DoD Duchenne Muscular Dystrophy, Investigator-Initiated Research Award | W81XWH 18 DMDRP IIRA

Opportunity Information: Apply for W81XWH 18 DMDRP IIRA

The DoD Duchenne Muscular Dystrophy Research Program (DMDRP) Investigator-Initiated Research Award (IIRA) is designed to fund later-stage translational research that can realistically move promising Duchenne muscular dystrophy (DMD) findings toward real-world clinical use. The emphasis is on work that actively bridges basic science and clinical practice, with a clear intent to speed up development of therapies, devices, and other interventions that could benefit patients. Rather than treating translation as a one-way path from laboratory experiments to human trials, the program expects a two-way exchange where clinical observations shape lab work and lab insights loop back to inform clinical strategies.

This award mechanism is geared toward projects that are already beyond the earliest discovery steps and are ready for more advanced translation. Supported efforts may include early-phase, proof-of-principle clinical trials, as well as correlative and supportive studies that make therapy development more efficient and evidence-based. The scope can also include strong preclinical work when it is clearly positioned as a bridge to clinical application, including studies using animal models, human participants, or human anatomical substances. At the same time, the program is explicit about what it does not want to fund under this mechanism: proposals centered on target discovery, broad drug screening, or basic mechanism-of-action studies fall outside the IIRA intent. In other words, the IIRA is for advancing and de-risking interventions on a path to use, not for identifying brand-new targets or running early exploratory screens.

A major area of interest within the opportunity is biomarker-focused research, particularly projects involving the discovery and qualification of pharmacodynamic, prognostic, or predictive biomarkers. In this context, a biomarker is any objectively measured characteristic that indicates normal biological processes, disease processes, or responses to a therapeutic intervention. The announcement draws a practical distinction between biomarker qualification and biomarker validation: qualification is the evidence-based, fit-for-purpose process that links a biomarker to biological effects and clinically meaningful endpoints, while validation focuses on proving the biomarker assay or measurement technology is accurate, reliable, and performs consistently. The program encourages biomarkers that can be measured through minimally invasive approaches, such as blood, urine, tissue samples, and imaging. Examples include genetic or epigenetic signatures, gene expression patterns, proteins, metabolites, and other molecular, physiological, or imaging-based indicators.

The IIRA also offers optional add-ons that can expand the project scope and budget if they align with program goals. One option is adding an Optional Interdisciplinary Collaborator (OIC), reflecting the program’s strong push for cross-disciplinary teams. The intent is to bring in collaborators from different fields or to attract new investigators into the Duchenne space, enabling approaches that are conceptually and technically novel and that likely would not succeed with a narrowly defined team. The examples given highlight collaborations that could span areas such as experimental biology and immunology, orthopedics, and engineering, and they also encourage partnerships that include clinicians, industry scientists, military Services, the VA, or other federal agencies.

Another optional element is a nested Resident or Medical Student Traineeship, which is meant to create a structured, mentored research experience in Duchenne. Only one trainee slot may be included per application, and the training plan must be carefully developed and clearly described, with an emphasis on meaningful mentorship and career development value for the trainee. This reflects a workforce-development angle alongside the main translational research mission.

Like many DoD-funded biomedical opportunities, the proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public, reinforcing that the public health impact is part of the justification for funding. Funding is provided as either a grant or cooperative agreement under the Department of Defense (Department of the Army, USAMRAA). For FY18, the anticipated direct cost cap for the full period of performance is $600,000, or $750,000 if the application includes the Optional Interdisciplinary Collaborator. Additional funds above those caps may be requested specifically to support the optional resident or medical student trainee component. The opportunity (W81XWH-18-DMDRP-IIRA; CFDA 12.420) was open broadly to eligible applicants without restrictive organizational categories, with an expected two awards listed in the source information and an original closing date of December 5, 2018.

• The Department of Defense, 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.
• This funding opportunity was created on Jun 11, 2018.
• Applicants must submit their applications by Dec 05, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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