Top CBER CGT leaders placed on leave

FDA’s Office of Therapeutic Products (OTP) director, Nicole Verdun, and deputy director, Rachael Anatol, have been placed on administrative leave.

Verdun and Anatol were escorted out of FDA headquarters on June 18, multiple sources familiar with the matter told media outlets. Verdun had been with the agency since 2012 and was appointed director of the OTP when the CBER ‘super office’ was created in 2023. Anatol spent 16 years at the FDA, left for a year to work with the Biotechnology Innovation Organization, and then returned to the agency to join Verdum at the OTP in December 2023.

The OTP, which consists of six sub-offices, 14 divisions and 33 branches, was designed to streamline workflow processes to improve efficiencies for vaccines and cell and gene therapies.

Sources told Citeline that Verdun disagreed with CBER director Viany Prasad over the regulation of CAR-T products, as well as Capricor Therapeutics’ experimental Duchenne muscular dystrophy cell therapy, deramiocel, which currently has an August 31, 2025 PDUFA date. Capricor stock fell 20% following the news, as Verdun was the key overseer of the company’s application for approval.

CGT advocacy group, Alliance for Regenerative Medicine, expressed its disappointment with the news, stressing the importance of CBER and OTP operating at the “highest level of productivity, efficiency, and scientific rigor" in order to facilitate CGT regulatory decisions. “Over the past two years, Nicole and Rachael have modernized the FDA’s regulatory approach to cell and gene therapy, earning the trust and respect of the CGT community and helping to ensure that the FDA was the global leader in this evolving field,” said the ARM statement.

The continued shakeup at CBER comes just months after Peter Marks resigned as director, reportedly after he was called to the Department of HHS, helmed by Robert F. Kennedy Jr., and told to choose between quitting or be fired.