Join us for CASSS' CMC Strategy Forum Summer 2017: Manufacturing, Quality and Regulatory Considerations for Cell & Gene Therapies
Siddharth Advant, Celgene Corporation
Stefanie Pluschkell, Pfizer, Inc.
Andrew Weiskopf, Biogen
Scientific Organizing Committee:
Paul Husak, Amgen Inc.
Steven Oh, CBER, FDA
Cindy Riggins, Novartis Pharmaceuticals Corporation
Shian-Jiun Shih, Tessa Therapeutics
Bruce Thompson, Pfizer, Inc.
Cell therapy and gene therapy products stand at the threshold of revolutionizing patient care, offering treatments for unmet medical needs and even the potential to cure some diseases with a single dose. However, the complexities of these advanced therapies pose unique challenges for drug substance and drug product manufacturing, quality and safety, analytical characterization, and supply chains. Elements of manufacturing and controls, including those considered routine for conventional biologics, demand a closer look when developing these products which may be highly perishable, biologically complex, produced with low yield, and in some cases, manufactured for a specific patient. Similarly, regulatory expectations for the CMC of these products are continually evolving, with a degree of nascency not seen since the emergence of recombinant protein biologics in the 1990s. At this CMC Strategy Forum, industry professionals and regulators alike will gather to discuss the many technical, practical, and regulatory aspects and challenges of cell therapy and gene therapy products.
Example topics include:
• Analytical tools and approaches to characterization, release, and stability testing of cell therapies and gene therapy viral vectors
• Controls, supply continuity, and quality assurance of critical raw materials
• Phase-appropriate specifications and “comparability” assessment of complex advanced therapy products
• Quality considerations for ex vivo gene therapies and gene editing modalities
• Strategies for manufacturing, process validation, and supply chain management of viral vectors and autologous/allogeneic cell therapies
• The landscape of global regulatory guidances and standards for cell and gene therapies
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