2026 Regulatory Roadmap

Join Cell & Gene’s Chief Editor, Erin Harris, for this timely Cell & Gene Live offering an in-depth regulatory outlook with 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.

Drawing on his tenure leading the FDA’s OTAT, Dr. Bryan will share a rare, inside view of how regulators think about CGTs across CMC, potency and comparability expectations, and the next wave of guidances. Drago, a global regulatory strategist who has led 100+ applications and secured orphan, fast track, breakthrough, and RMAT designations across multiple modalities, will translate those expectations into practical strategies for CGT sponsors as they design trials, plan filings, and position programs for global success. Together, they will unpack 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. This event will be a critically important hour for every role in the CGT value chain. See you there. Registration is free.