Seraphin Kuate
Director - Global CMC Regulatory, CAR T Cell Therapy Bristol Myers Squibb
Seminars
Tuesday 15th September 2026
Panel Discussion: Navigating Regulatory GMP Expectations to De-Risk Development & Enable Market Access
12:00 pm
- Interpreting updated cell therapy GMP and advanced manufacturing technology expectations to leverage regulatory flexibility without compromising compliance
- Examining how evolving regulatory guidance influences clinical outcomes and commercialization pathways to align manufacturing quality with long-term market success
Tuesday 15th September 2026
Evolving Regulatory Strategy with Cell Therapy Innovation
9:00 am
- 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
