Eli Lilly hires former FDA cell and gene therapies official Rachael Anatol

[Indianapolis - April 2016: Eli Lilly and Company V]
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Rachael Anatol, a former high-ranking official in the U.S. FDA's Office of Therapeutic Products who was placed on administrative leave in June, has been hired by Eli Lilly (NYSE:LLY [https://seekingalpha.com/symbol/LLY]) as Associate VP, Global Regulatory Policy and Strategy-Genetic Medicine.

Anatol, the former deputy director of the agency office, made the announcement on her LinkedIn page [https://www.linkedin.com/feed/update/urn:li:activity:7370852826576523265/]. The hiring was also confirmed to Seeking Alpha by a company spokesman. "In my new role I will be working to advance product development across Lilly’s impressive genetic medicine portfolio," Anatol wrote in her post.

The Center for Biologics Evaluation and Research's (CBER) Office of Therapeutic Products is in charge of regulating cell and gene therapies, plasma protein therapeutics, xenotransplantation products, human tissues, devices, and combination products.

Before joining the agency, Anatol was SVP, Science and Regulatory Affairs, at the Biotechnology Innovation Organization.

Nicole Verdun, director of the Office of Therapeutic Products, was put on administrative leave at the same time as Anatol. The Alliance for Regenerative Medicine decried the FDA's action [https://alliancerm.org/press-release/statement-on-the-departure-of-otp-director/], stating, "Over the past two years, Nicole and Rachael have modernized the FDA’s regulatory approach to cell and gene therapy (CGT), earning the trust and respect of the CGT community and helping to ensure that the FDA was the global leader in this evolving field."

In June, an HHS spokesman told _Biopharma_ _Dive_ [https://www.biopharmadive.com/news/nicole-verdun-rachael-anatol-fda-leave-gene-therapy/751156/] that "center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science."

In March, CBER Director Peter Marks resigned [https://seekingalpha.com/news/4426692-top-fda-vaccine-official-resigns-citing-rfk-jrs-misinformation-and-lies] amid disagreements with HHS Secretary Robert F. Kennedy Jr. over vaccines.

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