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. 

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. 

Click here to read the full article at Fierce Biotech

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Comments are closed.