This Event has now run. Thank You to our Speakers, Sponsors, and Delegates who joined us in Boston for the Summit!

If you are interested in the 2025 event, please get in touch at

Define, Characterize & Measure Potency Effectively to Speed Clinical Translation & Gain Regulatory Approval

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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 However, with the recently released draft guidance released by the FDA, “Potency Assurance for Cellular and Gene Therapy Products”, there is hope on the horizon!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 brought 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 offered an unparalleled opportunity to glean insights from esteemed organizations like BMS, J&J, Fate Therapeutics, Health Canada, Atara Biotherapeutics, and many more.

The cell therapy meeting equipped you with industry insights 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 was New for 2024?

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2 Brand-New Tracks of Content: One track completely dedicated to alpha beta T cells, with the other dedicated to other cell types including NK cells, macrophages, stem cells, cardiomyocytes and more!

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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!

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Representation from Health Canada: Christopher Storbeck, a Senior Scientific Evaluator discussed how to optimize assay design and phase-appropriate expectations from a regulators perspective

The World-Class Speaker Faculty Included:

“The quality of the speakers and engaging discussions during the workshops made the conference stand out.” 

Associate Scientist, Tune Therapeutics