Can FDA replicate Operation Warp Speed for rare diseases? Not yet, but Peter Marks has some ideas

As COVID-19 continues to dominate the FDA’s bandwidth, Peter Marks, M.D., Ph.D., director of the agency’s Center for Biologics Evaluation and Research (CBER), is playing financial whack-a-mole to figure out where resources should flow. Topping his priority list is more money to regulate the budding cell and gene therapy field, an effort he hopes can at least partly mirror the regulator’s response to the pandemic.