Mo Heidaran, PhD
Owner & Chief Regulatory Scientist
Cellx Inc., Consulting, Potomac
United States
Dr. Mohammad A. (Mo) Heidaran, PhD, is Owner and Chief Regulatory Scientist at Cellx Inc., where he advises on regulatory strategy, product development, and FDA submissions for advanced therapies. With more than 35 years of experience spanning government, industry and academia, he has held leadership roles at FDA/CBER, Celgene, Becton Dickinson, and Parexel, and most recently led translational and regulatory strategy at GC Therapeutics.
Dr. Heidaran spent nine years at FDA’s Center for Biologics Evaluation and Research (CBER), where he served as Acting Branch Chief in the Office of Tissues and Advanced Therapies and was recognized as a subject matter expert in CMC policy, GMP compliance, and regulatory review of cell and gene therapies. Earlier in his career, he conducted research at the National Cancer Institute, contributing to the understanding of growth factor signaling and oncology.
He is an active member of professional organizations including ISCT and USP, contributes to regulatory and legal committees, and has authored over 50 publications and more than 25 issued patents. A frequent invited speaker, Dr. Heidaran is recognized globally for his expertise in regulatory strategy, CMC development, and advancing cell and gene therapies from research to the clinic.