Eli Lilly has tapped former US Food and Drug Administration (FDA) biologics lead, Peter Marks, as its new head of infectious disease and senior VP of molecule discovery.
Marks’ hiring comes six months after the former Centre for Biologics Research and Evaluation (CBER) boss was ousted from the FDA after locking horns with US health secretary, Robert F Kennedy (RFK) Jr, over vaccine policy.
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Prior to his forced resignation, Marks spent 13 years at the FDA – nine of which were as the head of CBER. Throughout his time at the agency, he oversaw the evaluation of vaccines and biologics, while being a key contributor to the development and approval of the first Covid-19 jabs.
Marks’ unexpected departure from the FDA came just half a year after he made some foreboding comments at the Jefferies London Healthcare Conference, predicting that the arrival of RFK Jr as US health secretary could result in “very vigorous dialogue” around the benefits and risks of vaccines.
Despite his expulsion from the agency, new employer Lilly has high hopes for Marks in his new role, noting that he will be an asset to the company in a statement to Pharmaceutical Technology.
“Peter’s expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas,” the spokesperson said.
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By GlobalDataEx-FDA staff make industry transition
While Marks is the latest example of an ex-FDA colleague making the move over to industry, he is certainly not the first, with Racheal Anatol recently joining Lilly as the associate VP of global regulatory policy and strategy for genetic medicine in September.
Anatol followed a similar fate to Marks, being escorted out of the FDA headquarters after a row with the current CBER head, Vinay Prasad. The exchange was allegedly over a complete response letter (CRL) sent by Prasad to Capricor Therapeutics for its Duchenne muscular dystrophy (DMD) therapy, deramiocel.
However, Lilly isn’t the only pharma company to snag some former FDA officials, as Pfizer added ex-commissioner Scott Gottlieb to its board of directors in 2019. More recently, the New York-based pharma also rehired ex-Centre for Drug Research and Evaluation (CDER) head Patrizia Cavazzoni, this time as CMO and executive VP.
AstraZeneca has also been partial to hiring ex-FDA staff. Between 2017 and 2018, the UK-Swedish pharma hired the former acting director of CDER’s new drug products office, Sarah Pope Miksinski, director of FDA’s oncology products division Geoffrey Kim and CDER’s pulmonary, allergy and rheumatology division lead, Badrul Chowdhury.
These appointments across the industry have raised concerns around the potential loss of impartiality from the agency, as the industry has close ties to staff making regulatory decisions.
