Peter Marks, the former top Food and Drug Administration vaccine official who abruptly resigned from the regulator earlier this year, has joined Eli Lilly, the company confirmed Tuesday.
Lilly has named Marks the senior vice president of molecule discovery as well as the head of its infectious disease work. Lilly didn’t specify in an email to BioPharma Dive exactly what his duties will be in that role — the company is known for its obesity and diabetes medicines, as opposed to infectious disease research — but said that his appointment will become effective this month. The news was first reported by BioCentury.
“Lilly continually evaluates breakthrough science which could benefit patients,” a spokesperson said in an email. “Peter's expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas.”
Marks’ hiring comes six months after his sudden departure from the agency amid a dispute with Health and Human Services Secretary Robert F. Kennedy, Jr. That resignation ended a nearly decade-long stint as the head of the FDA’s Center for Biologics Evaluation and Research, where he oversaw the agency’s review of vaccines, blood products and some genetic medicines.
As head of CBER, Marks played a starring role during the coronavirus pandemic by helping craft the idea for Operation Warp Speed, a cross-government initiative that led to the approval of several safe and effective COVID-19 vaccines. Marks also oversaw the approval of dozens of cell and gene therapies for cancer and rare diseases and, along the way, pushed the regulator to become more flexible in reviewing them — sometimes controversially so.
Marks’ resignation came amid a wave of departures among top FDA leaders. In his resignation letter, he claimed to have tried to address Kennedy’s concerns about vaccine safety and transparency, but found that the HHS Secretary “wishes subservient confirmation of his misinformation and lies” instead.
At CBER, Marks was replaced by one of his longtime critics, Vinay Prasad, who himself quickly became embroiled in controversy over an attempt to block continued sales of Elevidys, the Duchenne muscular dystrophy gene therapy from Sarepta Therapeutics. Prasad stepped down for a short time afterwards.
Lilly, meanwhile, stands to gain “significant value” given Marks’ “tremendous experience and background,” wrote Leerink Partners analyst David Risinger in a Tuesday client note.
Still, hiring a former regulator who criticized top Trump administration officials could carry some risk. Many large pharmaceutical companies, including Lilly, have announced plans to boost U.S. drug production to appease the White House’s demands and sidestep the threat of tariffs. The administration is also pushing for deals meant to equalize U.S. drug prices with what’s paid in other developed nations.
