Curtis Scribner, M.D., M.B.A.
Senior Clinical and Regulatory Advisor
Curtis Scribner, MD, MBA, is a board-certified internist with very long experience in drug development as a clinical investigator, regulatory reviewer, and product life cycle consultant. After his post-doctoral fellowship in the Arthritis and Rheumatology Section of NIH, Dr. Scribner spent 10 years at the Center for Biologic Evaluation and Research (CBER), FDA reviewing all phases of clinical development (discovery, preclinical testing, clinical trials, and regulatory) in a wide breadth of areas (blood, plasma, recombinant proteins, cells, tissues, etc.). He worked for 6 years in a small venture-based drug, biologic and combination development company (Intarcia) as the Chief Regulatory Officer. He has more than 12 years of experience as a consultant to drugs and biologics companies working on everything from discovery and preclinical models through clinical trials, Data Safety Monitoring Committees and regulatory interactions in the US (FDA) and Europe (EMA and Member States), including the RAC (NIH) for gene therapy companies. He has extensive experience in oncology, infectious disease, rheumatology, immunology, and gene therapy, but he has also interacted with essentially every Division at CBER and CDER FDA in the last 6 years.