Opportunity Information: Apply for W81XWH 09 PRMRP TTDA
Apply for W81XWH 09 PRMRP TTDA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Peer Reviewed Medical Research Program Technology/Therapeutic Development 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 Jan 29, 2009 and posted on Jan 29, 2009.
- Applicants must submit their applications by Apr 16, 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 $5,800,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 DoD Peer Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development Award (TTDA) is a Department of the Army (USAMRAA) funding opportunity designed to move strong preclinical research results toward real-world medical products that can be used in clinical settings. The core purpose is translation: taking promising laboratory or animal-model findings and advancing them along the development pathway so they are positioned for early clinical trials or for practical deployment. Projects must fit within at least one of the congressionally directed FY09 PRMRP topic areas and must be framed around clear health care needs affecting the Armed Forces, their family members, and/or U.S. Veterans. A central requirement is that the application explicitly explains military relevance in a concrete way rather than treating it as a general statement of potential benefit.
This program is focused on product-driven outcomes rather than basic discovery. The kinds of deliverables envisioned include pharmacologic agents (traditional drugs or biologics), medical devices (diagnostic or therapeutic), and even clinical guidance when it can be supported by rigorous data development and validation. In practice, the award is meant to pay for the expensive and technically demanding steps that stand between a compelling preclinical concept and a clinical-ready product, such as manufacturing scale-up, regulated preclinical testing, and preparation of regulatory submissions. Collaboration with military researchers and clinicians is encouraged, reflecting the program goal of keeping proposed products grounded in operational military medicine needs and realistic implementation environments.
The announcement lists several examples of supported work that illustrate the intended “late preclinical to early clinical†maturity level. These include collecting and analyzing data specifically to develop and validate clinical guidance; testing new therapeutic modalities such as novel agents, delivery systems, or chemically modified lead compounds using established models or validated new preclinical systems; and establishing Good Manufacturing Practice (GMP) production at pilot or full scale for therapeutics and/or delivery systems intended for advanced preclinical studies or initial clinical trials. For drugs and biologics, the scope can include key development work like ADMET (absorption, distribution, metabolism, excretion, and toxicity) studies, as well as advancing a candidate to the Investigational New Drug (IND) stage, which is typically the regulatory threshold needed to begin Phase I human trials. For devices, the program can support development of prototypes up to the Investigational Device Exemption (IDE) stage, commonly needed to initiate early clinical testing, and it can also support optimization of diagnostic or treatment devices for field deployment, which is especially relevant for military settings where ruggedization, portability, usability, and environmental constraints matter.
A defining feature of the TTDA is the requirement for a credible transition plan. The Principal Investigator must lay out how the product will continue moving forward after the award ends, including what funding sources, partners, and resources are expected to carry the work into clinical trials and/or into delivery pathways for the military or the broader civilian market. This pushes applicants to think beyond the research plan and address practical translation issues such as regulatory strategy, manufacturing and quality systems, potential commercialization or military acquisition paths, and the partnerships needed to sustain development once PRMRP support concludes.
Administratively, the opportunity was posted January 29, 2009, with an application deadline of April 16, 2009, and an archive date of May 16, 2009. The total estimated funding was $5.8 million with an expected two awards, indicating a competitive, high-investment mechanism intended for projects with a clear development trajectory and strong justification for why the work is ready for technology/therapeutic development support. The funding instrument type is listed as cooperative agreement/grant, and there is no cost sharing or matching requirement. Eligibility is described as unrestricted, meaning applications could come from a wide range of organizations, subject to any additional eligibility clarifications in the full announcement. The CFDA listing is 12.420 (Military Medical Research and Development), and applicant support contacts were provided through CDMRP/USAMRAA help channels for both announcement access and electronic submission assistance.
FAQs: DoD PRMRP Technology/Therapeutic Development Award (TTDA)
What is the PRMRP Technology/Therapeutic Development Award (TTDA)?
