Department of Defense Post-traumatic Stress Disorder Adaptive Platform Trial Regulatory Sponsor Partner

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC in support of the U.S. Army Medical Materiel Development Activity (USAMMDA). Proposals selected for award as a result of this RPP will be awarded under the authority of 10 U.S.C. § 4022. Strategic oversight for the award(s) supported by this RPP will be provided by USAMMDA.

The overall objective of effort is to identify organizations that are willing and able to fulfill responsibilities as the regulatory sponsor of clinical trial protocol S-21-02 entitled, “A Phase 2, Multi-Center, Multi-Arm, Randomized, Placebo-Controlled, Double-Blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Therapeutic Interventions in Active-duty Service Members and Veterans with Post-traumatic Stress Disorder” (NCT05422612). Expected enrollment for this trial is expected to begin in June 2023. The U.S. Department of Defense (DoD) is funding and has established this post-traumatic stress disorder (PTSD) adaptive platform trial (APT). The team is now seeking interested partners to serve as the regulatory sponsor and holder of the existing Master Protocol Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).

Scope of Work

This RPP focuses on identifying an organization capable of serving as the regulatory Sponsor to hold the existing Master Protocol IND application to the FDA for the DoD PTSD APT, scheduled to begin enrollment the second quarter of 2023. The DoD Warfighter Brain Health Project Management Office (WBH PMO) requires a partnership with a regulatory Sponsor who will include the WBH PMO as part of the Sponsor Organization.

The replacement regulatory sponsor will work closely with the WBH PMO PTSD-DT PdM, and must be willing and able to interact with the other partners described above, with the exception of the current regulatory sponsor, in coordination with the WBH PMO. It is the intent that a contractual relationship with the new regulatory sponsor would be executed under the MTEC Other Transactional Agreement (OTA). Interested parties are encouraged to review the MTEC Base Agreement, which includes the overarching terms and conditions from the OTA for prototype projects between the Government and MTEC that all Research Project Awardees are expected to agree to.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.