- The Food and Drug Administration office that oversees gene and cell therapies is about to lose its leader amid a major organizational transition and expansion.
- Wilson Bryan, who’s served as director of the Office of Tissues and Advanced Therapies since 2016, has decided to retire, an agency spokesperson confirmed to BioPharma Dive. The FDA expects the retirement to become effective in March. Pink Sheet first reported the news.
- Bryan’s departure comes as the FDA shifts his group, newly christened as the Office of Therapeutics Products, to a “super office” with more resources, high-level officials and employees. The agency last year posted a job opening for a super office director for the OTP.
Bryan has been a key deputy to Peter Marks, the head of the Center for Biologics Evaluation and Research, as the field of gene and cell therapy field expanded in recent years. His office oversaw the first U.S. approvals of gene therapies for inherited diseases, as well as cell therapies for cancer.
As the field has advanced, the workload for Bryan’s office grew substantially. In 2014, there were fewer than 200 applications to begin human trials of products regulated by the Office of Tissues and Advanced Therapeutics. That number jumped to 666 in 2020 and 556 in 2021, according to a recent presentation by Bryan.
Bryan, like other top officials at the FDA, has also had to contend with staff turnover. A list of officials within CBER posted on the FDA website contains 22 vacancies, including six within Bryan’s office.
The new director will be faced with the challenge of hiring qualified people fast enough to stay ahead of a quickly advancing field. A new prescription drug user fee agreement with the industry makes room for more than 200 new full-time employees at CBER as a whole, and the reorganization of Bryan’s office into OTP will create six sub-offices.
A neurologist by training, Bryan is a graduate of the University of Chicago’s medical school. He taught at the University of Texas Southwestern Medical School for 13 years and served as a researcher in clinical trials for conditions including ALS. He joined the FDA in 2000.
Bryan’s office will adjust to his departure while preparing for several consequential decisions. The regulator is currently reviewing an accelerated approval application for Sarepta Therapeutics' experimental gene therapy for Duchenne muscular dystrophy. It’s also evaluating a hemophilia gene therapy from BioMarin Pharmaceutical, a medicine it rejected in 2020.
A ruling on Sarepta’s gene therapy is expected by May 29. A decision on BioMarin’s treatment could come by the end of March, though the company has signaled the review could be extended further.
Ned Pagliarulo contributed reporting