this increased attention. The size of a biologic, susceptibility to stresses and impact on stability, aerodynamic properties, and bioavailability all present challenges. We are already seeing significant drive to develop and innovate both formulation and device design and we anticipate this continuing to be primary focus for us and our development services.
\nSolution- and suspension-based sprays are inexpensive; however, some devices do not tolerate freeze–thaw cycles, which raises fill-finish concerns. Reconstitution of drug product close to administration or careful device screening and design can circumvent that problem and can also address drug product stability challenges where lyophilization can be used to extend the shelf life. Pressurized metered-dose inhalers (pMDIs) present significant formulation challenges for biologics, and so the focus is primarily on aqueous and solid formulations for pulmonary delivery where particle engineering must be carefully considered for solid or suspension-based products. A nebulizer solution does not require significant particle engineering and is a common target for development for early clinical trials, acute hospital-based treatment regimes, as well as the treatment of pediatric, elderly, ventilated, and sedated patients.
\n","showOnHomepage":true,"author":{"title":"Mark Parry","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Parry_Intertek.png","mediaDetails":{"height":274,"width":211}}},"authorFields":{"title":"Technical Director","linkedin":"https://www.linkedin.com/in/mark-parry-40130627/","email":null,"company":{"title":"Intertek"}}}},{"answer":"There has been a significant increase in the implementation of technology within the pharma and biopharma industries. Wearables have become more popular among consumers, because they help individuals track their daily physical activity and overall health. These tech products have also allowed healthcare professionals to monitor their patients’ vitals and health at home, which has proven extremely beneficial during the pandemic.
\nI also predict that the U.S. population will expect greater convenience with their drug supply delivery, as more companies make their products and solutions accessible at home. As a society, we are now accustomed to quick and easy at-home delivery for almost everything we need, so it is likely the industry will hear more requests from patients for the “Amazon Prime effect” regarding their prescriptions and lifesaving drugs. Similarly, our industry’s recruitment and talent process will change completely due to remote work. This will lead to more diverse talent pools, as well as more fluid and accelerated advancements than the industry has ever seen.
\n","showOnHomepage":true,"author":{"title":"Brian Keesee","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/B_Keesee_PCI_Pharma_Services.png","mediaDetails":{"height":298,"width":211}}},"authorFields":{"title":"Vice President & General Manager, Global Operations and Supply, Clinical Services","linkedin":"https://www.linkedin.com/in/brian-keesee-90725724/","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"The pandemic has changed our minds and reality. The new normal will be that drugs and devices will be brought to market faster. It used to take 10 years to take a molecule from R&D to manufacturing. Today, that won’t fly, and mankind won’t wait. The concepts of what we’ve traditionally thought of as product velocity and speed-to-market will be shattered. To meet these new demands, organizations must alter their traditional operational and business models.
\nThe main issue facing this industry is: How can facilities be produced faster and to regulatory standards without compromising on quality, safety and efficacy? Even prior to the pandemic, organizations were struggling with speed-to-market from R&D to manufacturing. The key to the puzzle is a well-governed, transparent, and collaborative model that supports dynamic and effective decision-making.
\nOrganizations are looking to end-to-end service providers like Verista to manage, automate, and validate their data, systems, and operations to ensure they comply with regulations, all while facilitating faster and more informed decision making. To achieve this, there is a push toward digital transformation. Legacy processes and systems are being replaced with streamlined digital solutions that enable data to get from R&D and the manufacturing shop floor to decision makers in record time. For example, Verista helped a top 5 pharma client implement Veeva Vault as their regulatory information management systems (RIMS), resulting in faster time to submission. By evaluating and streamlining their processes, they can now complete their fully compliant dossiers faster, meaning their molecules get to market faster too.
\n","showOnHomepage":true,"author":{"title":"Manny Soman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Soman_Verista.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/manny-manish-soman-6a40181/","email":null,"company":{"title":"Verista"}}}},{"answer":"The trend, which has been apparent for some time but which will become more significant, is the rise of targeted therapies leading to a greater number of products coming to the market — though each product by itself is not likely to be very significant in terms of size. We will have to be able to manage more projects while optimizing operations to ensure agility and capability to manage a number of products.
\n","showOnHomepage":true,"author":{"title":"Saharsh Davuluri","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Davuluri_Neuland_Laboratories_Limited.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Vice Chairman and Managing Director","linkedin":"https://www.linkedin.com/in/saharshdavuluri/","email":null,"company":{"title":"B&P Littleford"}}}},{"answer":"Traditionally, the treatment of diseases has been led by small molecule drugs, but there’s a mega trend of shifting to large molecule drugs, which are more complex and used to treat a wider range of diseases. Because of this and the rise of new therapeutic systems (in the form of personalized medicines like cell and gene therapies and antibody engineering) across the U.S. pharma market, there is a growing need for traditional analytical tools to enable higher and faster characterization of these more convoluted drug systems and drug products. Right now, the tools available are not meeting the needs of these sophisticated systems.
\nThat’s why high-resolution technologies like our HRIM instrument MOBIE are so important. With so much pressure to diagnose and treat diseases, researchers need to be able to quickly and easily detect and analyze molecules that are indicative of disease and explore biologic systems that reach far beyond genomics. However, to do that, they need systems capable of superior sensitivity to detect even minute traces of many disease-specific biomolecules, and that’s really what’s driving our R&D efforts.
\nUltimately, by providing technology that reduces analysis times from days and hours to minutes and seconds, we’re helping researchers to accelerate the process of bringing safer and more effective drugs to market.
\n","showOnHomepage":true,"author":{"title":"Melissa Sherman, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Sherman_MOBILion_Systems_Inc.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/melissa-sherman-ph-d-4711004/","email":null,"company":{"title":"MOBILion Systems Inc."}}}},{"answer":"As COVID continues to change the markets and the future of healthcare, I believe that more large molecule products will become the forefront of drug product development, calling for advancements in testing, equipment, and environmental controls.
\nTo support the increasing demand for biologics, Alcami is staying ahead of the curve with continued investment in biotechnology testing by renovating and expanding our biologics infrastructure. Approximately 5,200 ft2 of lab space and 40 scientists are being added to our existing footprint and headcount in North Carolina. Beyond established capabilities in high-resolution mass spectrometry, ELISA, cell-based bioassays, capillary isoelectric focusing (cIEF), and glycan analysis, Alcami will be introducing new instrumentation and capabilities in support of DS/DP characterization in early-phase development.
\nThe expanded footprint will incorporate three different laboratories; one focusing on chromatography, one housing a wide range of mass spectrometry equipment for characterization and sequencing, and a bioassay lab with a separate cell culture room.
\n","showOnHomepage":true,"author":{"title":"Alex Dunlap","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Dunlap_Alcami.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Business Development Manager, Lab Services","linkedin":"https://www.linkedin.com/in/alex-dunlap-02440b4b/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"Pharma 4.0 was born out of the need for a bespoke approach in the regulated pharmaceutical industry to adopting Industry 4.0 and represents the inevitable next step in its evolution. The success of an organization's digital transformation strategy depends on the volume, accuracy, and quality of the information available in its digital systems.
\nThe foundation of a digital transformation strategy lies in bringing together the vast amounts of data generated by scientific research and development. The goal is to gather, store and retrieve all data in a correct, structured, and useable format — all while maintaining regulatory compliance — and therefore unlock meaningful insights from that data. The potential of this connected approach to enable faster and more accurate decision-making in the drug discovery and development process, and so bring new drugs to market more quickly, is recognized across the pharmaceutical industry.
\nWithin the lab, a significant barrier to success is the lack of proper infrastructure that connects all data sources across a very diverse environment. The “next big thing,” therefore, is a universal digital data connectivity solution unencumbered by legacy systems, data siloes, or manual processes that connects any instrument, resource, app, and software in the lab. Enabling the free flow of data in this way will allow the development of reliable data models that ultimately provide scientists with the insights they need to inform better research outcomes.
\nOffering a new solution to this decades-old problem, the Scitara Digital Laboratory Exchange (DLX™) was conceived by a team with long experience in the laboratory environment and developed specifically for the scientific lab. The DLX offers a rapid connectivity infrastructure for any instrument in the lab in a fully compliant and auditable cloud-based platform.
\n","showOnHomepage":true,"author":{"title":"David Levy","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Levy_Scitara_Corporation.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Global Product Director","linkedin":"https://www.linkedin.com/in/dave-levy-6843551/","email":null,"company":{"title":"Scitara Corporation"}}}},{"answer":"While it may seem cliché, I strongly believe in the disruption potential of digitalization for the pharma industry. Despite the aforementioned innovation power, the pharmaceutical industry still relies very heavily on analogue systems. The ability to create, test, scale-up, and commercialize modern complex formulations and biopharmaceutics takes an enormous team of specialists and experts, and yet, the way we share data, collaborate, and exchange information between entities remains largely on paper. As a supplier of high-quality pharmaceutical ingredients, the volume of analogue paperwork, technical know-how, and compliance documentation that is exchanged with our customers in the industry is astronomical — and this is multiplied further through the use of tollers and contract manufacturing organizations to bring a drug to market. Yet, all of these things within this business can be automated, digitized, and ultimately brought into the 21st century within the next few years. This simplifies an overly complex business, and simultaneously raises the level of accuracy over error-prone analogue transitions — directly impacting patient outcomes. To address this, at BASF we have pioneered ZoomLab™, a complex, proprietary algorithm allowing pharmaceutical formulators in over 91 countries the ability to model and optimize drug formulations, saving months of research time and thousands if not millions in development costs. While our RegXcellence® program allows for instant access and full compliance with the formerly analogue quality, regulatory, and safety data for our products. As a key supplier and integral part of the pharmaceutical value chain, we see digitalization as a true enabler of innovation and compliance, and we are happily leading the industry in building a platform for technical, quality, and regulatory truth. While I’m passionate and excited for quantum computing, we have a lot of “fix the basics” to do in the analogue world of pharma, and this is where I see the next few years going.
\n","showOnHomepage":true,"author":{"title":"Frank Romanski, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Dr. Frank Romanski_BASF_Corp_web.png","mediaDetails":{"height":263,"width":211}}},"authorFields":{"title":"Global Technical Marketing Manager, Pharma Solutions","linkedin":"https://www.linkedin.com/in/frank-romanski-ph-d-1a480542/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Decentralized manufacturing in cell and gene therapy will become the dominant way commercial cell therapies for oncology and auto-immunity are manufactured. Shipping cell therapies requires ultra-cold-chain logistics with complex interactions. While early commercial approvals in cell therapies were for relatively small patient populations, current shipping standards are untenable in the future as we see approvals for larger patient populations. As additional cell therapies are approved, staffing facilities will become the primary pain point. It will not make sense for every company to build out their own manufacturing capabilities, given already fierce competition for talent, which will ultimately drive up the cost of goods and sold for manufacturing. This will mean any facility that is built must be highly utilized to be profitable and will ultimately keep the cost of therapeutics high. Building out a biopharma industry–CDMO partnered hub-and-spoke decentralized, multi-modal (multi-therapy) manufacturing network is one vision that would maximize utilization while lowering therapeutics costs. This will also allow us to stratify the workforce to better utilize people. There will be challenges, the primary one likely being supply chain logistics, but it’s hoped that, as the field moves to manufacturing using closed, automated, scalable platforms, this will become easier.
\n","showOnHomepage":true,"author":{"title":"Matthew Hewitt, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Hewitt_Charles_River.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Executive Director, Scientific Services, Cell and Gene Therapy (CGT)","linkedin":"https://www.linkedin.com/in/matthewmhewitt/","email":null,"company":{"title":"Stilmas"}}}},{"answer":"Quantum will be one of the ‘next big things’ in the coming years that will affect the life science industry, accelerating scientific discoveries through the production of higher-resolution data and new computing paradigms.
\nQuantum microscopes and quantum computing will drive a further explosion in collecting in vivo biological data, solving the problems of resolution either directly via imaging or computationally. While quantum computing is still in its infancy, it holds the potential to elevate our understanding of complex biological phenomena, as well as to revolutionize the way drugs are discovered and developed.
\nWith a digital transformation already underway across pharma, quantum methods will create an increased need for scientists to have their data organized and rapidly accessible in scalable analytics platforms future-proofed to meet emerging requirements.
\n","showOnHomepage":true,"author":{"title":"Zachary Pitluk, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Z_Pitluk_Paradigm4.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Vice President, Life Sciences and Healthcare","linkedin":"https://www.linkedin.com/in/zachpitluk/","email":null,"company":{"title":"Paradigm4"}}}},{"answer":"While the COVID-19 pandemic continues to create elements of uncertainty for the pharmaceutical market, it is more important that we continue to reinvent the approach of how to bring lifesaving drugs to market faster without impacting product quality, safety, or efficacy.
\nThere are several takeaways from our experience in response to the pandemic:
\nSupply chains can be at significant risk when there is overreliance on a location that may be vulnerable to disruption. Shifting production locations closer to end markets or in lower-risk countries could be a new approach.
\nTo avoid global clinical supply chain disruption, selection of clinical investigators/locations, as well as regional clinical warehouse supply centers, would be key.
\nIncreased focus on operational resilience and accelerating initiatives that enable more agility with the use of digital tools and automation.
\nCompanies will consider reevaluating their strategies, risk tolerance, and overall network footprint to address these risks. Key decisions include dual sourcing, geographic diversification, or outsourcing to CDMOs.
\nR&D will focus on analytical tools, big data, and artificial intelligence to bring drugs and therapies faster to the clinic. Digitization in clinical trial management, patient recruitment, monitoring, data collection, data analysis, and reporting will utilize digital platforms and remote decentralized units.
\nDigital tools will also enable some key business processes — such as auditing, regulatory inspections or product release.
The risk of significant price controls or price negotiations by the U.S. government has the potential to greatly impact all aspects of our industry. If it happens, we are likely to see a significant amount of pipeline programs shut down, particularly in cases where companies may not be able to generate enough money to justify the expense. And one challenge with that is, oftentimes, the maximum potential of a pipeline product isn’t fully discovered or completely understood until it’s used repeatedly in a broad base of patients — which can ultimately reveal new indications or different ways of using a given therapy. If current price-negotiating proposals from Medicare go through, we run the risk that the cutting-edge of innovation will be significantly curtailed. Many smaller pharma and biotech companies will eventually run the risk of going out of business — and power will be consolidated, much like what happened in the tech industry.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"With more clinical data being available from more sources with greater veracity and velocity, we can apply new tools — especially those derived from machine learning and artificial intelligence (AI) methodologies.
\nWe will see AI support the understanding of adverse events, help identify new patient cohorts, optimize clinical trial design, guide us to new clinical sites to accelerate accruals, and actually to avoid the prior generations of health inequities and under-representations. We can create models and AI-enabled optimizations to overcome historical biases. Of course, AI predicated on legacy data can perpetuate bias, but we are getting more sophisticated and purposeful about avoiding this.
\nIn the coming 3–5 years, AI will not be making clinical decisions, but it will be an integral part of why new medicines are available more rapidly; why we will have more confidence in trial design, realize shorter study execution times, and be able to translate study outcomes into evidence and rules guiding clinical practice decisions.
\nBut you can’t have AI unless you have data — a lot of it, with depth and confidence that it lacks bias. This will cause a change in operating models that the United States is posed for, one that’s already starting within the biopharma innovators. The front-edge of the ‘next big thing’ emerged during the pandemic out of necessity. However, now seen, experienced, and assessed, it is clear the new ways can bend the historical curves of time, cost, and precision for the benefit of biomedical innovators, providers, and patients.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"Despite the global disruption resulting from the pandemic, Sterling continued to grow its business and learned how to adapt and work in new ways.
\nCannabinoid medicines and antibody–drug conjugates will continue to advance and become more mainstream, while flow chemistry is looking to become adopted more widely as a technology in API manufacturing. Sterling has invested to increase its capabilities in all these areas, as well as looking at further high-growth markets to meet future customer demands.
\nWhere face-to-face meetings are not possible, ensuring transparency and the sharing of information through effective IT communication interfaces becomes even more important in building trusting customer partnerships. Sterling also recognizes the need for continuous investment in people and skills with a focus on customer service, building on its core values of transparency, caring, and reliability.
\nSterling is expanding capabilities and capacity at each of its four sites in the U.S. and the UK, but more importantly, its CEO and management team are taking time to ensure that all of Sterling’s 800+ employees work by the company’s values in every decision made.
\nThrough investment in equipment, infrastructure, and people, Sterling is striving to enhance its customers’ experiences and ensure its market position as a trusted partner of choice for API development.
\n","showOnHomepage":true,"author":{"title":"Mike Hopkins","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Hopkins_Sterling_Pharma.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Vice President, Business Development, U.S.","linkedin":"https://uk.linkedin.com/in/michael-hopkins-74b05a146","email":null,"company":{"title":"Sterling Pharma Solutions"}}}},{"answer":"There are many exciting new innovative research programs that have the potential to change treatment in many important therapeutic areas. We are also excited about the meaningful advancements the role of technology can play in our industry.
\nHowever, one area of particular concern we all need to be very aware of is antimicrobial resistance (AMR). We believe this is a real and immediate global threat, and significant advancements must be made to prevent this from becoming the “next big thing” globally.
\nThe damaging effects caused by resistant pathogens are already responsible for an estimated 700,000 deaths per year globally, and future projections of the impact of unresolved AMR infections surpass the projected number of deaths caused by cancer by 2050. AMR could also have a substantial impact on the global economy, in the form of both direct and indirect costs to society.
\nIn the future, a lack of effective antibiotics could make routine medical interventions extremely challenging or even impossible.
\nFor these reasons, we believe AMR must be regarded as a global, regional, and national priority for health organizations and governments, to be addressed with the utmost urgency on a global scale.
\n","showOnHomepage":true,"author":{"title":"Nate McCutcheon","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Mccutcheon_Shionogi.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Executive Vice President and Chief Operating Officer","linkedin":"https://www.linkedin.com/in/nlmccutcheon/","email":null,"company":{"title":"Shionogi Inc."}}}},{"answer":"The recent advances in mRNA technologies driven by the COVID-19 pandemic has brought gene therapy — previously thought to be pharmaceuticals of the future — into the here and now. In response to the demand for the mRNA COVID-19 vaccines, Evonik rapidly built out capacity for lipid manufacturing and expanded production of parts of our portfolio, such as the plant-based cholesterol PhytoChol. In the long-term, we are investing in technologies that complement and go beyond lipid nanoparticles (LNPs). An example of such investment is a recent collaboration we started with Stanford University to develop a polymer-based delivery system for mRNA.
\nAs gene therapy and related technologies become more widespread, managing complex or challenging supply chains — such as those requiring extremely cold storage — will be paramount. Lyophilization is a method of obtaining stable drug products for fragile (bio)pharmaceutical substances. We are therefore planning for more intensive use of our VarioSys® fill line with lyophilized products.
\n","showOnHomepage":true,"author":{"title":"Maaike Everts, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Everts_Evonik.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Director of Strategic Marketing, Parenteral Drug Delivery Solutions","linkedin":"https://www.linkedin.com/in/maaike-everts/","email":null,"company":{"title":"Evonik"}}}},{"answer":"Precision and targeted medicine is here and, while genetic testing has been partially adopted, our full power to unlock discoveries, providing the best and most effective treatment, won’t be achieved until standard of care evolves. Full testing, protecting patient privacy, should occur earlier in a patient’s care and disease journey. Testing occurs too late to have the most impact on care and treatment, and testing is not yet comprehensive for all patients. This wonderful tech and data are meant to help patients, and as a society we are not yet fully using it for the best interest of the patient.
\nTake this down a step. Clinical research no longer needs to be limited to legacy ways of matching patients to clinical trials, to academic centers, or by patient access to clinical trials when first diagnosed. Unlock the next generation of novel therapeutics. Bring together patients regardless of treatment location. Open opportunities to participate in research at the beginning of the patient journey. The immensity of the administrative process is painful, as finding the genetic details to match a patient has been manual. A new focus on genetic testing, improved global data infrastructure, and easy-to-implement software platforms means patients who were once outside the clinical research process can be included.
\nThese are important steps along the treatment and innovation continuum that move novel therapeutics and discoveries faster through development and into the hands of treating physicians and their patients and impact our global society as a whole.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"Genomics data is only as powerful as it can be interpreted, which is why the integration of genomics into our electronic medical records is going to be a huge step toward maximizing the clinical benefit. Soon, it will be routine for doctors and patients to have access to genomic data, with the potential to guide every medical decision. The low-hanging fruit is better diagnoses for rare genetic disorders, which affect 25 million undertreated Americans. As new research expands understanding of the links between genetics and more common diseases, doctors will be able to continuously improve how they guide patients toward better treatments and disease prevention.
