Lesson Description
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) hosted a virtual scientific public workshop on February 25, 2025, titled “Cell Therapies and Tissue-based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development.” The purpose of the workshop was to identify and discuss the current state of the science, development, and regulation for cellular therapies and tissue-based products.
In this session, presentations on “CMC Considerations for Cell Therapy Characterization”:
“Case Study: A Cell-based Therapy Proves Efficious, Safe, Rational, & Mechanistically-justified in an Authentitic Pre-Clinical Model of a Major Unmet Medical Need, Suggesting a Clinical Trial Should Be the Next Step”
- Evan Snyder, MD, PhD, Director of the Stem Cell Research Center and Professor, Sanford Burnham Prebys Medical Discovery Institute
“CMC Considerations for Assay Development: How Much is Enough?”
- Deborah Hursh, PhD, Principal, Hursh Cell Therapy Consulting, LLC
“CMC Considerations for Cell Therapy Characterization: The Industry Perspective”
- Jane Lebkowski, PhD, President, Regenerative Patch Technologies