Seraphin Kuate
Director, Global CMC Regulatory, CAR T Cell Therapy Bristol Myers Squibb
Dr. Seraphin Kuate, Ph.D., MBA, RAC, CCRP, is a CMC Regulatory Subject Matter Expert with over 24 years of experience in biotechnology product development, manufacturing, and regulation, including more than 12 years as a CMC reviewer at the U.S. FDA’s Center for Biologics Evaluation and Research. His expertise spans regulatory strategy for biologics, biosimilars, conjugates, IVIGs, and gene/cell therapies, engaging with global health authorities and leading regulatory submissions worldwide. Dr. Kuate holds advanced degrees in Biochemistry, Molecular Virology/Immunology, Epidemiology/Biostatistics, International Management, and an MBA, and is certified in Regulatory Affairs (RAC) and Clinical Research (CCRP).
Seminars
- 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
- 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
