DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

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.

Award Mechanism Eligibility Key Mechanism Elements Funding
Idea Development Award Investigators at all academic levels (or equivalent).

New Investigators:

Terminal degree must be within the last 10 years.

Must not have received National Institutes of Health R01 funding.

Must not have received a New Investigator Award previously from any program within the CDMRP.

  • Supports conceptually innovative, high-risk/high-reward research that could ultimately lead to critical discoveries and/or major advancements in scleroderma research and/or improvements in patient care and/or quality of life.
  • Innovation and impact are important aspects of the award.
  • Preliminary data are required but does not need to be from the scleroderma research field.
  • Inclusion of veteran populations are encouraged.
  • Clinical trials are not allowed.
  • New Investigator Collaboration Option: Supports the continued development of promising independent investigators that are early in their faculty appointment through collaboration with an established scleroderma investigator. The initiating Principal Investigator must be the New Investigator.
  • A letter of intent is required; an invitation to submit a full application is not required.
  • Maximum funding of $300,000 for direct costs (plus indirect costs).

New Investigator Collaboration Option

  • Maximum funding of $450,000 for direct costs (plus indirect costs).
  • 50% of the funding must be allocated to the new investigator
  • Maximum period of performance is 3 years.
Translational Research Partnership Award Clinicians must be an M.D., M.D./Ph.D., D.O., D.O/Ph.D. or equivalent with clinical duties and/or responsibilities.

At least one member of the partnership must have experience in either scleroderma research or scleroderma patient care as demonstrated by active funding and/or recent publications.

  • Supports partnerships that accelerate the movement of promising ideas in scleroderma research into clinical applications. At least one partner must be a clinician.
  • Preliminary data are required.
  • Inclusion of veteran populations are encouraged.
  • Clinical trials are not allowed.
  • A letter of intent is required; an invitation to submit a full application is not required.
  • Maximum funding of $750,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the SRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil


Last updated Monday, April 5, 2021