Opportunity Information: Apply for W81XWH 09 PHTBI ATTDA
Apply for W81XWH 09 PHTBI ATTDA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "Psychological Health and Traumatic Brain Injury Advanced Technology/Therapeutic Devleopment Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on Jul 16, 2009 and posted on Jul 10, 2009.
- Applicants must submit their applications by Oct 28, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $24,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program Advanced Technology/Therapeutic Development Award is a Department of Defense funding opportunity designed to push promising PH and TBI solutions closer to real-world use, especially in military settings. Instead of focusing on basic discovery research, this mechanism is built for projects that can demonstrate whether a new product or approach is scientifically ready and practical for deployment or adoption, including the unique constraints of operational environments. The program is looking for work that can plausibly lead to tangible outcomes such as treatments, preventive interventions, diagnostic or detection tools, deployable devices, validated clinical guidance, or other emerging technologies that improve care for psychological health conditions and/or traumatic brain injury.
A defining requirement is clear military relevance. Applicants must directly explain why the problem matters to Service members, how the proposed solution fits military needs, and how it could be used in the field or within the military health system. Just as important, each Principal Investigator (PI) must provide a serious transition plan that lays out the next steps after the award ends. That plan is expected to address what funding, partners, manufacturing or production capabilities, regulatory strategy, and other resources will be used to move the product toward clinical trials and/or delivery into the military marketplace. The overarching purpose is acceleration: getting improved PH/TBI therapies and technologies into clinical practice faster by supporting late-stage preclinical development, translational work, and early clinical evaluation where appropriate.
The scope of supported research is intentionally broad as long as it advances a concrete product or deliverable. Examples listed in the announcement include collecting and analyzing data to develop and validate clinical guidance; creating and refining behavioral or cognitive interventions; testing therapeutic modalities such as new agents, delivery systems, or chemically modified lead compounds in established or validated preclinical systems; comparing activity or efficacy across a small set of candidate agents to select a single lead; and running pilot or full-scale Good Manufacturing Practice (GMP) production efforts so a therapeutic or delivery system is suitable for advanced preclinical studies and initial clinical trials. For drug and biologic development, the program allows work through ADMET (absorption, distribution, metabolism, excretion, and toxicity) and can support progress up to an Investigational New Drug (IND) stage in preparation for Phase I trials. For device efforts, it can support prototype development and optimization up to an Investigational Device Exemption (IDE) stage for early clinical testing. The announcement also notes support for generating safety and efficacy data in Phase I or Phase I/II studies, developing and validating assays and reagents to measure biological responses and molecular endpoints, building and validating computational models, and optimizing diagnostic or treatment devices specifically for field deployment.
While preliminary data is preferred, it is not strictly required. Proposals that already have relevant preliminary or published findings are viewed favorably because they suggest a higher likelihood of successful advancement within the award period, but the program states that not having such data will not automatically disqualify an application. The key expectation is that the work is mature enough to justify an “advanced development†award and that the project plan credibly moves an intervention or technology toward real implementation.
To speed progress and encourage stronger translational teams, the program offers a Partnering PI option. Under this structure, up to three PIs can jointly design one integrated project, with one designated as the Initiating PI (handling most submission administration) and up to two Partnering PIs completing their own required submission tasks. The intent is genuine co-development with a reciprocal exchange of ideas and equal intellectual contribution, not a token partnership where one site merely provides samples, services, or patient access. Separate awards are issued to each PI’s institution, and the mechanism supports multidisciplinary and multi-institutional projects. For multi-institution efforts, the application is expected to include concrete plans for communication, coordination, data transfer, and how specimens and imaging outputs will be handled. Participating institutions must also be prepared to resolve intellectual property and material transfer issues and remove barriers that could undermine collaboration; a separate intellectual and material property plan agreed upon by all institutions is required for multi-institution research.
For applications that involve clinical research in humans, the announcement calls for fundamentals that reviewers will look for: clearly defined and appropriate clinical endpoints, a well-articulated statistical analysis plan, and a clear explanation of how the results could affect patients with the target condition. A named study coordinator is expected for clinical submissions, with responsibilities that include guiding the protocol through regulatory approvals (such as local Institutional Review Boards and DOD-specific boards), coordinating multi-site activities when relevant, and supporting participant recruitment and accrual.
The opportunity strongly encourages alignment with Department of Defense and Department of Veterans Affairs research programs and laboratories, reflecting the emphasis on military relevance and real pathways to adoption. The announcement points applicants to multiple DOD and VA resources and organizations (for example, the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, DVBIC, DARPA, service research laboratories, and VA research offices) as places to identify related efforts and potential collaboration opportunities. The message is that projects that connect to existing military priorities, infrastructure, and translation pathways are more likely to fit the award’s intent.
