Peter Marks (he/him)

Director, Center for Biologics Evaluation and Research (CBER)

Hematologist and oncologist—pivotal in COVID-19 vaccine development and expert in regulatory science and biologics.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (CBER), has seen his share of medical emergencies. In fact, he was at Wagner during the AIDS crisis, working closely with HIV patients. But when it became clear, in March of 2020, that the coronavirus was blossoming into a full-blown pandemic, Dr. Marks faced the biggest challenge of his professional life. All the major drug developers pitched a two-year timeline to a vaccine, but data available to him suggested that a vaccine-less winter could cost as many as three million lives.

He soon found himself laying the blueprint for “Operation Warp Speed,” the nation's vaccine-acceleration program, identifying three potential “levers” that could help speed development: Guidance (persuading methodical scientists to think differently and to innovate); Communication (fast-tracking interactions with companies); and Expedition (establishing a higher “speed limit” for development—without sacrificing safety or quality). “There was a lot of pressure,” he says, “to go even faster. But you have to ignore that and do what's right.”

Under Dr. Marks' leadership, the FDA facilitated halving the expected timeline to a vaccine, saving many thousands of lives in the US following the deployment of high quality, safe, and effective vaccines. Dr. Marks' coolness under pressure has been lauded across the medical community, and he's a finalist for the prestigious Samuel J. Heyman Service to America Medal. “We really learned from Operation Warp Speed,” he says. “And we'll be able to bring this blueprint to other potentially lifesaving therapies.”