Opportunity Information: Apply for W81XWH 19 ALSRP TIA
The Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Idea Award (Funding Opportunity Number W81XWH-19-ALSRP-TIA) is a discretionary research funding opportunity run through the Department of Defense, Department of the Army, USAMRAA. It is intended to spark and support early-stage, high-potential concepts that could lead to new drugs or other treatments for ALS, with an emphasis on ideas that are not yet mature but have a clear translational direction. The mechanism supports science and technology and other research and development activities and may be offered through a grant or cooperative agreement.
The central goal is drug or treatment discovery rather than basic disease biology. Proposals that primarily investigate the pathophysiology of ALS (for example, projects focused mainly on understanding disease mechanisms without a defined therapeutic angle) are considered outside the scope. In contrast, projects that build toward therapeutic leads are strongly aligned, particularly those that develop or refine preclinical model systems relevant to ALS or that apply high-throughput screening approaches to identify, define, or evaluate lead compounds and candidate interventions. The program also highlights the importance of early pharmacology-style rigor by encouraging methods that can measure whether a proposed therapy actually engages its intended target (target binding and proximal downstream effects, often referred to as target engagement) and whether it avoids unwanted activity against related off-targets (selectivity).
Applications are expected to be hypothesis-driven and grounded in a strong scientific rationale, even when extensive preliminary data are not available. Preliminary data are allowed, but the competitiveness of the submission is not supposed to depend on having a large dataset already in hand. Instead, the award is structured to reward an innovative approach that is testable and plausibly capable of improving ALS treatment or enabling a novel treatment modality. Review emphasis is placed on innovation and impact: innovation can include introducing a new paradigm, challenging existing assumptions, applying novel concepts or technologies, or pursuing uniquely creative strategies that could plausibly generate therapeutics. Impact can be near-term or long-term, but it needs to be meaningful and more than incremental progress.
A notable priority is the use of existing human data and specimens to inform or validate therapeutic directions. The opportunity encourages identification of treatment approaches using biological correlates of disease activity and progression derived from pre-existing, de-identified human specimens drawn from well-characterized, adequately controlled, and sufficiently powered cohorts. Examples include samples tied to controlled clinical trials, observational studies, and registries, explicitly including resources such as the CDC National ALS Registry and/or Biorepository. The announcement also asks applicants to consider active duty military and Veteran patient populations or related resources where appropriate, reflecting the DoD mission context. Importantly, the program will not support collection of new specimens; all human specimens proposed for use must already exist at the time the application is submitted.
Collaboration is another emphasized feature. The award encourages meaningful, productive collaborations between investigators and suggests that, when appropriate, teams should include or partner with established ALS researchers. The overall intent is to combine fresh therapeutic ideas with the disease-specific expertise, tools, and validation pathways needed to move a concept toward a credible treatment discovery trajectory.
From a funding and logistics standpoint, eligibility is listed as unrestricted (open to any entity type, subject to any additional eligibility details in the full announcement). The original opportunity was posted November 20, 2018, with an original closing date of July 25, 2019. The anticipated direct costs for the entire period of performance were capped at $500,000, and the program anticipated making about five awards. Applicants aiming for work beyond early discovery (for example, more advanced preclinical development and product-focused activities) are directed to a separate ALSRP Therapeutic Development Award opportunity, which is designed for later-stage preclinical advancement rather than early therapeutic ideation and lead discovery.Apply for W81XWH 19 ALSRP TIA
- 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 Research, 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 Nov 20, 2018.
- Applicants must submit their applications by Jul 25, 2019. (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 5 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.
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FAQs: DoD ALSRP Therapeutic Idea Award (W81XWH-19-ALSRP-TIA)
1) What is this funding opportunity?
The Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Idea Award is a discretionary research funding opportunity managed through the Department of Defense (DoD), Department of the Army, USAMRAA. It is designed to spark and support early-stage, high-potential therapeutic concepts for amyotrophic lateral sclerosis (ALS) that have a clear translational direction.
2) What is the main goal of the Therapeutic Idea Award?
The central goal is drug or treatment discovery. The program is intended to help generate or validate therapeutic leads or candidate interventions, rather than to focus on basic disease biology.
3) What kinds of projects are considered out of scope?
Projects that primarily investigate the pathophysiology of ALS without a defined therapeutic angle are considered outside the scope. For example, studies centered on understanding disease mechanisms alone (without a clear plan to drive toward a treatment) do not align with this award’s stated purpose.
4) What kinds of projects are strongly aligned with this award?
