3rd Cell Therapy Potency Assay SummitMarch 19 - 21, 2024 - MA US
Determining MoA and 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. With unclear licensing standards and the surge in cell therapy products advancing through phase development, linking mechanisms of action to potency assays scientifically has become a pressing concern. At the 3rd Cell Therapy Potency Assay Summit, we bring together over 120 analytical, quality control, and regulatory experts to address these pressing concerns. Our goal is to collaboratively design more effective potency assays that not only streamline regulatory approval but also reduce hold times significantly. Whether you are on the brink of your first 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 and J, Atara Biotherapeutics, Fate Therapeutics, Health Canada and more. Join the 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.