\nElectronic medical records are an opportunity to leverage genomics in ways that can help every patient. They’ll connect genotype and phenotype in a real-world setting, which can open new insights for disease prediction, prevention, and early treatment. Therapeutics companies will be able to design and test combinations of treatments highly specific to patients based on their genetic likelihood of success. Diagnostics companies will use new insights to design tests that can stratify patients for specific cancer or cardiac disease screenings based on their predisposed risks. Doctors will be better able to guide patients to the right tests at the right time and ultimately to medicines with less risk of side effects. Patients will get treated for diseases before symptoms escalate.
\n","showOnHomepage":true,"author":{"title":"Yan Zhang, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Y_Zhang_Mission Bio.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/yan-zhang-6983911/","email":null,"company":{"title":"Mission Bio"}}}},{"answer":"One of the biggest impacts to the cell therapy market will be the pace of progress of allogeneic products. Marketed autologous cell therapies are powerful but made from each patient’s own cells in a time-consuming, costly, and complex process –– although automation is improving each of these.
\nOff-the-shelf allogeneic cell therapies are now in development that may push the industry forward. Allogeneic therapies are derived from healthy donors rather than the patients, meaning they can be manufactured and stored, ready for administration to the patient at any time. Ideally, allogeneic products can be manufactured at a larger scale and at lower cost, opening the door to treat many more patients than the current made-to-order products.
\nMost of the approved cell therapies today are chimeric antigen receptor (CAR) T cell therapies, which have shown tremendous promise in hematologic cancers. With the FDA approval of Abecma® this year for patients with multiple myeloma, the class is beginning to expand into more clinical indications and larger patient populations. Still, everyone is waiting for the allogeneic leap, when cell therapies can finally be manufactured at a larger scale and treat an order-of-magnitude more patients, and, critically, at much lower cost.
\nAt Cellares, we are well prepared to support this jump. With our automated technologies that support manufacturing at scale, we have the potential to bring these lifesaving treatments to millions of patients in need. Exactly how quickly these therapies will be ready for approval remains an open question, but we’ll be ready when they are.
\n","showOnHomepage":true,"author":{"title":"Fabian Gerlinghaus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/F_Gerlinghaus_Cellares.png","mediaDetails":{"height":287,"width":211}}},"authorFields":{"title":"Co-founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/fabian-gerlinghaus/","email":null,"company":{"title":"Cellares"}}}},{"answer":"The global COVID-19 pandemic has served as a wake-up call and altered the way the pharma manufacturing industry works and is viewed globally. The old binary choice between insource or outsource is being replaced by a more flexible collaboration model. The drug development pipeline is also changing; small, emerging, or even virtual biotech companies now bring the majority of early-phase drug candidates. These companies have limited in-house capabilities and need to outsource development and manufacturing.
\nWith an increasing number of companies looking for flexibility and relying on outsourcing parts of their development and manufacturing processes to CDMOs, speed, access to manufacturing capacity, and collaborative business models to manage risk and uncertainty will soon take center stage.
\nInfectious disease outbreaks are very hard to predict, which increases the emphasis on speed to market. In addition, what has become clear is the diversity of biological approaches that have been developed, from novel monoclonal antibodies to viral vectors, cell and gene therapy, to the breakthrough of mRNA.
\nOur business needs to adapt fast and provide capacity across all modalities. Providing expertise, process development, fast scale-up, and commercial high-volume capacity as soon as the need arises is becoming more critical.
\nLonza has a track record of scaling up and commercializing novel therapies. Our unique flexible offering, Ibex®Solutions, spans the complete product life cycle of a biopharmaceutical — from preclinical to commercial stages, from drug substance to drug product, all in one location. The manufacturing space already includes utilities and supporting infrastructure and is ready to be fitted out for any technology and scale, thus saving at least 12–18 months in building a new manufacturing line.
\nIn summary, we can expect major changes to our business that are being challenged to move at a faster and faster pace and provide capacity for manufacturing of standard and novel modalities. We need to give customers the flexibility to manage supply, addressing drug development uncertainty and market demand changes. The goal will be to help new medicines reach patients faster, enabling a healthier world.
\n","showOnHomepage":true,"author":{"title":"Charles Christy","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Christy_Lonza.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Head of Commercial Solutions Ibex® Dedicate","linkedin":"https://www.linkedin.com/in/charleschristy1/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"The global pandemic changed the pharma landscape in terms of speed to market, storage, and distribution, and we believe this revolution in the industry is here to stay and will continue to focus on drug delivery mechanisms that enable easier access, both from a manufacturing perspective and platform development perspective. Developing technologies that can be applicable to a variety of biological products and chemical entities can reduce cost in addition to facilitating rapid scale-up and rollout. Within the COVID space and other indications, there is an increasing trend of using small molecules and biologics. Administration of large, complex molecules via injection is also challenging, as they do not directly target the initial site of infection. Liquid injections are subject to the difficulties of cold-chain handling, storage, and degradation. While injectables have been the current standard for vaccines and therapies, we believe that alternate routes of administration for more targeted delivery will not only change the drug delivery field but address dosage issues, resulting in improved efficacy and safety profiles. We may see an increase in technologies and mechanisms of delivery using alternative methods of drug administration.
\n","showOnHomepage":true,"author":{"title":"Glenn Mattes","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/G_Mattes_TFF.png","mediaDetails":{"height":239,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"http://www.linkedin.com/in/glenn-mattes-78617349/","email":null,"company":{"title":"TFF Pharmaceuticals, Inc."}}}},{"answer":"Our next great achievement as an industry will be bringing gene therapies to much larger patient populations than we’ve seen before.
\nAdvancements in gene therapy have given us the tools to address diseases that we once thought were untouchable. Several gene therapy products have already been approved by the FDA, with monogenic diseases as the primary targets.
\nMany monogenic diseases are a natural fit for viral vector gene therapy, which replace and restore a missing gene. As a company at the forefront of new advances in genetic medicines, we believe that gene therapy will soon be extended beyond monogenic disease and begin to address multifactorial conditions that represent a significant portion of global disease burden. We are now beginning to see viral vectors as yet another safe and effective mode of delivery, and with advances in technology, it will no longer matter whether a disease is monogenic or multifactorial. I predict that this change in our mindset regarding viral vectors will enable gene therapies to benefit and access much larger patient populations.
\nFive years from now, we will drastically increase the number and type of diseases we can target with gene therapy — ranging from orphan diseases to indications like Parkinson’s disease and diabetes. The first successes of “larger-market” gene therapies in clinical trials will spur improved access to life-changing treatments and drive even greater innovation in this frontier of biotechnology.
\n","showOnHomepage":true,"author":{"title":"Pavan Cheruvu, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Cheruvu_M.D._Sio_Gene_Therapies_.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/pavan-cheruvu-m-d-117b5310a","email":null,"company":{"title":"Sio Gene Therapies"}}}},{"answer":"We are moving past a one-size-fits-all approach for disease treatment generally, but especially in the field of oncology. I expect that the “next big thing” that is going to significantly alter the biopharma industry is the advent of newer, more evolved precision technologies that allow physicians to match the right medicine to the right patient. Previously, we didn’t have access to the necessary tools to profile which treatments would be better for specific patients. As a result, we developed medicines that had broad-reaching effects, but many patients who receive these treatments don’t see an adequate benefit. Today, we have more tools in the toolbox to accelerate the development of safer and more effective medicines.
\nWe’ve also seen a greater push to identify which patients would respond best to which treatments and have started to see a greater need for profiling and more specific diagnostic technology, which ultimately should lead to soaring efficacy rates. This shift will drastically shift how drug developers identify, select, and use drug candidates going forward, so represents a major change but will also — hopefully — result in a major benefit to patients. It also changes the cost–benefit equation for developing drugs. If you have a highly effective treatment, you need fewer patients to prove its benefit (translates to less expensive faster clinical trials). A large part of what is going to push this shift forward is the increasing recognition of combination therapies as the most effective path to precision cancer treatment. We will continue to see customized treatment plans for patients that include multiple therapies tailored to fit specific patients’ needs.
\nAt Portage Biotech, we’re taking all of these changes into account as we advance our novel immuno-oncology therapies through the clinic. It’s an exciting time to be in this field, and I look forward to continuing to collaborate with other experts as we work toward a brighter future for people with cancer.
\n","showOnHomepage":true,"author":{"title":"Ian B. Walters, M.D., MBA","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/I_Walters_Portage_Biotech.png","mediaDetails":{"height":243,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":null,"email":null,"company":{"title":"Portage Biotech, Inc."}}}},{"answer":"Patients deserve therapies that preserve their quality of life. For difficult-to-treat diseases, current treatments often result in broad immunosuppression, non-disease specific, or non-selective modulation of immune function. These side effects can ultimately compromise patients’ health and quality of life and lead to treatment discontinuation. The advancement of immunotherapies with improved precision and long-lasting therapeutic potency that do not induce harsh and systemic adverse events have the potential to revolutionize treatment and, therefore, the biotech market.
\nTargeted drug therapies preserving a good safety profile that are easy to administer in an office setting and remain cost-effective is the next game changer in cancer therapies. For difficult-to-treat cancers, strategies focusing on generating a targeted and sustained immune response against tumor cells is a driving force in the development of novel solutions. Purposeful, precise activation of the immune system against tumor cells by these newer treatment options has shown unique advantages, such as efficacy in vulnerable patient populations or in patients that are non-responsive and even refractory through other lines of treatment.
\nThe biotech industry needs to push the boundaries beyond precision medicine by focusing on patients’ quality of life, and this is changing the way many companies do business, forcing researchers and investors to concentrate their efforts on treatment options that also improve patients’ experience while undergoing therapy. At IMV, our DPX technology allows us to align our efforts on this vision to create novel immunotherapies to re-train cancer patient's own immune system for relentless, persistent disease control and eradication without the traditional toxicities.
\n","showOnHomepage":true,"author":{"title":"Andrew Hall","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Hall_IMV.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/andrewhall29/","email":null,"company":{"title":"IMV"}}}},{"answer":"With the COVID pandemic still a global crisis, the biopharma market is in a persistent battle to keep up. While it seems hard to imagine anything positive coming from the pandemic, its unpredictability has forced us to make significant improvements. These include efficient decision making, hiring remote talent, and improvements in development timelines. While we have made great strides in these areas, COVID has also highlighted a key need that has remained unmet long before it — universal viral protection.
\nFor the millions of people globally with weakened immune systems, there is a massive drop-off in vaccine effectiveness. This is not unique to COVID, as other vaccines, such as the seasonal flu vaccine, also protect a staggeringly low percentage of those with compromised immune systems. Additionally, as evidenced by COVID and seasonal influenza, vaccine effectiveness in general often wanes over time due to viral variation — losing protection for even those with robust natural immunity. Monoclonal antibodies for viral diseases have not provided adequate effectiveness, either.
\nI predict the “next big thing” will be the development of true universal protection, not in the form of a vaccine. Our company has seen preclinical success with our Cloudbreak® platform to provide universal protection for all viral strains. Now the race to usher in a new era of viral protection is being pushed to the forefront. We anticipate that, in the next decade, we will have begun reshaping the antiviral therapeutic landscape and create a world in which universal protection is available for everyone.
\n","showOnHomepage":true,"author":{"title":"Jeffrey Stein, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Stein_Cidara_Therapeutics.png","mediaDetails":{"height":256,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jeff-stein-774bb24/","email":null,"company":{"title":"Cidara Therapeutics"}}}},{"answer":"There are two significant “next big things” ahead to highlight:
\nFirst, a coming positive force on the horizon is the increased adoption of in silico models in infectious disease drug discovery and development to accelerate the identification of new promising treatments. Spurred by advancements in artificial intelligence and machine learning, in silico approaches may help bypass the slower and more expensive “classic” approaches. We are approaching a point where we will be able to better leverage cumulative understanding of medicine and biology. Ultimately, this approach may allow for more efficient and cost-effective drug development and even potentially lead to new innovative treatments that may have never been identified without the help of advanced computational methods.
\nSecond, a potential major challenge to the biotech industry’s ability to innovate is the possible introduction of new legislation and/or government reimbursement policies that may negatively impact the financial health of pharma and biotech companies, impacting their ability to develop new treatments. This is especially critical in the case of small biotech companies, which are the backbone of the U.S. R&D ecosystem. It is important for regulators, payers, physicians, patients, and legislation/policy sponsors to work together to identify a path forward that strikes a balance between providing patients affordable access to live-saving medicines without hampering the ability of small biotechs to pursue breakthrough scientific innovations. Although there is no easy solution, any new policies being considered should be measured against the potential impact on small biotech companies, as well as the overall healthcare ecosystem.
\n","showOnHomepage":true,"author":{"title":"Marco Taglietti, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Taglietti_SCYNEXIS.png","mediaDetails":{"height":246,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/marco-taglietti-md/","email":null,"company":{"title":"SCYNEXIS, Inc."}}}},{"answer":"For me, it’s two words: digital transformation. That is applying AI and machine learning approaches to drive innovation in R&D and to speed up drug discovery and development and, ultimately, manufacturing. We’ve seen some preliminary examples of this throughout the pandemic. We were applying in-line process controls to optimize real-time production parameters, giving us higher yields and excellent right-first-time metrics, which is differentiating for any company. Digital transformation, I believe, will be a big trend in our industry. We’re seeing some of it already; I don’t think it’s that far in the future.
\nCuria is transforming. At the end of the day, in our business, as a CDMO partner to pharma and biopharma, it’s all about safe and reliable supply. Our goal is to delight our customers with reliable supply and intelligent partnership — taking them from curiosity to cure. A big part of that is our embrace of digital transformation — that’s an area of focus for us at Curia — to stay ahead of that “next, big thing.”
\n","showOnHomepage":true,"author":{"title":"Prakash Pandian","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Pandian_Curia.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"Chief Information Officer","linkedin":"https://www.linkedin.com/in/prakash-pandian-468773/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"There are so many developments happening in our industry. One that is particularly exciting is what I’ll call “novel modalities.” The first novel modality on the horizon is in therapeutics, and, more specifically, medicines that actually cure a disease versus simply treating it. Methods like CRISPR and gene therapy are examples of novel approaches that may prove to be curative for patients with debilitating chronic conditions. Another example is mRNA technology, which could change how we vaccinate against different diseases. COVID-19 is just the beginning as companies like Moderna and BioNTech are looking at vaccines to treat and cure a variety of diseases.
\nAnother novel modality is drug delivery. A lot of drugs work well, but are difficult to use, are painful, or are inconvenient for the patient. For example, our company, Rani Therapeutics, is trying to solve a long-standing problem: how to convert drugs traditionally administered by injection into a pill. Rani takes traditionally injected medications like octreotide and insulin and loads them into the RaniPill. The RaniPill, after being swallowed, travels through the stomach and into the intestines, where it delivers the drug directly into the intestinal wall. Denali Therapeutics is going after another novel modality: crossing the blood–brain barrier to better target neurodegenerative diseases. These are just two examples that I believe will be meaningful for our industry, and most importantly, transformative for patients.
\n","showOnHomepage":true,"author":{"title":"Talat Imran","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Imran_Rani Therapeutics.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/talat/","email":null,"company":{"title":"Rani Therapeutics"}}}},{"answer":"We believe it is emergence of large-scale, unbiased, and deep proteomics. We’re on our way to mapping the proteome more deeply, which is going to unlock new possibilities for disease biology, detection, and therapies. In recent decades, huge leaps in genomic discovery led to rapid genetic testing, broader knowledge of genetic drivers of disease, and new classes of therapeutics, like complex biological molecules and cell therapies. As we integrate proteomics, genomics, and multi-omics approaches with machine learning and data science, scientists will gain more comprehensive insights leading to earlier disease detection, more curative therapies, and more personalized medicine.
\nThe convergence of proteomics with other data sets will further change the course of disease treatment. By more deeply exploring biology’s “machinery” and all of its variation — a new gateway to insights human health and disease will be opened.
\nChronic diseases like neurodegenerative disorders are extremely difficult to treat in part because of how they present: by the time symptoms surface, the damage is already irreversible. But new insights into the proteome could lead to earlier opportunities to intervene, perhaps even with existing therapies.
\nIn cancer, the heterogeneity of disease has long prevented one-size-fits-all therapeutic approaches. But we’re on our way to understanding the specific biological pathways to target for specific cancers in specific patients, which will lead to novel, curative approaches.
\n","showOnHomepage":true,"author":{"title":"Omid Farokhzad, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/O_Farokhzad_Seer.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chair and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/omidfarokhzad/","email":null,"company":{"title":"Seer Bio"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-what-do-you-think-most-differentiates-the-u-s-pharma-biopharma-industry-or-the-market/","uri":"/roundtable/articles-q-what-do-you-think-most-differentiates-the-u-s-pharma-biopharma-industry-or-the-market/","slug":"articles-q-what-do-you-think-most-differentiates-the-u-s-pharma-biopharma-industry-or-the-market","title":"Q: What do you think most differentiates the U.S. pharma/biopharma industry or the market?","roundtable":{"topic":"The U.S. Pharma/Biopharma Industry","question":"What do you think most differentiates the U.S. pharma/biopharma industry or the market?","roundtable":[{"answer":"I think it’s the incredible pace of incremental and breakthrough innovation. Incremental innovation, for example, would be converting a product from reconstituted to ready-to-use (RTU) or reducing dosing frequency (e.g., 3 a day to once a day or daily injection to weekly injection). In other words, innovations that increase patient adherence or improve ease of use or safety for a caregiver or patient. Often, incremental innovation contributes to better outcomes, improved patient adherence, and reduced medication errors.
\nThe breakthrough innovations are the new chemical entities (NCEs) or new biological entities (NBEs), cell and gene therapy, or those that offer a disease cure versus a symptomatic treatment. For example, consider the evolution of hepatitis C drugs from treatment to cure. When I started in the pharma business, which is not that long ago (1997), the treatment for hep C was interferon alfa, with significant side effects and limited efficacy. Today, the antivirals offer a cure. It’s a great example of breakthrough innovation made possible by advances in high-throughput assays, creating and screening massive combinatorial libraries and quickly analyzing massive databases to find the one or two molecules that actually hit the target with minimum side effect. Breakthrough innovation leads to improvements in the quality of patients’ lives and ultimately leads to cures.
\nWhat makes the U.S. market unique is a wonderfully dynamic and complex interplay between physicians, patients, providers, distributors, marketers, and developers. It’s a vibrant and maddeningly complex ecosystem that we have in the U.S. that is a real differentiator. There are inputs and feedback loops into what is needed to serve patients from all those parts of the ecosystem. On one hand, it can make for an unnecessarily long gestation period for any innovation to come to fruition. On the other hand, when we get it right, the innovative solutions are excellent, and the outcomes are great for patients. We need to set aside protectionism and individualism more often to better serve the greater good, alleviating our own human suffering. We need more collaboration.
\n","showOnHomepage":true,"author":{"title":"Kurt R. Nielsen, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/K_Nielsen_Pii.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"President and CEO","linkedin":"https://www.linkedin.com/in/kurt-nielsen-ph-d-0013217/","email":null,"company":{"title":"Pii (Pharmaceutics International, Inc.)"}}}},{"answer":"Innovation, reliability, and transparency are some of the biggest differentiators when it comes to the U.S. pharma/biopharma industry. The number and percentage of new chemical or biological entities developed in the United States continues to grow both in terms of total numbers and percentage breakdown relative to other regions. Additionally, core areas of the United States continue to be hubs for development of new technologies.
\nReliability and transparency are crucial in an industry focused on safely and efficiently saving lives and improving health.
\nAs a key supplier into the industry, these are aspects that Grace has long embodied and are integral to our core model and the value we deliver to our clients.
\n","showOnHomepage":true,"author":{"title":"Dave Short","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Short_W.R.Grace_Co.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Global Business & Technology Manager, Fine Chemicals","linkedin":"https://www.linkedin.com/in/david-short-96292113/","email":null,"company":{"title":"W.R. Grace"}}}},{"answer":"The United States has scale, which is a competitive edge in a highly globalized industry like pharma or biopharma. From drug development and production to revenue generation, the U.S. is leading overall — representing nearly half of the global market. Five out of the top 10 pharma companies in the world are based in the U.S., spending more than $60 billion combined per year on research and development (R&D). And due to demographic mix and chronic indications, pharmaceutical spending is only increasing, with the U.S. expected to spend up to $650 billion in medicine by 2023.
\nThe robust U.S. pharma or biopharma ecosystem is also a key differentiator. The U.S. has multiple geographical areas where noteworthy stakeholders interact closely, to innovate the pharma solutions of tomorrow — such as Boston, Research Triangle Park in North Carolina, and Cambridge, Massachusetts. Within those clusters of innovation, you can find the best and brightest minds — from top universities, venture capitalists and governmental institutions — who are willing to fund long-term research programs. On top of that, you’ll find privately held companies seeking to commercialize their products and large pharma companies ready to bring those innovations to market. Supporting companies, such as leading excipient or technology providers, also participate by providing enabling technologies that accelerate the process of bringing new drugs to market. For other countries across the globe, the U.S.’ advanced pharma ecosystem would be incredibly difficult to replicate.
