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Amyotrophic Lateral Sclerosis

NEWS RELEASE

Released: December 8, 2021

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Amyotrophic Lateral Sclerosis Research Program
Anticipated Funding Opportunities for Fiscal Year 2022 (FY22)

The FY22 Defense Appropriations Bill has not been signed into law. Although FY22 funds have not been appropriated for the Amyotrophic Lateral Sclerosis Research Program (ALSRP), the ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

The FY22 Defense Appropriations Act is anticipated to provide funding for the ALSRP to support the development of effective treatments for amyotrophic lateral sclerosis (ALS). The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities. This pre-announcement should not be construed as an obligation by the Government. The FY22 ALSRP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

Award Mechanism Eligibility Key Mechanism Elements Funding
Pilot Clinical Trial Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Supports exploratory clinical trials of novel therapeutics to demonstrate feasibility and inform the design of more advanced trials in ALS.
  • Must support a clinical trial and may not be used for preclinical research studies.
  • Preliminary data are required.
  • Biomarkers must be incorporated into the trial design. Biomarkers may measure target engagement, pharmacodynamic effects, and/or be predictive/cohort-selective.

    • Clinical Care Tier:
  • Applications not investigating a novel therapeutic, but proposing a clinical trial to optimize established ALS clinical care may submit under the Clinical Care Option.
  • Types of efforts that will be supported include:
    • Optimization of respiratory care strategies
    • Improvements to approved devices and assistive technologies
    • Specific symptom management strategies
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $2,000,000 for direct costs (plus indirect costs)

  • Maximum funding of $1,000,000 for direct costs (plus indirect costs) if applying for the Clinical Care Tier

  • Maximum period of performance is 3 years
Therapeutic Development Award Independent investigators at all academic levels (or equivalent)
  • Supports secondary preclinical validation and Investigational New Drug (IND)-enabling studies of therapeutics for ALS.
  • Preliminary data are required, including strong rationale and efficacy data for the chosen therapeutic in at least one ALS-relevant model system.
  • Biomarker development and/or characterization (if not already validated), in parallel to the main therapeutic effort, is a critical component of the Therapeutic Development Award.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $1,000,000 for direct costs (plus indirect costs)

  • Maximum period of performance is 3 years
Clinical Biomarker Development Award Independent investigators at all academic levels (or equivalent)
  • Supports maximization of clinical ALS resources and biorepositories to better define subtypes, predict therapeutic response, or assess prognosis.
  • Emphasis is on the development of clinical biomarkers to enrich clinical trials in ALS. Biomarkers may measure target engagement, pharmacodynamic effects, and/or be predictive/cohort-selective.
  • Plans for Resource Sharing (biosamples/data sets/analyses) are important and scored criteria.
  • Types of efforts that will be supported include:
    • Using patient-based resources to link biosamples to rigorous molecular data
    • Collecting and analyzing biospecimens as a companion to an anticipated/ongoing clinical trial
    • Correlating clinical trial-related data (e.g., biosample analyses, imaging, or epidemiological data) with clinical outcomes/ responses to therapies
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $500,000 for direct costs (plus indirect costs)

  • Maximum period of performance is 2 years
Therapeutic Idea Award Independent investigators at all academic levels (or equivalent)
  • Supports hypothesis-driven preclinical therapeutic development.
  • Projects focusing primarily on investigating ALS pathophysiology, without consideration of therapeutic development, are outside the scope of this award mechanism.
  • Preliminary data are not required.
  • Early Career Investigators are encouraged to apply.
  • Biomarker Option: Applications that include development of biomarkers in parallel to the main therapeutic effort and that meet criteria outlined in the Funding Opportunity Announcement will qualify for a higher level of funding.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $500,000 for direct costs (plus indirect costs)

  • Maximum funding of $600,000 for direct costs (plus indirect costs) if applying for the Biomarker Option

  • Maximum period of performance is 2 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 funding opportunity announcements that will be available for 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 funding opportunity announcements are released. For email notification when 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 ALSRP 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 Tuesday, January 4, 2022