Curtis Scribner

Curtis Scribner, MD, is a board-certified internal medicine specialist with very long 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 (discovery, preclinical testing, clinical trials, and regulatory) 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 20 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 strategic and operational regulatory interactions in the US (FDA) and Europe (EMA and Member States).

He has extensive experience in oncology, hematology, infectious disease, rheumatology, immunology, very rare and Orphan diseases, and gene therapy.