\n","showOnHomepage":true,"author":{"title":"Dago Caceres","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Caceres_DOW.png","mediaDetails":{"height":238,"width":211}}},"authorFields":{"title":"Global Strategy Director","linkedin":"https://www.linkedin.com/in/dago-caceres-6491a4/","email":null,"company":{"title":"IFF"}}}},{"answer":"A common challenge that the pharma/biopharma industry faces globally is managing high-risk R&D programs. These programs are lengthy as well as costly. These factors lend the pharma/biopharma industry to be the most R&D-intensive sector of the world economy. At approximately 15% of net revenues reinvested into R&D, pharma/biopharma companies are twice as R&D-intensive as the next two high-intensity sectors: technology/hardware and technology/software.
\nWhat differentiates U.S.-based pharma/biopharma companies is their historically higher contribution to the worldwide R&D effort, which currently stands at approximately 45–50%. As a result, the number of new chemical and new biological entities (NCE, NBE) introduced to the market by U.S.-based companies almost matches the number of all other geographies combined.
\nThis U.S. dominance in pharma/biopharma R&D will persist for some time. Still, it will likely get less prominent as the industry globalization drivers continue to rebalance investments toward other regions with solid pharma/biopharma economic and R&D activities, such as Europe and China.
\n","showOnHomepage":true,"author":{"title":"Sergey Vlasenko, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Vlasenko_Agilent.png","mediaDetails":{"height":265,"width":211}}},"authorFields":{"title":"Associate Vice President Pharma and Biopharma End Markets","linkedin":"https://www.linkedin.com/in/sergey-vlasenko-645a477/","email":null,"company":{"title":"Agilent Technologies, Inc"}}}},{"answer":"The two main differentiators of the U.S. pharma/biopharma industry are that the funding availability is much higher and there is a single drug supply across the entire United States, making trial design and packaging easier. The additional funding allows for more research and clinical development, leading to more lifesaving therapies for patients. In 2019, the pharmaceutical industry devoted $83 billion to research and development, and in 2020, clinical research funding by the National Institutes for Health reached $17.6 billion.
\nAdditionally, trial design and packaging is more simplified in the U.S. compared with other countries, such as those in the European Union. Products must be adjusted to accommodate the various languages spoken across the EU, as well as ensure the specific design and packaging requirements of each country are followed and met.
\n","showOnHomepage":true,"author":{"title":"Brian Keesee","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/B_Keesee_PCI_Pharma_Services.png","mediaDetails":{"height":298,"width":211}}},"authorFields":{"title":"Vice President & General Manager, Global Operations and Supply, Clinical Services","linkedin":"https://www.linkedin.com/in/brian-keesee-90725724/","email":null,"company":{"title":"O’Hara Technologies"}}}},{"answer":"The United States is heavily investing in and chasing new discoveries in cell and gene therapy, especially in the post-pandemic era, which is creating tremendous opportunities for emerging biopharma in major hubs like Massachusetts and California. There is clear indication that the industry will double or even triple with products launching in record time. During the pandemic, we’ve seen mRNA drugs launch in 10 months, so we know how to get more drugs to market in a shorter time. With that said, the industry is highly regulated, which slows things down. Furthermore, the extensive data generated throughout the product life cycle, from R&D to manufacturing, needs to go through rigorous safety and efficacy scrutiny that stresses the system.
\nThe advantages that Verista brings to our clients to enable them to achieve these goals includes our risk-based approach to validation, ensuring that critical business and regulatory functions are adequately tested to show that systems are fit for intended use and data is accurate and not compromised. We also leverage our partnerships with companies like Veeva and Kneat to help our clients with digital transformation, which enables them to get systems implemented faster to streamline business processes and bring data from the benchtop and manufacturing shop floor to the decision makers in less time.
\nVerista is the only compliance services company that can cover the entire drug development continuum. We have invested heavily to be able to help our clients maintain compliance from early drug development and R&D through commercialization, manufacturing, and post-approval support.
\n","showOnHomepage":true,"author":{"title":"Manny Soman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Soman_Verista.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/manny-manish-soman-6a40181/","email":null,"company":{"title":"Verista"}}}},{"answer":"The U.S. market helps drive a lot of the innovation in the pharma industry, as the free-market pricing policies allow for risk-taking. We see this across the spectrum, as both innovative and generic players shape their product development strategy with the U.S. being the central component. The number of new drugs that are being brought to the market by small companies is a testimony to an environment that allows innovators to capitalize on their strengths while partnering with contract players across geographies. This is especially significant as we see a number of orphan diseases for which companies are able to provide solutions. This environment has allowed for advances in technology and increase in targeted therapies. Another aspect that is a key element is the role played by patient advocacy organizations in ensuring treatment reaches patients, as is seen in the recent case of the approval of Aducanumab for Alzheimer’s disease.
\n","showOnHomepage":true,"author":{"title":"Saharsh Davuluri","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Davuluri_Neuland_Laboratories_Limited.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Vice Chairman and Managing Director","linkedin":"https://www.linkedin.com/in/saharshdavuluri/","email":null,"company":{"title":"B&P Littleford"}}}},{"answer":"The U.S. pharma industry is one of the most pioneering groups in the world. There’s a real focus on collaboration and innovation as the foundations of its success, and we’re incredibly lucky to have some of the world’s best academic institutions driving a lot of that collaboration. For example, Dr. Richard Smith at Pacific Northwest National Laboratory has worked on most if not all ion mobility technology developments and is renowned across the mass spec industry for his achievements. His lab developed the structures for lossless ion manipulation (SLIM) technology that MOBILion’s first commercial high-resolution ion mobility (HRIM) instrument is driven by.
\nMOBILion Systems Inc. is based in the Northeast biotech corridor, so we have been lucky enough to see firsthand some of the outstanding work that happens through industry partnerships. Without collaboration, none of U.S. can work effectively –– we rely on our partners to tell U.S. how to develop instruments that meet their exact needs, and they rely on U.S. for the technology that can provide vast improvements to the data they’re able to generate from daily research.
\nStrong alliances across all aspects of the industry have enabled so much improvement not only to the development, manufacture, and marketing of new medicines, but ultimately to changing people’s lives for the better by diagnosing, treating, and curing diseases more quickly and effectively.
\n","showOnHomepage":true,"author":{"title":"Melissa Sherman, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Sherman_MOBILion_Systems_Inc.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/melissa-sherman-ph-d-4711004/","email":null,"company":{"title":"MOBILion Systems Inc."}}}},{"answer":"Our industry distinguishes itself through its flexibility to meet patient needs. The continually evolving global healthcare landscape leads to new requirements for safe and effective drug products. Supporting clients across 35+ countries, Alcami continues to adapt and advance our technologies like nitrosamines testing, extractables and leachables, elemental impurities, and rapid sterility to achieve evolving regulatory requirements in order to support our clients in producing high quality, safe, and effective drug products.
\nBeyond that, the industry must stay agile by keeping an eye on the future while having a pulse on the ground. This means investing in the right instrumentation, scientific teams, and forward-looking capabilities while ensuring that efficiency and customer service aren’t compromised. Companies like Alcami must continually strive to advance internal regulatory and subject matter expertise to reduce project obstacles.
\n","showOnHomepage":true,"author":{"title":"Alex Dunlap","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Dunlap_Alcami.png","mediaDetails":{"height":285,"width":211}}},"authorFields":{"title":"Business Development Manager, Lab Services","linkedin":"https://www.linkedin.com/in/alex-dunlap-02440b4b/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"There are marked differences as well as notable similarities between the United States and rest of world.
\nWhile the U.S. represents the largest pharma industry in the world, it is followed closely by China and India, both of which, like the U.S. industry, are seeing growth and attracting investors. One major difference is that the U.S. maintains the strictest regulatory framework, although China and India are catching up fast.
\nThe United States is home to some of the world’s biggest pharma companies, in contrast to India, for example, where smaller contract manufacturing organizations (CMOs) dominate and focus mainly on manufacturing generics. The symbiotic relationship is clear: R&D is high on the U.S. agenda, and manufacturing can often be provided by Indian CMOs, further driving the imperative for unified regulatory frameworks, which will make the pharma industry truly global.
\nThe U.S. pharma industry is characterized by the availability of capital and the market appetite to support a high-risk/high-reward R&D strategy in complex therapeutic areas. It spends far more on R&D than any other country and, therefore, has the highest healthcare costs.
\nUnifying factors across the globe include the length of the drug development cycle, the length of time data needs to be kept, and the rigor of the regulatory process — all of which have left a legacy of resistance to adopting new technology.
\nThis resistance is crumbling and comes at an exciting time for the U.S. life science community. Maturing technology, including the IoT, artificial intelligence (AI), computational power, and sequencing, coupled with the spirit of innovation that is now — finally — making inroads into pharma is revolutionizing the sector. The science community welcomes new disruption and is starting to take a high-tech approach to solving old problems, like connecting the diversity of analytical equipment in the lab to feed new machine learning strategies that unlock data-driven insights into developing new therapies.
\n","showOnHomepage":true,"author":{"title":"David Levy","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Levy_Scitara_Corporation.png","mediaDetails":{"height":275,"width":211}}},"authorFields":{"title":"Global Product Director","linkedin":"https://www.linkedin.com/in/dave-levy-6843551/","email":null,"company":{"title":"Scitara Corporation"}}}},{"answer":"The U.S. pharmaceutical and biopharmaceutical market is truly a unique driving force within the industry; despite consuming only about 10% of the world’s medicines by volume, the total healthcare spend in final dosage forms equates to roughly 50% of pharmaceutical total market by value. The impact of this means that most drug targets for approval are focused with the U.S. as one of if not the primary market. Moreover, the total spend on pharma from the United States has a direct impact on the pharmaceutical R&D pipelines, whose comparatively large financial allocation to R&D is based largely on the profits derived in the U.S. market. This also gives a comparatively large responsibility to the U.S. FDA on the approval of these medicines and often sets the standard for approval within the globe. This was quite evident with the recent COVID-19 pandemic, where medicines where researched, developed, scaled-up and distributed first within the U.S. markets and the Western EU. The U.S. market is also ripe for innovation, as nowhere else in the world are small and medium sizes companies able to take an idea through to commercialization through the systems of funding available to entrepreneurs. To address this corner of the market, we at BASF, a leading supplier of innovative pharmaceutical and biopharma ingredients, established strong technical competencies, laboratories, and manufacturing sites within the United States to match the innovation power. We have also established expert colleagues geographically positioned in the leading markets, like Boston and California, in addition to our headquarters in New Jersey, the leading region for pharmaceutical innovation. The U.S. remains highly important for us, to ensure collaboration and co-development of leading medicines with innovative, biopharma, and generic pharmaceutical companies.
\n","showOnHomepage":true,"author":{"title":"Frank Romanski, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Dr. Frank Romanski_BASF_Corp_web.png","mediaDetails":{"height":263,"width":211}}},"authorFields":{"title":"Global Technical Marketing Manager, Pharma Solutions","linkedin":"https://www.linkedin.com/in/frank-romanski-ph-d-1a480542/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Understanding complex biological phenomena has required concurrent advances in experimental methods and computing power. As Freeman Dyson observed, “new directions in science are launched by new tools much more often than by new concepts.” Advances in new tools are generating novel data modalities and higher-resolution data. These data, along with rapid advances in algorithms and large-scale computing, are driving the creation of ever more comprehensive models of disease, disease progression, and health at both the individual level and the population level.
\nWhile the U.S. invests more aggressively in innovation across all these fronts, collecting and connecting data is hindered by the greater fragmentation of healthcare data in the U.S. than in countries with national healthcare systems, as well as by cumbersome electronic heath record (EHR) systems that do not yet incorporate patient omics data. Even so, pharma/biopharma companies that are leveraging new integrated analytics platforms are able to combine multi-modal, multi-sourced data, expediting the discovery and delivery of new, more effective, and safer therapies to patients.
\n","showOnHomepage":true,"author":{"title":"Marilyn Matz","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Matz_Paradigm4.png","mediaDetails":{"height":251,"width":211}}},"authorFields":{"title":"Chief Executive Officer and Co-Founder","linkedin":"https://www.linkedin.com/in/marilynmatz/","email":null,"company":{"title":"Paradigm4"}}}},{"answer":"COVID-19 has demonstrated that we need a healthcare system that is better prepared for future public health emergencies for all patients. The substantial challenges faced by the U.S. and its local public health authorities in testing, treating, and vaccinating Americans during the pandemic highlight key infrastructure gaps in the healthcare system that need to be addressed.
\nCOVID-19 has demonstrated the critical importance of globally diverse biopharmaceutical manufacturing supply chains to respond to crises and has highlighted the potential benefits of bringing back the manufacturing base to the U.S. and the Western world.
\nBy continuing to foster collaboration, steps to address gaps in the science, technology, engineering, its workforce, and policies to incentivize investment in R&D and manufacturing infrastructure, the U.S. pharma industry could plug key gaps and be ready for the future.
\nDespite the influence of several emerging countries, the United States has captured a dominant share of the pharmaceutical market worldwide. The country is home to some of the biggest pharma companies worldwide, and American consumers have access to one of the most advanced pharmaceutical systems in the world, albeit at a cost. According to Statista, the pharmaceutical sales revenues in the United States have accounted for nearly half of the global total in recent years. Five of the leading pharma companies worldwide were from the U.S. in 2019-2020. (https://www.statista.com/topics/1719/pharmaceutical-industry/)
\nU.S.-based pharma companies spend around 20% of their revenues on R&D, which is a sizeable investment. The R&D expenditure of the U.S. pharmaceutical industry was more than U.S $10 billion in 2018.). It is very likely that this figure will significantly increase in the years to come due to the costs associated with developing safe and effective COVID-19 treatments and vaccines.
Simply put, no other market or country develops and commercializes nearly the same volume and scope of innovative drugs as the U.S. We have an incredible innovation engine in the U.S., and it allows us to save more lives. The COVID-19 vaccines are a prime and timely example of this.
\n","showOnHomepage":true,"author":{"title":"Nancy Lurker","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Lurker_EyePoint_Pharmaceuticals.png","mediaDetails":{"height":293,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/nancy-lurker/","email":null,"company":{"title":"EyePoint Pharmaceuticals"}}}},{"answer":"The story less told is that the U.S market has the strongest foundation for advanced AI and other insight tools of any in the world. It has 100% consistent digital clinical infrastructure in place as a result of the full implementation of the HITECH Act, giving us more access to clinical data in electronic form than any other country. This is why the real-world data (RWD) market is larger and growing faster here. If you have data derived according to consistent standards, you have the basis for AI and machine learning solutions.
\nWe saw the benefits of this market with COVID-19 research initiatives –– the mobilization and speed of clinical research was breathtaking. We were able to accelerate our understanding of primary modes of transition; catalyze an almost entirely digital and decentralized trial infrastructure ‘incubating’ for years; and make determinations of benefit and risk for narrow populations in record time.
\nRWD is being used to plan almost every trial. It is supporting the growth of the digital armamentarium of evidence-generation approaches — extending and augmenting the legacy approaches of randomized controlled trials — by bringing more evidence together, faster, for provider, biomedical innovator, payer, and regulatory decisions. While the F.D.A. may have issued preliminary perspective on RWD in 2018, the real advances in use and utility have been in the last 18 months. Even with the debates of late around accelerated approval processes, it is clear that standard of care analyses and complementary views on the effectiveness and safety of current therapies will become part of almost every regulatory submission and integrated into every decision.
\n","showOnHomepage":true,"author":{"title":"Jeff Elton, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Elton_ConcertAI.png","mediaDetails":{"height":286,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/jelton/","email":null,"company":{"title":"ConcertAI"}}}},{"answer":"The key differentiator for the U.S. pharma/biopharma industry is the diversity and current availability of funding and investment. Innovator drug development companies can readily access funding through venture and equity investment, while the IPO market is also very favorable in the United States.
\nWith this increased access to funding, coupled with the rise in orphan drug designations, smaller companies are able to support clinical development of programs further than previously possible — even to commercial launch — when, typically, their focus would have been to out-license or divest a product soon after successfully completing phase II trials.
\nThis has led to an increase in innovation and the development of new products, with the majority of small molecules in the clinical pipeline being developed by small and virtual companies, some with only limited numbers of internal programs. This combination of factors has resulted in a healthy emerging pharma sector within the United States, and for contract development and manufacturing organizations (CDMOs), the small nature of many of these companies has been a key growth driver.
\n","showOnHomepage":true,"author":{"title":"Mike Hopkins","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Hopkins_Sterling_Pharma.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Vice President, Business Development, U.S.","linkedin":"https://uk.linkedin.com/in/michael-hopkins-74b05a146","email":null,"company":{"title":"Sterling Pharma Solutions"}}}},{"answer":"Globally, our industry has an obligation to contribute to society in a way different from other industries by advancing scientific innovation to help patients live longer, healthier lives. However, how this innovation is encouraged greatly depends on the environmental factors in place to reward this critical work.
\nInnovation today is significantly supported by private investment, and, to receive any investment, there is a requirement to show a stronger opportunity for return than other industries. Striking the right balance of obligation and incentive is difficult for many U.S. pharma/biopharma companies. As an example, we have seen multiple companies committed to advancing science to help address antimicrobial resistance fail in their mission, despite the critical need for advances in this disease area.
\nTo date, and with some exceptions, the U.S. government has not extensively regulated the price of prescription medicines, instead relying primarily on market forces to determine prices. This has created a complicated and unique reimbursement system, but a stronger incentive than other markets worldwide to develop new innovative drugs, while also increasing incentives for the use of generic products.
\nWhile the U.S. system may not be perfect, it is still one of the world’s largest markets, helping to ensure a sustainable model that encourages breakthrough innovation on a global scale, the core of what drives our industry.
\n","showOnHomepage":true,"author":{"title":"Nate McCutcheon","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Mccutcheon_Shionogi.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Executive Vice President and Chief Operating Officer","linkedin":"https://www.linkedin.com/in/nlmccutcheon/","email":null,"company":{"title":"Shionogi Inc."}}}},{"answer":"One important factor that differentiates the pharma/biopharma industry in the U.S. from others around the world is the drivers for investment. In the U.S., early-entry pharma and early technologies — such as the mRNA technologies we are seeing now — are encouraged and rewarded. The availability of venture funds and a culture of capitalizing on novel ideas from academia makes the U.S. an attractive environment for early adopters of new technologies. In contrast, the EU often lags in terms of investment and funding, even though they catch up in the long term. An advantage of the EU, on the other hand, is its more expansive capabilities for handling biologicals. With our global presence in locations across the U.S. and the EU, Evonik is well positioned to benefit from the best of both markets.
\n","showOnHomepage":true,"author":{"title":"Maaike Everts, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Everts_Evonik.png","mediaDetails":{"height":273,"width":211}}},"authorFields":{"title":"Director of Strategic Marketing, Parenteral Drug Delivery Solutions","linkedin":"https://www.linkedin.com/in/maaike-everts/","email":null,"company":{"title":"Evonik"}}}},{"answer":"The U.S. market is defined by size in terms of both population and investment in innovation, and also by complexity.
\nThe size and diversity of the U.S. population, the number of diverse healthcare organizations competing to provide better care, and a system that rewards entrepreneurship and taking a chance on finding better solutions has continued to make the U.S. either the home of innovators or a destination for them. Our higher education system in particular rewards the practical application and testing of new ideas in a free and competitive market. That translates the brilliance of scientists into access for patients, and innovators are rewarded and celebrated. Consider the number of technology and science accelerators as an example of this.
\nThe complexity of the U.S. market can also be the most frustrating in the world. There are layers of process between manufacturers, the payers of treatment, care, or therapeutics, and the patient. These layers of complexity often make it difficult to understand how funds flow and the true cost of healthcare. Yet while frustrating, this very complexity engenders creativity, technology revolutions, and unconventional solutions, which dramatically change how care and treatment are delivered. Social determinants of health are an important focus for the WHO and countries around the world, but the U.S. market using intriguing technology and data is a leader in using population health to drive care options and health offerings to it citizens.
\n","showOnHomepage":true,"author":{"title":"Marie E. Lamont","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_E_Lamont_Inteliquet.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"President","linkedin":"https://www.linkedin.com/in/marieelamont/","email":null,"company":{"title":"Inteliquet"}}}},{"answer":"We have so many accelerators here — great science, tons of experience, creative corporate leadership, and a strong regulatory structure. But there’s a clear bottleneck in getting the benefits of our industry to patients, and that’s the U.S. insurance system.
\nThere are well-established issues around fair access to healthcare, cost structure, and the tension between lowering costs while improving quality care. All of these things will be further exacerbated as we develop the next generation of diagnostics and advanced therapeutics.
