Defining Phase-Appropriate Control Strategies for Diverse Cell Therapy Products
- Exploring how phase-appropriate control strategies differ across CAR-T products, to ensure fit-for-purpose development strategies
- Evaluating potency and functional assays tailored to each modality to guide safe and effective transition from first-in-human through later clinical phases
- Discussing the evolution of control strategies from FIH to BLA to establish regulatory confidence
- Considerations for post-license control strategy revisions