Opportunity Information: Apply for W81XWH 15 DMDRP IIRA
Apply for W81XWH 15 DMDRP IIRA
- 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 Duchenne Muscular Dystrophy Investigator Initiated Research 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 Jun 4, 2015 and posted on Jun 4, 2015.
- Applicants must submit their applications by Oct 21, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 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 Duchenne Muscular Dystrophy Investigator Initiated Research Award (IIRA) is a funding opportunity from the Department of the Army, administered through the Congressionally Directed Medical Research Programs (CDMRP) and tied to the Duchenne Muscular Dystrophy Research Program (DMDRP). Its central purpose is to push Duchenne muscular dystrophy (DMD) research closer to real-world clinical use by supporting translational projects that bridge laboratory findings and clinical observations. The program frames translational science as a two-way path between bench and bedside, meaning it values projects that both move promising discoveries toward patient application and also use clinical insights to refine and strengthen the underlying science in ways that make therapies more practical and testable.
This award is geared toward mid-stage to later-stage translational work rather than early discovery research. In practical terms, the IIRA is meant to support efforts that are mature enough to plausibly inform near-term therapeutic development, including early-phase, proof-of-principle clinical trials and correlative human studies that help clarify how a candidate drug, device, or intervention performs in relevant settings. Applicants can also propose well-justified preclinical studies, including work in animal models, studies involving human subjects, or research using human anatomical substances, as long as the project is clearly positioned to accelerate clinical application rather than to explore basic mechanisms for their own sake.
The announcement also draws clear boundaries around what it does not want to fund. Projects focused on target discovery, broad drug screening, mechanism-of-action work, or hypothesis-driven pathophysiology studies are explicitly excluded. In other words, the IIRA is not meant for early pipeline steps like finding a new molecular target, running large screens to identify candidate compounds, or doing primarily exploratory biology to explain disease mechanisms. Instead, it prioritizes studies that help translate an existing therapeutic concept or strategy toward human testing, clinical decision-making, or development milestones.
A notable emphasis within the opportunity is biomarker research, particularly for efforts aligned with the DMDRP focus area around discovering and qualifying pharmacodynamic, prognostic, and predictive biomarkers. The opportunity defines a biomarker broadly as any objectively measured characteristic that indicates normal biological processes, disease processes, or a biological response to a therapy. It distinguishes between biomarker qualification and biomarker validation: qualification is described as an evidence-based, fit-for-purpose process that links a biomarker to the effects of an intervention on biological processes and meaningful clinical endpoints, while validation refers to demonstrating that the biomarker measurement method or assay performs reliably and accurately (including technologies such as imaging). The program signals a preference for biomarkers that can be obtained through minimally invasive approaches such as blood, urine, tissue sampling, or imaging. Examples mentioned include genetic or epigenetic signatures, specific gene expression patterns, proteins, metabolites, and other molecular, physiological, or imaging-based measures.
From an administrative and funding standpoint, this opportunity was posted June 4, 2015 under Funding Opportunity Number W81XWH-15-DMDRP-IIRA. It used grant and cooperative agreement mechanisms under the broader category of science and technology and other research and development. The estimated total funding was $2,000,000, with an expectation of making about two awards, and it did not require cost sharing or matching funds. Eligibility was listed as unrestricted, meaning it was broadly open to a wide range of entity types, subject to any additional eligibility details that may have been included in the full announcement. The original and final application deadline was October 21, 2015, and the opportunity was archived on November 20, 2015. For technical access issues related to the full announcement, the listed point of contact was the CDMRP Help Desk at 301-682-5507.
DoD Duchenne Muscular Dystrophy Investigator Initiated Research Award (IIRA) - FAQs
What is the DoD Duchenne Muscular Dystrophy Investigator Initiated Research Award (IIRA)?
The IIRA is a Department of Defense funding opportunity from the Department of the Army, administered through the Congressionally Directed Medical Research Programs (CDMRP) under the Duchenne Muscular Dystrophy Research Program (DMDRP). It supports translational Duchenne muscular dystrophy (DMD) research intended to move scientific findings closer to real-world clinical use.
What is the central purpose of this award?
The central purpose is to advance DMD research toward clinical application by funding translational projects that bridge laboratory findings and clinical observations. The program emphasizes translation as a two-way path between bench and bedside, valuing projects that move discoveries toward patients and projects that use clinical insights to strengthen and refine the underlying science for practical testing.
