Opportunity Information: Apply for HT9425 23 ALSRP TIA
The DOD Amyotrophic Lateral Sclerosis (ALSRP) Therapeutic Idea Award (FY23) is a Department of Defense funding opportunity focused on jumpstarting bold, early-stage therapeutic concepts for ALS. It is designed for the initial exploration of innovative, high-risk, high-reward ideas that could lead to new drugs, new treatment strategies, or novel treatment modalities. The central expectation is that projects will be hypothesis-driven and will produce interpretable results that generate the kind of early evidence needed to justify and shape later-stage therapeutic development work. In other words, the award is meant to help investigators take a promising therapeutic concept from an idea to a first set of credible data that can support a follow-on application such as the ALSRP Therapeutic Development Award or another translational funding pathway.
A strong application under this mechanism is built around a well-formulated, testable hypothesis backed by a solid scientific rationale and clear translational potential for improving ALS treatment. Importantly, the program explicitly allows applicants to propose work without preliminary data, as long as the study design can still deliver interpretable outcomes and the rationale is convincing. Preliminary data can be included, but the application is not supposed to lean on it as the primary justification; the key selling point should be the novelty and promise of the approach itself. This structure is meant to make room for genuinely new directions that may not yet have accumulated extensive supporting evidence.
The opportunity draws a clear boundary around what it will and will not support. Projects that primarily investigate ALS pathophysiology without a concrete connection to therapy development are considered outside the scope. Basic mechanistic work is not automatically excluded, but it must be meaningfully tied to therapeutic discovery or advancement, such as identifying and validating a tractable target, demonstrating feasibility of a treatment concept, testing an intervention strategy, or generating actionable data that de-risks the next step in therapy development.
Innovation and impact are central review priorities. Innovation can mean proposing a new paradigm, challenging existing assumptions, or applying novel concepts, tools, or technologies in a way that opens up fresh therapeutic possibilities for ALS. Impact is framed as transformative potential: the project should have a credible chance of laying groundwork for a new direction in ALS therapeutic development rather than producing incremental advances. The program is essentially asking applicants to aim for ideas that could change how the field thinks about treating ALS, while still being disciplined about hypothesis testing and translational relevance.
The Therapeutic Idea Award also emphasizes the people and partnerships behind the work. Early-career investigators are encouraged to apply, and the program values meaningful collaborations that bring together the expertise needed to execute the project well. Applicants who are new to ALS research are welcome, but they are encouraged to partner with collaborators who have relevant ALS experience, including familiarity with ALS model systems, appropriate endpoints, and established pathogenic findings. This reflects an interest in broadening the pipeline of therapeutic innovation while maintaining rigor and disease-specific credibility.
A notable feature is the optional Biomarker Option, which offers the chance to co-develop biomarker(s) alongside the main therapeutic concept, with additional funding available for this purpose (subject to the solicitation rules). The biomarker work must directly support the therapeutic development process rather than general clinical characterization. Supported biomarker efforts may include target engagement biomarkers that show a therapy is hitting its intended target, pharmacodynamic biomarkers that objectively measure biological response to the therapy, or predictive or cohort-selective biomarkers that help identify which patients (or subgroups) are more likely to respond. Biomarkers aimed only at diagnosis, prognosis, or tracking disease progression, without a direct role in advancing the therapy, are not supported under this option. To pursue the Biomarker Option, applicants must clearly define the proposed marker and explain how it will improve therapeutic development effectiveness (for example, by informing dose selection, confirming mechanism, enabling patient stratification, or strengthening go/no-go decisions).
Administratively, this opportunity is run by the Department of Defense, Department of the Army, through USAMRAA. It is listed as a discretionary program and may be offered through grants and cooperative agreements. Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility details in the full announcement. The opportunity number is HT9425 23 ALSRP TIA, it was created on February 8, 2023, and the original closing date was July 13, 2023. The listing indicates an expectation of around 16 awards, and the award ceiling is shown as 0 in the provided source data, which typically means applicants need to rely on the full funding announcement for the actual maximum budget guidance and any cost restrictions tied to the mechanism and optional biomarker add-on.Apply for HT9425 23 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, 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 Feb 08, 2023.
- Applicants must submit their applications by Jul 13, 2023. (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.
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FAQs: DOD ALSRP Therapeutic Idea Award (FY23)
What is the DOD ALSRP Therapeutic Idea Award (FY23)?
The DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Idea Award (FY23) is a Department of Defense funding opportunity intended to jumpstart bold, early-stage therapeutic concepts for ALS. It supports the initial exploration of innovative, high-risk, high-reward ideas that could lead to new drugs, new treatment strategies, or novel treatment modalities.
What is the main purpose of this award?
The main purpose is to help investigators take a promising therapeutic concept from an idea to an initial set of credible, interpretable data. The expectation is that the results will provide early evidence that can justify and shape later-stage therapeutic development work and support follow-on applications (for example, the ALSRP Therapeutic Development Award or other translational pathways).
