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 However, with the recently released draft guidance released by the FDA, “Potency Assurance for Cellular and Gene Therapy Products”, there is hope on the horizon!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.