Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the “Program”), an initiative launched under HHS Operation TrialBlazer[i] that aims to shorten the path from IND-enabling activities to first-in-human (FIH) trials while preserving FDA’s existing safety and scientific review standards.
For sponsors racing to get novel candidates into trials, this pilot may offer a different approach: a rolling, collaborative IND review process built around third-party scientific partners.
Operation TrialBlazer and FDA’s Drug Development Initiatives
The Program does not stand alone and is part of a broader HHS initiative, Operation TrialBlazer, under which FDA has committed to streamlining processes across the drug development continuum, from IND-enabling work through late-stage pivotal trials.
FDA has been explicit about the competitive rationale behind the Program. FIH clinical trials can currently take up to two years to initiate in the United States, a timeline the agency has said is being outpaced by other jurisdictions, including China and Australia. FDA has framed this gap as a threat to America’s leadership in scientific innovation and has tied the Program to a broader administration priority of accelerating clinical trial timelines and reducing regulatory hurdles to keep the country competitive in global drug development, while maintaining the agency’s existing safety and scientific rigor.
What the Expedited IND Pilot Aims to Accomplish
One of the core innovations under this Program is the introduction of “Qualified Research Institutions,” or QRIs. QRIs may be academic medical centers, health networks, contract research organizations, regulatory advisors, or other research organizations that partner with a sponsor to provide expert recommendations across the three pillars of an FIH IND: (i) pharmacology and toxicology, (ii) clinical, and (iii) chemistry, manufacturing, and controls (CMC).
FDA will concurrently establish a new real-time rolling submission platform to allow agency reviewers the ability to accept and review individual IND components on a rolling basis as they are completed. FDA hopes for this process to allow sponsors to work with QRIs and the agency to identify and resolve issues in real time, minimize the risk of a late-stage clinical holds, and increase the speed and predictability of the path to an FIH trial.
Notably, the Program does not modify FDA’s statutory or regulatory standards for IND review, safe-to-proceed determinations, or clinical trial conduct, and participation in the pilot program is voluntary. Further, FDA retains full regulatory authority throughout, including the ultimate determination of whether a trial may proceed and whether a clinical hold is warranted.
Application Considerations
Sponsors may apply for a single IND program. A sponsor may apply for the Program with only one designated QRI, though it may continue to separately engage other contract research or manufacturing organizations.
FDA has indicated it will prioritize applications where:
- The product falls under CDER’s Office of New Drugs, CBER’s Office of Therapeutic Products, or the Oncology Center of Excellence;
- The IND is a Commercial IND, i.e., the sponsor intends to eventually pursue a marketing application;
- The program targets an FIH Phase 1 submission for a product without prior clinical experience, to be run in the United States;
- The sponsor has sufficient preliminary nonclinical data at the time of application for FDA to evaluate the proposed development and submission timeline; and
- For platform technologies, the Program’s support is limited to the specific investigational product as defined in the application, not the broader platform.
FDA has been explicit that sponsor and QRI applications will be evaluated together as a single package, and holistically against one another rather than against a fixed bar. Drug sponsors and prospective QRIs apply to the pilot as a single pair, with the sponsor submitting the application to FDA. Furthermore, the agency has stated that it is seeking to build a cohort with breadth across therapeutic areas, product modalities, sponsor sizes, and QRI types. FDA has also indicated that applications addressing underrepresented therapeutic areas, rare diseases, pediatric indications, or novel modalities may add value to the overall cohort, and be considered accordingly.
On the QRI side, FDA will prioritize institutions that are U.S.-organized legal entities with a U.S. principal place of business and U.S.-based core advisory personnel, that commit to providing nonclinical, CMC, and clinical advisory support for the specific IND program, and that commit to supporting accelerated Phase 1 trial initiation through owned infrastructure or documented partnership arrangements.
More specifically, FDA has stated that prospective QRIs will be evaluated on their documented experience across nonclinical, CMC, clinical, and (where relevant) clinical pharmacology, regulatory affairs, and program specific expertise. Another important factor for potential QRI applicants to consider is its operational capacity, whether in-house or through documented partnerships, to support Phase 1 site activation activities such as IRB review and site contracting in parallel with IND review. However, FDA has acknowledged that many prospective QRIs may not have every capability in-house and has said it will accept QRIs that supplement gaps through subcontracted experts, provided the QRI remains primarily responsible for assessing application submission readiness.
Eligibility and Conflict-of-Interest Considerations
FDA has stated that identifying and managing conflicts between sponsors and QRIs is the responsibility of the participating organizations. A particular issue arises where a QRI also owns or operates an IRB reviewing the same protocol. In that scenario, FDA requires written procedures ensuring IRB members do not simultaneously hold a role on the QRI’s pilot advisory team. Subject matter experts from the QRI may still be invited to advise the IRB on complex issues, consistent with 21 C.F.R. § 56.107(f).[ii]
FDA expects QRIs to maintain written conflict of interest (COI) procedures, available to FDA on request, addressing (i) disclosure of financial, employment, collaborative, and personal relationships, (ii) a process for assessing whether a conflict is manageable, and (iii) mitigation procedures for such conflict management.
Sponsors and QRIs should consider building this separation into governance documents, and thoroughly evaluating other potential areas of COI risk before applying, as FDA has stated that a compromised QRI-sponsor pair will be removed from the pilot.
Looking Forward
With roughly six weeks before the application deadline, sponsors seeking to participate in the Program with a qualifying FIH program may want to begin identifying, evaluating, and formalizing a QRI relationship. If proceeding with an application, sponsors and their prospective QRIs should put in place conflict-of-interest procedures before applying, particularly where the QRI has any IRB affiliation.
FDA has said it expects to select only 8 to 10 sponsor-QRI pairs for the initial cohort, so the Program will reach a small fraction of sponsors with qualifying programs this cycle. It is also not yet clear how FDA will handle a sponsor-QRI pair that is removed from the Program mid-stream, including whether that IND reverts to standard review timelines or carries any residual disadvantage. The rolling submission format is itself untested at scale, and sponsors should expect some friction as FDA and QRIs calibrate real-time issue resolution during the pilot’s early months. FDA has indicated the Program is intended to generate evidence toward a possible future accreditation model for QRIs, but has not committed to expanding or continuing the Program beyond this initial cohort.
Key Takeaways
- Application Timeline and Selection Process:*
- September 15: FDA opened the application window for the Expedited IND Pilot Program.
- October 30: Deadline for sponsors to submit applications.
- December 18: FDA expects to select the Program cohort and notify all applicants of their status.
*Per FDA, these dates may shift depending on submission volume.
- The Program creates a new, voluntary path to pair sponsors with a Qualified Research Institution for rolling, collaborative IND review, without changing FDA’s underlying safety or scientific standards.
- Applications are due October 30, 2026, with FDA expecting to notify the initial cohort of 8 to 10 sponsor-QRI pairs by mid-December.
- Conflict-of-interest management, particularly where a QRI also operates an IRB, is a documented compliance obligation, not a formality, and FDA has said it will remove compromised pairs from the pilot.
- With a competitive, small cohort and a compressed application window, sponsors with a qualifying program should begin evaluating fit and formalizing a QRI relationship now.
FOOTNOTES
[i] U.S. Department of Health and Human Services, Operation TrialBlazer, https://www.hhs.gov/sites/default/files/operation-trialblazer.pdf.
[ii] 21 C.F.R. § 56.107(f).