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

How to Apply: 

he 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 posted on the Grants.gov website. 

 

Pilot Clinical Trial Award – Preproposal due April 13, 2023

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 amyotrophic lateral sclerosis (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.
  • Preliminary data are required.
  • New for FY23:  Applications are expected to name at least one community partner (e.g., person with ALS, family member or caregiver, representative of a community-based organization) who will provide advice and consultation throughout the planning and implementation of the clinical trial.
  • 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 Tier.
  • Examples of efforts that will be supported include:
  • Optimization of respiratory care strategies
  • Improvements to approved devices and assistive technologies
  • Specific symptom management strategies
  • Telemedicine strategies
  • Pre-application submission is required; full application submission is by invitation only.
  • The maximum allowable funding for the entire period of performance is $2,000,000 for direct costs.
  • Clinical Care Tier:  The maximum allowable funding for the entire period of performance is $1,000,000 for direct costs.
  • Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
  • The maximum period of performance is 3 years.

 

https://cdmrp.health.mil/funding/alsrp

 

Therapeutic Development Award – Preproposal due April 13, 2023

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 therapeutic efficacy in at least one ALS-relevant model system.
  • Mechanism-specific predictive/cohort-selective, target engagement, or 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.
  • Pre-application submission is required; full application submission is by invitation only.
  • The maximum allowable funding for the entire period of performance is $1,500,000 for direct costs.
  • •Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
  • •The maximum period of performance is 3 years.

 

 

Clinical Biomarker Development Award – Preproposal due April 13, 2023

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
  • Correlating clinical trial-related data (e.g., biosample analyses, imaging, or epidemiological data) with clinical outcomes/ responses to therapies
  • Strategies to better measure disease progression, including development or use of digital biomarkers

Pre-application submission is required; full application submission is by invitation only.

  • The maximum allowable funding for the entire period of performance is $750,000 for direct costs.
  • Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
  • The maximum period of performance is 2 years.

 

Therapeutic Idea Award – Preproposal due April 13, 2023

Independent investigators at all academic levels (or equivalent) 

  • Supports highly innovative, hypothesis-driven preclinical therapeutic development in ALS.
  • 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 Program Announcement, will qualify for a higher level of funding.

Pre-application submission is required; full application submission is by invitation only.

  • The maximum allowable funding for the entire period of performance is $600,000 for direct costs.
  • Biomarker Option:  The maximum allowable funding for the entire period of performance is $750,000 for direct costs.
  • Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
  • The 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 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.

 

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.health.mil).

 

Point of Contact:

CDMRP Help Desk
301-682-5507
help@eBrap.org

Please contact Jill Sherman for more information at intl.research@lakeheadu.ca

External Deadline: 
Thursday, April 13, 2023
Funding Source: 
External
Funding Level: 
Research