\nPowered by the growth of genomics, we are on the verge of turning medicine into what we’d always dreamed it could be: preventive instead of reactive, personalized instead of prescriptive, curative instead of lifetimes of treatments.
\nBut if a new therapy costs $1 million, insurance companies may not pick up the tab, even if it is curative, less expensive long-term than years of ongoing therapy, and prevents further, costly complications down the road. The insurance market is structured around employers as payers, and, since employees don’t stay with one company or insurer for a lifetime, the long-term benefits may be less attractive than keeping down short-term costs.
\nThe pool of uninsured and underinsured also are at higher risk for inferior treatment of their chronic illnesses. That’s unfortunate on its own but is compounded by the fact it shrinks the potential market for new therapies that disproportionately impact this group, which slows down bringing the benefits of genomics and most advanced therapeutics to those who can benefit the most.
\n","showOnHomepage":true,"author":{"title":"Yan Zhang, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Y_Zhang_Mission Bio.png","mediaDetails":{"height":276,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/yan-zhang-6983911/","email":null,"company":{"title":"Mission Bio"}}}},{"answer":"Uniquely, the U.S. biopharma industry benefits from robust long-term support for novel technologies. The two key pieces here are public funders, which continue to back early research, and investors who are willing to place big bets on novel ideas. This is exemplified in the cell and gene therapy space on the one hand by billions of dollars in long-term support from NIH and California’s CIRM, and on the other by the record-level venture investments and IPOs seen last year alone.
\nAs a result, the cell and gene therapy space has added so much momentum that demand well outpaces supply for approved therapies. Cell therapies in particular have extended manufacturing timelines, with challenging complexities due to their level of patient personalization. Addressing the manufacturing bottlenecks will be key to unlocking the next generation of therapies, which have the promise to treat more patients more quickly.
\nThis unique ability of the U.S. market to find and support innovative solutions promises solutions for these manufacturing hurdles, and is already on track to do so. We are gratified that investors have backed Cellares, for one, recognizing the possibilities for our automated Cell Shuttle technology as an exciting tool for meeting this burgeoning demand.
\n","showOnHomepage":true,"author":{"title":"Fabian Gerlinghaus","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/F_Gerlinghaus_Cellares.png","mediaDetails":{"height":287,"width":211}}},"authorFields":{"title":"Co-founder and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/fabian-gerlinghaus/","email":null,"company":{"title":"Cellares"}}}},{"answer":"What differentiates the U.S pharma/biopharma industry is its size and the diverse approaches to addressing different target indications. The U.S. is the world's largest single pharmaceutical market, generating more than $490 billion of revenue.
\nR&D is focused on precision medicine, offering more targeted therapies by discovering specific disease biomarkers, tumor antigens, and molecular targets that maximize efficacy and reduce side effects. At TFF Pharma, we are also focusing on targeted delivery by administering drugs directly to the site of infection, which could lower dosage and potentially improve efficacy and adverse side effects.
\nWe have also seen that partnerships and collaborations can really be a perfect marriage for getting products to market. Collaboration is part of our DNA, so we partner with a broad array of pharmaceutical companies, academic institutions, and government partners, merging resources and expertise to advance research efforts and improve patient outcomes.
\n","showOnHomepage":true,"author":{"title":"Glenn Mattes","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/G_Mattes_TFF.png","mediaDetails":{"height":239,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"http://www.linkedin.com/in/glenn-mattes-78617349/","email":null,"company":{"title":"TFF Pharmaceuticals, Inc."}}}},{"answer":"In my view, it all starts from the ground up. In the U.S., the biopharma industry greatly favors early-stage company formation. The appetite for risk is also quite different. The funding ecosystem for early-stage startups is more advanced than in other countries, which allows for more innovation and greater acceleration of clinical development for biopharma products. Additionally, the U.S. capital markets are more rewarding of novel technologies, which further enables both development and innovation. This means that more technologies discovered in the U.S. have various avenues to move toward the market and also means that novel and innovative products that may carry more risk still have the funding and development opportunities that they need to be successful.
\nAt Portage Biotech, we have capitalized on the advantages of the U.S. pharma and biopharma industry while also bringing technologies into our pipeline from places that don’t have the same opportunities as in the U.S. market. These historically under-appreciated technologies — including our lead invariant natural killer T cell (iNKT agonists), developed via technology licensed from Oxford University — allow us to stand out from the typical U.S. market, but our footprint in the U.S. ensures we have the funding and resources to aid in their successful development.
\n","showOnHomepage":true,"author":{"title":"Ian B. Walters, M.D., MBA","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/I_Walters_Portage_Biotech.png","mediaDetails":{"height":243,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":null,"email":null,"company":{"title":"Portage Biotech, Inc."}}}},{"answer":"The U.S. pharma/biopharma industry has been and remains the most dynamic and productive in the world, thanks to a combination of resources, scientific talents, financing opportunities, marketing incentives, and ingenuity. It’s this extraordinary and unique combination that has allowed the U.S. biopharma industry to advance the field of medicine at an unprecedented pace. The pandemic has underscored what can be achieved when pharmaceutical companies collaborate with each other and academic research institutions to develop safe and effective therapies and vaccines. New promising discovery paths open when companies explore novel approaches, such as in silico medicine, mRNA technology, or individualized medicine, to list just a few examples.
\nHowever, we should not take for granted that this marvelous ecosystem will last forever unless we work to preserve its strengths and vitality. Policy changes, even if well-intentioned, may have unexpected consequences that could disrupt the ability to attract new talent, achieve adequate return on investment or find adequate financing resources, which ultimately could limit the industry’s capacity to find new treatments to help improve the health and wellbeing of us all.
\n","showOnHomepage":true,"author":{"title":"Marco Taglietti, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Taglietti_SCYNEXIS.png","mediaDetails":{"height":246,"width":211}}},"authorFields":{"title":"President and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/marco-taglietti-md/","email":null,"company":{"title":"SCYNEXIS, Inc."}}}},{"answer":"The changing dynamics of healthcare — whether from a policy standpoint or patients taking more control of their own health — stand out as a differentiator when comparing the biopharma industry in the U.S. to other countries. Things can move fast here. The coronavirus pandemic is a good example of that. It created urgency unlike any other and as an industry, we had to research, develop, manufacture, and deliver large amounts of vaccines and drugs to the market quickly. In addition, the pandemic forced us, especially here in the U.S. as innovators, to focus on advanced technologies — both biological and digital. We are actively engaging in AI and machine learning and dealing with cybersecurity. There is competition for talent, which is in high demand. The U.S. is a leader in innovation, but other countries are nipping at our heels. It’s no time for U.S. to be complacent.
\n","showOnHomepage":true,"author":{"title":"Prakash Pandian","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/P_Pandian_Curia.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"Chief Information Officer","linkedin":"https://www.linkedin.com/in/prakash-pandian-468773/","email":null,"company":{"title":"Societal™ CDMO"}}}},{"answer":"The U.S. has an amazing appetite for innovation. There is a high concentration of talented researchers and scientists at universities and corporations here, and they come from around the world. I know this firsthand, as my father, Mir Imran, an accomplished medical innovator and entrepreneur, came from India to the United States because he believed the U.S. was the best place to learn, create innovations, and build companies. With so many great minds collaborating, innovation flourishes in the U.S.; it’s no surprise that roughly two-thirds of the biggest pharma companies are based here.
\n","showOnHomepage":true,"author":{"title":"Talat Imran","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/T_Imran_Rani Therapeutics.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/talat/","email":null,"company":{"title":"Rani Therapeutics"}}}},{"answer":"The United States has a biopharma market that encourages innovation and risk-taking, letting new technologies take root and grow — often before they can do so elsewhere in the world. Part of that is due to the huge amount of capital available, which enables companies to dream big and plan long-term, and certainly the open and transparent regulatory environment means innovation is enabled. U.S. biopharma companies have often set the pace for the incorporation of novel technologies and approaches to arrive at discoveries otherwise not possible. Today, this spirit of innovation and risk-taking is more alive than ever before and we are all beneficiaries of it.
\n","showOnHomepage":true,"author":{"title":"Omid Farokhzad, M.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/O_Farokhzad_Seer.png","mediaDetails":{"height":280,"width":211}}},"authorFields":{"title":"Chair and Chief Executive Officer","linkedin":"https://www.linkedin.com/in/omidfarokhzad/","email":null,"company":{"title":"Seer Bio"}}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-how-have-evolving-technologies-like-artificial-intelligence-ai-and-machine-learning-ml-changed-how-you-conduct-research-manufacturing-or-business/","uri":"/roundtable/articles-q-how-have-evolving-technologies-like-artificial-intelligence-ai-and-machine-learning-ml-changed-how-you-conduct-research-manufacturing-or-business/","slug":"articles-q-how-have-evolving-technologies-like-artificial-intelligence-ai-and-machine-learning-ml-changed-how-you-conduct-research-manufacturing-or-business","title":"Q: How have evolving technologies like artificial intelligence (AI) and machine learning (ML) changed how you conduct research, manufacturing, or business?","roundtable":{"topic":"Evolving Technologies","question":"How have evolving technologies like artificial intelligence (AI) and machine learning (ML) changed how you conduct research, manufacturing, or business?","roundtable":[{"answer":"Artificial intelligence (AI) nowadays represents the cross-industrial dream of acceleration through automation and precision. This near-magic set of technologies has already proven its value in highly regulated industries and, in particular, is establishing itself in the pharmaceutical landscape. The increasing manufacturing complexity of new medicines and the desire to reduce “time to market” are driving faster development and implementation of AI solutions in our activities.
\nIndeed, we see improvement through AI resulting in shorter cycle times in our operations while increasing quality and/or reducing overall costs and raw material consumption — an additional step toward sustainability.
\nIn particular, we successfully optimized product quality using computer vision technologies in quality assurance and are taking our first steps towards AI-enhanced genetic engineering based on bioinformatics methods. One of our latest endeavors is to develop hybrid approaches leveraging AI, mechanistic models, and traditional statistics for process scale-ups.
\nNevertheless, AI is not the only answer to new challenges and is often only one part of the puzzle, though a pivotal one. In practice, already established methods still deserve their place in innovation next to AI, supporting human intelligence. Reaching the ultimate goal of lights-out manufacturing — closer and closer to the vision of artificial general intelligence — will still require tremendous effort and a substantial boost in IT infrastructure.
\nAt present, AI already provides a strong basis for greater automation and knowledge expansion as an enabler of better, faster decision-making. We believe the industry is at a critical stage in our digital transformation journey.
\n","showOnHomepage":true,"author":{"title":"Stephan Rosenberger, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/S_Rosenberger_Lonza.png","mediaDetails":{"height":260,"width":211}}},"authorFields":{"title":"Head of Digital Transformation","linkedin":"https://www.linkedin.com/in/stephan-rosenberger-98632087/?originalSubdomain=ch","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"With respect to research, which impacts manufacturing and business operations generally, we have pursued machine learning (ML) to leverage data for optimizing process engineering and formulations to arrive at more robust solutions more efficiently for our clients.
\nThe pharmaceutical industry is data-rich, yet these data are generally not used as effectively as they could be, so we are working to make use of data to be more predictive of technical outcomes to give us better results more quickly. This is important, as a large fraction of new chemical entities in the industry are being advanced under accelerated development programs, such as breakthrough therapy designations, where speed is critical to bring new medicines to patients.
\nIn addition, the complex nature of the chemical matter (modality, size, solubilities), as well the need to deliver these new modalities effectively into the body with speed and agility in the development program, adds an extreme need to be predictive and use all of the data that came before to be successful.
\nArtificial intelligence (AI) and ML are likely going to be cornerstone technologies in drug development of the future.
\n","showOnHomepage":true,"author":{"title":"David Vodak, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/D_Vodak_Lonza.png","mediaDetails":{"height":242,"width":211}}},"authorFields":{"title":"Senior Director, Head of Small Molecules R&D","linkedin":"https://www.linkedin.com/in/david-vodak-10583054/","email":null,"company":{"title":"Sharpe Mixers"}}}},{"answer":"The application of evolving technologies like artificial intelligence (AI), machine learning (ML), and mixed reality (MR) is an important pillar of our digital agenda at Rentschler Biopharma. Hence, these are an integral part of our planning for strategic expansions and new services in the future. It is no secret that innovative technologies provide us and our clients a competitive edge in our sector by enhancing traditional services by digital means. I believe that — against the background of continued democratization of healthcare — this new dimension of digital maturity is becoming increasingly important in the CDMO selection process, beyond pure manufacturing capabilities. As a premium CDMO, our strategic vision drives us to not only offer exclusive services but also make digital differentiating capabilities available to our clients.
\n","showOnHomepage":true,"author":{"title":"Wolfram Schulze","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/W_Schulze_Rentschler_Biopharma.png","mediaDetails":{"height":261,"width":211}}},"authorFields":{"title":"Vice President Information Systems, Organization, & Digital Transformation and Head of Infection Prevention Task Force","linkedin":"http://www.linkedin.com/in/wolfram-schulze-654b3b65/","email":null,"company":{"title":"Rentschler Biopharma SE"}}}},{"answer":"At CatSci, we accelerate the development of the processes used to make the medicines of tomorrow. We are increasingly seeing opportunities to use high-quality data sets to predict outcomes, supplementing our use of theory-driven models. There are now browser-accessible tools, trained using test data calculated computationally, that allow our chemists to establish bond-dissociation energies, redox potentials, and other molecular properties.
\nOur collaborators in the areas of catalysis have used supervised machine learning to predict outcomes in “workhorse” chemical transformations like C–N couplings, Suzuki reactions, and C–H activation transformations. This has involved feeding a neural network model with calculated descriptor data for reactants and reagents, together with test experimental data.
\nAs well as being informed around the likely outcome when using certain reactants and conditions, the broader suite of computer-aided synthesis planning tools is increasingly catching up with chemists in its ability to establish the most suitable way of putting together a target active pharmaceutical ingredient. These tools also inform around the choice of reagents and solvents used in process design work packages. If nothing else, they bring a different set of perspectives to the table compared with an experienced scientist!
\nFrom an analytical perspective, algorithms trained using years’ worth of chromatographic retention time data, together with 3D structural information for the analytes, are enabling the prediction of retention times for new compounds. While our leveraging of machine-learning methods is likely to increase going forward, we cannot subcontract too much to a data-driven algorithm. Knowing how it works is still required so we know when we are being misled!
\n","showOnHomepage":true,"author":{"title":"Alan Stevens, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/A_Stevens_CatSci_Ltd.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"Senior Principal Scientist","linkedin":"https://www.linkedin.com/in/alan-steven/","email":null,"company":{"title":"CatSci Ltd."}}}},{"answer":"Evolving technologies have transformed BASF’s ability to offer new services and solutions to our customers in the pharmaceutical industry. From a service perspective, one example is BASF’s ZoomLab™, an online virtual formulation assistant that allows formulators to predict their next starting formulation for a pharmaceutical product and solve other formulation challenges. In terms of technology, ZoomLab™’s soon-to-be-released chatbot uses artificial intelligence to assess a formulator’s intention and provide personalized recommendations to specific formulation challenges. Additionally, several ZoomLab™ features, including the Decision Support for Solubility module, were developed via machine learning. Because of developing technologies, BASF will be able to continue to advance digital services such as ZoomLab™.
\nDigitalization has also enhanced the solutions we can provide to our customers. BASF’s R&D teams are exploring machine learning in molecular modeling to predict trends in experimental data. Our manufacturing and supply chain teams are leveraging “big data” to streamline the production of our active ingredients and excipients. We know there are many opportunities to leverage digitalization, and we will continue to invest in advancing technologies.
\n","showOnHomepage":true,"author":{"title":"Valerie Van Hulle","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/V_Van_Hulle_BASF.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"Global Strategic Marketing Manager","linkedin":"https://www.linkedin.com/in/valerie-van-hulle-82726669/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Technologies such as AI and ML are poised to transform current pharmaceutical approaches, with the potential of increasing productivity, ensuring robustness, reducing costs, and accelerating timelines, all of which are key objectives of the industry. The advantages of AI are the detection and extraction of information from patterns in complex data sets that are difficult to observe conventionally and to automate actions based on that information. ML provides the ability to “learn” by analyzing data over time.
\nThe application of AI and ML technologies in the biopharmaceutical industry is still in its infancy, and they are mainly used where GMP requirements do not apply. A progressive and phased approach in their implementation is crucial, so that knowledge and experience gained in the early phases can be incorporated into systems for the later phases. Biopharmaceutical process development can be highly complex, with multiple interactions potentially affecting the critical quality attributes of products. As biomanufacturing evolves from batch processing to a more continuous operation supported by inline sensors and process analytical technology (PAT), AI/ML could be naturally introduced alongside, leading to data-driven continuous operations that could significantly improve product quality, reduce production costs, and shorten the time to market.
\nTo ensure support from regulators, these processes need time to demonstrate their robustness and compliance within the GMP guidance. Initial examples, such as AI-based real-time maintenance or the use of imaging in quality control or cell characterization, could potentially help to build some level of basic confidence.
\n","showOnHomepage":true,"author":{"title":"Behzad Mahdavi, Ph.D., MBA","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/B_Mahdavi_Catalent.png","mediaDetails":{"height":245,"width":211}}},"authorFields":{"title":"Vice President of Open Innovation, Biologics, Cell and Gene Therapy","linkedin":"https://www.linkedin.com/in/behzadmahdavi/","email":null,"company":{"title":"Catalent"}}}},{"answer":"Even simpler than technologies like AI and ML, access to low-cost computing power, IoT and automation technologies have dramatically changed the way we do research and process development. Early in Snapdragon’s history, we invested in developing a lab operating system that would allow us to communicate with all manner of equipment. LabOS is particularly useful for continuous manufacturing process development. IoT integrated into LabOS allows supervisory control and data acquisition of all electronic lab equipment via a web-based interface. LabOS is continuously gathering data from in-line sensors and PAT for continuous process monitoring. With all components of the system connected, advanced automation is enabled, allowing for scripted automated experimentation. With programmed safety interlocks and automated text message alerts, unattended and remote operation of lab equipment can be done routinely and safely. Moving into simple AI applications, Snapdragon has created an algorithm-driven autonomous optimization platform connecting automated reactor systems to online analytical systems (e.g., UHPLC). The algorithm will search multivariable landscape optimizing for an objective function, such as yield, which can be read out from the connected PAT. We are hopeful that the data gathered from these systems can subsequently be used in ML applications to accelerate reactions and process development.
\n","showOnHomepage":true,"author":{"title":"Matthew Bio, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Bio_Snapdragon_Chemistry.png","mediaDetails":{"height":255,"width":211}}},"authorFields":{"title":null,"linkedin":"https://www.linkedin.com/in/matthew-bio-3ba27020/","email":null,"company":{"title":"Snapdragon Chemistry, Inc."}}}},{"answer":"For contract development and manufacturing organizations (CDMOs), investment in technology is crucial to ensure that capabilities are in place to respond to customer demand and the forecasted nature of future projects. Whereas previously, the primary consideration for innovators seeking partners was the lowest cost, for many companies accelerated program development is now crucial, so minimized lead times are preferable. This means that CDMOs are looking to invest in technologies that can reduce the project timeline while at the same time enhancing manufacturing efficiency and minimizing costs, as well as ensuring product quality.
\nDigitization and machine learning strategies are technologies that are becoming more important, and they can play a key role in reducing the timescales of projects. At Sterling, we are working with partners to develop a solution that will allow us to monitor process parameters during manufacturing and identify as early as possible if there is any deviation from pre-set limits. This should ultimately allow appropriate steps to be taken to prevent any event that might lead to a product becoming out of specification, and reduce the risk of unexpected increases in costs.
\nThis approach differs from traditional process control networks and could enable the integration of historic data and events into systems — so that any actions taken will factor these in — and thus allow faster and more accurate interventions. Such technology is core to supporting operational excellence by reducing variation in and between batches of API and optimizing the quality of customers’ products.
\n","showOnHomepage":true,"author":{"title":"James Rogers","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/J_Rogers_Sterling_Pharma_Solutions.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Head of Manufacturing and Supply","linkedin":"https://www.linkedin.com/in/james-rogers-40106021/","email":null,"company":{"title":"Sterling Pharma Solutions"}}}},{"answer":"Developments in artificial intelligence (AI) and machine learning (ML) over the last decade are, in fact, one of the two pillars that made the origin of Fountain possible. The other is our experienced team of biologists and computer scientists, who turn large data sets into biologically meaningful information for the development of therapeutics for age-related diseases. Research confirms that aging is the major risk factor of disease and that the aging process is, in fact, malleable — it can be delayed and reversed. Diseases of aging can involve multiple biological pathways shared among different cells, tissues, and organs. Yet, traditional target-based drug discovery approaches do not adequately identify the pathways and molecules responsible for cellular aging and its reversal, since they assume single pathway malfunction and look for known biological pathways of disease. Advances in AI and ML have enabled Fountain to spearhead a new unbiased approach to drug discovery and development. We have built an AI-based platform and ML-driven model using computer vision that can predict the biological age of cells with unprecedented precision by discerning patterns in young versus old cells based on visual features. This highly scalable platform enables us to screen thousands of molecules and discover those with the ability to produce younger, rejuvenated cells, without focusing on specific pharmaceuticals targets, at least at first. This unique AI-driven platform, in combination with our highly parallel in vivo disease testing, positions us to develop a unique pipeline of truly disease-modifying therapies for age-related diseases.
