FDA Expedited IND Pilot Program

Duke is Accepting Expressions of Interest Through October 2, 2026

The Duke University School of Medicine, including the Office of Regulatory Affairs & Quality (ORAQ), is accepting applications from sponsors interested in partnering with Duke as a prospective Qualified Research Institution (QRI) for the FDA Expedited Investigational New Drug (IND) Pilot Program. The pilot is intended to evaluate new approaches for accelerating first-in-human (FIH) clinical development through collaboration between sponsors and QRIs, while maintaining FDA's standards for participant safety and scientific oversight.

Submit an Interest Form

Survey Deadline: October 2, 2026, at 5:00 PM ET

Notification of Duke Selection Decisions: Targeting October 9, 2026

Application Survey: Interest Form

Duke is seeking to participate as a Qualified Research Institution (QRI) because of its strong track record supporting novel drug and biologic development and its ability to provide integrated expertise across regulatory affairs, nonclinical development, CMC and manufacturing, clinical research, product development, GTP/GMP quality systems, and program management. Through ORAQ and Duke's broader research ecosystem, sponsors can access the multidisciplinary support needed to efficiently advance innovative therapies toward first-in-human clinical trials.

Sponsors selected by Duke will work collaboratively with ORAQ and Duke subject matter experts to prepare a joint Sponsor/QRI submission package for FDA consideration before the FDA application deadline of October 30, 2026. FDA evaluates Sponsor and QRI applications as a single package. 

Please note that completion of the interest survey does not guarantee selection by Duke or participation in the FDA pilot program.

About the FDA Expedited IND Pilot Program

The FDA Expedited IND Pilot Program is designed to assess whether a new collaborative framework between sponsors and QRIs can:

• Accelerate preparation of first-in-human IND submissions
• Support rolling submission and review of IND components
• Improve development efficiency through coordinated scientific and regulatory planning
• Facilitate earlier identification and resolution of regulatory issues
• Potentially reduce time from IND-enabling activities to clinical trial initiation

Under the pilot, sponsors partner with a designated QRI that provides expertise across key disciplines including regulatory strategy, nonclinical development, manufacturing and CMC, clinical development, project management, and FDA interactions. Sponsors retain ownership of and responsibility for their IND submissions throughout the process. 

For complete program details, visit the FDA webpage: FDA Expedited IND Pilot Program.

Who Should Apply?

Sponsors may wish to apply if they:

• Are developing a novel therapeutic product regulated by CDER or CBER
• Intend to submit a commercial IND
• Are planning a U.S.-based Phase 1 first-in-human clinical trial
• Have sufficient supporting development information to allow evaluation of project readiness
• Are willing to participate in the pilot's rolling submission model and associated evaluation activities

FDA will ultimately determine eligibility and participant selection for the pilot program. 

Confidentiality

Information submitted through the interest survey will be reviewed only by the Duke evaluation team and treated as confidential. 

Duke Review Process

Applications received by October 2, 2026 will be reviewed by Duke leadership’s cross-functional evaluation team. Due to the FDA deadline of October 30, 2026, decisions will be made quickly with a target to communicate by October 9, 2026.

The review will consider:

• Fit with FDA pilot program objectives
• Scientific and regulatory readiness
• Alignment with Duke expertise and available resources
• Likelihood of successfully developing a competitive joint Sponsor/QRI application
• Feasibility of meeting FDA timelines

Additional Regulatory Support Opportunities

Sponsors not selected to partner with Duke for the FDA Expedited IND Pilot Program may still benefit from Duke's extensive regulatory and translational development expertise. ORAQ provides support across the product development lifecycle from Phase 1 to commercialization, including regulatory strategy, FDA engagement, IND authoring and submission, regulatory publishing, GMP quality system expertise, analytical testing and method development, and FDA inspection management and readiness. Opportunities to engage ORAQ for services are available through separate contractual agreements and are not dependent upon participation in the QRI initiative.

Organizations interested in regulatory support are encouraged to learn more about ORAQ's Regulatory Services and submit a request through our regulatory services consultation request form. 

Questions?

For questions regarding Duke's interest process, please contact:

Amanda Parrish, PhD, RAC
Office of Regulatory Affairs & Quality (ORAQ)
amanda.b.parrish@duke.edu