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

Frequently Asked Questions (FAQs): DoD DMDRP Investigator-Initiated Research Award (IIRA)

1) What is the DMDRP Investigator-Initiated Research Award (IIRA)?

The DoD Duchenne Muscular Dystrophy Research Program (DMDRP) Investigator-Initiated Research Award (IIRA) is a funding mechanism intended to support later-stage translational research in Duchenne muscular dystrophy (DMD). It is meant for projects that can realistically move promising DMD findings closer to real-world clinical use, with an emphasis on speeding the development of therapies, devices, and other interventions that could benefit patients.

2) What kind of research stage is this award meant to support?

This award is geared toward projects that are beyond the earliest discovery steps and are ready for more advanced translation. The focus is on de-risking and advancing interventions on a path to use, rather than early exploratory work.

3) What does the program mean by "translational research"?

The IIRA emphasizes research that actively bridges basic science and clinical practice. Translation is framed as a two-way exchange: clinical observations should inform laboratory work, and laboratory insights should loop back to shape clinical strategies. The overall intent is to accelerate movement toward clinical impact.

4) What types of studies are encouraged under the IIRA?

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.

5) Are clinical trials allowed under this award?

Yes. The program states that supported efforts may include early-phase, proof-of-principle clinical trials, especially when they are part of a realistic pathway toward clinical use.

6) Can preclinical studies be funded?

Yes, when they are clearly designed as a bridge to clinical application. The opportunity mentions that the scope can include strong preclinical work positioned to support clinical translation, including studies using animal models, human participants, or human anatomical substances.

7) What research areas are specifically not a fit for the IIRA?

The IIRA is explicit that it does not support proposals centered on target discovery, broad drug screening, or basic mechanism-of-action studies. The intent is to advance interventions toward use, not to identify brand-new targets or run early exploratory screens.

8) Is biomarker research a priority area for this opportunity?

Yes. A major area of interest is biomarker-focused research, particularly projects involving discovery and qualification of pharmacodynamic, prognostic, or predictive biomarkers.

9) How does the opportunity define a biomarker?

A biomarker is described as any objectively measured characteristic that indicates normal biological processes, disease processes, or responses to a therapeutic intervention.

10) What is the difference between biomarker qualification and biomarker validation in this announcement?

The opportunity draws a practical distinction: biomarker qualification is the evidence-based, fit-for-purpose process that links a biomarker to biological effects and clinically meaningful endpoints, while biomarker validation focuses on showing the biomarker assay or measurement technology is accurate, reliable, and performs consistently.

11) What types of biomarkers and measurement approaches are encouraged?

The program encourages biomarkers that can be measured through minimally invasive approaches such as blood, urine, tissue samples, and imaging. Example biomarker types mentioned include genetic or epigenetic signatures, gene expression patterns, proteins, metabolites, and other molecular, physiological, or imaging-based indicators.

12) What is the Optional Interdisciplinary Collaborator (OIC)?

The Optional Interdisciplinary Collaborator (OIC) is an add-on option that can expand project scope and budget when aligned with program goals. It reflects the program's push for cross-disciplinary teams and is intended to bring in collaborators from different fields or attract new investigators into the Duchenne space.

13) What is the purpose of including an Optional Interdisciplinary Collaborator?

The stated intent is to enable conceptually and technically novel approaches that likely would not succeed with a narrowly defined team. The opportunity highlights that interdisciplinary collaboration can strengthen translational impact.

14) What kinds of cross-disciplinary collaborations are encouraged?

Examples mentioned include collaborations spanning experimental biology and immunology, orthopedics, and engineering. The program also encourages partnerships that include clinicians, industry scientists, military Services, the VA, or other federal agencies.

15) What is the nested Resident or Medical Student Traineeship option?

This is an optional element that provides a structured, mentored research experience in Duchenne muscular dystrophy. It is designed to add a workforce-development component alongside the main translational research mission.

16) How many trainee positions can be included in an application?

Only one trainee slot may be included per application under the nested Resident or Medical Student Traineeship option.

17) What does the opportunity require for the traineeship plan?

The training plan must be carefully developed and clearly described, with an emphasis on meaningful mentorship and career development value for the trainee.

18) What populations must the research be relevant to?

The proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. This relevance is part of the justification for funding.

19) What type of funding instrument is used for this opportunity?

Funding is provided as either a grant or a cooperative agreement under the Department of Defense (Department of the Army, USAMRAA).

20) What is the direct cost cap for this award?

For FY18, the anticipated direct cost cap for the full period of performance is $600,000. If the application includes the Optional Interdisciplinary Collaborator (OIC), the anticipated direct cost cap is $750,000.

21) Can an applicant request funding above the direct cost cap?

Yes, additional funds above the stated caps may be requested specifically to support the optional resident or medical student trainee component.

22) What is the opportunity number and CFDA listing for this funding?

The opportunity is listed as W81XWH-18-DMDRP-IIRA, with CFDA 12.420.

23) Who was eligible to apply based on the information provided?

The opportunity was described as being open broadly to eligible applicants without restrictive organizational categories.

24) How many awards were expected?

The source information indicated an expectation of two awards.

25) What was the original closing date for the opportunity?

The original closing date listed was December 5, 2018.