Accelerated CGT Pathways Favor Programs Built On Strong Science

In this final segment of Cell & Gene Live, “2026 Regulatory Roadmap,” Cell & Gene's Chief Editor, Erin Harris, 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 shared that accelerated regulatory designations can meaningfully speed development only when backed by strong biology, compelling early data, and thoughtful use of increased FDA engagement.

At the same time, global regulatory divergence remains the norm, making rigorous science, early multi-agency planning, patient engagement, and close attention to evolving policies essential to future-proof CGT programs.