The FDA is continuing its push to accelerate early-stage drug development and is now accepting applications for a new pilot program designed to move sponsors into first-in-human trials faster. Called the Expedited IND Pilot, the effort sits inside a broader Department of Health and Human Services initiative dubbed Operation TrialBlazer, a multi-agency effort aimed at luring drugmakers back to the U.S. from overseas by removing regulatory hurdles that slow domestic early-stage research.
The pilot pairs drug sponsors with qualified research institutions, which can include academic centers, contract research organizations, health networks, or regulatory advisors. Sponsors can apply with a prospective partner until October 30. From there, the FDA expects to select 8 to 10 sponsor and institution teams by December, though the timeline could vary with the number of submissions. Selected teams will prepare IND applications with rolling review of completed components, giving sponsors real-time feedback. The pilot does not change regulatory requirements or standards.
The agency said it wants companies of all sizes in the mix, but the program is likely most valuable to small biotechs that lack in-house regulatory depth. The FDA will prioritize novel products headed for first-in-human Phase 1 trials in the U.S., with a mix of therapeutic areas and sponsor types. The stated benchmark is the speed of early-stage development in Australia and China; as regulatory strategist Bill Holtz of Foley and Lardner put it, “it’s going to have to be a pretty efficient program to overcome the benefits that going to China currently represents.” Whether running site setup and ethics review concurrently with IND development actually shortens timelines is one of the things the pilot is designed to test.