DOD Amyotrophic Lateral Sclerosis, Therapeutic Idea Award | HT942524ALSRPTIA

FY24 DOD ALSRP Therapeutic Idea Award (TIA) FAQs

What is the FY24 DOD ALSRP Therapeutic Idea Award (TIA)?

The Therapeutic Idea Award (TIA) is a Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) funding opportunity administered by the Department of the Army (USAMRAA). It is intended to accelerate new drug and therapy discovery ideas for ALS by supporting early-stage, high-risk, high-gain therapeutic concepts.

What is the main goal of this award?

The goal is to enable hypothesis-driven projects that can produce interpretable results and generate preliminary evidence that supports later-stage therapeutic development. The award is designed to open new therapeutic directions rather than fund small, incremental extensions of existing work.

What types of projects does the TIA specifically encourage?

The TIA encourages bold, testable, hypothesis-driven therapeutic discovery concepts, especially those that introduce a new paradigm, challenge prevailing assumptions in ALS research, or apply novel technologies or creative strategies aimed at producing an actionable therapeutic direction.

Does the TIA require preliminary data?

No. A defining feature of this award is that applicants are not required to already have preliminary data that prove the hypothesis. Applications are expected to stand on the strength of the scientific rationale, rigor of the experimental design, feasibility, and the likelihood of producing meaningful, interpretable outcomes.

Can an applicant include preliminary data anyway?

Yes. Preliminary data may be included, but the application is expected to be evaluated primarily on the logic and rigor of the plan rather than extensive prior results.

What will reviewers look for most closely?

Reviewers are expected to focus on whether the hypothesis is clearly formulated, whether the experiments directly test the hypothesis, whether the methods are appropriate, and whether the project is likely to generate decision-quality data that can guide next steps in therapy development.

What does "high-risk, high-gain" mean in the context of this award?

It means the program is intentionally designed to support early, potentially transformative ideas that may carry uncertainty but could open a fresh therapeutic direction if successful, rather than supporting routine or incremental advances.

Are incremental advances or routine extensions of existing work appropriate for this award?

No. The opportunity emphasizes innovation and non-incremental advances. The expectation is that funded projects will be capable of producing transformative insights that lay a foundation for a new therapeutic direction.

Are projects that mainly study ALS biology or disease mechanisms eligible?

Not if they lack a clear therapeutic development component. Projects that primarily investigate ALS biology or mechanisms without a direct connection to therapy development are considered out of scope for this award.

Does the proposed therapeutic idea need to apply to all ALS patients?

No. Impact is defined broadly. A proposed therapy may be aimed at a specific ALS subtype, genetic form, or patient subgroup, as long as the project presents a credible translational path toward improving treatment or enabling a new treatment modality.

What is meant by a "credible translational path" in this opportunity?

Based on the description provided, it means the project should connect a strong scientific rationale and a testable hypothesis to experiments that plausibly support therapeutic development and future steps toward treatment impact.

Is a biomarker component required in the application?

Yes. A required component is consideration of biomarker development alongside the therapeutic concept, with an eye toward eventual clinical trials.

How should the biomarker component relate to the therapeutic concept?

The biomarker component should be aligned with the mechanism of the proposed therapy and should support therapeutic development rather than general disease characterization.

What biomarker types are described as aligned with this award?

Examples include: target engagement biomarkers (showing the therapy is hitting its intended target), pharmacodynamic biomarkers (objectively measuring biological response to the therapy), and predictive or cohort-selective biomarkers (helping identify which patients, including pre-symptomatic gene carriers, are most likely to benefit).

What kinds of biomarker efforts are not supported under the TIA mechanism?

Biomarkers intended primarily for diagnosis, prognosis, or tracking disease progression without a direct tie to the therapeutic development process are described as not supported under this mechanism.

If my project is focused on diagnosis, prognosis, or disease progression biomarkers, where should it go instead?

The description indicates those efforts are directed to a separate mechanism: the Clinical Outcomes and Biomarkers Award (HT942524ALSRPCOBA).

Who is the awarding/administrating organization for this opportunity?

The opportunity is from the Department of Defense ALSRP and is associated with the Department of the Army (USAMRAA).

What is the Funding Opportunity Number (FON) for this award?

The Funding Opportunity Number provided is HT942524ALSRPTIA.

What category and CFDA number are associated with this opportunity?

The opportunity is in the Science and Technology/Research and Development category and lists CFDA 12.420.

What type of grant opportunity is this?

It is described as a discretionary grant opportunity.

Who is eligible to apply?

Eligibility is listed as unrestricted.

What was the original application closing date?

The original application closing date was July 10, 2024.

How many awards were anticipated?

The program anticipated making about 10 awards.

When was this opportunity posted?

The posting was created on March 25, 2024.

What is the expected outcome of a funded TIA project?

Based on the opportunity description, the expected outcome is interpretable, decision-quality preliminary evidence that supports subsequent, more advanced therapeutic development, including biomarker considerations relevant to eventual clinical trials.