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STAT+: Top gene therapy regulator forced out at FDA
Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her deputy Rachael Anatol have been placed on administrative leave and…
Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her deputy Rachael Anatol have been placed on administrative leave and escorted out of the agency, according to a recording of a meeting obtained by STAT.
Verdun had worked closely with Peter Marks, the former head of the Center for Biologics Evaluation and Research, on establishing new paths for bringing gene therapies to market, particularly in rare diseases. Marks was forced out by the Trump administration in March for his role in regulating Covid-19 vaccines.
Verdun was seen as a key figure in the center, especially after Marks’ departure. At that time, the CEO of a gene therapy maker told STAT, “We value continuity, so having Verdun stay at the FDA is really important.”
