Dr. Heidaran has over 30 years of experience spanning regulatory compliance, biomanufacturing, and product development in the field of cell and gene therapy. He currently serves as the Chief Regulatory Scientist at Cellx Inc. and has previously held significant roles, such as Head of Translational and Regulatory Strategy at GC Therapeutics (GCTx). Dr. Heidaran’s expertise is built upon his extensive career at the FDA’s Center for Biologics Evaluation and Research (CBER) where he spent over 9 years working in product and compliance offices, as well as his tenure as VP of Technical at Parexel International, a large CRO. In addition, he has held leadership roles in research and product development within major biotech companies like Celgene, BD, and the Johnson & Johnson family, giving him a deep understanding of scalable CAMP-compliant biomanufacturing of cell and gene therapy products.

His academic foundation includes a Ph.D. in biochemistry with a focus on molecular and cellular biology from the University of South Carolina. Dr. Heidaran has been instrumental in founding the Gordon Research Conference on Synthetic Biology and has contributed to scientific knowledge with more than 50 peer-reviewed publications, 25 issued patents, and 54 pending patents. He serves on prestigious committees, such as the International Society of Cell Therapy Legal and Regulatory Affairs Committee and the United States Pharmacopeia Bio5 Expert Committee.