DoD Amyotrophic Lateral Sclerosis, Therapeutic Idea Award | W81XWH 22 ALSRP TIA

Opportunity Information: Apply for W81XWH 22 ALSRP TIA

The Department of Defense (DoD), through the U.S. Army Medical Research Acquisition Activity (USAMRAA), offered the FY22 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Idea Award (TIA) to push forward early-stage, hypothesis-driven work that could lead to new drugs, biologics, devices, or other treatment approaches for ALS. The central purpose of this opportunity is to accelerate therapeutic discovery and development by funding creative, translationally focused ideas that may not yet have extensive supporting datasets. In other words, applicants are expected to propose a clear, testable hypothesis grounded in a solid scientific rationale, and to design experiments that move a potential therapy closer to practical use in ALS rather than simply adding to basic disease knowledge.

A key feature of the TIA is that preliminary data are not required. Applicants may include preliminary findings if they have them, but the application is not supposed to depend on those data to be considered competitive. Instead, review emphasis is placed on the originality of the concept, the rigor of the hypothesis and experimental plan, and the likelihood that the work could translate into improved ALS treatment or enable a genuinely new treatment modality. The program is explicitly not meant to support projects that mainly study ALS pathophysiology without a direct and credible connection to therapeutic development. Applicants need to show how the proposed work will inform, produce, or de-risk a therapeutic strategy, rather than stopping at disease mechanism description.

Innovation and impact are highlighted as major evaluation themes. The DoD signals that it is looking for projects that introduce new paradigms, challenge existing assumptions, apply novel technologies, or combine ideas in unusually creative ways, as long as those innovations plausibly point toward therapeutic outcomes for ALS. In practice, this means a strong application should make a convincing case that the approach is not just incremental, and that success would matter in a tangible way for drug or treatment development.

The opportunity is also structured to broaden participation in ALS therapeutics research. It encourages submissions from early-career investigators and values meaningful, productive collaborations. It also welcomes applicants who are not traditionally in the ALS field, with an important caveat: teams coming from outside ALS are encouraged to include collaborators who bring ALS-specific expertise, such as familiarity with relevant model systems, clinically meaningful endpoints, and established ALS pathogenic findings. This reflects an intent to combine fresh perspectives with the practical know-how needed to design therapeutically relevant ALS studies.

In addition to the standard Therapeutic Idea Award pathway, the FY22 announcement included a Biomarker Option. This option is intended for applicants who want to develop one or more biomarkers alongside the main therapeutic development effort, with additional funds available specifically to support biomarker co-development that strengthens the drug development pipeline. The program frames biomarkers here in a very translational, utility-driven way: examples include target engagement biomarkers (to show a therapy is hitting its intended target), pharmacodynamic biomarkers (to objectively measure biological response to the investigational therapy), and predictive or cohort-selective biomarkers (to help identify which patients, or patient subgroups, are most likely to benefit). Importantly, biomarkers aimed only at diagnosis, prognosis, or tracking disease progression are not supported unless they are directly tied to improving the therapeutic development process for the proposed investigational approach. Applicants pursuing the Biomarker Option must clearly describe the marker, how it will be developed, and exactly how it will make the therapeutic development effort more effective.

Administratively, this was a discretionary funding opportunity (Funding Opportunity Number W81XWH 22 ALSRP TIA) under CFDA 12.420, using grant and/or cooperative agreement mechanisms. Eligibility was listed as unrestricted, meaning it was broadly open to many applicant entity types, subject to any specific eligibility clarifications in the full announcement. The announcement was created March 16, 2022, with an original closing date of July 28, 2022, and the program anticipated making around 17 awards. The award ceiling was listed as 0 in the provided source data, which typically indicates that the ceiling was not specified in that particular field and would need to be confirmed in the full funding announcement or accompanying program guidance.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Amyotrophic Lateral Sclerosis, Therapeutic Idea Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Mar 16, 2022.
• Applicants must submit their applications by Jul 28, 2022. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 17 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for W81XWH 22 ALSRP TIA

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: