The former director of the FDA’s Center for Biologics Evaluation and Research (CBER), Peter Marks, has joined Eli Lilly as head of molecular discovery and infectious disease research.
Marks follows in the footsteps of other senior FDA staffers who have joined the pharma industry, making the move six months after resigning from CBER – apparently before being ousted – citing irreconcilable differences with HHS Secretary Robert F Kennedy Jr.
He had been head of CBER for nearly 10 years and, on his departure, said Kennedy was pushing vaccine policy changes that are “irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.”
In a statement, Lilly said that Marks’ expertise “strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas.”
The role in infectious diseases is notable, as this has been a fringe area for Lilly for many years, despite pioneering work at the company in the 20th century that resulted in important antibiotics like cefaclor and vancomycin, and it sold off the remainder of its business in 2019.
Now, its R&D main focus is on cancer, cardiometabolic health, immunology, neurogenerative diseases, and pain, although last year it started working with OpenAI on an antimicrobial project. Lilly was also a player in vaccines at one point – a key part of Marks’ job at CBER – but exited that area long ago, although it developed an antibody-based therapy for COVID-19 during the pandemic.
Marks is a haematologist and oncologist by training and worked in the pharma industry for years – contributing to the development of Novartis’ Exjade (deferasirox), the first oral iron chelator to reach the US market – before joining the FDA in 2012.
His move to Lilly is another example of what has been described as a “revolving door” between the FDA and the pharma industry, which this year also saw the former head of the agency’s Center for Drug Evaluation and Research, Patricia Cavazzoni, resign and subsequently join Pfizer as chief medical officer.
Former Commissioner Robert Califf left to work at Verily Life Sciences before returning to the agency under the Biden administration, while Scott Gottlieb, FDA Commissioner in Trump’s first term, now serves on the boards of Pfizer and Illumina.
Secretary Kennedy has railed against the revolving door in public, repeatedly saying he will close it, but did the opposite when he appointed George Tidmarsh – who founded and held senior positions at a string of biopharma companies – to the role of CDER director in July.
