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

FAQs: DoD ALSRP Therapeutic Idea Award (FY20)

1) What is the purpose of the ALSRP Therapeutic Idea Award (FY20)?

The Therapeutic Idea Award (TIA) is a Department of Defense (DoD) funding opportunity designed to jump-start early-stage, hypothesis-driven therapeutic development for amyotrophic lateral sclerosis (ALS). It prioritizes new, creative therapeutic ideas that are still relatively early and may not yet have extensive supporting datasets, but that have a strong scientific rationale and a credible path toward translation into future ALS treatment approaches.

2) What kinds of therapies or interventions are in scope?

The opportunity is intentionally therapeutic and is aimed at work that could lead to drugs, biologics, devices, or other treatment approaches for ALS. The emphasis is on concepts that can plausibly influence how ALS is treated or that could open a genuinely new treatment modality.

3) Are preliminary data required to apply?

No. Preliminary data are not required. If applicants have early results, they may include them, but applications are expected to stand primarily on the strength of the concept, the logic of the hypothesis, and the innovation of the approach rather than relying on a large body of prior findings.

4) Does the project need a hypothesis?

Yes. Projects are expected to be built around a clearly stated, testable hypothesis supported by a strong scientific rationale, along with a credible line of sight to translation.

5) What does “line of sight to translation” mean in this context?

It means the proposed work should be positioned to eventually influence ALS treatment or enable a new therapeutic modality. Even if the work is early-stage, the application should make a convincing case that it can feed a development pathway rather than remaining purely exploratory or descriptive.

6) Can the award support enabling work like model development or screening?

Yes. The program allows enabling work that supports therapeutic discovery, including developing or modifying preclinical model systems and using high-throughput screening strategies to identify or evaluate lead compounds for ALS.

7) Do projects have to focus on a single drug candidate?

No. The scope is not limited to testing a single candidate. Earlier steps that help define, refine, and assess therapeutic leads (for example, screening and lead evaluation) can be supported if they are clearly tied to therapeutic development for ALS.

8) What types of applications are considered out of scope?

Applications that mainly study ALS disease mechanisms or pathophysiology without a real therapeutic development component are considered out of scope. The therapeutic development angle must be central, not an add-on.

9) What review themes are emphasized?

Review emphasis is placed on innovation and impact. Innovation may include challenging prevailing assumptions, introducing a new paradigm, applying a novel technology, or combining ideas in a uniquely creative way that plausibly leads to an ALS therapy. Impact may be near-term or longer-term, but it should be meaningful and clearly beyond incremental progress, with a convincing argument for advancing the search for effective ALS treatments.

10) Are early career investigators encouraged to apply?

Yes. The opportunity encourages participation from early career investigators.

11) Are collaborations encouraged?

Yes. Strong collaborations are valued. The program specifically notes that researchers coming from outside the ALS field are welcome and are encouraged to partner with ALS-experienced collaborators who understand relevant model systems, endpoints, and known pathogenic findings to keep the proposed work grounded in ALS drug development needs.

12) Can applicants who are new to ALS research apply?

Yes. Researchers from outside the ALS field are welcome. The opportunity encourages partnering with ALS-experienced collaborators to strengthen disease-specific relevance and feasibility.

13) Does the program encourage use of existing human biospecimens and datasets?

Yes. The program encourages leveraging 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.

14) What sources of existing specimens or data are acceptable?

Acceptable sources include specimens or data from controlled clinical trials, observational studies, registries, and public biorepositories. The CDC National ALS Registry and Biorepository is specifically mentioned as an example resource.

15) Does the opportunity highlight any particular patient populations?

Yes. The program specifically suggests considering active duty military and Veteran patient populations and notes that ALSRP maintains a list of relevant resources.

16) Can award funds be used to collect new biospecimens?

No. The award does not support collecting new specimens for the project. Samples must already exist at the time of application.

17) If using an external repository, what documentation is expected?

Applications relying on outside repositories typically need strong documentation (for example, letters of support) describing the repository, cohort characteristics, and how access to data and samples is managed.

18) What is the “Therapeutically Relevant Biomarker Option”?

It is an optional feature in the FY20 announcement that offers additional funding to co-develop biomarkers alongside the main therapeutic development work, as long as the biomarkers directly support the drug development process.

19) What kinds of biomarkers are supported under the Biomarker Option?

Examples include target engagement biomarkers (showing whether a therapy is hitting its intended target), pharmacodynamic biomarkers (objectively measuring biological response to treatment), and predictive or cohort-selective biomarkers (helping identify which patients or subgroups are most likely to benefit).

20) What biomarker work is not supported under the Biomarker Option?

Biomarker work aimed only at diagnosis, prognosis, or tracking disease progression is not supported if it does not clearly enable or accelerate therapeutic development.

21) Which agency administers this funding opportunity?

This is a discretionary DoD opportunity administered by the Department of the Army (USAMRAA).

22) What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is W81XWH-20-ALSRP-TIA.

23) What funding mechanisms are available under this opportunity?

The opportunity allows funding through grants and cooperative agreements.

24) Who is eligible to apply?

The summary indicates unrestricted eligibility (open to essentially any eligible entity type), subject to any specific clarifications in the full announcement.

25) When was the opportunity posted and when did it close?

The opportunity was originally posted in January 2020 and had a July 2020 closing date.

26) About how many awards were expected?

The listing indicated an expectation of roughly 16 awards.

27) What is the maximum award amount (ceiling)?

The award ceiling was not specified in the provided summary.