Projects that build toward therapeutic leads are strongly aligned. Examples highlighted include:
- Developing or refining preclinical model systems relevant to ALS, when the intent is to enable therapeutic discovery
- Using high-throughput screening approaches to identify, define, or evaluate lead compounds and candidate interventions
- Generating evidence that a proposed therapy engages its intended target (target engagement) and demonstrates selectivity (avoids off-target activity against related targets)
5) Does the program require extensive preliminary data?
No. Applications are expected to be hypothesis-driven and grounded in a strong scientific rationale, but competitiveness is not supposed to depend on having extensive preliminary data. Preliminary data are allowed, but the award is structured to support innovative, testable ideas that may still be early in maturity.
6) What does “hypothesis-driven” mean in this context?
Based on the announcement summary provided, “hypothesis-driven” means the work should be guided by a clear, testable idea supported by a strong scientific rationale, even if large preliminary datasets are not available yet.
7) What is the review emphasis for this award?
Review emphasis is placed on innovation and impact:
- Innovation can include introducing a new paradigm, challenging existing assumptions, applying novel concepts or technologies, or pursuing uniquely creative strategies with a plausible path to therapeutics.
- Impact can be near-term or long-term, but it must be meaningful and more than incremental progress.
8) What is meant by “target engagement” and why is it encouraged?
The opportunity encourages “pharmacology-style rigor,” including methods that can measure whether a proposed therapy engages its intended target (such as target binding and proximal downstream effects). This is referred to as target engagement. The intent is to support early evidence that an intervention is acting on the biology it is designed to affect.
9) What is meant by “selectivity” and why does it matter?
Selectivity refers to whether a proposed therapy avoids unwanted activity against related off-targets. The program highlights the value of assessing selectivity early, to reduce the risk that a candidate intervention has unintended effects that could complicate therapeutic development.
10) Does the program prioritize using human data and specimens?
Yes. A notable priority is using existing human data and specimens to inform or validate therapeutic directions, including using biological correlates of disease activity and progression derived from pre-existing, de-identified human specimens.
11) What kinds of human cohorts or resources are mentioned as examples?
Examples include pre-existing, de-identified specimens from well-characterized, adequately controlled, and sufficiently powered cohorts, such as those associated with controlled clinical trials, observational studies, and registries. The announcement explicitly mentions resources such as the CDC National ALS Registry and/or Biorepository.
12) Can applicants collect new human specimens under this award?
No. The program will not support the collection of new specimens. Any human specimens proposed for use must already exist at the time the application is submitted.
13) Are de-identified specimens specifically encouraged?
Yes. The opportunity emphasizes using pre-existing, de-identified human specimens drawn from well-characterized cohorts to inform or validate therapeutic approaches.
14) Does the award mention military or Veteran populations?
Yes. Applicants are asked to consider active duty military and Veteran patient populations or related resources where appropriate, reflecting the DoD mission context.
15) Is collaboration encouraged?
Yes. The award encourages meaningful, productive collaborations between investigators. Where appropriate, it suggests teams include or partner with established ALS researchers to combine new therapeutic ideas with disease-specific expertise and validation pathways.
16) Who is eligible to apply?
Eligibility is listed as unrestricted, meaning it is open to any entity type, subject to any additional eligibility details that may be included in the full announcement.
17) What type of funding instrument is used?
The mechanism supports science and technology and other research and development activities and may be offered through a grant or a cooperative agreement.
18) What was the maximum funding amount?
The anticipated direct costs for the entire period of performance were capped at $500,000.
19) How many awards were anticipated?
The program anticipated making about five awards.
20) When was this opportunity posted and when did it close?
The original opportunity was posted on November 20, 2018, with an original closing date of July 25, 2019.
21) Is this award intended for late-stage preclinical development?
No. Applicants aiming for work beyond early discovery (such as more advanced preclinical development and product-focused activities) are directed to a separate opportunity: the ALSRP Therapeutic Development Award, which is designed for later-stage preclinical advancement.
22) If my project is more “basic science,” can it fit?
Based on the scope description provided, a project focused mainly on ALS disease mechanisms without a defined therapeutic angle is considered out of scope. To align, the work should clearly drive toward discovering or enabling drugs or other treatments.
23) If my concept is early and not fully mature, is that acceptable?
Yes. The award is explicitly intended to support early-stage, high-potential concepts that are not yet mature, as long as they are testable, grounded in strong rationale, and have a clear translational direction toward ALS therapeutics.
24) What is the funding opportunity number?
The Funding Opportunity Number is W81XWH-19-ALSRP-TIA.
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