DoD Amyotrophic Lateral Sclerosis Therapeutic Idea Award | W81XWH 20 ALSRP TIA

Opportunity Information: Apply for W81XWH 20 ALSRP TIA

The DoD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Idea Award (FY20) is a Department of Defense funding opportunity meant to jump-start early-stage, hypothesis-driven therapeutic development for ALS. The focus is on new, creative ideas that could lead to drugs, biologics, devices, or other treatment approaches, especially when those ideas are not yet mature enough to come with extensive supporting datasets. Projects need to be built around a clearly stated, testable hypothesis with a strong scientific rationale and a credible line of sight to translation, meaning the work should be positioned to eventually influence how ALS is treated or to open a genuinely new treatment modality.

A key point is that preliminary data are not required. Applicants can include early results if they have them, but the application is expected to stand on the strength of the concept, the logic behind the hypothesis, and the innovation of the approach rather than relying on a large package of prior findings. The program also allows enabling work that supports therapeutic discovery, such as developing or modifying preclinical model systems and using high-throughput screening strategies to identify or evaluate lead compounds for ALS. In other words, it is not limited to testing a single drug candidate; it can support earlier steps that help define, refine, and assess therapeutic leads in a way that could feed a development pipeline.

The scope is intentionally therapeutic. Applications that mainly study ALS disease mechanisms or pathophysiology without a real therapeutic development component are considered out of scope. The award is looking for projects where the therapeutic angle is central, not an afterthought. Review emphasis is placed on innovation and impact. Innovation can mean challenging prevailing assumptions, introducing a new paradigm, applying a novel technology, or combining ideas in an unusually creative way that plausibly leads to an ALS therapy. Impact can be near-term or longer-term, but it needs to be meaningful and clearly beyond incremental progress, with a convincing argument that the work could materially advance the search for effective ALS treatments.

The opportunity encourages participation from early career investigators and also values strong collaborations. Researchers coming from outside the ALS field are welcome, but they are encouraged to partner with ALS-experienced collaborators who understand relevant model systems, endpoints, and known pathogenic findings, so that the proposed work remains grounded in what is needed for ALS drug development. This collaborative emphasis is meant to speed progress by combining fresh perspectives with practical disease-specific expertise.

A notable feature is the encouragement to leverage existing, de-identified human biospecimens and datasets from well-characterized and adequately controlled patient cohorts to identify treatment approaches using biological correlates of disease activity and progression. Acceptable sources include specimens or data from controlled clinical trials, observational studies, registries, and public biorepositories, including resources like the CDC National ALS Registry and Biorepository. The program specifically suggests considering active duty military and Veteran patient populations and highlights that ALSRP maintains a list of relevant resources. Importantly, the award does not support collecting new specimens for the project; samples must already exist at the time of application, and applications relying on outside repositories typically need strong documentation (such as letters of support) describing the repository, cohort characteristics, and how access to data and samples is managed.

The FY20 announcement also includes an optional “Therapeutically Relevant Biomarker Option,” which offers additional funding to co-develop biomarkers alongside the main therapeutic development work, as long as those biomarkers directly support the drug development process. Examples include target engagement biomarkers that show whether a therapy is hitting its intended target, pharmacodynamic biomarkers that objectively measure biological response to treatment, and predictive or cohort-selective biomarkers that help identify which patients (or subgroups) are most likely to benefit. Biomarker work aimed only at diagnosis, prognosis, or tracking disease progression, without a clear link to enabling or accelerating therapeutic development, is not supported under this option.

Administratively, this is a discretionary DoD opportunity administered by the Department of the Army (USAMRAA) under Funding Opportunity Number W81XWH-20-ALSRP-TIA. It allows funding through grants and cooperative agreements, is open to essentially any eligible entity type (unrestricted eligibility, subject to any specific clarifications in the full announcement), and was originally posted in January 2020 with a July 2020 closing date. The listing indicated an expectation of roughly 16 awards, and the award ceiling was not specified in the provided summary.

• 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 Jan 17, 2020.
• Applicants must submit their applications by Jul 23, 2020. (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 16 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 20 ALSRP TIA

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