Opportunity Information: Apply for W81XWH 13 ALSRP TDA
Apply for W81XWH 13 ALSRP TDA
- The 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 Development Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on May 3, 2013 and posted on May 3, 2013.
- Applicants must submit their applications by Sep 18, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,800,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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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Opportunity Summary:
The DoD Amyotrophic Lateral Sclerosis (ALS) Therapeutic Development Award (TDA) is a funding opportunity from the U.S. Army (USAMRAA) under the ALS Research Program (ALSRP) that is meant to push ALS treatment candidates through key preclinical development steps. The award is explicitly geared toward product-driven work that generates concrete development outcomes, such as validated assays, strengthened preclinical models, drug development packages, or other deliverables that make a therapy more ready to move toward human testing. While projects may be hypothesis-driven, the central requirement is that the research stays tightly focused on therapeutic development rather than basic biology. The program expects that the agents and data produced will help advance new therapies for ALS, but it also makes clear that clinical trials are not allowed under this announcement.
A major theme of the opportunity is readiness and realism. Applicants must include preliminary data that directly supports the specific preclinical development phase(s) they plan to complete during the award period. The application is also expected to lay out a clear statistical analysis plan when appropriate, reflecting the program's emphasis on empirical testing and decision-quality data. Another key requirement is that the proposal must clearly and explicitly explain how the project will impact ALS therapeutic development, meaning reviewers are looking for a direct line from proposed work to an actionable next step in the development pathway (for example, improved lead selection, IND-enabling studies, manufacturing readiness, or an IND submission package). Because the mechanism is designed for preclinical development, any proposal that crosses into clinical trial execution falls outside the scope and will not be supported.
Program fit is strict and tied to specified areas of interest. Applications must focus on at least one stated programmatic interest area or they will be administratively withdrawn, which is an important point because it means an otherwise strong proposal can be removed before review if it does not clearly align. The allowable areas include: (1) developing and/or validating high-throughput screening approaches to identify drug targets or lead therapeutic candidates, with an emphasis on creating assets useful to the broader ALS community; (2) developing, modifying, and/or validating preclinical model systems that can evaluate lead compounds via pharmacology and/or pharmacokinetics and also serve as improved community tools; (3) developing and optimizing pharmacologic agents through ADME (adsorption, distribution, metabolism, excretion) studies and toxicology testing, including IND-enabling pharmacology/toxicology; (4) formulation and stability work, plus the design and implementation of full-scale or pilot current Good Manufacturing Practice (cGMP) production of therapeutics or delivery systems suitable for advanced preclinical work and initial clinical use; and (5) development of pharmacologic agents up to IND submission, positioning the agent to enter Phase I clinical trials after the award ends. The announcement also notes that investigators doing earlier-stage, more basic therapeutics research should look to the ALSRP Therapeutic Idea Award, which does not require preliminary data; if a candidate therapy originated under that earlier mechanism, the TDA application should explain how the prior award contributed to the agent's development.
Collaboration is encouraged because preclinical drug development often exceeds the capabilities of any single lab or institution. The program allows and welcomes multi-party efforts, but it expects the collaboration to be organized around one integrated preclinical development project rather than a bundle of loosely related subprojects. If collaborations are included, the application must provide letters confirming and supporting the partnership. For multi-organizational teams, the announcement requires proactive planning around intellectual property and material transfer issues, along with a plan to remove organizational barriers that could slow progress. Applicants must include an Intellectual and Material Property Plan that explains how these issues will be handled so the project can move quickly and cooperatively.
The eligibility scope is broad and described as unrestricted, meaning a wide range of entity types may apply, including academic institutions, nonprofits, and private-sector organizations. Biotechnology and pharmaceutical companies are specifically invited because the work aligns naturally with industry development capabilities; however, the announcement emphasizes that companies are expected to leverage their own resources alongside award funding, whether they apply alone or as part of a partnership. The funding instrument is listed as a cooperative agreement/grant under CFDA 12.420 (Military Medical Research and Development), with an estimated total funding amount of $4.8 million and an expected two awards for this cycle. No cost sharing or matching is required. The opportunity was posted May 3, 2013, with a closing date of September 18, 2013 (archived October 18, 2013). For access issues, the listing directs applicants to the CDMRP Help Desk at 301-682-5507.
FAQs: DoD ALS Therapeutic Development Award (TDA)
What is the DoD ALS Therapeutic Development Award (TDA)?
