DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: March 20, 2019

Pharmacotherapies for Alcohol and Substance Abuse (PASA) Consortium
Congressionally Directed Medical Research Program
Alcohol and Substance Abuse Disorders Research Program
Research Funding Opportunities

The goal of the PASA Consortium is to fund study applications for developing new medications that can be brought to therapeutic use to improve treatment outcomes for alcohol and substance use disorders (ASUD), especially as related to post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). The two upcoming Research Funding Opportunities are focused on: 

  1. Request for Application (RFA) #4a: Small-cost and short-duration planning grant awarded to investigators concerning a specific compound or combination of compounds. Designed to determine the clinical development plan (CDP) and associated studies needed to advance the compound to FDA approval for ASUD treatment.
  2. Request for Application (RFA) #4b: Full study implementation awards for proof-of-principle basic research to determine which compounds are most appropriate for human research trials.

The RFAs are available from the PASA Consortium website at: https://pasa.rti.org/About/Grant-Program

The PASA Consortium is administered by a Management Core led by RTI International in collaboration with the Baylor College of Medicine. The Management Core is responsible for soliciting and prioritizing applications. Successful applications will be selected by a Government Steering Committee formed by the U.S. Department of Defense. The Management Core will provide oversight and coordination for future proof-of-principle basic research studies and proof-of-principle human clinical trials supported by the Consortium. The Management Core will provide the administrative, protocol development and review, regulatory, statistical, resource, and data management/storage functions necessary to facilitate rapid development of research that would perhaps not otherwise be feasible without the Consortium approach. The Management Core contains multidisciplinary expertise and experience in support of ASUD research. The Management Core will coordinate the regulatory strategy for FDA compliance, in collaboration with the industry sponsor, leading to potential product development and licensing. Additional information about PASA is available on its website:  https://pasa.rti.org/.


Award Mechanism Eligibility Key Mechanism Elements Funding & Period of Performance
RFA #4a Planning Grants

Subcontract
Independent investigators at all academic levels (or equivalent) Small-cost and short-duration planning grant awarded to investigators concerning a specific compound or combination of compounds. Designed to determine the clinical development plan (CDP) and associated studies needed to advance the compound to FDA approval for ASUD treatment. The protocol for the first study will be developed as part of the planning grant and will be considered for funding and implementation by the PASA Consortium.

Preference will be given to compounds that have potential value to a pharmaceutical company to gain support for final development by the company. Participation in the grant by a company will be highly valued.

Maximum total costs of $150,000.

Maximum period of performance is 9-12 months.

RFA #4b Full study implementation awards

Subcontract
Independent investigators at all academic levels (or equivalent) Full study implementation awards for proof-of-principle basic research to determine which compounds are most appropriate for human research trials.

Discovery of new medications for ASUD and PTSD can greatly benefit from animal models of these disorders. Medications can reduce the aberrant behaviors in these models of PTSD and ASUD and potential dosages of these medications can be estimated for human studies.

Maximum total costs of $295,000.

Maximum period of performance is 18 months.


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Last updated Wednesday, March 27, 2019