Dr. Celia Witten is a physician and regulatory leader with nearly three decades of experience guiding medical product development across biologics and medical devices. Renowned for her expertise in FDA regulatory strategy and clinical development, Dr. Witten has played a pivotal role in shaping the pathways that drive innovation in cell and gene therapy (CGT), rare disease programs, patient engagement, and human tissue regulation.

Before joining ELIQUENT, Dr. Witten served for nine years as Deputy Director of the FDA’s Center for Biologics Evaluation and Research (CBER), where she oversaw the restructuring of the Office of Tissues and Advanced Therapies into the Office of Therapeutic Products. In this role, she enhanced the agency’s review capacity for CGT products, launched strategic initiatives like the START pilot to improve industry communication, and led key programs in advanced manufacturing, international collaboration, and horizon scanning. Prior to that, she served as Director of the Office of Cellular, Tissue, and Gene Therapies, helping to catalyze the growth of investigational studies and product licensure during a transformative period in CGT.

Earlier in her FDA career, Dr. Witten spent a decade as Division Director of the Division of General, Restorative, and Neurological Devices, where she advanced evidence development strategies for products with complex scientific or clinical histories. Her early career included ten years in clinical practice at the National Rehabilitation Hospital, where she held multiple leadership positions, including Chair of the Department of Rehabilitation Medicine.

At ELIQUENT, Dr. Witten brings unmatched regulatory insight to support clients developing novel therapies, guiding them through today’s complex and evolving development and approval landscape.