Curtis L. Scribner

Regulatory Affairs

Curtis Scribner, MD, is a board certified internal medicine specialist with very wide experience in drug development as a clinical investigator, regulatory reviewer, and strategic product life cycle consultant. Dr. Scribner spent 10 years at the Center for Biologics Evaluation and Research (CBER), FDA, reviewing all phases of clinical development in a wide breadth of areas (blood, plasma, recombinant proteins, cells, tissues, vaccines, etc.). He worked for 6 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 Safety Monitoring Committees, and strategic and operational regulatory interactions in the US (FDA) and Europe (EMA and Member States). He has helped to develop or write orphan drug, rare pediatric disease, breakthrough, fast track, and RMAT designation requests. He has extensive experience in virology and viral diseases, oncology, hepatology, infectious disease, rheumatology, immunology, very rare and Orphan diseases and cell and gene therapy.