Overview of Grant Program
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 PASA Consortium accepts applications for study funding during open solicitation periods. The exact number and type of studies approved during each solicitation period will depend on the quantity and quality of applications received and amount of available funding. Notices of study application solicitation periods will be posted here on the PASA Consortium’s website, publicly advertised via professional organization e-mail list serves and conference postings, and distributed to investigators, pharmaceutical companies, and academic research institutes that are known to have potentially viable candidate compounds. Please check here regularly for funding announcements and updates.
Current Funding Opportunities
The two current 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:
a. Conduct of proof-of-principle basic research to determine which compounds are most appropriate for human research trials; or
b. Conduct of human proof-of-concept trials with promising compounds. The human trials must be ready-to-implement as defined in the RFA.
Links for downloading the RFAs are provided below.
- Links to Current RFAs
- Application Forms and Templates
- August 22, 2018 - Letter of Intent for RFA 3b: Full Study Implementation Grant
- August 22, 2018 - Full Application for RFA 3a: Planning Grant
- September 19, 2018 - Full Application for RFA 3b: Full Study Implementation Grant
FAQs for PASA RFA#3 (FY18, Round 1)
Q1: For basic research, are you also encouraging applications for combined animal models of TBI and ASUD or combined models of PTSD and ASUD only?
A1: Combined models of TBI with ASUD are appropriate and will be considered. A justification of the potential of the compound for use to treat ASUD and TBI should be included.
Q2: Will applications for basic science research be accepted from institutions outside of the U.S.?
A2: Yes, basic science applications from institutions outside of the U.S. will be accepted and considered. However, human clinical trials from other countries will need prior approval from the PASA Management Core to determine the U.S. military relevance of the study population.
Q3: Is transcranial direct-current stimulation something that your consortium would be interested in, even though it is not a pharmacotherapy?
A3: Unfortunately, transcranial direct-current stimulation is not something we are pursuing at this time. The current grants are specifically looking for pharmacotherapy research ideas.
Q4: We are interested in investigating the use of a commercially available medication for heavy drinking smokers with PTSD. In our previous conversations with the manufacturing pharmaceutical company, they are not interested in pursuing a new indication of the medication for alcohol use. In light of not working with a pharmaceutical company, would this project be a fit for this program?
A4: Commercially available medications can be proposed, but should be commercially viable for obtaining sponsorship to obtain a new drug (NDA) through the FDA approval process. In the RFA, we note the following recommendations and evaluation criteria:
- A demonstrated relationship with a pharmaceutical company with a path to eventual marketing of the pharmacotherapy will be a factor in the award selections.
- Whether the investigators demonstrate an ability via pharmaceutical collaboration or otherwise for compound to continue to progress long term on regulatory pathway.
A pathway to commercial viability is a topic that you will need to specifically address in your application.
Q5: We have a VAMC here, however, we have not been able to engage them with research studies such as this. Is that something PASA could assist with? We would very much like to collaborate with them, as it is a mid-size city that serves a relatively large VA population.
A5: The Management Core is available to facilitate collaboration between applicants and military and Veteran medical centers. The Consortium also has contacts at many VA medical centers and military treatment facilities that can be used to establish collaborators and clinical sites to support clinical studies
Q6: If unable to collaborate with the local VAMC, is community recruitment with a focus on recruiting Veterans or active Military Personnel a fundable recruitment strategy, or is collaboration with a VAM required?
A6: Collaboration with a VAMC or military treatment facility is not an absolute requirement. However, the military relevance of the study population must be well established. You should be guided by Section I.E of RFAs.
Q7: With reference to the RFA issued, are applications from a private company such as ours are acceptable both for 3a and 3b grants?
A7: Any institution can apply; however, a VA/military affiliation of an investigator is expected, and the study population should generally from a VA or military base. The proposal does not prohibit other sites but does note that a lack of focus on military and/or veterans will likely not be positively reviewed and that the anticipation is that the study will be largely conducted in the military and VA setting. Applications should address topics with a focus on military SMs and Veterans. The Management Core is available to facilitate collaboration between applicants and military and Veteran medical centers. The Consortium also has contacts at many VA medical centers (VAMCs) and military treatment facilities (MTFs) that can be used to establish collaborators and clinical sites to support clinical studies.
Q8: An existing collaboration between a military medical center and pharmaceutical group is looking at a promising novel acetaminophen analog that has demonstrated morphine like efficacy without hitting the opioid receptor nor having addiction potential. Currently this compound is funded by the DoD to complete a phase Ia safety study in healthy subjects. Would the exploration of novel non-opioid analgesics for surgical procedures in AUSD/OUD/PTSD/TBI populations be responsive to this RFA?
A8: We have discussed your question with our DoD client. They have indicated that the type of compound and study described in your question would be responsive to the RFA. We encourage you to apply to one of the 2 RFAs depending on the stage of your clinical development plans. It will still be important to demonstrate the military service member (SM) or Veteran relevance of your compound and the ability to include SMs or Veterans in a study.
Q9: We are assuming that the pre-submission teleconference is with successful letter of intent’s only. Could you please let us know what is the expected turn-around of the decision on the letter of intent and thus the approximate window of time available to have the teleconference and complete the full application?
A9: The pre-submission teleconference will be with all groups with submitted letters of intent. The intent of the call is to address any major comments/questions you or we have regarding whether the study is at the stage required for this funding application and also to provide you a quick background of the support that the PASA consortium provides for studies to help you know what you have to budget/plan for in your proposal. Therefore, we may make recommendations during the call regarding your proposal but all groups submitting a LOI will be able to submit a full application.
Q10: I don’t see any language in the above noted RFAs with regards to Multi-PI applications. Would you consider an application submitted with multi-PI leadership plans?
A10: Yes, applications with multi-PI leadership plans are welcome. On page 7 of the Full Study RFA you will find that the PI and any co-PIs need to be listed in the letter of intent and at the grant application submission phase please note that all PIs will need to demonstrate they are suited to the project and have ongoing record of accomplishments.
Q11: In Section B.1 of the PASA SRPP RFA3b, the list of information in the LOI lists 'The status of the IND submission to the FDA concerning the trial.' We're in the process of preparing a submission and would like to know if this component is necessary for the Basic Research applications?
A11: To answer your question on the requirement of 'The status of the IND submission to the FDA concerning the trial' within the LOI, only Human Proof-of-Concept Trials need an IND application to have been submitted to the FDA prior to application. For a basic science study this is not required.