Issue The Promise and Challenges of Gene Therapy

Current Issue: Q4 2019

The Breakthrough Issue

The Promise and Challenges of Gene Therapy

Our fourth quarter edition features leading insights from subject matter experts covering a range of cutting-edge scientific topics, including microbiome therapy, biofabrication, cell and gene therapy, antibody–drug conjugates (ADCs), high-potency APIs, next-generation chromatography, personalized medicine and the increasingly complex “zoo” of multifunctional antibody and protein formats.

Also In This Issue

Should You Choose a Commercial HPAPI Manufacturer for Your Clinical Program?

Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays. Partnering from the outset with a CDMO capable of supporting HPAPI projects from concept to launch can accelerate development timelines and reduce overall costs. Expanding HPAPI Market Leads to […]

Gene Therapy

Slow Progress and a Shaky Start—What’s Next for Gene Therapy?

NICE INSIGHT OVERVIEW: Gene Therapy Gene therapy is showing tremendous promise, with several treatments already on the market and hundreds more at all stages of development. The field had a pretty rocky start, though, and progress has been slow. Despite recent, more rapid advances, concerns and questions remain. What might the future hold? Shaky Start […]

Oral Peptides

Advances in the Oral Delivery of Peptides

Lipid-based technology can significantly aid in the oral delivery of peptides — a goal sought by emerging and major pharmaceutical companies. Real Market Potential Companies have been investigating the oral delivery of insulin, calcitonin, cyclosporine, leucine encephalin, HIV protease and other peptides for several years. Significant Challenges Oral delivery of biologics, including peptides, remains a […]

Microbiome

Supporting Commercialization of Live Biotherapeutic Products for Microbiome-Based Therapies

INDUSTRY LEADER INSIGHT There are around 200 private and public companies developing microbiome-based therapies intended to treat a wide range of serious diseases, with large pharmaceutical companies showing increased interest by partnering with early innovators. While most of these investigational treatments are in the earliest phases of development, many have reached early clinical development, and […]

Clinical Trial Logistics

Expediting Clinical Trials with a Global Transportation Footprint and Clinical Packaging

Clinical trials are increasingly global and include both traditional structures and newer siteless models with direct-to- and direct-from-patient delivery capabilities. Sponsor companies and trial managers need the support of clinical logistics service providers that can do more than pick up and deliver biologic samples and clinical trial materials. With its global transportation footprint and clinical […]

Analytical Development

Solving Process Challenges Requires Flexibility to Explore Alternative Analytical Methods

Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products. When standard or predefined methods fail because of buffer components or because proteins do not behave as expected, solutions can be found when the team has the knowledge and flexibility to explore the use […]

Project Management

Adhering to Delivery Milestones

Investors expect pharmaceutical companies to meet commercialization timelines, and failure to do so can have significant financial consequences. Contract development and manufacturing organizations (CDMOs) that have a track record of adhering to project timelines and delivering product on time and in full, regardless of the project’s complexity, have a competitive advantage. Foundation of Collaboration CDMOs […]

Commercial Manufacturing

Advancing Commercial Manufacturing from Orphan Drugs to Blockbusters

The key to success for pharmaceutical contract development and manufacturing organizations (CDMOs) is to understand the needs of the market and evolve the business to ensure that it can always meet customer needs as they change and grow. UPM Pharmaceuticals is dedicated to optimizing manufacturing processes for both small- and large-volume projects to ensure the […]

Quality Compliance

How a Quality Culture Contributes to Global Compliance

Almac Pharma Services successfully completed global regulatory GMP inspections at three different sites within two weeks, a milestone that reflects the company’s commitment to quality and global compliance. Quality as a Core Value As a global contract development and manufacturing organization (CDMO), Almac Pharma Services recognizes that quality determines the extent of our success. We […]

Corporate Social Responsibility

Giving Structure to a Long-Term CSR Strategy

Since its founding, Servier has adopted a patient-centric focus and has been committed to producing high-quality drugs while simultaneously providing a positive work environment for its employees. Four years ago, the company decided — in light of new challenges facing the pharmaceutical industry — that its corporate social responsibility (CSR) efforts would benefit from more […]

Past Issues

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The Innovation Issue

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Issue #4 | Volume #4 | Q4 2018

The Role of Innovative Technologies

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Issue #4 | Volume #2 | Q4 2016

The Executive Issue

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Issue #1 | Volume #6 | Q1 2020

The Business Development Issue

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Issue #1 | Volume #5 | Q1 2019