Grants / Department of Defense / Defense Health Agency Contracting Activity - DHACA

W81XWH-21-ALSRP-TBPTA: DoD Amyotrophic Lateral Sclerosis, Therapeutic/Biomarker Pilot Trial Award

Closed Closed July 15, 2021 Opportunity W81XWH-21-ALSRP-TBPTA ☆ Save

This grant is closed. A newer notice from the same program is open now: DoW Breast Cancer, Clinical Research Extension Award (HT942526BCRPCREA2). Status: Closes November 18, 2026 (11 days left). It is in our archive of Defense Health Agency Contracting Activity - DHACA notices from 2021.

• Total funding$9.6 million
• Expected awards3
• Cost sharingNot required
• Funding typeCooperative Agreement, Grant

Key dates

Who can apply

This opportunity was open to any type of organization.

• Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses, individuals.

Is this a realistic fit?

• Most of the program's money (59% over five years) went to colleges and universities.
• No cost sharing or match is required.

What the grant funds

The ALSRP Therapeutic/Biomarker Pilot Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preclinical data. Projects may range from Phase 1 to small-scale Phase 2 trials and should be designed to de-risk and inform the design of more advanced trials, by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Funding from this award mechanism must support a clinical trial and the trial design must include plans to generate compelling biomarker data. Principal Investigators (PIs) seeking funding for a preclinical research project or standalone biomarker development should alternatively consider one of the other FY21 ALSRP Funding Opportunity Announcements. Biomarker development and characterization can include target engagement biomarkers, pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, and/or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup. Applicants must clearly describe the biomarker(s) and its potential to de-risk and improve the design of anticipated later-stage trials. For further description, see Attachment 8: Biomarker Statement. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. More information is provided in the Human Subject Resource Document at https://cdmrp.army.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf. The following are important aspects of the FY21 ALSRP Therapeutic/Biomarker Pilot Trial Award: • Impact: The outcomes of the proposed project should directly and substantially de-risk and inform the design of anticipated later phase trials of the intervention under investigation. The intervention itself must offer significant potential impact for individuals affected by ALS, to include genetic or phenotypic patient subpopulations.

Category: Science and Technology and other Research and Development.

Applying now

This notice no longer takes applications. Apply under the newer notice, HT942526BCRPCREA2, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.