# DoD Amyotrophic Lateral Sclerosis, Therapeutic/Biomarker Pilot Trial Award

Source: https://welltoldgrants.com/grants/w81xwh-21-alsrp-tbpta-dod-amyotrophic-lateral-sclerosis-therapeutic-biomarker/  
Official notice: https://www.grants.gov/search-results-detail/331547

> Defense Health Agency Contracting Activity - DHACA offered grants to any type of organization. It expected to make about 3 awards worth $9.6 million in total. Applications closed on July 15, 2021.

| Field | Value |
|---|---|
| Opportunity number | W81XWH-21-ALSRP-TBPTA |
| Agency | Defense Health Agency Contracting Activity - DHACA |
| Status | Forecast |
| Deadline | July 15, 2021 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | 3 |
| Total funding | $9.6 million |
| Cost sharing | not required |
| Assistance Listings | 12.420 |

## Who can apply

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

## 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.

## Questions people ask

### Is W81XWH-21-ALSRP-TBPTA still open?

No. It closed on July 15, 2021. A newer notice is open: HT942526BCRPCREA2, closes November 18, 2026 (11 days left).

### Who can apply for DoD Amyotrophic Lateral Sclerosis, Therapeutic/Biomarker Pilot Trial Award?

Defense Health Agency Contracting Activity - DHACA accepted applications from any type of organization.

### What is the deadline for DoD Amyotrophic Lateral Sclerosis, Therapeutic/Biomarker Pilot Trial Award?

Closed July 15, 2021. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

About $9.6 million in total across about 3 awards.

### Who has won Military Medical Research and Development grants before?

The largest recipients over five fiscal years were The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., The Univeristy of Texas M.D. Anderson Cancer Center, The Johns Hopkins University. The program made 5,470 awards worth $6.9 billion in that time.