DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: December 12, 2022

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Amyotrophic Lateral Sclerosis Research Program
Anticipated Funding Opportunities for Fiscal Year 2023 (FY23)

The FY23 Defense Appropriations Bill has not been signed into law. Although FY23 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 FY23 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

The FY23 Defense Appropriations Act is anticipated to provide funding for the ALSRP to support development of effective treatments for amyotrophic lateral sclerosis (ALS). The managing agent for the anticipated funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The FY23 ALSRP funding opportunity announcements for the following award mechanisms are anticipated to 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 or devices 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.
  • Biomarkers specific to the intervention must be incorporated into the trial design.

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

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

  • Maximum period of performance is years
Therapeutic Development Award Independent investigators at all academic levels (or equivalent)
  • Supports secondary preclinical validation and/or Investigational New Drug (IND)-enabling studies of therapeutics for ALS.
  • Preliminary data are required including therapeutic efficacy in at least one ALS model system.
  • Mechanism-specific predictive/cohort-selective, target engagement, and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component. If mechanism-specific biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be described.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $1.5M for direct costs (plus indirect costs)

  • Maximum period of performance is years
Clinical Biomarker Development Award Independent investigators at all academic levels (or equivalent)
  • Supports development or improvement of clinical biomarkers to enrich clinical trials in ALS.
  • Biomarker analysis can be relevant to a specific therapeutic or a specific ALS subtype and does not have to broadly apply to all patients.
  • A description of the biomarker category and intended use in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials or clinical practice, is an important component.
  • Examples 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
    • Correlation of clinical trial-related data with clinical outcomes/responses to therapies
    • Strategies to better measure disease progression, including development or use of digital biomarkers
  • Submission of a pre-application is required; full application submission is by invitation only
  • Maximum funding of $750,000 for direct costs (plus indirect costs)

  • Maximum period of performance is years
Therapeutic Idea Award Independent investigators at all academic levels (or equivalent)
  • Supports highly innovative, hypothesis-driven preclinical therapeutic development in ALS.
  • Projects focusing primarily on ALS pathophysiology, without consideration of therapeutic development, are outside the scope of this award mechanism.
  • Preliminary data are not required.
  • 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 $600,000 for direct costs (plus indirect costs)

  • Maximum funding of $750,000 for direct costs (plus indirect costs) if applying for the Biomarker Option

  • Maximum period of performance is years

A pre-application is required and must be submitted through the Biomedical Research Application Portal (eBRAP) 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. For more information about the ALSRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).


Point of Contact:

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


Last updated Sunday, December 31, 1600