Curtis Scribner, MD

Curtis Scribner, M.D., is a board-certified internal medicine specialist with extensive experience in drug development as a clinical investigator, regulatory reviewer, and strategic product life cycle consultant. Dr. Scribner spent 10 years at the FDA’s Center for Biologics Evaluation and Research (CBER), reviewing all phases of clinical development in a wide breadth of areas (blood, plasma, recombinant proteins, cells, tissues, vaccines, etc.). He worked for six years in a small venture-based drug, biologic, and combination development company (BioMedicines/Intarcia) as the Chief Regulatory Officer. He has more than 25 years of experience as a consultant to drugs and biologics companies working on everything from discovery and preclinical models through clinical trials, especially early-stage clinical trials, Data and Safety Monitoring Committees, and strategic and operational regulatory interactions in the U.S. (FDA) and E.U. (EMA and Member States). He has extensive experience in oncology, hepatology, infectious disease, rheumatology, immunology, very rare and orphan diseases, and gene therapy.