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# Turn Gene Therapy into Reality: Marks
- URL: https://www.fdaweb.com/turn-gene-therapy-into-reality-marks/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:20:55.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5154029

Speaking on 3/20 to the 2023 Muscular Dystrophy Association Clinical and Scientific Conference, CBER director **Peter Marks** discussed three ways FDA is working to overcome barriers to developing gene therapies for rare diseases. In a video summary of his keynote address posted by *Neurology Live*, Marks [said](https://www.neurologylive.com/view/turning-gene-therapy-into-reality-peter-marks?ref=fdaweb.com) FDA is trying to find ways to:

- make gene therapy manufacturing less expensive and complicated;
- ease gene therapies through clinical trials, such as accelerated approval based on a biomarker that is then confirmed by a clinical endpoint; and
- expand the commercial viability of gene therapy manufacturing to global markets through regulatory convergence.