Peter Marks, the former top vaccine regulator who was ousted from the U.S. Food and Drug Administration earlier this year, has joined Eli Lilly as senior vice president of molecule discovery and head of infectious disease work, the pharmaceutical company confirmed Tuesday.
Marks will begin his new role this month, bringing nearly a decade of regulatory expertise from his tenure as director of the FDA's Center for Biologics Evaluation and Research (CBER). His appointment marks a significant addition to Lilly's leadership team as the company evaluates breakthrough science opportunities beyond its core diabetes and obesity portfolio.
Regulatory Leadership Background
During his time at CBER, Marks oversaw the agency's review of vaccines, blood products and genetic medicines, playing a starring role during the coronavirus pandemic. He helped craft the idea for Operation Warp Speed, the cross-government initiative that led to the approval of several safe and effective COVID-19 vaccines during President Donald Trump's first term.
Marks also supervised the approval of dozens of cell and gene therapies for cancer and rare diseases, pushing the regulator to become more flexible in reviewing these breakthrough treatments. He had publicly supported programs that expedited the development of rare disease treatments and gene therapies during his tenure.
Departure from FDA
Marks' resignation in March came amid a dispute with Health and Human Services Secretary Robert F. Kennedy Jr., ending his nearly decade-long stint at the FDA. In his resignation letter, Marks claimed he had 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.
His departure was part of a wave of resignations among top FDA leaders. At CBER, Marks was replaced by Vinay Prasad, one of his longtime critics, 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.
Industry Impact and Analysis
"Peter's expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas," Lilly said in a statement. The company noted that it "continually evaluates breakthrough science which could benefit patients."
Leerink Partners analyst David Risinger believes Lilly stands to gain "significant value" given Marks' "tremendous experience and background." Shares of U.S. drugmakers had fallen when reports of Marks' ouster from the FDA first emerged in late March.
Broader Trend of FDA-to-Industry Transitions
Marks' move follows similar transitions by other senior FDA officials to pharmaceutical companies. Former head of the FDA's drug evaluation unit, Patrizia Cavazzoni, joined Pfizer in February as its chief medical officer. Former U.S. FDA Commissioner Scott Gottlieb also serves as a member of Pfizer's board.
The appointment represents a strategic hire for Lilly as the company looks to expand its capabilities in infectious disease research and molecule discovery, areas where Marks' regulatory expertise and scientific background could prove valuable in navigating the complex development and approval processes for new therapies.
