DoD Duchenne Muscular Dystrophy, Investigator-Initiated Research Award

Description

The DMDRP Investigator-Initiated Research Award (IIRA) supports translational research that will accelerate the movement of promising ideas in Duchenne research into clinical applications. Translational research may be defined as an integration of basic science and clinical observations with the specific goal of developing new therapies. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, Principal Investigators (PIs) should not view translational research as a one-way continuum from bench to bedside. The research plan should involve a reciprocal flow of ideas and information between basic and clinical science. Within this continuum, the IIRA supports later-stage translational research projects, including early-phase, proof-of-principle clinical trials and correlative studies to better inform development of drugs, devices, and other interventions. Research projects may also include preclinical studies utilizing animal models, human subjects, or human anatomical substances. Studies proposed under this award should not include: Target discovery Drug screening Mechanism of action studies Biomarker Studies For projects addressing “discovery and qualification of pharmacodynamic, prognostic, and predictive biomarkers,” a biological marker, or biomarker, is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or biological responses to a therapeutic intervention.1 For the purpose of this award, biomarker qualification is defined as the evidentiary fit-for-purpose process of correlating a biomarker with the effects of an agent on biological processes and clinical endpoints.2 Alternatively, biomarker validation refers to the process of ensuring that a biomarker or technology (e.g., imaging) will be accurately and reliably measured through the performance characteristics of a biomarker assay.3 The DMDRP encourages the study of biomarkers that can be detected through minimally invasive procedures (e.g., blood, urine, tissue, imaging). Examples of biomarkers may include signatures of genetic or epigenetic changes, specifically expressed genes, proteins, or metabolites, and molecular, physiological, and/or imaging entities, among others. Optional Features: The IIRA mechanism allows for the inclusion of the following options, which would allow the applicant to request additional funds as described in Section II.D.5, Funding Restrictions. The Government reserves the right to fund an application at a lower funding level if it does not meet the eligibility criteria or intent of the optional feature(s). Optional Interdisciplinary Collaborator (OIC): The FY18 DMDRP strongly encourages interdisciplinary collaborations between diverse groups of academic scientists, clinicians, industry scientists, the military Services, the Department of Veterans Affairs (VA), and other Federal Government agencies. The goal of the OIC is to bring new perspectives from other disciplines and/or bring new investigators into the Duchenne field that through their collaboration the team can undertake conceptually and technically novel approaches that would be less likely to succeed if undertaken by a more narrowly focused group of investigators. Some examples would include projects that establish interdisciplinary collaborations between, but not limited to, experimental biologists and immunologists, orthopaedists, or engineers. Optional Nested Resident or Medical Student Traineeship: The intent of the Optional Nested Resident or Medical Student Traineeship is to provide mentored research opportunities in Duchenne. It is expected that the training will provide a valuable opportunity to develop the experience necessary to advance the trainee’s research career in Duchenne. Only one traineeship may be requested per application. Plans for training and mentorship must be well developed and clearly described by the PI in Attachment 9: Statement of Traineeship. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The anticipated direct costs budgeted for the entire period of performance for an FY18 DMDRP IIRA will not exceed $600,000 or $750,000 if applying for the IIRA with an OIC. Additional funding can be requested above the maximums specified for the IIRA or the IIRA with an OIC to specifically support the Optional Nested Resident or Medical Student Trainee. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

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