FDA Appoints George Tidmarsh as New CDER Director | Biotech Leadership Shift

According to major U.S. media outlets, U.S. FDA Commissioner Dr. Marty Makary has just appointed veteran biotech executive Dr. George Tidmarsh as the next Director of the Center for Drug Evaluation and Research (CDER).

“Dr. Tidmarsh is a highly accomplished physician-scientist and leader, with experience spanning the entire drug development lifecycle, from the lab bench to the clinic,” said Commissioner Makary in an official statement. “His leadership at CDER will bring exceptional scientific expertise, regulatory insight, and operational capability to the FDA.” Makary added that he looks forward to working with Tidmarsh to “strengthen the drug review system, promote innovative R&D, and enhance public health through cross-departmental collaboration.”

Tidmarsh assumes leadership of CDER after decades of experience in the biotech and academic sectors. He has led the development of seven FDA-approved new drugs and founded multiple biopharmaceutical companies, including Metronome Therapeutics, Revelation Biosciences, and Horizon Therapeutics — the latter acquired by Amgen for $27.8 billion. He also spearheaded the creation of Stanford University’s Master’s in Translational Research and Applied Medicine (M-TRAM) program and currently serves as a Visiting Professor of Pediatrics at his alma mater, Stanford University School of Medicine.

Tidmarsh will succeed Dr. Jacqueline Corrigan-Curay, who announced her retirement plans to colleagues last month. His appointment is the latest in a series of leadership changes at the FDA. Notably, Dr. Nicole Verdun, Director of the Office of Cellular and Gene Therapies, and her deputy Dr. Rachael Anatol, were suspended last month. In addition, the FDA’s Chief Medical Officer, Dr. Hilary Marston, resigned in April.

Also in April, Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER), abruptly resigned amid reported disagreements with Health and Human Services Secretary Robert F. Kennedy Jr. over vaccine policy.

Commissioner Makary has since appointed Dr. Vinay Prasad to replace Marks. Together, Prasad and Tidmarsh now lead the two most critical divisions within the FDA’s drug review system, having already spearheaded several reforms — including implementing stricter standards for COVID-19 vaccine approvals.