\n","showOnHomepage":true,"author":{"title":"William Greene, M.D","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/W_Greene_Fountain_Therapeutics.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/william-greene-83846/","email":null,"company":{"title":"Fountain Therapeutics"}}}},{"answer":"Drug development, especially for immunotherapies used in cancer and for autoimmune diseases, is an extremely challenging process with an incredible number of variables at play. In addition, modern immunotherapies are often large molecules, such as biologic drugs modified from proteins found in nature, which adds additional obstacles for early clinical testing and high-throughput screening of drug candidates. Together, this makes early-stage drug development — especially preclinical screening of potentially valuable new therapies — a costly endeavor fraught with failure in more cases than we see success.
\nAs a result, in the past few years at OSE, we have incorporated artificial intelligence (AI) and machine learning algorithms into our early screening of new drug candidates. In early 2020, we initiated a partnership, which was expanded in early 2021, with a leading developer of AI-based software for antibody discovery and development, MAbSilico, to help accelerate drug development efforts, including improvements in the selection of a promising drug target to the optimization of the final humanized lead.
\nMAbSilico's software platform, in combination with OSE's expertise in immune-relevant antibodies, allows for rapid in silico screening of potential candidates. A great example of this in action is OSE's CoVepiT, a prophylactic multi-target vaccine against COVID-19. AI-assisted peptide modeling identified vaccine target epitopes in only two weeks, helping OSE move quickly into preclinical and human ex vivo studies in August 2020. We are excited to continue working with the MAbSilico team and their AI-software platform to help identify the next round of \"Immunotherapy 2.0\" drug candidates.
\n","showOnHomepage":true,"author":{"title":"Nicolas Poirier, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/N_Poirier_OSE_Immunotherapeutics.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Chief Scientific Officer","linkedin":"https://www.linkedin.com/in/nicolas-poirier-2203a919","email":null,"company":{"title":"OSE Immunotherapeutics"}}}},{"answer":"At Fore Biotherapeutics, we are leveraging our functional genomics platform, Foresight, to match populations of patients with rare cancer mutations to targeted therapies that have a high probability of making a difference. Our mission is to provide patients with unaddressed cancer mutations with rapid access to the right medicines.
\nAdvances our team has made in machine learning, specifically in deep neural networks, allow us to analyze images of billions of cells emulating the patients’ mutations and assess their response to different targeted therapies.
\nBy conducting functional genomics screening of rare cancer mutations and analyzing the data, the Foresight engine can identify targeted therapies that could serve patients who might otherwise never have found a clinical match. We then in-license those therapies to guide them through clinical development, with the ultimate goal that hundreds of thousands of patients could receive precisely tailored, previously untapped treatments.
\nIt’s a new kind of precision oncology model that would not have been possible without the tools that are now available in AI and ML. We hope that, as we continue to advance the Foresight engine, we can guide additional technological progress that will enable faster development of and access to precision cancer treatments for years to come.
\n","showOnHomepage":true,"author":{"title":"Michael Vidne, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Vidne_Fore_Biotherapeutics.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Chief Business Officer / Chief Strategy Officer","linkedin":"https://www.linkedin.com/in/michael-vidne-7575294/","email":null,"company":{"title":"Fore Biotherapeutics"}}}},{"answer":"Evolving technologies are the foundation for our work in oncology, rare diseases, and neurodegenerative disorders. The power of supercomputing has paved the way for new methods of drug discovery. We are redefining drug discovery with our SEE-TxTM platform technology, designed to discover new allosteric binding sites on misfolded proteins and predict their druggability. Protein misfolding is the root cause of many diseases with high unmet needs such as Parkinson’s disease, cystic fibrosis, Gaucher disease and other lysosomal storage diseases. Advances in computing have enabled us to redefine drug discovery by targeting the cause of the disease rather than simply treating symptoms.
\nSEE-TxTM utilizes the known 3D structure of proteins and supercomputing technology to find druggable binding hotspots on misfolded proteins and correct their shape. This has the potential to up- or downregulate enzymatic activity, causing the protein to gain or lose function and eliminating the subsequent toxic substrate buildup that causes disease. The platform utilizes a unique algorithm, based on a patented method to analyze molecular dynamics. Once a druggable binding site is found, a separate algorithm is then used to scan libraries of small molecule compounds to identify those that have the potential to bind to the site and restore function. This offers a new drug discovery approach that is differentiated, highly specific, efficient, and cost-effective. Through SEE-TxTM, we look forward to changing the way the industry thinks about drug discovery and, thanks to evolving technologies, are one step closer to getting novel treatments to patients in need.
\n","showOnHomepage":true,"author":{"title":"Eric Richman","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/E_Richman_Gain_Therapeutics.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Chief Executive Officer","linkedin":"https://www.linkedin.com/in/eric-richman-516b79/","email":null,"company":{"title":"Gain Therapeutics, Inc."}}}},{"answer":"For us in the IP profession, we’re beginning to see some AI integration into our work, but we’re still a long way off from it becoming a major part of our daily lives. AI is being used by some patent offices for more efficient searching, for example, and I can see how AI might assist in drafting legal documents. When devising an IP strategy for a startup or conducting complex IP due diligence, there’s simply not enough data to train AI algorithms on, and it cannot replicate years of experience.
\nThe story is very different in the healthcare industry, as many of our clients in the sector are feeling a profound effect from the use of AI. Crucially, unlike in other industries, data is readily available in the healthcare sector. Patient data, especially in countries like the UK that have large healthcare systems, is easier to obtain and broad enough to train algorithms on for new product and treatment development. AI is becoming increasingly important in the personalized medicine and diagnostics space.
\nAI is also revolutionizing drug discovery. Traditionally, hundreds of researchers would spend hours developing and testing new drugs, and there was a high failure rate. By using AI to quickly sift through data to find possible treatments, healthtech startups are able to massively decrease the time taken and cost of developing new treatments. In vitro and in vivo data is still required of course, and the role of the pharmacologist is still very important, but it’s undeniable that AI is having an impact. Big pharma is recognizing this, and we’re seeing more partnerships forged between them and healthtech startups.
\n","showOnHomepage":true,"author":{"title":"Fiona Law","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/F_Law_Potter_Clarkson.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":null,"linkedin":null,"email":null,"company":null}}}]}},{"link":"https://thatsnice-testing3.com/roundtable/articles-q-how-is-your-organization-using-social-media-to-extend-your-marketing-efforts-what-are-your-goals-and-what-has-been-successful/","uri":"/roundtable/articles-q-how-is-your-organization-using-social-media-to-extend-your-marketing-efforts-what-are-your-goals-and-what-has-been-successful/","slug":"articles-q-how-is-your-organization-using-social-media-to-extend-your-marketing-efforts-what-are-your-goals-and-what-has-been-successful","title":"Q: How is your organization using social media to extend your marketing efforts?","roundtable":{"topic":"Social Media Marketing","question":"How is your organization using social media to extend your marketing efforts?","roundtable":[{"answer":"Social media is an important channel to engage with customers, current and prospective employees, shareholders, and investors. During the COVID-19 pandemic, with in-person activities significantly curtailed, it has become more so. Vectura has a global customer base with companies of all sizes. Given the complexity of inhaled drug development, no two programs are identical, and customers expect high levels of expertise and specific, tailored solutions.
\nOur social media goals have been to extend our geographical reach, personalize customers’ experience by connecting them with our experts, build meaningful dialogue, and match our capabilities with their needs.
\nEngaging this community effectively requires building trust and delivering compelling content. Platforms like LinkedIn and Twitter help us exchange insight and expertise, including articles from our development teams, scientific webinars, and insights from online congresses. We encourage colleagues to take an active role and share personal stories, allowing us to spotlight the energy and creativity of those who are delivering for customers, despite the pandemic challenges. In the past year, we have seen our LinkedIn and Twitter followers increase by 30% and 25% respectively.
\nSocial media clearly offers a cost-effective means to engage globally. Customers use multiple digital platforms to communicate with us, so social media forms part of an overall global digital strategy.
\nWhen COVID restrictions relax and in-person activities return, social media will remain critical to the success of organizations in building communities and sharing stories. If anything, COVID has taught us these channels are vital to facilitate meaningful conversations.
\n","showOnHomepage":true,"author":{"title":"Richard Harper","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/R_Harper_Vectura.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Vice President, Marketing","linkedin":"https://www.linkedin.com/in/richard1harper/","email":null,"company":{"title":"Vectura Group"}}}},{"answer":"Raising awareness of our sector’s contribution in simplifying the complexities of drug development, in the face of the pandemic and beyond, has been my personal mission in communication. Therefore, this also guides our social media strategy. Ever since the pandemic triggered the shift to the home-office format, social media has become all the more important in bringing Rentschler Biopharma closer to the world. For clients, social media platforms support us in ensuring brand visibility as a global leading CDMO and in showcasing our expertise in translating medical research into outstanding biopharmaceuticals. As a company driven by excellence and not financial KPIs, we don’t measure success by lead generation or client acquisition alone. It’s how we shape the global conversation on biopharmaceutical manufacturing, on offering innovative solutions and forging collaborative partnerships — all with the aim of empowering our clients in helping patients with serious and rare diseases. This also contributes to our visibility as a unique employer. On this front, we communicate and demonstrate our purpose, as well as provide intimate insights into the inner workings of our company. Ultimately, I see social media as a means to positioning biopharmaceutical manufacturing, sharing knowledge and expertise, dispelling myths associated with our sector, and celebrating the great work being done at Rentschler Biopharma.
\n","showOnHomepage":true,"author":{"title":"Cora Kaiser, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/C_Kaiser_Rentschler_Biopharma.png","mediaDetails":{"height":248,"width":211}}},"authorFields":{"title":"Senior Director Corporate Communication","linkedin":"https://www.linkedin.com/in/dr-cora-kaiser-87612260/","email":null,"company":{"title":"Rentschler Biopharma SE"}}}},{"answer":"Social media is a key pillar of BASF Pharma Solutions’ marketing communications strategy. Through LinkedIn, Twitter, and other platforms, we are able to reach a broad, global audience and develop a loyal follower base for our brand.
\nOur goals are to connect with people from the pharmaceutical industry and collaborate on complex problems, strengthen relationships, and share relevant content, such as industry insights and thought leadership. This means leveraging social media to understand and match our audience’s individual needs and challenges with BASF’s solutions and expertise. Our social media strategy is not a “one size fits all” approach, and we often test a variety of videos, graphics, and messaging to see what resonates with our audience. We are even more successful when we adapt our messaging and content to local languages and platforms.
\nWhen used correctly, social media is also a powerful networking resource for industry professionals. Many of our technical experts are active on social media and use these platforms to provide support and share knowledge and expertise with their networks. It’s a very effective way to connect with our customers, and we appreciate the valuable virtual engagements and conversations. From a talent attraction perspective, social media channels also play a relevant role. Today, candidates are being very active and strategic when looking for the next job opportunity, and the way companies position themselves and share their values will be determinant in attracting professionals that match the company's profile.
\n","showOnHomepage":true,"author":{"title":"Valerie Van Hulle","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/V_Van_Hulle_BASF.png","mediaDetails":{"height":266,"width":211}}},"authorFields":{"title":"Global Strategic Marketing Manager","linkedin":"https://www.linkedin.com/in/valerie-van-hulle-82726669/","email":null,"company":{"title":"PharmParts"}}}},{"answer":"Snapdragon Chemistry uses social media in limited ways. I wouldn’t say we have a social media strategy. Most all our social media presence is through LinkedIn. We use social media to celebrate corporate milestones, announce new capabilities, and highlight news about the company that may be of interest to the chemistry community. As in any marketing, it is difficult to gauge success, but there have been a few occasions where new clients have indicated that they became aware of our services through our LinkedIn posts.
\nWe also use social media for recruiting. We routinely post job openings on LinkedIn and do find that it generates some leads. Social media is a way for Snapdragon Chemistry to keep up with news on our client companies and other news from pharmaceutical and chemical manufacturing industry. Social media keeps us connected to our industry and our clients. I think of it more as an information source than a marketing tool.
\n","showOnHomepage":true,"author":{"title":"Matthew Bio, Ph.D.","featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/M_Bio_Snapdragon_Chemistry.png","mediaDetails":{"height":255,"width":211}}},"authorFields":{"title":null,"linkedin":"https://www.linkedin.com/in/matthew-bio-3ba27020/","email":null,"company":{"title":"Snapdragon Chemistry, Inc."}}}},{"answer":"Social media is an important part of a wider digital marketing strategy for Sterling Pharma Solutions for both internal and external audiences. As a fast-growing business expanding into new markets and new service provision, brand awareness is key for attracting new customers and to reinforce the decision-making process of existing ones.
\nCOVID-19 has highlighted the importance of this strategy, with the need to overcome the challenges in prospecting and engaging with customers in the absence of in-person meetings and engaging with employees who were working remotely.
\nSocial media is a vital tool to share content with audiences. It has allowed us to create new ways to engage, advertise, and communicate with our clients, as they changed the way they consumed information and searched for knowledge. We use social media to interact with our customers and our employees; sharing content that includes live webinars, video, whitepapers, and animations. Our Knowledge Hub provides something for everyone at every stage of their customer journey. Analysis of the interactions allows us to better understand our customers’ needs and tailor content and build an archive of information for our business development and partnership management teams.
\nSocial media provides fantastic data to drive decision-making in our marketing strategy, and target specific audiences matched to lead generation mapping. From an employee perspective, social media assists greatly in recruitment, and for internal communities we use Facebook and Instagram rather than LinkedIn and Twitter. Our Facebook page was launched during the COVID-19 lockdowns when many people were working from home, and it received an excellent response from employees.
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The report will explore innovations in modalities and synthesis systems, manufacturing equipment and processes, automation, and analytics for APIs, including next-generation APIs, highly potent and controlled substances, and generics. The report will include a proprietary pricing study providing pricing data for a full range of line items associated with outsourced API development and manufacturing services.
\nNice Insight is in the process of compiling primary and secondary data to create a comprehensive report on the dynamic market for sterile injectable drugs, including development, manufacturing, packaging, and commercialization. The report will explore innovations in delivery systems, manufacturing equipment and processes, and automation for sterile injectable drugs, including established products and next-generation and personalized medicines. The report will include a proprietary pricing study providing pricing data for a full range of line items associated with sterile drug manufacturing and packaging.
\nInnovator companies looking to enter or extend their presence in the dynamic market for gene therapies and CAR-T and associated cell therapies need a complete understanding of the market dynamics and the landscape of providers capable of manufacturing plasmids and AAV and lentiviral vectors.
\nNice Insight’s 2021 Cell & Gene Therapy Report & Pricing Study is an ideal resource for innovators looking to outsource plasmid and viral vector manufacturing to support cell and gene therapy programs, providing profiles of relevant providers and pricing benchmarks for a range of relevant line items. Understand the market of outsourcing providers and what you should pay with competitive pricing comparisons for plasmid and viral vector manufacturing.
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\nNice Insight has compiled primary and secondary data to assess market trends, practices, and pricing for oral solid dose (OSD) drugs, including their formulation, development, and manufacturing. This report provides insights into each OSD segment, ongoing innovations, current processes, therapies in the pipeline, and regional activity.
\nA proprietary pricing study provides data for both buyers and sellers of services, with prevailing practices in the bundling of integrated formulation, development, and manufacturing of finished drug products in a range of solid dose forms. A directory of the leading players in major regions with a full listing of services offers readers insight into the global competitive landscape.
\nIf you are a CDMO serving the OSD outsourcing market — or a PE company or investor looking to refine your investing strategy with a comprehensive landscape of the market — you need our Oral Solid Dose Market Growth and Contract Manufacturing Report with Pricing Study to explore the competitive environment, examine how your pricing compares with your peers, and position your company more effectively to attract business. Access pricing data across a range of criteria and parameters spanning the full range of OSD products and processes.
\nIf you are a innovator looking to outsource your OSD development and manufacturing or seeking cost-efficient services for generics manufacturing, our Oral Solid Dose Market Growth and Contract Manufacturing Report with Pricing Study is an invaluable resource to find the ideal OSD CDMO with all of the services to fit your needs. Understand what you should pay by product type, process, and volume with competitive pricing comparisons.
