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.
Marks’ comments came Tuesday on a call with the Alliance for a Stronger FDA, a lobbying group that advocates on behalf of the agency and its regulatory efforts, to discuss CBER’s budget priorities. Marks touched on a number of topics ranging from the need to bolster the agency’s overall IT infrastructure to improving staff retention. But most notable were his calls to speed up the center’s cell and gene therapy review efforts, which he said have failed to meet his expectations on account of the workload.
“We are clearly in a position that we are not giving the kind of feedback that I’m comfortable with in real-time … to both vaccine developers, and particularly for those in the gene and cell therapy field,” he said.
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