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FDA’s Marks outlines plans to energize gene therapy, hopes for gene editing

ARTICLE | Regulation

CBER Director Peter Marks believes regulatory policies can help overcome barriers that are slowing gene therapy 

By Steve Usdin, Washington Editor

April 26, 2024 10:48 PM UTC

FDA is advancing a set of policies that are intended to help gene therapies overcome speed bumps that are slowing progress in bringing new treatments to patients with rare diseases, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said on a recent webinar hosted by the Alliance for a Stronger FDA. The agency will soon roll out guidance for a new platform technology designation, plans to aggressively use accelerated approval, and is launching an initiative to collaborate with European regulators on harmonized submissions, he said.

Marks also described his enthusiasm for gene editing technologies, suggesting that advancing the technology should be a national priority because it has the potential to increase life expectancy and reduce healthcare costs.