Nicole Verdun, director of the FDA's cell and gene therapy office, and her deputy Rachael Anatol have been placed on administrative leave and escorted out of the agency without explanation21.
Verdun and Anatol's exits follow the departure of Peter Marks, former head of the Center for Biologics Evaluation and Research (CBER), who resigned in March 202543.
These abrupt leadership changes have raised industry concerns about the FDA’s ability to maintain continuity and regulatory clarity for cell and gene therapy development, especially regarding rare diseases12.
The Alliance for Regenerative Medicine and several biotech CEOs expressed disappointment at Verdun's exit, citing her importance for stable leadership and predictable regulatory guidance12.
There are broader worries about further talent losses within CBER, potentially impacting the FDA’s capacity to review and support innovative therapies in a rapidly advancing field5.
Sources:
1. https://www.fiercebiotech.com/biotech/industry-deeply-disappointed-fdas-cell-and-gene-therapy-chief-put-administrative-leave
2. https://www.statnews.com/2025/06/18/top-gene-therapy-regulator-forced-out-at-fda/
3. https://www.isctglobal.org/telegrafthub/blogs/isct-head-office1/2025/06/17/north-america-legal-and-regulatory-affairs-watchdo
4. https://www.biopharmadive.com/news/peter-marks-cell-gene-therapy-champion-fda-departure/744026/
5. https://www.fiercepharma.com/pharma/cell-and-gene-therapies-peter-marks-fda-exit-jolts-struggling-field-deep-uncertainty