Defining Potency in CAR-T & Cell Therapies to Align with FDA Expectations

• Exploring FDA draft guidance on potency assurance to clarify approaches for demonstrating product functionality and consistency data
• Evaluating matrix and orthogonal potency strategies to ensure robust measurement across diverse patient groups and clinical contexts

Speakers:

Yu Qian

Head Director, Analytical Project Leads, Cell Therapies

Novartis AG