Addressing Potency Assay Development Challenges

Potency assays present a significant challenge for developers and regulators of gene and cell therapy products. As a new and complex field of therapeutics, cell and gene therapies require a bespoke and multi-faceted approach to demonstrating potency. For developers, this represents a significant investment with uncertain returns, as achieving regulatory acceptance of a developer’s approach to demonstrating potency has often led to delays. This webinar is a follow on from a meeting held by ARM and ASGCT with FDA last October. We will highlight conclusions and recommendations from the meeting and share candid perspectives from some of the participants.
Speakers:
Peter Marks, M.D., Ph.D. - Director, Center for Biologics Evaluation and Research (CBER), FDA
Denise Gavin, Ph.D. - Director, Office of Gene Therapy CMC (CBER), FDA
Matthew Klinker, Ph.D., CMC Reviewer, Cell Therapy Branch 2, Division of Cell Therapy 1, Office of Cellular Therapy and Human Tissue CMC
Herbert Runnels, Ph.D. - Senior Research Fellow, AAV Analytical Global Sponsor, Pfizer
Eliana Clark, Ph.D. - Chief Technical Officer, Intellia Therapeutics
Michael Lehmicke, MSc. - Vice President, Science and Industry Affairs, The Alliance for Regenerative Medicine