2026 Regulatory Roadmap

Cell & Gene’s Chief Editor, Erin Harris, was joined by two of the field’s most trusted experts, Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners, to translate regulatory expectations into practical strategies for CGT sponsors as they design trials, plan filings, and position programs for global success. They unpacked the major regulatory developments CGT biotechs need to watch in 2026, including evolving CMC rigor and clinical design for small populations to shifting global policies that will shape development, approval, and market access in the year ahead.