Bridging Regulatory & Commercial Expectations to Restructure the Pathway to Commercialization & Long-Term Follow Ups

• Clarifying CAR-T FDA regulations within existing biologics frameworks to understand current expectations for CMC, preclinical, and clinical development
• Interpreting evolving regulatory frameworks to enable adaptive decisions that balance patient safety, operational feasibility and commercial sustainability
• Adapting development and regulatory strategies to align with evolving FDA guidance, to advance novel cell therapy programs

Speakers:

Seraphin Kuate

Director, Global CMC Regulatory, CAR T Cell Therapy

Bristol Myers Squibb

Lana Shiu

Global Head of Regulatory Affairs

Kite Pharma Inc