The US Food and Drug Administration (FDA) has launched a pilot program intended to shorten the path from preclinical drug development to first-in-human trials by allowing earlier regulatory review and greater involvement from qualified research institutions.

Under the Expedited Investigational New Drug (IND) Pilot Program, drug sponsors will partner with qualified research institutions (QRIs), which may include academic medical centers, contract research organizations, health networks, and regulatory advisers. The institutions will provide scientific input on nonclinical, clinical, and chemistry, manufacturing, and controls components of IND applications.

A key change is that the FDA will review individual IND components on a rolling basis during the pre-IND period rather than waiting for a complete application. The agency said this approach could identify regulatory or scientific issues earlier and potentially reduce clinical holds. The program also encourages sponsors to coordinate Institutional Review Board review and trial-site activation with IND development.

The voluntary pilot could apply to novel drugs and biologics, including products regulated by the FDA’s Center for Biologics Evaluation and Research, making it potentially relevant to early-stage retinal gene and cell therapy programs.

Applications are due October 30. The FDA expects to select 8 to 10 sponsor-QRI pairs for the initial cohort. GP