\nAlthough a growing number of antibody–drug conjugates (ADCs) have been approved as cancer therapeutics, the full promise of ADCs has yet to be fully realized, owing to issues with stability and the resulting toxic side effects. In this Q&A, Philipp Spycher, Ph.D., Chief Executive Officer and founder of Araris Biotech, discusses his company’s new peptide […]
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\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q3_wheeler3_main.jpg"}},"mainTopic":{"mainTopic":"Cell Line Development"},"articleFields":{"articleId":"PAO-06-022-CL-12","authors":[{"author":{"title":"Stephen Hamilton, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"Alloy Therapeutics","slug":"alloy-therapeutics","id":"dGVybToxMjYxMQ=="}},{"node":{"name":"Cell Line Development","slug":"cell-line-development","id":"dGVybToxMDI4Mw=="}},{"node":{"name":"CHO","slug":"cho","id":"dGVybToxMTcxMw=="}},{"node":{"name":"Clone Selection","slug":"clone-selection","id":"dGVybToxMzA2Nw=="}},{"node":{"name":"Open-Source Manufacturing","slug":"open-source-manufacturing","id":"dGVybToxMzA0Mw=="}},{"node":{"name":"Portable CMC","slug":"portable-cmc","id":"dGVybToxMjYwOA=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Transposons","slug":"transposons","id":"dGVybToxMzA2OQ=="}},{"node":{"name":"Wheeler Bio","slug":"wheeler-bio","id":"dGVybToxMjYxMg=="}}]}},{"title":"Who’s Left to Acquire in CDMO Biomanufacturing? A Select Few.","slug":"articles-whos-left-to-acquire-in-cdmo-biomanufacturing-a-select-few","uri":"/uncategorized/articles-whos-left-to-acquire-in-cdmo-biomanufacturing-a-select-few/","excerpt":"Publicly funded biotechs have experienced drastic reductions in market value in recent months, while private companies continue to attract financing and are in-licensing technologies and expanding staff. With the slower economy, companies are often expected to drop early-stage projects to focus on more advanced lead candidates. These changes will impact demand for CDMO services beginning […]
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\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_new_drug.jpg"}},"mainTopic":{"mainTopic":"Column: New Drug Watch"},"articleFields":{"articleId":"PAO-06-022--NI-08","authors":[{"author":{"title":"David Alvaro, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"Diabetes","slug":"diabetes","id":"dGVybTo5NTI0"}},{"node":{"name":"Eli Lily","slug":"eli-lily","id":"dGVybTo5NDEz"}},{"node":{"name":"FDA Approval","slug":"fda-approval","id":"dGVybTo5MzIx"}},{"node":{"name":"Mounjaro","slug":"mounjaro","id":"dGVybToxMzAyMg=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Twincretin","slug":"twincretin","id":"dGVybToxMzAwMQ=="}}]}},{"title":"IPOs Have Not Recovered In 2022. When Will Biotech Bounce Back?","slug":"articles-ipos-have-not-recovered-in-2022-when-will-biotech-bounce-back-1","uri":"/uncategorized/articles-ipos-have-not-recovered-in-2022-when-will-biotech-bounce-back-1/","excerpt":"After a record-breaking year for biotech IPOs, the market slowdown that began in the second half of 2021 is here to stay. 2022 opened on a much cooler market, and the first quarter was the slowest in three years for new stock offerings.1 For young biotechs and their investors, life after the IPO cliff is […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_IPO2.jpg"}},"mainTopic":{"mainTopic":"Column: Investment"},"articleFields":{"articleId":"PAO-06-022--NI-02","authors":[{"author":{"title":"Danielle Alvarez"}}]},"articleTags":{"edges":[{"node":{"name":"Biotechs","slug":"biotechs","id":"dGVybToxMjc5Nw=="}},{"node":{"name":"Investment","slug":"investment","id":"dGVybTo5MDE3"}},{"node":{"name":"IPO","slug":"ipo","id":"dGVybToxMDg0Mg=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Valuation","slug":"valuation","id":"dGVybTo5MDA1"}}]}},{"title":"The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative","slug":"articles-the-price-of-pain-acknowledging-a-crisis-and-encouraging-an-alternative","uri":"/uncategorized/articles-the-price-of-pain-acknowledging-a-crisis-and-encouraging-an-alternative/","excerpt":"Pain is nearly ubiquitous in the United States. According to a 2016 National Health Interview Survey featured by the CDC, one in five Americans — 50 million people — suffer from chronic pain. For 8% (19.6 million Americans) of chronic pain sufferers, this pain is so debilitating that it interferes with their daily lives.1 Groups […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_pain.jpg"}},"mainTopic":{"mainTopic":"Column: Regulatory Spotlight"},"articleFields":{"articleId":"PAO-06-022--NI-05","authors":[{"author":{"title":"David Alvaro, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"Analgesics","slug":"analgesics","id":"dGVybToxMzAxNA=="}},{"node":{"name":"FDA","slug":"fda","id":"dGVybTo4OTk5"}},{"node":{"name":"FDA Guidance","slug":"fda-guidance","id":"dGVybTo5NjAy"}},{"node":{"name":"Opioid Epidemic","slug":"opioid-epidemic","id":"dGVybToxMTM2MQ=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Regulatory","slug":"regulatory","id":"dGVybTo5MDUw"}}]}},{"title":"Digital Frontiers: What NFTs Can Do for Pharma","slug":"articles-digital-frontiers-what-nfts-can-do-for-pharma","uri":"/uncategorized/articles-digital-frontiers-what-nfts-can-do-for-pharma/","excerpt":"2021 was the year that non-fungible tokens, or NFTs, received widespread attention on the internet and entered the corporate world in a significant way. Now, these crypto assets and the blockchain technology that makes them possible may have major real-world applications for supply chain GMP, patient data management, and the future of pharma. An Overview […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_nft.jpg"}},"mainTopic":{"mainTopic":"NFTs"},"articleFields":{"articleId":"PAO-06-022--NI-01","authors":[{"author":{"title":"Danielle Alvarez"}}]},"articleTags":{"edges":[{"node":{"name":"Blockchain","slug":"blockchain","id":"dGVybToxMTg3Mg=="}},{"node":{"name":"Marketing","slug":"marketing","id":"dGVybTo5MDk1"}},{"node":{"name":"NFT","slug":"nft","id":"dGVybToxMjk3MQ=="}},{"node":{"name":"Pharma","slug":"pharma","id":"dGVybTo5MDU4"}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}}]}},{"title":"Creating a More Resilient Pharmaceutical Supply Chain One Segment at a Time","slug":"articles-creating-a-more-resilient-pharmaceutical-supply-chain-one-segment-at-a-time","uri":"/uncategorized/articles-creating-a-more-resilient-pharmaceutical-supply-chain-one-segment-at-a-time/","excerpt":"Weaknesses within the highly complex and global pharmaceutical supply chain are not a new topic. However, the many conferences, working groups, and regulatory body discussions have led to minimal foundational change. Then, the COVID-19 pandemic made pharmaceutical supply chain vulnerabilities impossible to ignore, and much work has been done across many public and private organizations […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_supply_chain.jpg"}},"mainTopic":{"mainTopic":"Column: Supply Chain"},"articleFields":{"articleId":"PAO-06-022--NI-09","authors":[{"author":{"title":"Tonia Becker"}}]},"articleTags":{"edges":[{"node":{"name":"COVID-19 Impacts","slug":"covid-19-impacts","id":"dGVybToxMjQzNw=="}},{"node":{"name":"Domestic Sourcing","slug":"domestic-sourcing","id":"dGVybToxMjA1Ng=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Regulatory","slug":"regulatory","id":"dGVybTo5MDUw"}},{"node":{"name":"Reshoring","slug":"reshoring","id":"dGVybToxMjIyMg=="}},{"node":{"name":"Sourcing","slug":"sourcing","id":"dGVybToxMzAyMw=="}},{"node":{"name":"Supply Chain","slug":"supply-chain","id":"dGVybTo4OTg5"}}]}}]},"contentNodes":{"pageInfo":{"hasNextPage":true,"hasPreviousPage":false,"startCursor":"YXJyYXljb25uZWN0aW9uOjg1NDg3","endCursor":"YXJyYXljb25uZWN0aW9uOjg1NDk3"},"nodes":[{"id":"cG9zdDo4NTQ4Nw==","title":"Improving the Therapeutic Index of ADCs with a Peptide Linker Technology","slug":"articles-improving-the-therapeutic-index-of-adcs-with-a-peptide-linker-technology","uri":"/uncategorized/articles-improving-the-therapeutic-index-of-adcs-with-a-peptide-linker-technology/","excerpt":"Although a growing number of antibody–drug conjugates (ADCs) have been approved as cancer therapeutics, the full promise of ADCs has yet to be fully realized, owing to issues with stability and the resulting toxic side effects. In this Q&A, Philipp Spycher, Ph.D., Chief Executive Officer and founder of Araris Biotech, discusses his company’s new peptide […]
\n","mainTopic":{"mainTopic":"ADCS"},"articleFields":{"vimeoId":null,"articleId":"PAO-07-022-CL-01","authors":[{"author":{"title":"Philipp Spycher","authorFields":{"bio":"As the inventor of the Araris Linker Technology, Philipp has a profound background in Bioconjugation and ADCs. He obtained his master’s degree and Ph.D. from ETH Zurich at the interface of material science and protein engineering. During his post-doctoral work at PSI, he introduced the novel approach using transglutaminases for antibody conjugation that led to the discovery of the Araris Linker Technology.
\n","email":"pspycher@ararisbiotech.com","linkedin":"https://www.linkedin.com/in/philipp-spycher-45958640/","title":"Co-founder and CEO","company":{"id":"cG9zdDo3Njg0MQ==","companyId":76841,"title":"Araris Biotech","slug":"araris-biotech"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q3_araris_main.png"}},"articleTags":{"nodes":[{"name":"ADC","slug":"adc"},{"name":"Drug Development","slug":"drug-development"},{"name":"Linker","slug":"linker"},{"name":"Manufacturability","slug":"manufacturability"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Q3 2022","slug":"q3-2022"},{"name":"Strategic Partnership","slug":"strategic-partnership"}]}},{"id":"cG9zdDo4NTQ5Ng==","title":"CAR-T Study Shines New Spotlight on Clinical Trials Representation","slug":"articles-car-t-study-shines-new-spotlight-on-clinical-trials-representation","uri":"/uncategorized/articles-car-t-study-shines-new-spotlight-on-clinical-trials-representation/","excerpt":"A study published by researchers at the University of Arkansas for Medical Sciences has caused quite a stir, reminding regulators and the public that, even in clinical studies for such cutting-edge therapeutics, the industry continues to struggle with achieving the goal of making clinical trials representative for all prospective patient demographic groups. Examining Black Representation […]
\n","mainTopic":{"mainTopic":"Column: Clinical Trials"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-06","authors":[{"author":{"title":"David Alvaro, Ph.D.","authorFields":{"bio":"David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That’s Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.
\n","email":null,"linkedin":"https://www.linkedin.com/in/david-alvaro-3305a1165/","title":"Scientific Editor in Chief","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_cinical_trials.jpg"}},"articleTags":{"nodes":[{"name":"CAR-T","slug":"car-t"},{"name":"Cell Therapy","slug":"cell-therapy"},{"name":"Clinical Trials","slug":"clinical-trials"},{"name":"Diversity","slug":"diversity"},{"name":"FDA Approval","slug":"fda-approval"},{"name":"Features","slug":"features"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Representation","slug":"representation"}]}},{"id":"cG9zdDo4NTQ5MA==","title":"Applying an Advanced Pharma 4.0 Perspective to Design the Facility of the Future","slug":"articles-applying-an-advanced-pharma-4-0-perspective-to-design-the-facility-of-the-future","uri":"/uncategorized/articles-applying-an-advanced-pharma-4-0-perspective-to-design-the-facility-of-the-future/","excerpt":"Disruptive new biopharmaceutical CDMO Wheeler Bio is aiming to push the boundaries of biomanufacturing, designing a new facility that will advance along the Pharma 4.0 path and potentially set a new paradigm for applying risk-based thinking to introduce new concepts in manufacturing to support their clients. A panel of experts from Wheeler Bio, including Chief […]
\n","mainTopic":{"mainTopic":"Pharma 4.0"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022-CL-11","authors":[{"author":{"title":"Yuk Chun Chiu, M.S.E.","authorFields":{"bio":"Mr. Yuk Chun Chiu has over 20 years of GMP manufacturing experience in both large pharma and CDMO environments. He currently serves as Wheeler’s Chief Manufacturing Officer with overall responsibilities for capital projects, manufacturing operations, facilities, engineering and supply chain. Prior to joining Wheeler, he was the VP of Manufacturing at Cytovance Biologics in Oklahoma City and the Head of Manufacturing and Engineering at AstraZeneca in Redwood City, CA. Yuk also spent 12 years working in various technical roles (PD, engineering, manufacturing) of increasing responsibility at GSK, Amgen, Dow Chemical and Lonza. Yuk holds a B.Sc. in Chemical Engineering and a masters in Pharmaceutical Engineering from the University of Michigan, Ann Arbor.
\n","email":null,"linkedin":"https://www.linkedin.com/in/yuk-chun-c-1085795/","title":"Chief Operating Officer","company":{"id":"cG9zdDo3NzAxMw==","companyId":77013,"title":"Wheeler Bio","slug":"wheeler-bio"}}}},{"author":{"title":"Yvonne Duckworth","authorFields":{"bio":"Yvonne Duckworth is a registered Automation Engineer at CRB with 30+ years of experience working in the pharmaceutical and biotech industries. Ms. Duckworth is also an Industry 4.0 thought leader and Subject Matter Expert (SME) providing Digitalization consulting for the Pharma, Biotech, Cell & Gene Therapy and Oligonucleotides industries.
\nMs. Duckworth has spoken at multiple industry events featuring Automation as well as Digitalization. She has written multiple magazine articles featuring Pharma 4.0TM/Industry 4.0. She is a Co-Chair for the Pharma 4.0 Special Interest Group “Holistic Digital Enablement”. In addition, Ms. Duckworth is a key member of the ISPE Pharma 4.0 Leadership Team. She is a key member of the ISPE Workforce of the Future for Automation and Robotics Initiative.
\nMs. Duckworth has a BSEE from Widener University and an MBA from Rider University. She is an active member of ISPE, IEEE, Women in Bio, and ISA.
\n","email":null,"linkedin":"https://www.linkedin.com/in/yvonne-duckworth-pe-609a3317a/","title":"Director of Digital Technology","company":{"id":"cG9zdDo3NjI1Nw==","companyId":76257,"title":"CRB USA","slug":"crb-usa"}}}},{"author":{"title":"Steve Attig","authorFields":{"bio":"Steve Attig is a Chemical Engineer and Bioprocess Specialist at CRB with 25+ years of experience working in the pharmaceutical and biotech industries. Steve has supported capital projects working on both the engineering and client side as a project manager, discipline engineer and Subject Matter Expert in the mRNA, Therapeutic Proteins and Plasma Fractionation life science sectors.
\nSteve is involved in various industry initiatives with ISPE, BPSA and the Biophorum Group and is passionate about bringing his unique skillset to mentor younger engineers on what is means to be a Biopharmaceutical Process Engineer.
\nSteve supported CRB in the opening of their first two European offices living in Switzerland for 4 years. Steve is a recognized expert in front-end feasibility studies and in process-closure analysis. Steve currently lives in Kansas City, Missouri and supports the delivery of projects throughout the world.
\n","email":null,"linkedin":"https://www.linkedin.com/in/steve-attig-81106815/","title":"Bioprocess Engineering Subject Matter Expert","company":{"id":"cG9zdDo3NjI1Nw==","companyId":76257,"title":"CRB USA","slug":"crb-usa"}}}},{"author":{"title":"Patricia Robbins","authorFields":{"bio":"Patricia Robbins is a Project Manager and registered Mechanical Engineer at CRB. She has 15+ years of experience working in the MEP and construction industries. Patricia obtained her Bachelors Degree in General Engineering from the University of Illinois at Champaign/Urbana and her Masters Degree in Mechanical Engineering from the University of Texas at Austin.
\n","email":null,"linkedin":"https://www.linkedin.com/in/patricia-robbins-2321463/","title":"Project Manager","company":{"id":"cG9zdDo3NjI1Nw==","companyId":76257,"title":"CRB USA","slug":"crb-usa"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q3_wheeler2_main.jpg"}},"articleTags":{"nodes":[{"name":"Biomanufacturing","slug":"biomanufacturing"},{"name":"Biomanufacturing Facility","slug":"biomanufacturing-facility"},{"name":"CRB","slug":"crb"},{"name":"Design-Build","slug":"design-build"},{"name":"Digital Plant Maturity Model","slug":"digital-plant-maturity-model"},{"name":"Facility of the Future","slug":"facility-of-the-future"},{"name":"Facility of the Year","slug":"facility-of-the-year"},{"name":"Industry 4.0","slug":"industry-4-0"},{"name":"Pharma 4.0","slug":"pharma-4-0"},{"name":"Q2 2022","slug":"q2-2022"}]}},{"id":"cG9zdDo4NTQ5MQ==","title":"Integrating Cell Line and CMC Development","slug":"articles-integrating-cell-line-and-cmc-development","uri":"/uncategorized/articles-integrating-cell-line-and-cmc-development/","excerpt":"Wheeler Bio hopes to change the paradigm for biologic drug discovery and development by providing open-source manufacturing processes and parallel integration between collaborating service providers to simplifying the pathway between drug discovery and scalable clinical biomanufacturing. More Disruptive Approaches Are Needed in the Pharma Services Industry Innovators of INDs (investigational new drugs) often face uncertainties […]
\n","mainTopic":{"mainTopic":"Cell Line Development"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022-CL-12","authors":[{"author":{"title":"Stephen Hamilton, Ph.D.","authorFields":{"bio":"Dr. Hamilton has over 20 years of industrial and academic research experience delivering on key technical milestones in both small biotech and large pharma environments. He has an extensive track record of leading successful platform and product development projects resulting in numerous regulatory filings and patent awards. Across the span of his career, he co-authored over 25 research articles, including two first author manuscripts in the journal Science. His technical expertise is in protein production, glycobiology and host cell engineering, and his areas of interest are in innovation and technology development around optimized workflows and new product development. He completed his postdoctoral research at Dartmouth Medical School in Hanover, NH. Steve earned a Ph.D. in biochemistry and molecular biology from the University of Leeds, UK, and a B.Sc. in biochemistry from Heriot-Watt University in Edinburgh, UK.
\n","email":null,"linkedin":"https://www.linkedin.com/in/stephenrhamilton/","title":"Chief Technical Officer","company":{"id":"cG9zdDo3NzAxMw==","companyId":77013,"title":"Wheeler Bio","slug":"wheeler-bio"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q3_wheeler3_main.jpg"}},"articleTags":{"nodes":[{"name":"Alloy Therapeutics","slug":"alloy-therapeutics"},{"name":"Cell Line Development","slug":"cell-line-development"},{"name":"CHO","slug":"cho"},{"name":"Clone Selection","slug":"clone-selection"},{"name":"Open-Source Manufacturing","slug":"open-source-manufacturing"},{"name":"Portable CMC","slug":"portable-cmc"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Transposons","slug":"transposons"},{"name":"Wheeler Bio","slug":"wheeler-bio"}]}},{"id":"cG9zdDo4NTQ5OA==","title":"Who’s Left to Acquire in CDMO Biomanufacturing? A Select Few.","slug":"articles-whos-left-to-acquire-in-cdmo-biomanufacturing-a-select-few","uri":"/uncategorized/articles-whos-left-to-acquire-in-cdmo-biomanufacturing-a-select-few/","excerpt":"Publicly funded biotechs have experienced drastic reductions in market value in recent months, while private companies continue to attract financing and are in-licensing technologies and expanding staff. With the slower economy, companies are often expected to drop early-stage projects to focus on more advanced lead candidates. These changes will impact demand for CDMO services beginning […]
\n","mainTopic":{"mainTopic":"Column: M&A"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-12","authors":[{"author":{"title":"Nigel Walker","authorFields":{"bio":"Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.
\n","email":"nigel@thatsnice.com","linkedin":"http://www.linkedin.com/in/walkernigel","title":"Founder and Life Sciences Investor","company":{"id":"cG9zdDo3NjU4Nw==","companyId":76587,"title":"Nice Insight","slug":"nice-insight"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_MA.jpg"}},"articleTags":{"nodes":[{"name":"Biomanufacturing","slug":"biomanufacturing"},{"name":"CDMO","slug":"cdmo"},{"name":"Investment","slug":"investment"},{"name":"Life Science Industrials","slug":"life-science-industrials"},{"name":"M&A","slug":"ma"},{"name":"mRNA Manufacturing","slug":"mrna-manufacturing"},{"name":"Nice Match","slug":"nice-match"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Sterile Fill-Finish Services","slug":"sterile-fill-finish-services"},{"name":"Valuation","slug":"valuation"}]}},{"id":"cG9zdDo4NTUwMg==","title":"New Drug Watch: A Validation of the ‘Twincretin’ Approach to Type 2 Diabetes","slug":"articles-new-drug-watch-a-validation-of-the-twincretin-approach-to-type-2-diabetes","uri":"/uncategorized/articles-new-drug-watch-a-validation-of-the-twincretin-approach-to-type-2-diabetes/","excerpt":"The diabetes market is crowded but no one has nailed it yet — here’s why Eli Lilly’s new drug performs better than the competition. The most buzzed-about drug of Q2 2022 wasn’t a cell and gene therapy, mRNA platform, or CAR-T treatment. Instead of a rare disease being targeted — which has become the standard […]
\n","mainTopic":{"mainTopic":"Column: New Drug Watch"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-08","authors":[{"author":{"title":"David Alvaro, Ph.D.","authorFields":{"bio":"David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That’s Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.
\n","email":null,"linkedin":"https://www.linkedin.com/in/david-alvaro-3305a1165/","title":"Scientific Editor in Chief","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_new_drug.jpg"}},"articleTags":{"nodes":[{"name":"Diabetes","slug":"diabetes"},{"name":"Eli Lily","slug":"eli-lily"},{"name":"FDA Approval","slug":"fda-approval"},{"name":"Mounjaro","slug":"mounjaro"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Twincretin","slug":"twincretin"}]}},{"id":"cG9zdDo4NTQ5NQ==","title":"IPOs Have Not Recovered In 2022. When Will Biotech Bounce Back?","slug":"articles-ipos-have-not-recovered-in-2022-when-will-biotech-bounce-back-1","uri":"/uncategorized/articles-ipos-have-not-recovered-in-2022-when-will-biotech-bounce-back-1/","excerpt":"After a record-breaking year for biotech IPOs, the market slowdown that began in the second half of 2021 is here to stay. 2022 opened on a much cooler market, and the first quarter was the slowest in three years for new stock offerings.1 For young biotechs and their investors, life after the IPO cliff is […]
\n","mainTopic":{"mainTopic":"Column: Investment"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-02","authors":[{"author":{"title":"Danielle Alvarez","authorFields":{"bio":"Danielle is a Scientific Editor at Pharma’s Almanac, responsible for generating and developing scientific original and client-owned content. She also serves as a Project Manager for Nice Insight’s promotional and multimedia initiatives, including Pharma’s Almanac TV and other upcoming ventures. Before joining Nice Insight, Danielle worked in digital marketing in the biotech industry. She holds a BS in biology from Brown University.
\n","email":null,"linkedin":"https://www.linkedin.com/in/daniellebalvarez/","title":"Associate Scientific Editor","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_IPO2.jpg"}},"articleTags":{"nodes":[{"name":"Biotechs","slug":"biotechs"},{"name":"Investment","slug":"investment"},{"name":"IPO","slug":"ipo"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Valuation","slug":"valuation"}]}},{"id":"cG9zdDo4NTQ4OQ==","title":"The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative","slug":"articles-the-price-of-pain-acknowledging-a-crisis-and-encouraging-an-alternative","uri":"/uncategorized/articles-the-price-of-pain-acknowledging-a-crisis-and-encouraging-an-alternative/","excerpt":"Pain is nearly ubiquitous in the United States. According to a 2016 National Health Interview Survey featured by the CDC, one in five Americans — 50 million people — suffer from chronic pain. For 8% (19.6 million Americans) of chronic pain sufferers, this pain is so debilitating that it interferes with their daily lives.1 Groups […]
\n","mainTopic":{"mainTopic":"Column: Regulatory Spotlight"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-05","authors":[{"author":{"title":"David Alvaro, Ph.D.","authorFields":{"bio":"David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That’s Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.