What type of research does this funding opportunity prioritize?
This mechanism prioritizes hypothesis-driven projects that generate interpretable results and demonstrate clear translational potential to improve ALS treatment. It is designed for early-stage therapeutic exploration rather than late-stage development.
Does the project need to be hypothesis-driven?
Yes. A central expectation is that projects will be hypothesis-driven and designed to produce interpretable outcomes that can guide subsequent therapeutic development decisions.
Is preliminary data required to apply?
No. The program explicitly allows applicants to propose work without preliminary data, as long as the scientific rationale is convincing and the study design can still deliver interpretable results.
Can applicants include preliminary data if they have it?
Yes. Preliminary data may be included, but the application should not rely on it as the primary justification. The emphasis is on the novelty and promise of the therapeutic concept itself.
What makes an application strong under this mechanism?
A strong application is built around a well-formulated, testable hypothesis supported by a solid scientific rationale and clear translational potential. The proposed work should generate actionable, early evidence that de-risks the next steps in therapeutic development.
What kinds of projects are considered out of scope?
Projects that primarily investigate ALS pathophysiology without a concrete connection to therapy development are considered outside the scope of this award.
Is basic mechanistic research allowed?
Basic mechanistic work is not automatically excluded, but it must be meaningfully tied to therapeutic discovery or advancement. Examples include identifying and validating a tractable target, demonstrating feasibility of a treatment concept, testing an intervention strategy, or generating actionable data that supports next-step therapy development.
What does the program mean by innovation?
Innovation can include proposing a new therapeutic paradigm, challenging existing assumptions, or applying novel concepts, tools, or technologies in ways that open new therapeutic possibilities for ALS.
What does the program mean by impact?
Impact is framed as transformative potential. The project should credibly lay the groundwork for a new direction in ALS therapeutic development rather than producing incremental advances, while still remaining disciplined in hypothesis testing and translational relevance.
Who is encouraged to apply?
Early-career investigators are encouraged to apply. The opportunity also welcomes applicants who are new to ALS research.
Are collaborations important for this opportunity?
Yes. The program values meaningful collaborations that bring together the expertise needed to execute the project well, particularly when ALS-specific experience is important to ensure rigor and relevance.
If an applicant is new to ALS research, is that acceptable?
Yes. Applicants new to ALS research are welcome, and they are encouraged to partner with collaborators who have relevant ALS experience.
What kind of ALS experience is the program encouraging teams to include?
The program encourages collaborations with investigators who have ALS-relevant experience, such as familiarity with ALS model systems, appropriate endpoints, and established pathogenic findings.
What is the optional Biomarker Option?
The optional Biomarker Option allows applicants to co-develop biomarker(s) alongside the main therapeutic concept, with additional funding potentially available for this purpose (subject to the solicitation rules).
What is the purpose of adding biomarker work to the project?
Biomarker work must directly support therapeutic development. The intent is to strengthen and accelerate development decisions (for example, confirming mechanism, informing dose selection, enabling patient stratification, or improving go/no-go decision-making).
What types of biomarkers may be supported under the Biomarker Option?
Supported examples include target engagement biomarkers, pharmacodynamic biomarkers that measure biological response to the therapy, and predictive or cohort-selective biomarkers that help identify patients or subgroups more likely to respond.
What biomarker approaches are not supported under this option?
Biomarkers aimed only at diagnosis, prognosis, or tracking disease progression, without a direct role in advancing the therapy, are not supported under the Biomarker Option.
What must an applicant include to pursue the Biomarker Option?
Applicants must clearly define the proposed biomarker(s) and explain how the biomarker will improve the effectiveness of therapeutic development (for example, by informing dose selection, confirming target engagement, enabling stratification, or strengthening development decisions).
Which agency administers this funding opportunity?
This opportunity is run by the Department of Defense, Department of the Army, through USAMRAA.
What is the opportunity number?
The opportunity number is HT9425 23 ALSRP TIA.
What kind of program is this listed as?
It is listed as a discretionary program and may be offered through grants and cooperative agreements.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility details in the full announcement.
When was this opportunity created and when did it close?
The listing indicates it was created on February 8, 2023, and the original closing date was July 13, 2023.
How many awards are expected?
The listing indicates an expectation of around 16 awards.
What is the maximum award amount (award ceiling)?
The award ceiling is shown as 0 in the provided source data. This typically indicates applicants should rely on the full funding announcement for the actual maximum budget guidance and any cost restrictions, including any rules tied to the optional Biomarker Option.
What is the program ultimately trying to produce at the end of the project?
The program is aiming for early, interpretable evidence that supports the therapeutic idea and helps shape a translational development path, including creating a foundation for a follow-on therapeutic development application.
How does the program distinguish between therapy-focused work and general ALS research?
The key distinction is whether the work directly advances therapeutic development. Projects centered on understanding disease mechanisms without a concrete therapeutic development connection are out of scope, while mechanistic work that identifies targets or de-risks therapeutic strategies can fit if it is clearly tied to treatment advancement.
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