If a project proposes to use military populations, there are specific access and coordination expectations. For Active Duty, National Guard, and Reserve populations outside the CENTCOM area, investigators without an established Service member population must coordinate access through CDMRP and should not contact unit commanders during proposal preparation. For CENTCOM-area populations (such as in Iraq or Afghanistan, as described in the FY09-era text), access is described as highly constrained and subject to in-theater oversight, command approvals, and specific IRB review processes; investigators without existing, appropriate military collaborations are cautioned to consider alternatives due to operational and approval constraints. For VA Medical Center patient populations or VA data systems, access must be coordinated by the PI, and investigators without a VA appointment must include a collaborator who has a VA appointment and can serve as PI for the VA component.
Human subjects protections are treated as a major practical consideration. Any DOD-funded research involving human subjects or human biological substances must undergo review not only by local IRBs but also by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO). The announcement emphasizes that DOD requirements are rigorous and may require additional information beyond what local boards request, and applicants are advised to plan for at least six months for regulatory review and approvals for studies involving human subjects. In other words, a realistic timeline and regulatory strategy is part of feasibility.
Administrative details in the listing identify this as a discretionary opportunity from the Department of the Army/USAMRAA under CFDA 12.420 (Military Medical Research and Development), with an estimated total funding amount of $24,000,000 and an expectation of around three awards. The funding instrument is listed as a cooperative agreement and/or grant, with eligibility described as unrestricted (open to any entity type, subject to any additional eligibility notes in the full announcement). The specific opportunity reference provided is W81XWH-09-PHTBI-ATTDA, originally posted in July 2009 with an October 28, 2009 closing date (and later archived), which mainly matters for historical context but still clearly illustrates the program’s structure and expectations for advanced-stage translational PH/TBI development work.
Frequently Asked Questions (FAQs)
What is the PH/TBI Research Program Advanced Technology/Therapeutic Development Award?
It is a Department of Defense funding opportunity under the Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program intended to move promising PH and TBI products and approaches closer to real-world use, especially in military settings. The focus is on advanced development and translation rather than basic discovery research.
What kinds of outcomes is this award trying to produce?
The opportunity is aimed at tangible deliverables that could realistically be adopted or deployed, such as treatments, preventive interventions, diagnostic/detection tools, deployable devices, validated clinical guidance, or other emerging technologies that improve care for psychological health conditions and/or traumatic brain injury.
Is basic discovery research a good fit for this mechanism?
No. The mechanism is designed to test whether a product or approach is scientifically ready and practical for deployment or adoption. It is positioned for late-stage preclinical development, translational work, and early clinical evaluation (where appropriate), rather than early discovery.
What does "military relevance" mean for this award?
Applicants are expected to directly explain why the problem matters to Service members, how the proposed solution fits military needs, and how it could be used in operational environments or within the military health system. Military relevance is described as a defining requirement.
What is a transition plan, and why is it required?
Each Principal Investigator (PI) must provide a serious transition plan describing what happens after the award period ends. The plan is expected to address items like follow-on funding, partners, manufacturing or production capabilities, regulatory strategy, and other resources needed to move the product toward clinical trials and/or delivery into the military marketplace.
What types of research activities are within scope?
The scope is intentionally broad as long as the work advances a concrete product or deliverable. Examples include: developing and validating clinical guidance (data collection and analysis); creating/refining behavioral or cognitive interventions; testing therapeutic modalities (new agents, delivery systems, chemically modified lead compounds) in established or validated preclinical systems; comparing a small set of candidate agents to select a single lead; and conducting pilot or full-scale Good Manufacturing Practice (GMP) production so a therapeutic or delivery system is suitable for advanced preclinical studies and initial clinical trials.
Does the program support drug and biologic development work up to IND?
Yes. For drug and biologic development, the announcement allows work through ADMET (absorption, distribution, metabolism, excretion, and toxicity) and can support progress up to an Investigational New Drug (IND) stage in preparation for Phase I trials.
Does the program support device development work up to IDE?
Yes. For devices, the award can support prototype development and optimization up to an Investigational Device Exemption (IDE) stage for early clinical testing.
Can the award support early clinical studies?
The announcement notes support for generating safety and efficacy data in Phase I or Phase I/II studies, where appropriate, along with the associated translational elements needed to credibly move toward implementation.
Are assays, reagents, and computational models allowed under this mechanism?
Yes. The announcement mentions developing and validating assays and reagents to measure biological responses and molecular endpoints, building and validating computational models, and optimizing diagnostic or treatment devices specifically for field deployment.
Is preliminary data required to apply?