\n","email":null,"linkedin":"https://www.linkedin.com/in/david-alvaro-3305a1165/","title":"Scientific Editor in Chief","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_pain.jpg"}},"articleTags":{"nodes":[{"name":"Analgesics","slug":"analgesics"},{"name":"FDA","slug":"fda"},{"name":"FDA Guidance","slug":"fda-guidance"},{"name":"Opioid Epidemic","slug":"opioid-epidemic"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Regulatory","slug":"regulatory"}]}},{"id":"cG9zdDo4NTQ5OQ==","title":"Digital Frontiers: What NFTs Can Do for Pharma","slug":"articles-digital-frontiers-what-nfts-can-do-for-pharma","uri":"/uncategorized/articles-digital-frontiers-what-nfts-can-do-for-pharma/","excerpt":"2021 was the year that non-fungible tokens, or NFTs, received widespread attention on the internet and entered the corporate world in a significant way. Now, these crypto assets and the blockchain technology that makes them possible may have major real-world applications for supply chain GMP, patient data management, and the future of pharma. An Overview […]
\n","mainTopic":{"mainTopic":"NFTs"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-01","authors":[{"author":{"title":"Danielle Alvarez","authorFields":{"bio":"Danielle is a Scientific Editor at Pharma’s Almanac, responsible for generating and developing scientific original and client-owned content. She also serves as a Project Manager for Nice Insight’s promotional and multimedia initiatives, including Pharma’s Almanac TV and other upcoming ventures. Before joining Nice Insight, Danielle worked in digital marketing in the biotech industry. She holds a BS in biology from Brown University.
\n","email":null,"linkedin":"https://www.linkedin.com/in/daniellebalvarez/","title":"Associate Scientific Editor","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_nft.jpg"}},"articleTags":{"nodes":[{"name":"Blockchain","slug":"blockchain"},{"name":"Marketing","slug":"marketing"},{"name":"NFT","slug":"nft"},{"name":"Pharma","slug":"pharma"},{"name":"Q2 2022","slug":"q2-2022"}]}},{"id":"cG9zdDo4NTQ5Mw==","title":"Creating a More Resilient Pharmaceutical Supply Chain One Segment at a Time","slug":"articles-creating-a-more-resilient-pharmaceutical-supply-chain-one-segment-at-a-time","uri":"/uncategorized/articles-creating-a-more-resilient-pharmaceutical-supply-chain-one-segment-at-a-time/","excerpt":"Weaknesses within the highly complex and global pharmaceutical supply chain are not a new topic. However, the many conferences, working groups, and regulatory body discussions have led to minimal foundational change. Then, the COVID-19 pandemic made pharmaceutical supply chain vulnerabilities impossible to ignore, and much work has been done across many public and private organizations […]
\n","mainTopic":{"mainTopic":"Column: Supply Chain"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-09","authors":[{"author":{"title":"Tonia Becker","authorFields":{"bio":"Tonia has nearly 30 years of expertise in content creation, strategic branding, marketing communications, and audience development. She has worked with market leaders in various industries but has been deeply entrenched in the pharmaceutical and healthcare industries for the last 15 years. She spent much of her career in B2B publishing and particularly enjoyed leading Pharmaceutical Manufacturing website and magazine as its publisher for over seven years. Tonia has a B.S. in Journalism from Ohio University’s E.W. Scripps School of Journalism.
\n","email":null,"linkedin":"https://www.linkedin.com/in/toniabecker/","title":"Strategy Director","company":{"id":"cG9zdDo3NjU4Nw==","companyId":76587,"title":"Nice Insight","slug":"nice-insight"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_supply_chain.jpg"}},"articleTags":{"nodes":[{"name":"COVID-19 Impacts","slug":"covid-19-impacts"},{"name":"Domestic Sourcing","slug":"domestic-sourcing"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Regulatory","slug":"regulatory"},{"name":"Reshoring","slug":"reshoring"},{"name":"Sourcing","slug":"sourcing"},{"name":"Supply Chain","slug":"supply-chain"}]}},{"id":"cG9zdDo4NTQ5Mg==","title":"Mental Health During a Global Pandemic","slug":"articles-mental-health-during-a-global-pandemic","uri":"/uncategorized/articles-mental-health-during-a-global-pandemic/","excerpt":"With more and more countries lifting their COVID restrictions and trying to return to a version of normal similar to what existed before a series of lockdowns, we want to explore a topic that is not being talked about enough even two years after the start of COVID-19: the overall state and impact of the […]
\n","mainTopic":{"mainTopic":"Mental Health"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-03","authors":[{"author":{"title":"Marc Technow","authorFields":{"bio":"Marc has been a long-time friend of Pharma’s Almanac and has helped on numerous projects, such as editing texts and contributing to several strategic and journalistic articles. Marc has over seven years of experience in communications and holds a Master’s Degree in Arts from the University of Fresenius. He resides in Cologne, Germany.
\n","email":null,"linkedin":"https://www.linkedin.com/in/marc-technow-24372b158/","title":"Contributor","company":{"id":"cG9zdDo3NjU4Nw==","companyId":76587,"title":"Nice Insight","slug":"nice-insight"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_mental_health.jpg"}},"articleTags":{"nodes":[{"name":"COVID-19","slug":"covid-19"},{"name":"COVID-19 Impacts","slug":"covid-19-impacts"},{"name":"Mental Health","slug":"mental-health"},{"name":"Q2 2022","slug":"q2-2022"}]}},{"id":"cG9zdDo4NTQ5Nw==","title":"10 More Biotechs Making Moves in 2022","slug":"articles-10-more-biotechs-making-moves-in-2022","uri":"/uncategorized/articles-10-more-biotechs-making-moves-in-2022/","excerpt":"The biotech market is competitive and constantly evolving, and the next breakthrough could emerge at any moment. We’ve rounded up the technology that’s positioned to change the way diseases with a high unmet need are identified and treated — from innovative approaches to curing cancer to an assay that can scan for 7,000 proteins, as […]
\n","mainTopic":{"mainTopic":"Biotechs"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-07","authors":[{"author":{"title":"David Alvaro, Ph.D.","authorFields":{"bio":"David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That’s Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.
\n","email":null,"linkedin":"https://www.linkedin.com/in/david-alvaro-3305a1165/","title":"Scientific Editor in Chief","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}},{"author":{"title":"Danielle Alvarez","authorFields":{"bio":"Danielle is a Scientific Editor at Pharma’s Almanac, responsible for generating and developing scientific original and client-owned content. She also serves as a Project Manager for Nice Insight’s promotional and multimedia initiatives, including Pharma’s Almanac TV and other upcoming ventures. Before joining Nice Insight, Danielle worked in digital marketing in the biotech industry. She holds a BS in biology from Brown University.
\n","email":null,"linkedin":"https://www.linkedin.com/in/daniellebalvarez/","title":"Associate Scientific Editor","company":{"id":"cG9zdDo3NzEwNA==","companyId":77104,"title":"Pharma’s Almanac","slug":"pharmas-almanac"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_biotech.jpg"}},"articleTags":{"nodes":[{"name":"Adagio Therapeutics","slug":"adagio-therapeutics"},{"name":"Arcellx","slug":"arcellx"},{"name":"Armata Pharmaceuticals","slug":"armata-pharmaceuticals"},{"name":"Biotech","slug":"biotech"},{"name":"Blue Water Vaccines","slug":"blue-water-vaccines"},{"name":"Caribou Biosciences","slug":"caribou-biosciences"},{"name":"CinCor Pharma","slug":"cincor-pharma"},{"name":"Eikon Therapeutics","slug":"eikon-therapeutics"},{"name":"Erasca","slug":"erasca"},{"name":"Medgene Labs","slug":"medgene-labs"}]}}]}}},"dataMA":{"articleTag":{"name":"M&A","posts":{"nodes":[{"title":"Sartorius to Acquire Albumedix, Creating a Powerhouse for Innovative Advanced Therapy Solutions","slug":"articles-sartorius-to-acquire-albumedix-creating-a-powerhouse-for-innovative-advanced-therapy-solutions","uri":"/uncategorized/articles-sartorius-to-acquire-albumedix-creating-a-powerhouse-for-innovative-advanced-therapy-solutions/","excerpt":"Through its combined forces, Sartorius and Albumedix will accelerate the availability of critical components for the manufacture of advanced therapies and next-generation biopharmaceuticals, globally. The Albumedix Campus in Nottingham, UK will be established as a bio-innovation and cGMP-compliant manufacturing Centre of Excellence in Sartorius. Life science group Sartorius will acquire all outstanding shares in Albumedix Ltd. for […]
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\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner2.gif"}},"mainTopic":{"mainTopic":"Audit Service Merger"},"articleFields":{"articleId":"PR-M07-22-01","authors":[{"author":{"title":"Nice Insight"}}]},"articleTags":{"edges":[{"node":{"name":"Forum Auditorias","slug":"forum-auditorias","id":"dGVybToxMzA1MA=="}},{"node":{"name":"GMP Auditing","slug":"gmp-auditing","id":"dGVybToxMjc2NQ=="}},{"node":{"name":"M&A","slug":"ma","id":"dGVybTo5MDM2"}},{"node":{"name":"Nice Match","slug":"nice-match","id":"dGVybToxMDg1Ng=="}},{"node":{"name":"Press Releases","slug":"press-releases","id":"dGVybTo5NDg5"}},{"node":{"name":"Regulatory Compliance","slug":"regulatory-compliance","id":"dGVybToxMjEwNA=="}},{"node":{"name":"Rephine Ltd","slug":"rephine-ltd","id":"dGVybToxMjc0Nw=="}},{"node":{"name":"Supply Chain","slug":"supply-chain","id":"dGVybTo4OTg5"}},{"node":{"name":"TDV","slug":"tdv","id":"dGVybToxMzA1NA=="}}]}},{"title":"ProductLife Group Strengthens Foothold in Northern Europe with Pharma IT Acquisition","slug":"articles-productlife-group-strengthens-foothold-in-northern-europe-with-pharma-it-acquisition","uri":"/uncategorized/articles-productlife-group-strengthens-foothold-in-northern-europe-with-pharma-it-acquisition/","excerpt":"Following the recent acquisition of Quoretex in May 2022, ProductLife Group (PLG), a global leader in regulatory and compliance services for the life sciences industry, expands its service offering by acquiring Pharma IT. The acquisition of Pharma IT will enable PLG to strengthen its foothold in Northern Europe and offer new services in the context […]
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\n","mainTopic":{"mainTopic":"M&A"},"articleFields":{"vimeoId":null,"articleId":"PR-M06-22-08","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner2.gif"}},"articleTags":{"nodes":[{"name":"Consulting","slug":"consulting"},{"name":"M&A","slug":"ma"},{"name":"Nice Match","slug":"nice-match"},{"name":"Pharma IT","slug":"pharma-it"},{"name":"Press Releases","slug":"press-releases"},{"name":"ProductLife Group","slug":"productlife-group"},{"name":"Regulatory Compliance","slug":"regulatory-compliance"}]}},{"id":"cG9zdDo4NTQ5OA==","title":"Who’s Left to Acquire in CDMO Biomanufacturing? A Select Few.","slug":"articles-whos-left-to-acquire-in-cdmo-biomanufacturing-a-select-few","uri":"/uncategorized/articles-whos-left-to-acquire-in-cdmo-biomanufacturing-a-select-few/","excerpt":"Publicly funded biotechs have experienced drastic reductions in market value in recent months, while private companies continue to attract financing and are in-licensing technologies and expanding staff. With the slower economy, companies are often expected to drop early-stage projects to focus on more advanced lead candidates. These changes will impact demand for CDMO services beginning […]
\n","mainTopic":{"mainTopic":"Column: M&A"},"articleFields":{"vimeoId":null,"articleId":"PAO-06-022--NI-12","authors":[{"author":{"title":"Nigel Walker","authorFields":{"bio":"Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.
\n","email":"nigel@thatsnice.com","linkedin":"http://www.linkedin.com/in/walkernigel","title":"Founder and Life Sciences Investor","company":{"id":"cG9zdDo3NjU4Nw==","companyId":76587,"title":"Nice Insight","slug":"nice-insight"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_MA.jpg"}},"articleTags":{"nodes":[{"name":"Biomanufacturing","slug":"biomanufacturing"},{"name":"CDMO","slug":"cdmo"},{"name":"Investment","slug":"investment"},{"name":"Life Science Industrials","slug":"life-science-industrials"},{"name":"M&A","slug":"ma"},{"name":"mRNA Manufacturing","slug":"mrna-manufacturing"},{"name":"Nice Match","slug":"nice-match"},{"name":"Q2 2022","slug":"q2-2022"},{"name":"Sterile Fill-Finish Services","slug":"sterile-fill-finish-services"},{"name":"Valuation","slug":"valuation"}]}},{"id":"cG9zdDo4NTU1OQ==","title":"Growing a Forward-Thinking CDMO","slug":"articles-growing-a-forward-thinking-cdmo","uri":"/pa-tv/articles-growing-a-forward-thinking-cdmo/","excerpt":"On another Road to 50 States visit, Hank Nowak, Executive Director and Head of Global Business Development and Marketing at CoreRx, talks to Nigel about how the financial support from NovaQuest Capital Management’s acquisition of CoreRx has helped the company continue to grow and invest from 2021 into 2022.
\n","mainTopic":{"mainTopic":"M&A"},"articleFields":{"vimeoId":"696665991","articleId":"PAO-04-22-R250-78","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/1409044485-f9c203c3063ffafba29f44ba7d35513d59a452d8516d5afbdc4d9fa5519ad944-d_640.jpeg"}},"articleTags":{"nodes":[{"name":"CoreRx","slug":"corerx"},{"name":"M&A","slug":"ma"},{"name":"NovaQuest Capital Management","slug":"novaquest-capital-management"},{"name":"PA TV","slug":"pa-tv"},{"name":"Strategic Growth","slug":"strategic-growth"},{"name":"The Road to 50 States","slug":"the-road-to-50-states"}]}},{"id":"cG9zdDo4NTYxMA==","title":"Novo Holdings Portfolio Company ReViral to be Acquired by Pfizer","slug":"articles-novo-holdings-portfolio-company-reviral-to-be-acquired-by-pfizer","uri":"/uncategorized/articles-novo-holdings-portfolio-company-reviral-to-be-acquired-by-pfizer/","excerpt":"Deal value of up to US$525 million Novo Holdings co-led ReViral Series B financing in 2018 ReViral developing novel antiviral therapies to treat RSV infections Validation of Novo Holdings’ strategy to identify and invest in high quality European biotech opportunities COPENHAGEN, Denmark – Novo Holdings A/S, a leading international life sciences investor, today announces that its portfolio […]
\n","mainTopic":{"mainTopic":"M&A"},"articleFields":{"vimeoId":null,"articleId":"PR-M04-22-05","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner2.gif"}},"articleTags":{"nodes":[{"name":"Acquisition","slug":"acquisition"},{"name":"Antiviral","slug":"antiviral"},{"name":"M&A","slug":"ma"},{"name":"Nice Match","slug":"nice-match"},{"name":"Novo Holdings","slug":"novo-holdings"},{"name":"Novo Nordisk","slug":"novo-nordisk"},{"name":"Pfizer Inc.","slug":"pfizer-inc"},{"name":"Press Releases","slug":"press-releases"},{"name":"ReViral","slug":"reviral"},{"name":"RSV","slug":"rsv"}]}},{"id":"cG9zdDo4NTY0MQ==","title":"Incannex to Acquire APIRx Pharmaceuticals USA, LLC","slug":"articles-incannex-to-acquire-apirx-pharmaceuticals-usa-llc","uri":"/uncategorized/articles-incannex-to-acquire-apirx-pharmaceuticals-usa-llc/","excerpt":"APIRx has twenty-two (22) active clinical and pre-clinical research and development projects therapeutic candidates are targeted at treating pain, dementia, Parkinson’s disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions therapeutic candidates are underpinned by an extensive intellectual property portfolio that includes 19 granted patents and 23 pending patents proposed […]
\n","mainTopic":{"mainTopic":"M&A"},"articleFields":{"vimeoId":null,"articleId":"PR-M03-22-12","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner7.gif"}},"articleTags":{"nodes":[{"name":"APIRx Pharmaceuticals","slug":"apirx-pharmaceuticals"},{"name":"Cannabis","slug":"cannabis"},{"name":"Clinical Research","slug":"clinical-research"},{"name":"Incannex","slug":"incannex"},{"name":"M&A","slug":"ma"},{"name":"Nice Match","slug":"nice-match"},{"name":"Preclinical R&D","slug":"preclinical-rd"},{"name":"Press Releases","slug":"press-releases"}]}},{"id":"cG9zdDo4NTYyOQ==","title":"Why the Big Shifts in Gene Therapy Investments? It’s Late in the Game","slug":"articles-why-the-big-shifts-in-gene-therapy-investments-its-late-in-the-game","uri":"/uncategorized/articles-why-the-big-shifts-in-gene-therapy-investments-its-late-in-the-game/","excerpt":"For everyone, entering the market late carries a price. Biopharma market dynamics have shifted focus from fermentation and cell culture to plasmids and viral vectors. There are few assets to buy, and only large-cap private equity (PE) firms and strategic buyers can afford the outlandishly high multiples they come with. Big CDMOs are electing to […]
\n","mainTopic":{"mainTopic":"Column: M&A"},"articleFields":{"vimeoId":null,"articleId":"PAO-03-022-NI-08","authors":[{"author":{"title":"Nigel Walker","authorFields":{"bio":"Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.
\n","email":"nigel@thatsnice.com","linkedin":"http://www.linkedin.com/in/walkernigel","title":"Founder and Life Sciences Investor","company":{"id":"cG9zdDo3NjU4Nw==","companyId":76587,"title":"Nice Insight","slug":"nice-insight"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PA_Q122_MandA_banner-scaled.jpg"}},"articleTags":{"nodes":[{"name":"Build or Buy","slug":"build-or-buy"},{"name":"Cell and Gene Therapy","slug":"cell-and-gene-therapy"},{"name":"Gene Therapies","slug":"gene-therapies"},{"name":"Gene Therapy","slug":"gene-therapy"},{"name":"M&A","slug":"ma"},{"name":"Nice Insight","slug":"nice-insight"},{"name":"Nice Match","slug":"nice-match"},{"name":"Q1 2022","slug":"q1-2022"}]}},{"id":"cG9zdDo4NTY4Mg==","title":"Ginkgo Bioworks Signs Definitive Agreement to Acquire FGen AG, a Leading Bioengineering Company and Its Proprietary Ultra-High-Throughput Screening Platform","slug":"articles-ginkgo-bioworks-signs-definitive-agreement-to-acquire-fgen-ag-a-leading-bioengineering-company-and-its-proprietary-ultra-high-throughput-screening-platform","uri":"/uncategorized/articles-ginkgo-bioworks-signs-definitive-agreement-to-acquire-fgen-ag-a-leading-bioengineering-company-and-its-proprietary-ultra-high-throughput-screening-platform/","excerpt":"BOSTON and BASEL, Switzerland – Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the entry into a definitive agreement to acquire FGen AG (“FGen”), a Swiss company specializing in strain development and optimization. FGen has developed an ultra-high-throughput (uHT) screening platform built on nanoliter reactor technology. Ginkgo believes that FGen’s technology will significantly enhance […]
\n","mainTopic":{"mainTopic":"M&A"},"articleFields":{"vimeoId":null,"articleId":"PR-M03-22-05","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner4.gif"}},"articleTags":{"nodes":[{"name":"Cell and Gene Therapy","slug":"cell-and-gene-therapy"},{"name":"CRO","slug":"cro"},{"name":"FGen AG","slug":"fgen-ag"},{"name":"Ginkgo Bioworks","slug":"ginkgo-bioworks"},{"name":"High-Throughput Screening","slug":"high-throughput-screening"},{"name":"M&A","slug":"ma"},{"name":"Nice Match","slug":"nice-match"},{"name":"Platform Technology","slug":"platform-technology"},{"name":"Press Releases","slug":"press-releases"}]}},{"id":"cG9zdDo4NTcxNA==","title":"Vibalogics Acquired by Top Global CDMO Recipharm AB","slug":"articles-vibalogics-acquired-by-top-global-cdmo-recipharm-ab","uri":"/uncategorized/articles-vibalogics-acquired-by-top-global-cdmo-recipharm-ab/","excerpt":"Boxborough, MA – Vibalogics, a contract development and manufacturing organization (CDMO), and an Ampersand Capital Partners portfolio company, focused on the manufacture of oncolytic viruses, viral vaccines and gene therapies, has today announced that it will be acquired by top global CDMO Recipharm AB (Stockholm, Sweden). The acquisition comes as part of a series of […]
\n","mainTopic":{"mainTopic":"CDMO Acquisition"},"articleFields":{"vimeoId":null,"articleId":"PR-M02-22-18","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner2.gif"}},"articleTags":{"nodes":[{"name":"Ampersand Capital Partners","slug":"ampersand-capital-partners"},{"name":"CDMO","slug":"cdmo"},{"name":"M&A","slug":"ma"},{"name":"Nice Match","slug":"nice-match"},{"name":"Oncolytic Viruses","slug":"oncolytic-viruses"},{"name":"Press Releases","slug":"press-releases"},{"name":"Recipharm","slug":"recipharm"},{"name":"Vibalogics","slug":"vibalogics"},{"name":"Viral Vaccines","slug":"viral-vaccines"}]}},{"id":"cG9zdDo4NTcyNg==","title":"Recipharm Acquires Arranta Bio, a CDMO Leader in Advanced Therapy Medicinal Products (ATMPs), to Expand its Biologics Offering in the U.S.","slug":"articles-recipharm-acquires-arranta-bio-a-cdmo-leader-in-advanced-therapy-medicinal-products-atmps-to-expand-its-biologics-offering-in-the-u-s","uri":"/uncategorized/articles-recipharm-acquires-arranta-bio-a-cdmo-leader-in-advanced-therapy-medicinal-products-atmps-to-expand-its-biologics-offering-in-the-u-s/","excerpt":"Stockholm, SWEDEN – Recipharm, a leading global contract development and manufacturing organization (CDMO), today announced the acquisition of Arranta Bio, a prominent advanced therapy CDMO. Under the stewardship of Mark Bamforth and backed by Ampersand Capital Partners, the company has established a strong service portfolio as a leader in delivering microbiome therapeutic products and mRNA […]
\n","mainTopic":{"mainTopic":"CDMO Acquisition"},"articleFields":{"vimeoId":null,"articleId":"PR-M02-22-17","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PR_Banner2.gif"}},"articleTags":{"nodes":[{"name":"Arranta Bio","slug":"arranta-bio"},{"name":"Biologics","slug":"biologics"},{"name":"CDMO","slug":"cdmo"},{"name":"M&A","slug":"ma"},{"name":"mRNA Manufacturing","slug":"mrna-manufacturing"},{"name":"Nice Match","slug":"nice-match"},{"name":"Press Releases","slug":"press-releases"},{"name":"Recipharm","slug":"recipharm"}]}},{"id":"cG9zdDo4NTcyNw==","title":"Integrating Services Across the Full Spectrum of Cell and Gene Therapy","slug":"articles-integrating-services-across-the-full-spectrum-of-cell-and-gene-therapy","uri":"/pa-tv/articles-integrating-services-across-the-full-spectrum-of-cell-and-gene-therapy/","excerpt":"On the Road to 50 States, Jennifer Chadwick, Vice President of Analytical Development at BioAnalytix (now ProtaGene), talks to Nigel about how the merger of the companies allows them to perform an integrated service function across the full spectrum of what’s needed for gene and cell therapy development.