What kind of research stage is the IIRA designed to support?
This award is geared toward mid-stage to later-stage translational work rather than early discovery research. Projects should be mature enough to plausibly inform near-term therapeutic development.
Does the IIRA support clinical trials?
Yes. The IIRA is intended to support efforts that can include early-phase, proof-of-principle clinical trials, as well as correlative human studies that clarify how a candidate drug, device, or intervention performs in relevant settings.
Are preclinical studies allowed under this opportunity?
Yes. Applicants may propose well-justified preclinical studies, including research in animal models, studies involving human subjects, or research using human anatomical substances, as long as the project is clearly positioned to accelerate clinical application rather than focus on basic mechanisms for their own sake.
What does the program mean by "translational science"?
The opportunity frames translational science as a two-way path between bench and bedside. It values both directions: moving promising lab findings toward patient application, and using clinical observations to refine and strengthen the science so therapies become more practical and testable.
What types of projects are explicitly not funded?
The announcement states that projects focused on target discovery, broad drug screening, mechanism-of-action work, or hypothesis-driven pathophysiology studies are excluded. The IIRA is not meant for early pipeline steps or primarily exploratory biology intended to explain disease mechanisms.
Is target discovery research eligible for funding?
No. Target discovery is explicitly excluded from funding under this opportunity.
Is broad drug screening eligible for funding?
No. Broad drug screening is explicitly excluded from funding under this opportunity.
Are mechanism-of-action studies eligible for funding?
No. Mechanism-of-action work is explicitly excluded from funding under this opportunity.
Are hypothesis-driven pathophysiology studies eligible for funding?
No. Hypothesis-driven pathophysiology studies are explicitly excluded from funding under this opportunity.
What is the program trying to prioritize instead of early discovery work?
The IIRA prioritizes studies that translate an existing therapeutic concept or strategy toward human testing, clinical decision-making, or development milestones, rather than exploring basic mechanisms or running early-stage discovery pipelines.
Is biomarker research a focus area for this award?
Yes. A notable emphasis is biomarker research, particularly efforts aligned with the DMDRP focus area on discovering and qualifying pharmacodynamic, prognostic, and predictive biomarkers.
How does the opportunity define a biomarker?
A biomarker is defined broadly as any objectively measured characteristic that indicates normal biological processes, disease processes, or a biological response to a therapy.
What is the difference between biomarker qualification and biomarker validation in this announcement?
The opportunity distinguishes the two concepts as follows: biomarker qualification is an evidence-based, fit-for-purpose process linking a biomarker to the effects of an intervention on biological processes and meaningful clinical endpoints. Biomarker validation refers to demonstrating that the biomarker measurement method or assay performs reliably and accurately, including imaging technologies.
Does the program prefer certain types of biomarker collection methods?
Yes. The program signals a preference for biomarkers that can be obtained through minimally invasive approaches such as blood, urine, tissue sampling, or imaging.
What biomarker examples are mentioned?
Examples include genetic or epigenetic signatures, specific gene expression patterns, proteins, metabolites, and other molecular, physiological, or imaging-based measures.
Which agency and program administer this opportunity?
The opportunity is from the Department of the Army and is administered through CDMRP under the DMDRP.
What is the Funding Opportunity Number (FON) for this announcement?
The Funding Opportunity Number is W81XWH-15-DMDRP-IIRA.
When was this opportunity posted?
The opportunity was posted on June 4, 2015.
What was the application deadline?
The original and final application deadline was October 21, 2015.
Is this opportunity still open?
No. The opportunity was archived on November 20, 2015.
What was the estimated total funding amount?
The estimated total program funding was $2,000,000.
How many awards were expected to be made?
The announcement indicated an expectation of making about two awards.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching funds.
Who was eligible to apply?
Eligibility was listed as unrestricted, meaning it was broadly open to a wide range of entity types, subject to any additional eligibility details that may have been included in the full announcement.
What funding mechanisms were used?
The opportunity used grant and cooperative agreement mechanisms under the broader category of science and technology and other research and development.
Who should be contacted for technical access issues related to the full announcement?
For technical access issues related to the full announcement, the listed contact was the CDMRP Help Desk at 301-682-5507.
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