The U.S. Food and Drug Administration has opened applications for its Expedited Investigational New Drug (IND) Pilot, a new program aimed at cutting the time it takes to move a drug candidate from discovery to a first-in-human clinical trial. The agency announced the final program design on September 15, 2026, and will accept applications from paired drug sponsors and Qualified Research Institutions (QRIs) through October 30, 2026.
For sponsors developing cell and gene therapies, biologics, and other complex modalities, the pilot is a notable signal: FDA is actively looking for ways to compress a timeline that has become a competitive liability for U.S.-based drug development.
Why the FDA Is Moving on This Now
According to the agency, first-in-human clinical trials in the United States can currently take up to two years to get underway, a timeline the FDA says is now meaningfully slower than comparable trials conducted in China and Australia. That gap has become a point of concern for U.S. competitiveness in biomedical innovation, and it’s the direct motivation behind the pilot.
The Expedited IND Pilot is positioned as part of the Department of Health and Human Services’ broader Operation TrialBlazer initiative, which is aimed at modernizing clinical trial regulation without loosening safety oversight.
“Under the Trump Administration, boosting domestic innovation and ensuring American patients have first access to groundbreaking treatments is a top priority,” said Acting FDA Commissioner Kyle Diamantas, J.D. “The FDA will continue implementing Operation TrialBlazer to modernize regulatory processes to keep our country ahead of global competitors without compromising patient safety.”
How the Pilot Works
The core mechanism is a pairing model: drug sponsors apply jointly with a Qualified Research Institution that brings deep scientific and regulatory expertise to the IND preparation process. Rather than waiting for a complete IND package before FDA review begins, the pilot allows individual components of the application to be reviewed and accepted on a rolling basis during the pre-IND phase.
The intent is to surface and resolve issues in real time, rather than after a full 30-day IND review cycle is already underway, reducing the risk that a first-in-human protocol gets placed on clinical hold late in the process. The pilot also encourages sponsors to coordinate other pre-trial activities, such as Institutional Review Board review and clinical site activation, earlier and in parallel with IND development.
Importantly, FDA retains full regulatory authority throughout: the agency still makes every determination about whether a trial may proceed or should be placed on hold. The pilot changes the process and pacing of review, not the agency’s oversight authority.
“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” said Karim Mikhail, B.Pharm., M.S., Director of FDA’s Center for Biologics Evaluation and Research (CBER).
“The FDA greatly appreciates the public feedback we received on the proposed pilot, and we have incorporated that feedback into the final pilot design,” added Michael Davis, M.D., Ph.D., Director of FDA’s Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring the United States remains the global standard for pharmaceutical innovation and regulatory rigor for the benefit of American patients and innovators.”
Who Can Apply, and When
Drug sponsors and prospective QRIs submit applications as a pair, with the sponsor as the formal applicant to FDA. The agency expects to select 8–10 sponsor-QRI pairs for the initial pilot cohort, with applications reviewed by FDA scientific staff. The application window closes October 30, 2026, and full eligibility criteria, conflict-of-interest requirements, and selection criteria are detailed on FDA’s program webpage.
FDA has also indicated that the pilot’s results may inform a future, more formal accreditation model for QRIs, potentially building a durable network of institutions that sponsors could draw on to support IND development well beyond this initial pilot.
What It Could Mean for Cell and Gene Therapy Development
For sponsors in cell and gene therapy, biologics, and other advanced modalities, the pilot addresses a familiar pain point: getting from a promising preclinical data package to an approved IND without the delays that come from iterative back-and-forth during review. A rolling, component-by-component review model, run in partnership with an institution that already understands the regulatory bar, could meaningfully shorten that runway for the sponsors selected into the initial cohort.
It’s still a pilot, with a small initial cohort and an unproven track record. But it fits a broader pattern from FDA over the past year: a willingness to test structural changes to how CMC, IND, and early clinical development are reviewed, rather than relying solely on guidance documents. Sponsors preparing IND submissions for cell and gene therapy programs should keep an eye on how this pilot performs, and on whether the “rolling review” model it tests eventually finds its way into standard practice.
Avance Biosciences supports sponsors across preclinical, clinical, and CMC programs with CGMP-, GLP-, and CLIA-compliant analytical and bioanalytical testing for cell and gene therapies, biologics, and RNA therapeutics, the kind of regulatory-ready data that IND submissions, expedited or not, depend on.