\n","mainTopic":{"mainTopic":"Mergers and Acquisitions"},"articleFields":{"vimeoId":"674473427","articleId":"PAO-02-22-R250-10","authors":[{"author":{"title":"Nice Insight","authorFields":{"bio":"Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research – Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
\n","email":null,"linkedin":null,"title":null,"company":{"id":"cG9zdDo3Njc5MQ==","companyId":76791,"title":"Snapdragon Chemistry, Inc.","slug":"snapdragon-chemistry-inc"}}}}]},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/Roadto50_Thumbnail_ProtaGene.jpeg"}},"articleTags":{"nodes":[{"name":"BioAnalytix, Inc.","slug":"bioanalytix-inc"},{"name":"Capacity Expansion","slug":"capacity-expansion"},{"name":"Cell and Gene Therapy","slug":"cell-and-gene-therapy"},{"name":"CRO","slug":"cro"},{"name":"Data Analytics","slug":"data-analytics"},{"name":"GeneWerk GmbH","slug":"genewerk-gmbh"},{"name":"M&A","slug":"ma"},{"name":"PA TV","slug":"pa-tv"},{"name":"ProtaGene","slug":"protagene"},{"name":"The Road to 50 States","slug":"the-road-to-50-states"}]}}]}}},"columnSliderClinical":{"articleTag":{"name":"Clinical Trials","posts":{"nodes":[{"title":"Managing the Complexities of International Clinical Trials","slug":"articles-managing-the-complexities-of-international-clinical-trials-1","uri":"/uncategorized/articles-managing-the-complexities-of-international-clinical-trials-1/","excerpt":"The number and complexity of clinical trials is increasing dramatically. While trials tend to enroll fewer patients, those patients are often in remote locations and increasingly prefer to be treated in the home rather than at an investigator site. In addition, the drugs being evaluated often have complicated storage, handling and transportation requirements. Sponsor companies […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PA_Q319_Yourway.jpg"}},"mainTopic":{"mainTopic":"Worldwide Clinical Trials"},"articleFields":{"articleId":"PAP-Q3-19-CL-037","authors":[{"author":{"title":"Gulam Jaffer"}}]},"articleTags":{"edges":[{"node":{"name":"Clinical Supply Chain","slug":"clinical-supply-chain","id":"dGVybToxMTMyOQ=="}},{"node":{"name":"Clinical Trials","slug":"clinical-trials","id":"dGVybTo5MDI0"}},{"node":{"name":"International","slug":"international","id":"dGVybToxMTczMQ=="}},{"node":{"name":"Q3 2019","slug":"q3-2019","id":"dGVybToxMTc2MQ=="}},{"node":{"name":"Supply Chain","slug":"supply-chain","id":"dGVybTo4OTg5"}},{"node":{"name":"Worldwide Clinical Trials","slug":"worldwide-clinical-trials","id":"dGVybTo5OTU4"}},{"node":{"name":"Yourway","slug":"yourway","id":"dGVybToxMTIzMQ=="}}]}},{"title":"CAR-T Study Shines New Spotlight on Clinical Trials Representation","slug":"articles-car-t-study-shines-new-spotlight-on-clinical-trials-representation","uri":"/uncategorized/articles-car-t-study-shines-new-spotlight-on-clinical-trials-representation/","excerpt":"A study published by researchers at the University of Arkansas for Medical Sciences has caused quite a stir, reminding regulators and the public that, even in clinical studies for such cutting-edge therapeutics, the industry continues to struggle with achieving the goal of making clinical trials representative for all prospective patient demographic groups. Examining Black Representation […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_cinical_trials.jpg"}},"mainTopic":{"mainTopic":"Column: Clinical Trials"},"articleFields":{"articleId":"PAO-06-022--NI-06","authors":[{"author":{"title":"David Alvaro, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"CAR-T","slug":"car-t","id":"dGVybTo5NTQy"}},{"node":{"name":"Cell Therapy","slug":"cell-therapy","id":"dGVybToxMDE5NQ=="}},{"node":{"name":"Clinical Trials","slug":"clinical-trials","id":"dGVybTo5MDI0"}},{"node":{"name":"Diversity","slug":"diversity","id":"dGVybToxMTgzMQ=="}},{"node":{"name":"FDA Approval","slug":"fda-approval","id":"dGVybTo5MzIx"}},{"node":{"name":"Features","slug":"features","id":"dGVybTo5MTQ1"}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Representation","slug":"representation","id":"dGVybToxMzAxMw=="}}]}},{"title":"Real-World Data and Artificial Intelligence are Transforming Clinical Development","slug":"articles-real-world-data-and-artificial-intelligence-are-transforming-clinical-development","uri":"/uncategorized/articles-real-world-data-and-artificial-intelligence-are-transforming-clinical-development/","excerpt":"Among many advances in drug development and healthcare that were proceeding slowly only to be significantly boosted to overcome the novel challenges caused by the COVID-19 pandemic is the use of real-world data (RWD) and artificial intelligence (AI) solutions in clinical development. In this extended Q&A, Jeff Elton, Ph.D., Chief Executive Officer of ConcertAI, and […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_concertAI_main.jpg"}},"mainTopic":{"mainTopic":"Real-World Data"},"articleFields":{"articleId":"PAO-06-022-CL-09","authors":[{"author":{"title":"Jeff Elton, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"Artificial Intelligence","slug":"artificial-intelligence","id":"dGVybTo5NzM3"}},{"node":{"name":"Clinical Development","slug":"clinical-development","id":"dGVybTo5MDc2"}},{"node":{"name":"Clinical Trials","slug":"clinical-trials","id":"dGVybTo5MDI0"}},{"node":{"name":"ConcertAI","slug":"concertai","id":"dGVybToxMjYzMA=="}},{"node":{"name":"Machine Learning","slug":"machine-learning","id":"dGVybToxMTI3MQ=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Real World Data","slug":"real-world-data","id":"dGVybToxMDg4Nw=="}}]}},{"title":"The Future of Decentralized Trials","slug":"articles-the-future-of-decentralized-trials","uri":"/pa-tv/articles-the-future-of-decentralized-trials/","excerpt":"On the Road to 50 States, Eliana Burke, Executive Director of CRO Partnerships at ObvioHealth, talks to Nigel about the impacts of the pandemic on clinical trials and why a decentralized model is the future.
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/1404522761-28d278a2f52322e2bf591819518cca47e998e4eddd601b0b6afc595e4a77e8ad-d_640.jpeg"}},"mainTopic":{"mainTopic":"Decentralized Clinical Trials"},"articleFields":{"articleId":"PAO-04-22-R250-15","authors":[{"author":{"title":"Nice Insight"}}]},"articleTags":{"edges":[{"node":{"name":"Clinical Trials","slug":"clinical-trials","id":"dGVybTo5MDI0"}},{"node":{"name":"COVID-19 Impacts","slug":"covid-19-impacts","id":"dGVybToxMjQzNw=="}},{"node":{"name":"Decentralized Trials","slug":"decentralized-trials","id":"dGVybToxMjIwMA=="}},{"node":{"name":"ObvioHealth","slug":"obviohealth","id":"dGVybToxMjg4Mw=="}},{"node":{"name":"PA TV","slug":"pa-tv","id":"dGVybTo5MTg5"}},{"node":{"name":"The Road to 50 States","slug":"the-road-to-50-states","id":"dGVybToxMjUxOA=="}}]}},{"title":"How Artificial Intelligence May Drive the Future of Clinical Trials","slug":"articles-how-artificial-intelligence-may-drive-the-future-of-clinical-trials","uri":"/uncategorized/articles-how-artificial-intelligence-may-drive-the-future-of-clinical-trials/","excerpt":"Bringing a drug to market is no easy feat, and that’s putting it mildly. Traditional clinical trials are lengthy — taking nearly ten years on average,1 expensive — with an average cost of around $1 billion,1 and inefficient — with around a 10% success rate.1 Despite the level of scientific skill exhibited by some of […]
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\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PA_Q421_RoosterBio_Banner_4.jpg"}},"mainTopic":{"mainTopic":"Mesenchymal Stem Cells"},"articleFields":{"articleId":"PAO-12-21-NI-01","authors":[{"author":{"title":"David Alvaro, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"Cell Therapy","slug":"cell-therapy","id":"dGVybToxMDE5NQ=="}},{"node":{"name":"Clinical Trials","slug":"clinical-trials","id":"dGVybTo5MDI0"}},{"node":{"name":"Features","slug":"features","id":"dGVybTo5MTQ1"}},{"node":{"name":"hMSC","slug":"hmsc","id":"dGVybToxMjYxOQ=="}},{"node":{"name":"Mesenchymal Stem Cells","slug":"mesenchymal-stem-cells","id":"dGVybToxMjQ5Mg=="}},{"node":{"name":"MSCs","slug":"mscs","id":"dGVybToxMjQ4Mw=="}},{"node":{"name":"Q1 2022","slug":"q1-2022","id":"dGVybToxMjc0OA=="}},{"node":{"name":"RoosterBio","slug":"roosterbio","id":"dGVybToxMjQ5Ng=="}},{"node":{"name":"Tissue Engineering","slug":"tissue-engineering","id":"dGVybTo5NjE2"}}]}},{"title":"Rare Disease Patients Benefit from Clinical Trial Flexibility","slug":"articles-rare-disease-patients-benefit-from-clinical-trial-flexibility","uri":"/uncategorized/articles-rare-disease-patients-benefit-from-clinical-trial-flexibility/","excerpt":"A convergence of trends — including the continuously growing focus on drug development for rare diseases, the rising percentage of biologic drug candidates, and the expansion of decentralized trials — is creating opportunities for more efficient trials that are less burdensome for patients and their families. With a limited number of rare disease patients, clinically […]
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\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/PA_Q122_PPD_184.jpg"}},"mainTopic":{"mainTopic":"Women's Health"},"articleFields":{"articleId":"PAO-02-022-CL-17","authors":[{"author":{"title":"Rose Blackburne, M.D., MBA"}},{"author":{"title":"John M. Manns"}},{"author":{"title":"Davide Garrisi, D.Ph.C."}}]},"articleTags":{"edges":[{"node":{"name":"Clinical Research","slug":"clinical-research","id":"dGVybTo5NjY1"}},{"node":{"name":"Clinical Trials","slug":"clinical-trials","id":"dGVybTo5MDI0"}},{"node":{"name":"Decentralized Trials","slug":"decentralized-trials","id":"dGVybToxMjIwMA=="}},{"node":{"name":"Digitalization","slug":"digitalization","id":"dGVybToxMjA5NQ=="}},{"node":{"name":"Gender Gap","slug":"gender-gap","id":"dGVybToxMjc2MQ=="}},{"node":{"name":"PPD","slug":"ppd","id":"dGVybTo5NjQ3"}},{"node":{"name":"Q1 2022","slug":"q1-2022","id":"dGVybToxMjc0OA=="}},{"node":{"name":"Recruitment","slug":"recruitment","id":"dGVybTo5MjQx"}},{"node":{"name":"Women's Health","slug":"womens-health","id":"dGVybToxMDQzMA=="}}]}},{"title":"Expanding a Full-Service CRO Offering into the United States","slug":"articles-expanding-a-full-service-cro-offering-into-the-united-states","uri":"/pa-tv/articles-expanding-a-full-service-cro-offering-into-the-united-states/","excerpt":"On Pharma’s Almanac‘s Road to 50 States road trip campaign, Alex Fetkovsky, Chief Executive Officer at SanaClis, met with Nigel and the team to talk about the need for joint collaboration in the industry and how SanaClis is looking to expand their business to the U.S. market.
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\n","mainTopic":{"mainTopic":"Worldwide Clinical Trials"},"articleFields":{"vimeoId":null,"articleId":"PAP-Q3-19-CL-037","authors":[{"author":{"title":"Gulam Jaffer","authorFields":{"bio":"Gulam Jaffer is President of Yourway, an integrated biopharmaceutical supply chain solutions provider offering a full range of primary and secondary clinical packaging, comparator sourcing, logistics, storage and distribution services for the global pharmaceutical and biotech industries. Headquartered in Allentown, Pennsylvania, with additional strategic locations worldwide, Yourway specializes in time- and temperature sensitive clinical drug product and biological sample shipments. Yourway is a flexible and reliable logistics partner committed to the safe, efficient and on-time delivery of clients’ high-value, high-priority clinical materials.
\nFor more information on Yourway, view the Company Profile.
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\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q3_MSGM2_main_2.jpg"}},"mainTopic":{"mainTopic":"Lipid Excipients"},"articleFields":{"articleId":"PAO-07-022-CL-04","authors":[{"author":{"title":"Claudia Widmann"}}]},"articleTags":{"edges":[{"node":{"name":"Excipients","slug":"excipients","id":"dGVybTo4OTky"}},{"node":{"name":"Formulation","slug":"formulation","id":"dGVybTo4OTg4"}},{"node":{"name":"Lipid Excipients","slug":"lipid-excipients","id":"dGVybToxMzA0NA=="}},{"node":{"name":"Lipid Nanoparticles","slug":"lipid-nanoparticles","id":"dGVybToxMjQ2OA=="}},{"node":{"name":"MilliporeSigma","slug":"milliporesigma","id":"dGVybTo5MzEy"}},{"node":{"name":"mRNA","slug":"mrna","id":"dGVybToxMTIxMQ=="}},{"node":{"name":"Q3 2022","slug":"q3-2022","id":"dGVybToxMzA2Mg=="}},{"node":{"name":"Regulatory","slug":"regulatory","id":"dGVybTo5MDUw"}}]}},{"title":"The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative","slug":"articles-the-price-of-pain-acknowledging-a-crisis-and-encouraging-an-alternative","uri":"/uncategorized/articles-the-price-of-pain-acknowledging-a-crisis-and-encouraging-an-alternative/","excerpt":"Pain is nearly ubiquitous in the United States. According to a 2016 National Health Interview Survey featured by the CDC, one in five Americans — 50 million people — suffer from chronic pain. For 8% (19.6 million Americans) of chronic pain sufferers, this pain is so debilitating that it interferes with their daily lives.1 Groups […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_pain.jpg"}},"mainTopic":{"mainTopic":"Column: Regulatory Spotlight"},"articleFields":{"articleId":"PAO-06-022--NI-05","authors":[{"author":{"title":"David Alvaro, Ph.D."}}]},"articleTags":{"edges":[{"node":{"name":"Analgesics","slug":"analgesics","id":"dGVybToxMzAxNA=="}},{"node":{"name":"FDA","slug":"fda","id":"dGVybTo4OTk5"}},{"node":{"name":"FDA Guidance","slug":"fda-guidance","id":"dGVybTo5NjAy"}},{"node":{"name":"Opioid Epidemic","slug":"opioid-epidemic","id":"dGVybToxMTM2MQ=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Regulatory","slug":"regulatory","id":"dGVybTo5MDUw"}}]}},{"title":"Creating a More Resilient Pharmaceutical Supply Chain One Segment at a Time","slug":"articles-creating-a-more-resilient-pharmaceutical-supply-chain-one-segment-at-a-time","uri":"/uncategorized/articles-creating-a-more-resilient-pharmaceutical-supply-chain-one-segment-at-a-time/","excerpt":"Weaknesses within the highly complex and global pharmaceutical supply chain are not a new topic. However, the many conferences, working groups, and regulatory body discussions have led to minimal foundational change. Then, the COVID-19 pandemic made pharmaceutical supply chain vulnerabilities impossible to ignore, and much work has been done across many public and private organizations […]
\n","seo":{"metaDesc":""},"featuredImage":{"node":{"sourceUrl":"https://thatsnice-testing3.com/wp-content/uploads/2022_Q2_supply_chain.jpg"}},"mainTopic":{"mainTopic":"Column: Supply Chain"},"articleFields":{"articleId":"PAO-06-022--NI-09","authors":[{"author":{"title":"Tonia Becker"}}]},"articleTags":{"edges":[{"node":{"name":"COVID-19 Impacts","slug":"covid-19-impacts","id":"dGVybToxMjQzNw=="}},{"node":{"name":"Domestic Sourcing","slug":"domestic-sourcing","id":"dGVybToxMjA1Ng=="}},{"node":{"name":"Q2 2022","slug":"q2-2022","id":"dGVybToxMjgyNw=="}},{"node":{"name":"Regulatory","slug":"regulatory","id":"dGVybTo5MDUw"}},{"node":{"name":"Reshoring","slug":"reshoring","id":"dGVybToxMjIyMg=="}},{"node":{"name":"Sourcing","slug":"sourcing","id":"dGVybToxMzAyMw=="}},{"node":{"name":"Supply Chain","slug":"supply-chain","id":"dGVybTo4OTg5"}}]}},{"title":"Generis Celebrates New Milestones as Swathes of the Global Pharma Industry Default to CARA Life Sciences™ to Manage Critical Data and Content","slug":"articles-generis-celebrates-new-milestones-as-swathes-of-the-global-pharma-industry-default-to-cara-life-sciences-to-manage-critical-data-and-content","uri":"/uncategorized/articles-generis-celebrates-new-milestones-as-swathes-of-the-global-pharma-industry-default-to-cara-life-sciences-to-manage-critical-data-and-content/","excerpt":"Mid-sized companies & smaller biotechs join big names including Merck and Pfizer to manage data, content & processes via the single, cloud-based, SaaS platform & information lake. Japan, the world’s second-largest pharma market, embraces CARA Life Sciences at a quickening pace, with a six-fold increase in adoption across the country as word spreads. CARA unique […]
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\n","mainTopic":{"mainTopic":"Lipid Excipients"},"articleFields":{"vimeoId":null,"articleId":"PAO-07-022-CL-04","authors":[{"author":{"title":"Claudia Widmann","authorFields":{"bio":"Claudia Widmann is a Regulatory Expert in the pharma registration group. The main activities are the dossier creation and maintenance for the products, developed on the corresponding location in the subsidiary in switzerland. The product manufacturing is specialized among other products in lipid excipients . Claudia holds a Masters Degree in Regulatory Affairs from the “Technische Universität Lübeck”, as well as a Masters Degree and a PhD in a nanotechnological field of expertise.
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