# DoD Amyotrophic Lateral Sclerosis, Therapeutic Development Award

Source: https://welltoldgrants.com/grants/w81xwh-21-alsrp-tda-dod-amyotrophic-lateral-sclerosis-therapeutic-development/  
Official notice: https://www.grants.gov/search-results-detail/331544

> Defense Health Agency Contracting Activity - DHACA offered grants to any type of organization. It expected to make about 3 awards worth $4.8 million in total. Applications closed on July 15, 2021.

| Field | Value |
|---|---|
| Opportunity number | W81XWH-21-ALSRP-TDA |
| 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 | $4.8 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 FY21 ALSRP Therapeutic Development Award supports research ranging from validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology. Examples of activities that will be supported by this award include: · Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds. · Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses. · Studies on formulation and stability leading to Good Manufacturing Practice production methods. · IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems. Applications supported by this award must begin with lead compounds in hand and must include preliminary data relevant to the phase of development, such as: · Proof of identity and purity · Selectivity for the intended target over closely related targets · Availability of primary and secondary in vitro bioactivity assays for optimization or structure-activity relationship studies · Availability of proof-of-concept efficacy data in at least one preclinical model system of ALS, including whole animal and cellular model systems Development or further characterization of validated biomarkers, in parallel to the main therapeutic effort and for use in eventual clinical trials, is a critical component of the F 21 ALSRP Therapeutic Development Award. Efforts may include development/characterization of 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. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression without consideration of the therapeutic development process will not be supported.

## Questions people ask

### Is W81XWH-21-ALSRP-TDA 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 Development Award?

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

### What is the deadline for DoD Amyotrophic Lateral Sclerosis, Therapeutic Development 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 $4.8 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.