The U.S. FDA has officially launched its Expedited Investigational New Drug pilot, in a bid to rival the speed of first-in-human trials in China and Australia.
The pilot seeks to accelerate the time it takes from identifying a drug to initiating a FIH clinical trial by partnering drug companies with qualified research institutions (QRI) that have scientific expertise to support efficient development of IND applications.
The FDA will accept applications to participate in the pilot until October 30, 2026. Drug sponsors and prospective QRIs will apply as a pair with drug sponsors submitting applications to the FDA. The agency expects that 8-10 sponsor-QRI pairs will be selected to participate in the initial pilot cohort.
According to the agency, the QRIs selected for the pilot will bring “specialized and substantial scientific expertise to the IND application preparation process,” which will allow the FDA to review and accept components on a rolling review during the pre-IND phase, rather than waiting for all components to begin review. The pilot will help test whether this allows issues with an IND application to be identified and resolved sooner.
The FDA’s Expedited IND Pilot webpage provides detailed information on program eligibility criteria, conflict of interest requirements, and the selection criteria the agency will use to determine participation.
Read more about China’s rise in early-stage R&D.
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