Chief Regulatory Scientist
Cellx Inc. Consulting
Potomac, Maryland
Dr. Mo Heidaran is Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics) and member of Advanced Therapies (BIO5) Expert Committee at USP. and ISCT Legal and Regulatory Affairs Committee. He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the FDA’s Center for Biologics Evaluation and Research (CBER), 15 years of biotech industrial experience in research, product and intellectual property development, and 9 years at the National Cancer Institute. He has more than 28 years of in-depth expertise in product, process development, process optimization, and scalable CGMP compliant biomanufacturing of cell and gene therapeutic products.
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Comparability Assessment Regulatory Considerations of Cell and Gene Therapy Products
Thursday, May 16, 2024
10:30 AM – 11:00 AM PT