The FY19 Defense Appropriations Act provides $10 million (M) to the Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) to support innovative and high-impact research into preclinical development of therapeutics for Amyotrophic Lateral Sclerosis.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA), J9 Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

The ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY19 ALSRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in November 2018.  Pre-application and application deadlines will be available when the Program Announcements are released.  This pre-announcement should not be construed as an obligation by the government.

The mission of the ALSRP is to fund innovative preclinical research to develop new treatments for ALS for the benefit of Service members, Veterans, and the general public.

http://cdmrp.army.mil/pubs/press/2019/19alsrppreann

The following mechanisms are planned for release:

Therapeutic Development Award

• Independent investigators at all academic levels
• Pre-application is required; full application submission is by invitation only
• Supports post-discovery, preclinical advancement of therapeutics for ALS
• Preliminary data, including identity and purity of an identified bioactive compound(s), are required
• Clinical trials are not allowed
• Types of efforts that will be supported include:
• • Confirmation of candidate therapeutics obtained from screening or by other means
  • Validation of early pilot studies in multiple model systems and/or replicating preliminary data with more time points or additional doses
  • Optimization of potency and pharmacology, studies of formulation, stability, and production methods based on Good Manufacturing Practices
  • Investigational New Drug-enabling studies
  • Optional Therapeutic Relevance Option: Applications proposing development of markers to improve the drug development process in parallel with the main therapeutic advancement effort and that meet the criteria outlined in the Program Announcement/Funding Opportunity will qualify for a higher level of funding

• Maximum funding of $1,000,000 for direct costs (plus indirect costs)
• If applying for the Therapeutic Relevance Option, the maximum funding is $1,250,000 for direct costs (plus indirect costs)
• Maximum period of performance is 2 years

Therapeutic Idea Award

• Independent investigators at all academic levels
• Pre-application is required; full application submission is by invitation only
• Supports new ideas aimed at drug or treatment discovery that are still in the early stages of development
• Preliminary data are not required
• Types of efforts that will be supported include:
• • Exploitation of pathways known to be relevant to ALS for the purpose of improving treatment and/or advancing a novel treatment modality
  • Development, modification, and use of high-throughput screens and novel model systems to define or assess lead compounds
• Projects that focus primarily on investigating the pathophysiology of ALS are outside the scope of this award mechanism
• Maximum funding of $500,000 for direct costs (plus indirect costs)
• 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 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Applications must be submitted through the federal government’s single-entry portal, Grants.gov.  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 ALSRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

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

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