Define, Characterize & Measure Potency Effectively to Speed Clinical Translation & Gain Regulatory Approval
March 19-21, 2024 | Boston MA
Join the 3rd Cell Therapy Potency Assay Summit!
Determining MoA & Satisfying Regulatory Requirements
In the dynamic cell therapy landscape, the challenge of potency assay development looms large, as exemplified by clinical holds experienced by Mesoblast and Verve Therapeutics in recent years. However, with the recently released draft guidance released by the FDA, “Potency Assurance for Cellular and Gene Therapy Products”, there is hope on the horizon!
The 3rd Cell Therapy Potency Assay Summit will bring together analytical, QC and regulatory experts to discuss this new guidance and address all pressing concerns that are limiting clinical progression and regulatory approval.
Whether you’re on the brink of IND or gearing up for BLA submission, this gathering of brilliant minds offers an unparalleled opportunity to glean insights from esteemed organizations like BMS, J&J, Fate Therapeutics, Health Canada, Atara Biotherapeutics, and many more!
Join the cell therapy meeting and leave equipped with industry insights that enable you to develop practical and reproducible assays, providing a deeper understanding of your cell therapy products for autologous and allogeneic cell therapies across a variety of different cell types and indications.
What’s New for 2024?
2 Brand-New Tracks of Content: One track is completely dedicated to alpha beta T cells, with the other dedicated to other cell types including NK cells, macrophages, stem cells, cardiomyocytes and more!
6 Re-Vamped Workshop Sessions: Hot topics include reviewing key regulatory guidance, data analysis and statistics, setting specifications and assigning acceptance criteria, vector potency assay development, to name a few!
Representation from Health Canada: Christopher Storbeck, a Senior Scientific Evaluator will discuss how to optimize assay design and phase-appropriate expectations from a regulators perspective
The World-Class Speaker Faculty Includes:
Vice President, Vector Development, Analytical Development, And Quality Control
Adicet Bio Inc.
Scientific Director, Potency & Functional Characterization
Bristol Myers Squibb
Vice President, Quality
Vice President Quality Control
Head, Product Control Analytics, Cell Therapies Cell Therapies Analytical Development
Takeda Pharmaceutical Co. Ltd.
Director & Technical Leader - Platform Competitive Generic Therapies Analytical Development
“The quality of the speakers and engaging discussions during the workshops made the conference stand out.”
Associate Scientist, Tune Therapeutics