Issue Balancing Global & Local Consideration

Current Issue: Q3 2019

The Networking Issue

Balancing Global & Local Consideration

Our third quarter edition features leading insights from key opinion leaders with findings specific to global and local concerns for clinical trials, manufacturing, and the supply chain; next-generation therapies and technologies; and drug development.

Also In This Issue

Worldwide Clinical Trials

Managing the Complexities of International Clinical Trials

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 […]

Integration

True Integration Is Integral to Providing One-Stop-Shop CDMO Services

A truly integrated CDMO with the right structural foundation and top-down commitment can provide tremendous benefits to biopharmaceutical customers. Rising Demand for Contract Services The value of the global pharmaceutical contract manufacturing market is expected to reach $95.9 billion by 2025, with the API segment accounting for the largest share but the final drug formulation […]

Plasma Proteins

Sustainable Production of Plasma Proteins

Current methods for the extraction of plasma proteins have several limitations. Evolve Biologics is advancing a proprietary expanded bed chromatography solution that provides higher yields of high-quality proteins in a simpler, safer and more sustainable process that can be cost-effective at multiple scales. Importance of Plasma Proteins Many of the thousands of proteins found within […]

Orphan Drugs

Customer Engagement and Information Sharing are Essential for Success in Orphan Drug Outsourcing

Developing cost-effective manufacturing solutions for smaller volumes of highly specialized orphan drugs can be challenging, particularly for small and emerging pharmaceutical companies seeking to bring novel rare-disease treatments to market. A contract service provider with experience in specialized technologies and accelerated development programs that is also committed to customer engagement, information sharing and the formation […]

Glocalization

Impacts of Glocalization on the Pharmaceutical Industry

NICE INSIGHT OVERVIEW: Glocalization Globalization in the pharmaceutical industry has occurred simultaneously with glocalization — increasing local drug development and manufacturing in emerging markets. Not only large multinational firms, but regional and domestic drug companies are taking advantage of the opportunities presented by these growing markets. Glocalization vs. Globalization Globalization in the pharmaceutical industry has […]

The biosimilars market in the United States continues to lag behind the rest of the world. However, there are promising signs that the market is poised to gain momentum. Expanding Biosimilars Market Given biologics’ complexity, the global scientific community has rightfully questioned its collective understanding of these therapeutics. Could the industry really develop and manufacture […]

AAV Vector Production

Production of AAV Vectors Using Suspension Mammalian and Insect Cell Systems

INDUSTRY LEADER INSIGHT Adeno-associated viral (AAV) vectors are currently the most widely used gene transfer vectors in many gene therapies that are in development. Two commercial products, Spark Therapeutics’ Luxterna® and Novartis’ Zolgensma®, are now approved for sale. In an effort to provide additional gene therapy products for patients, there is a need for manufacturing […]

Clinical Trials

Managing the Complexities of International Clinical Trials

Strategic Partnership

Growing With a Flexible, Collaborative CDMO

When selecting a contract development and manufacturing organization (CDMO), companies typically place the greatest emphasis on price, quality and capabilities, but do not always appropriately weigh other factors – such as geographic proximity with its benefits to communication and collaboration when close and its challenges when distant – that can have a direct impact on […]

Collaborative Culture

Tech Transfer and Scale-Up for Custom APIs Driven by a Collaborative Culture

Technical expertise and access to state-of-the-art equipment and facilities are necessary but insufficient for successful completion of small molecule API technology transfer projects. Contract development and manufacturing organizations (CDMOs) must have a collaborative culture that encourages open and transparent communication among internal team members, client representatives and other external partners. Strong Technical Foundation is a […]

Past Issues

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Future Pharma Partner Models

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Issue #3 | Volume #2 | Q3 2016

Innovative & Expert Partners

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Issue #2 | Volume #2 | Q2 2016

Clinical Services, Contract Development & Manufacturing

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Issue #1 | Volume #2 | Q1 2016

The Next-Generation Issue

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Issue #2 | Volume #4 | Q2 2018