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Potency Measurements for Cellular and Gene Therapy Products
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Gain Insight into the global regulatory landscape on potency requirement for CGT products; Understand the latest FDA’s guidelines regarding potency testing and industry perspectives; Explore the Role of Surrogate Assays enhancing the overall potency assurance strategy; Learn from Industry Peers: Examine the approaches adopted by members of BIO companies to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Speakers
LR

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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