DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: June 28, 2018

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) #3a: Small-cost and short-duration planning grants awarded to investigators concerning a specific compound or combination of compounds.
  2. Request for Application (RFA) #3b: Full study implementation awards for either:
    1. Conduct of proof-of-principle basic research to determine which compounds are most appropriate for human research trials; or
    2. Conduct of human proof-of-concept trials with promising compounds. The human trials must be ready-to-implement as defined in the RFA.

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 #3a Planning Grants

Subcontract
Independent investigators at all academic levels (or equivalent) Small-cost and short-duration planning grants may be awarded to an investigator concerning a specific compound or combination of compounds. These grants are designed to determine the clinical development plan (CDP) needed to advance the compound to FDA approval for ASUD treatment through a series of studies, some of which might be funded through 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 $30,000

Maximum period of performance is 6 months

RFA #3b Full study implementation awards

Subcontract
Independent investigators at all academic levels (or equivalent) Letter of intent to submit and a pre-submission teleconference with the PASA Management Core is required.

Awards will be made in three areas.

Basic Research:
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.

Phase 1 Trials:
Phase 1 studies involve medical safety assessments and some surrogate markers of clinical efficacy in ASUD possibly with comorbid PTSD. Studies might examine the effects of administering alcohol, or some other abused drug, while taking a new medication(s). Studies of PTSD may examine the ability of a new medication(s) to reduce symptom expressions in human models of PTSD

Phase 2 Trials:
The goal of these trials is to determine if there is sufficient evidence of efficacy to support moving forward with formal Phase 3 clinical trials and, if so, to inform the study design and sample size needs of the Phase 3 trial.

Maximum total costs of:

Basic Research: $275,000
Phase 1 Trials: $700,000
Phase 2 Trials: $3,000,000

Maximum period of performance:

Basic Research: 12 months
Phase 1 Trials: 18-24 months
Phase 2 Trials: 28-32 months


Last updated Thursday, June 28, 2018