Preliminary data is preferred but not strictly required. Applications that already have relevant preliminary or published findings are viewed favorably because they suggest a higher likelihood of successful advancement within the award period, but a lack of preliminary data is not stated to be an automatic disqualifier.
What is the main maturity expectation for proposed work?
The work should be mature enough to justify an "advanced development" award and should credibly move an intervention or technology toward real implementation (including practicality in operational or military health system contexts).
What is the Partnering PI option?
The program offers a structure where up to three PIs can jointly design one integrated project. One PI serves as the Initiating PI (handling most submission administration), and up to two others serve as Partnering PIs who complete their own required submission tasks.
What qualifies as a real partnership under the Partnering PI option?
The intent is genuine co-development with reciprocal exchange of ideas and equal intellectual contribution. The announcement explicitly distinguishes this from arrangements where one site only provides samples, services, or patient access as a token partnership.
How are awards handled when there are multiple PIs and institutions?
Separate awards are issued to each PI's institution. The mechanism supports multidisciplinary and multi-institutional projects, but expects clear planning for communication, coordination, and operational execution across sites.
What coordination plans are expected for multi-institution research?
Applications are expected to include concrete plans for communication, coordination, data transfer, and how specimens and imaging outputs will be handled. Participating institutions must be prepared to resolve intellectual property and material transfer issues and remove barriers that could undermine collaboration.
Is an intellectual and material property plan required for multi-institution projects?
Yes. The announcement indicates that a separate intellectual and material property plan agreed upon by all participating institutions is required for multi-institution research.
What are reviewer expectations for clinical research applications?
For clinical research in humans, the announcement highlights fundamentals reviewers will look for: clearly defined and appropriate clinical endpoints, a well-articulated statistical analysis plan, and a clear explanation of how results could affect patients with the target condition.
Is a study coordinator required for clinical submissions?
Yes. A named study coordinator is expected for clinical submissions, with responsibilities that include guiding the protocol through regulatory approvals (including local IRBs and DOD-specific boards), coordinating multi-site activities when relevant, and supporting participant recruitment and accrual.
Are applicants encouraged to align with DOD and VA programs and labs?
Yes. The opportunity strongly encourages alignment with Department of Defense and Department of Veterans Affairs research programs and laboratories, emphasizing that connection to existing military priorities, infrastructure, and translation pathways is likely to fit the award's intent.
Which DOD/VA organizations are mentioned as potential resources or collaborators?
The announcement points to resources and organizations such as the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, DVBIC, DARPA, service research laboratories, and VA research offices as places to identify related efforts and potential collaboration opportunities.
What if a project proposes to use Active Duty, National Guard, or Reserve populations?
For Active Duty, National Guard, and Reserve populations outside the CENTCOM area, investigators without an established Service member population must coordinate access through CDMRP and should not contact unit commanders during proposal preparation.
What if a project proposes to use CENTCOM-area military populations?
The announcement describes access to CENTCOM-area populations (as referenced in FY09-era text, such as Iraq or Afghanistan) as highly constrained. Access is subject to in-theater oversight, command approvals, and specific IRB review processes. Investigators without existing, appropriate military collaborations are cautioned to consider alternatives due to operational and approval constraints.
What if a project proposes to use VA Medical Center patients or VA data systems?
Access must be coordinated by the PI. If an investigator does not have a VA appointment, the application must include a collaborator who has a VA appointment and can serve as PI for the VA component.
What human subjects oversight applies to DOD-funded research in this program?
Any DOD-funded research involving human subjects or human biological substances must undergo review not only by local IRBs but also by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO). The announcement emphasizes that DOD requirements may be more rigorous and may require additional information beyond local board requirements.
How long should applicants plan for human subjects regulatory review and approvals?
The announcement advises planning for at least six months for regulatory review and approvals for studies involving human subjects, reflecting the rigor of DOD review processes.
Who is the sponsoring/issuing agency and what is the CFDA number?
The listing identifies the opportunity as a discretionary program from the Department of the Army/USAMRAA under CFDA 12.420 (Military Medical Research and Development).
What is the total estimated funding and how many awards are expected?
The estimated total funding amount is $24,000,000, with an expectation of around three awards.
What funding instrument is used?
The funding instrument is listed as a cooperative agreement and/or grant.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any additional eligibility notes in the full announcement.
What is the opportunity reference number and timeline in the listing?
The opportunity reference provided is W81XWH-09-PHTBI-ATTDA. It was originally posted in July 2009 with an October 28, 2009 closing date and was later archived. The listing is presented mainly for historical context while illustrating the program structure and expectations.
What is the overall purpose of the award in one sentence?
The overarching purpose is acceleration: supporting advanced-stage translational PH/TBI therapies and technologies so improved solutions reach clinical practice and military use faster.
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