Evolving Regulatory Strategy with Cell Therapy Innovation

• Clarifying CAR-T FDA regulations within existing biologics frameworks to understand current expectations for CMC, preclinical, and clinical development
• Examining FDA regulatory considerations for emerging in vivo and innovative CAR products to highlight where requirements diverge from ex vivo cell therapies
• 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