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.
Drug Developer Pricing - Conference Only: USD 2999.00,
Drug Developer Pricing - Conference + Workshop Day: USD 4796.00,
Service Provider Pricing - Conference + Workshop Day: USD 5896.00,
Service Provider Pricing - Conference Only: USD 3799.00,
Discounted Pricing - Conference Only: USD 2599.00,
Discounted Pricing - Conference + Workshop Day: USD 4096.00
Speakers: Amanda Lee, Senior Manager, Regulatory Affairs, Atara Biotherapeutics Inc., Benjamin Espen, Principal Quality Engineer, Avobis Bio, Chien-Chung Chen, Director, Analytical Development, Cabaletta Bio, Christopher Kloss, Senior Scientist, Johnson and Johnson, Christopher Rold, Vice President, Vector Development, Analytical Development and Quality Control, Adicet Bio Inc., Christopher Storbeck, Senior Scientific Evaluator, Health Canada, Chui Yu Lau, Associate Scientist, Century Therapeutics, Darren Kamikura, Director, Potency and Functional Characterization, Bristol Myers Squibb, David Dilworth, Senior Scientist, Assay Development, BlueRock Therapeutics, David Schwalb, Director, Analytical Development, Cell and Gene Therapies, Pacira Biosciences, Dong Xu, Associate Director, TScan Therapeutics, Emily English, Vice President, Quality, Cartesian Therapeutics, Ena Wang, Vice President, Cell Therapy, Nurix Therapeutics, Ewoud van Tricht, Head of Bioprocess Analytics and Characterization, Sanofi, Fan Yang, Vice President, Cell Therapy, Aisar Biotechnology, Hadar Adams, Director, Analytical Development, Atara Biotherapeutics Inc., John Yu, Director, Cell Product Characterization, Sana Biotechnology, Jorge Burns, Associate Professor, University of Ferrara, Joseph Lee, Senior Director, Product Sciences, Affini-T Therapeutics, Khris Garcia, Senior Scientist, Potency and Functional Characterization, Bristol Myers Squibb, Mariska ter Haak, Senior Director, Analytical Development, IN8Bio, Mike Sonnenberg, Vice President, Quality Control, Fate Therapeutics, Monica Kukreja, Associate Director, Quality Control, Arsenal Bio, Monica Sassi, Head of Quality Control, Achilles Therapeutics Limited, Ramon Mendoza, Scientific Director, Analytical Development, Cell and Gene Therapies, Johnson and Johnson, Rita Barcia, Vice President, Process Development and Operations, SIRPant Immunotherapeutics, Sean Madsen, Principal Scientist, Bristol Myers Squibb, Sebastian Hymson, Scientist, BioNTech US, Shapnil Bhuiyan, Research Scientist, Vertex Pharmaceuticals, Shibani Mitra-Kaushik, Head, Product Control Analytics, Cell Therapies, Takeda Pharmaceutical Co. Ltd., Taisen Hao, Senior Scientist, Potency and Functional Characterisation, Bristol Myers Squibb, Therese Choquette, Head of Analytical Sciences, Tigen Pharma, Unnaamalai Meyyappan, Quality Control Team Lead, Achilles Therapeutics Limited, Xenia Peluffo Naj, Associate Director, Analytical Development, Cellectis, Zhu Pirot, Director and Technical Leader, Platform CGT Analytical Development, Bayer