FDA's gene therapy turmoil, and an alternative model for funding research

June 20, 2025

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Why did the Food and Drug Administration suddenly oust one of its top gene therapy regulators? Is the agency growing too political? And should private firms fund academic research?

We chat about all that and more on this on this week's episode of "The Readout LOUD," STAT's biotech podcast. We discuss the tragic news that a second teenage boy with Duchenne muscular dystrophy died after taking Sarepta Therapeutics' gene therapy, raising renewed questions about the FDA's standards for approving drugs.

We look at the continued turmoil within the FDA, including the forced dismissal of top gene therapy regulator Nicole Verdun, as well as the announcement of a controversial drug-review voucher program that seems to be steering the agency into politics.
We also talk about a private equity firm's decision to fund a research lab at Harvard University, filling a void created by government spending cuts. And we look at the approval of a groundbreaking HIV prevention medicine from Gilead Sciences, as well as a recap of the big BIO convention this week and a preview of the upcoming American Diabetes Association meeting this weekend."

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