The TTDA is a Department of Defense Peer Reviewed Medical Research Program (PRMRP) funding opportunity administered by the Department of the Army (USAMRAA). It is designed to move strong preclinical research results toward real-world medical products that can be used in clinical settings.
What is the main goal of this award?
The core goal is translation: advancing promising laboratory or animal-model findings along a development pathway so they are positioned for early clinical trials or practical deployment. The emphasis is on product-driven outcomes rather than basic discovery research.
What kinds of projects are a good fit for TTDA?
Projects that are beyond early discovery and are ready for late-preclinical to early-clinical development steps are the best fit. The opportunity supports technically demanding and costly work needed to progress a candidate product toward IND/IDE readiness or toward real-world field deployment.
What topic areas must a project address?
Projects must fit within at least one of the congressionally directed FY09 PRMRP topic areas and must be framed around clear health care needs affecting the Armed Forces, their family members, and/or U.S. Veterans.
How should an applicant address military relevance?
Military relevance must be explained explicitly and concretely. The application is expected to connect the proposed product and development plan to specific health care needs affecting Service Members, military families, and/or Veterans, rather than relying on a general statement of possible benefit.
What types of deliverables does the program expect?
The program envisions deliverables such as pharmacologic agents (traditional drugs or biologics), medical devices (diagnostic or therapeutic), and clinical guidance when it is supported by rigorous data development and validation.
Does TTDA support basic science or early-stage discovery?
Based on the stated purpose, TTDA is focused on product-driven outcomes and translation from strong preclinical results. It is intended to fund the work between a compelling preclinical concept and a clinical-ready product, rather than basic discovery.
What examples of supported work are listed in the announcement?
Examples include collecting and analyzing data to develop and validate clinical guidance; testing new therapeutic modalities (novel agents, delivery systems, or chemically modified lead compounds) using established models or validated new preclinical systems; and establishing GMP production at pilot or full scale for therapeutics and/or delivery systems intended for advanced preclinical studies or initial clinical trials.
What drug and biologic development activities may be supported?
For drugs and biologics, the scope can include key development work such as ADMET (absorption, distribution, metabolism, excretion, and toxicity) studies and advancing a candidate to the Investigational New Drug (IND) stage, which is typically the regulatory threshold needed to begin Phase I human trials.
What device development activities may be supported?
For devices, the program can support development of prototypes up to the Investigational Device Exemption (IDE) stage, which is commonly needed to initiate early clinical testing. It can also support optimization of diagnostic or treatment devices for field deployment, including considerations like ruggedization, portability, usability, and operation under environmental constraints relevant to military settings.
Does the program encourage collaboration with military partners?
Yes. Collaboration with military researchers and clinicians is encouraged to help ensure the proposed product is grounded in operational military medicine needs and realistic implementation environments.
What is a transition plan, and is it required?
A credible transition plan is a defining requirement of the TTDA. The Principal Investigator must describe how the product will continue moving forward after the award ends, including expected funding sources, partners, and resources to carry the work into clinical trials and/or into delivery pathways for the military or the broader civilian market.
What should a transition plan cover?
Based on the description provided, the transition plan should address how development will continue after PRMRP support concludes, including practical translation issues such as regulatory strategy, manufacturing and quality systems, potential commercialization or military acquisition paths, and partnerships needed to sustain development.
What is the funding mechanism for this opportunity?
The funding instrument type is listed as a cooperative agreement/grant.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning applications could come from a wide range of organizations, subject to any additional eligibility clarifications in the full announcement.
How much funding is available and how many awards are expected?
The total estimated funding is $5.8 million, with an expected two awards. This suggests a competitive, high-investment mechanism intended for projects with a clear development trajectory.
What were the key dates for the posted opportunity?
The opportunity was posted on January 29, 2009. The application deadline was April 16, 2009, and the archive date was May 16, 2009.
What does the CFDA number 12.420 refer to?
The CFDA listing provided is 12.420, identified as Military Medical Research and Development.
Where could applicants get help with the announcement or submission?
Applicant support contacts were provided through CDMRP/USAMRAA help channels for both announcement access and electronic submission assistance.
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