Key Takeaways:
- The Expedited Investigational New Drug (IND) Pilot Program is intended to evaluate whether leveraging qualified research institutions (QRIs) and a rolling review process can improve the efficiency of early clinical development.
- Before forming a business relationship with a QRI, sponsors should consider steps to protect intellectual property and trade secrets.
On September 15, 2026, the U.S. Federal Drug Administration’s (FDA) announced the final design of the Expedited Investigational New Drug (IND) Pilot Program.[1] The purpose of the program is to evaluate new approaches for accelerating first-in-human (FIH) clinical trials in the United States by testing a collaborative model in which sponsors work with prospective qualified research institutions (QRIs) to support more efficient drug development and a rolling submission model in an effort to change the timeline of pre-IND drug development. [2]
Sponsors are permitted to submit a participation request for a single IND submission. In making selections, FDA will prioritize 1) novel product candidates that will fall under the review jurisdiction of CDER Office of New Drugs (OND), CBER Office of Therapeutic Products (OTP), or Oncology Center of Excellence (OCE); 2) Commercial INDs for which the sponsor intends eventually submit a marketing application; 3) IND programs that will target Phase 1 First-In-Human (FIH) clinical trials that will be run in the United States and for which the investigational product does not have existing clinical experience; and 4) sponsors that have sufficient preliminary nonclinical data at the time of the application to support the FDA in evaluating the product’s proposed development timeline and IND submission timeframe. The deadline for sponsors to submit applications is October 30, 2026; on December 18, 2026, the FDA will notify all applicants of selections.[3]
Sponsors and prospective QRIs are expected to form a business relationship and to identify and manage conflict of interests external to FDA. Although the program may provide an opportunity to accelerate the timeline of product approval, sponsors should consider measures to protect their IP before forming a business relationship with a QRI and submitting an IND to the program. For example, sponsors should ensure their IP and the IP of the QRI are clearly defined. Sponsors may also consider filing provisional patent applications before engaging with QRIs and negotiating agreements, similar to IP-sensitive sponsored-research or strategic R&D agreements, before applying. Collaborative work with a QRI has the potential to produce follow-on inventions or trade secrets. Agreements with QRIs should explicitly address ownership and control of such improvements. Sponsors should also ensure that robust Non-Disclosure Agreements (NDAs) are in place so that QRI feedback and iterative reviews are not considered public disclosures that would bar patentability or trade secret protection. The FDA’s rolling review process necessitates the transfer of incremental information between internal teams, external QRIs, and the FDA. The flow of information should be managed with strict digital and contractual security to ensure that such communications are not considered public disclosures.
Questions regarding the Expedited IND Pilot Program can be sent to ExpeditedINDPilot@fda.hhs.gov , and an Educational Webinar recording is available.
Editor: Brenden S. Gingrich, Ph.D.
[1] https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development/fda-expedited-investigational-new-drug-ind-pilot-program
[2] https://www.fda.gov/industry/fda-expedited-investigational-new-drug-ind-pilot-program/expedited-ind-rolling-submission-process-and-program-structure
[3] https://www.fda.gov/industry/fda-expedited-investigational-new-drug-ind-pilot-program/expedited-investigational-new-drug-pilot-program-application-instructions
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