NEWS RELEASE

Released: April 5, 2021

Defense Health Program
Department of Defense Scleroderma Research Program
Anticipated Funding Opportunities for Fiscal Year 2021 (FY21)

The FY21 Defense Appropriations Act provides funding to the Department of Defense Scleroderma Research Program (SRP) to support innovative, high-impact scleroderma research. The managing agent for the anticipated program announcements/funding opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

The SRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY21 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY21 SRP program announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the program announcements are released. 

Applications submitted to the FY21 SRP Idea Development Award must address one or more of the following Focus Areas:

• Define biomarkers (‘omics and/or molecular markers, cell subsets, imaging, patient-reported outcomes) that help inform therapeutic choices (immunosuppressive/anti-fibrotic) or predict course (morbidity) and quality of life.
• Utilize systems biology, multi-omics and preclinical screening approaches (including but not limited to high-throughput screens, the development of animal models, three-dimensional [3D] tissue culture and/or organoids) with the intent to develop drug testing models in order to understand the heterogeneity of disease as well as to develop prevention and therapeutic interventions.
• Studies of diverse populations to include the development of cohorts and identification of potential measures of patient outcomes.
  • Understand the unique burden of disease in diverse populations.
• Define functional role of epigenetic changes, multiple cell types, and molecules that mediate pathogenesis and/or initiate or propagate organ-specific disease activity using preclinical models and clinical samples.
• Develop and validate short- and long-term organ-specific and composite clinical outcomes measures to determine treatment efficacy.
  • Develop better quantifiable and reproducible measures to assess clinical manifestations including skin, heart, Raynaud phenomenon, calcinosis cutis, or gastrointestinal tract morbidity in scleroderma.
  • Validate patient-reported outcome measurements to aid in the approval of drug and therapies.
  • Develop and validate intermediate biological/surrogate endpoints to support larger clinical proof-of-concept/proof-of-mechanism trials.

Applications submitted to the FY21 SRP Translational Partnership Research Award must address one or more of the following Focus Areas:

• Define biomarkers (‘omics and/or molecular markers, cell subsets, imaging, patient-reported outcomes) that help inform therapeutic choices (immunosuppressive/anti-fibrotic) or predict course (morbidity) and quality of life.
• Utilize systems biology, multi-omics and preclinical screening approaches (including but not limited to high-throughput screens, the development of animal models, 3D tissue culture and/or organoids) with the intent to develop drug testing models in order to understand the heterogeneity of disease as well as to develop prevention and therapeutic interventions.
• Studies of diverse populations to include the development of cohorts and identification of potential measures of patient outcomes.
  • Understand the unique burden of disease in diverse populations.
• Define functional role of epigenetic changes, multiple cell types, and molecules that mediate pathogenesis and/or initiate or propagate organ-specific disease activity using preclinical models and clinical samples.
• Conduct population-based or cohort studies to understand the prevalence, heterogeneity, and course of this disease, its manifestations, and its impact on health outcomes and activities for daily living.
  • Understanding the unique burden of disease in disease in diverse populations.
  • Understand disease heterogeneity (course of disease, prevalence, and associated factors).
  • Utilize disease registries linked to biological samples and high-quality clinical data and patient-reported outcomes.
  • Conduct fine phenotyping of clinical subsets to address heterogeneity.
• Understand and improve the impact of disease and its treatment on the patient’s experience and quality of life.
  • Develop interventions to improve coping with disease.
  • Identify main concerns of patients to inform development and validation of patient-reported outcomes.
  • Identify interventions that improve quality of life.
  • Understand the link between molecule, laboratory, and clinical measures and the patient’s quality of life.
• Develop and validate short- and long-term organ-specific and composite clinical outcomes measures to determine treatment efficacy.
  • Develop better quantifiable and reproducible measures to assess clinical manifestations including skin, heart, Raynaud phenomenon, calcinosis cutis, or gastrointestinal tract morbidity in scleroderma.
  • Validate patient-reported outcome measurements to aid in the approval of drug and therapies.
  • Develop and validate intermediate biological/surrogate endpoints to support larger clinical proof-of-concept/proof-of-mechanism trials.