The ALS Therapeutic Development Award (TDA) is a funding opportunity under the U.S. Army (USAMRAA) Amyotrophic Lateral Sclerosis Research Program (ALSRP) designed to move ALS treatment candidates through key preclinical development steps. It is intended to generate concrete, product-driven development outcomes that make a therapy more ready to progress toward human testing.
What is the main purpose of this award?
The purpose is to advance ALS therapeutic candidates by completing specific preclinical development phase(s) and producing decision-quality data and deliverables (for example, validated assays, improved preclinical models, drug development packages, formulation/stability outputs, or IND-oriented materials) that enable a clear next step in the development pathway.
Is this opportunity focused on basic research or therapeutic development?
The central requirement is therapeutic development. While the project may include hypothesis-driven elements, it must stay tightly focused on preclinical development work rather than basic biology.
Are clinical trials allowed under this announcement?
No. Clinical trials are explicitly not allowed under this announcement. Proposals that cross into clinical trial execution are outside the scope and will not be supported.
What kinds of outcomes or deliverables does the program expect?
The program emphasizes concrete development outcomes such as validated assays, strengthened or improved preclinical models, drug development packages, or other deliverables that increase readiness for later-stage development and movement toward human testing.
What is meant by the program's emphasis on "readiness and realism"?
Applicants are expected to propose work that is feasible within the award period and supported by preliminary data that directly aligns with the specific preclinical development phase(s) to be completed. The proposal should show a realistic, actionable path to an identifiable development next step.
Is preliminary data required?
Yes. The application must include preliminary data that directly supports the specific preclinical development phase(s) planned during the award period.
Is a statistical analysis plan required?
When appropriate, the application is expected to include a clear statistical analysis plan. This reflects the program's emphasis on empirical testing and generating decision-quality data.
How should applicants describe the project's impact on ALS therapeutic development?
The proposal must clearly and explicitly explain how the project will impact ALS therapeutic development, showing a direct line from the proposed work to an actionable next step in the development pathway (for example, improved lead selection, IND-enabling studies, manufacturing readiness, or an IND submission package).
What are the required areas of interest for program fit?
Applications must focus on at least one stated programmatic interest area. The allowable areas include:
- Developing and/or validating high-throughput screening approaches to identify drug targets or lead therapeutic candidates, emphasizing assets useful to the broader ALS community.
- Developing, modifying, and/or validating preclinical model systems to evaluate lead compounds via pharmacology and/or pharmacokinetics, also serving as improved community tools.
- Developing and optimizing pharmacologic agents through ADME (adsorption, distribution, metabolism, excretion) studies and toxicology testing, including IND-enabling pharmacology/toxicology.
- Formulation and stability work and the design/implementation of full-scale or pilot cGMP production of therapeutics or delivery systems suitable for advanced preclinical work and initial clinical use.
- Development of pharmacologic agents up to IND submission, positioning the agent to enter Phase I clinical trials after the award ends.
What happens if an application does not align with an area of interest?
Program fit is strict. If an application does not clearly focus on at least one stated programmatic interest area, it will be administratively withdrawn (meaning it can be removed before review even if it is otherwise strong).
If my work is earlier-stage and more basic, is this the right mechanism?
The announcement indicates that investigators conducting earlier-stage, more basic therapeutics research should consider the ALSRP Therapeutic Idea Award instead, which does not require preliminary data.
If my candidate therapy originated under the ALSRP Therapeutic Idea Award, what should I include?
If a candidate therapy originated under the earlier mechanism, the TDA application should explain how the prior award contributed to the agent's development.
Are collaborations allowed or encouraged?
Yes. Collaboration is encouraged because preclinical drug development may exceed the capabilities of a single lab or institution. Multi-party efforts are allowed and welcomed.
How should collaborative projects be structured?
The collaboration is expected to be organized around one integrated preclinical development project rather than a bundle of loosely related subprojects.
Are letters of support required for collaborations?
Yes. If collaborations are included, the application must provide letters confirming and supporting the partnership.
What planning is expected for intellectual property (IP) and material transfer in multi-organization teams?
The announcement requires proactive planning around intellectual property and material transfer issues, along with a plan to remove organizational barriers that could slow progress.
Is an Intellectual and Material Property Plan required?
Yes. Applicants must include an Intellectual and Material Property Plan describing how IP and material transfer issues will be handled to keep the project moving quickly and cooperatively.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning a wide range of entity types may apply, including academic institutions, nonprofits, and private-sector organizations.
Are biotech and pharmaceutical companies encouraged to apply?
Yes. Biotechnology and pharmaceutical companies are specifically invited because the work aligns with industry development capabilities.
Are companies expected to contribute their own resources?
Yes. The announcement emphasizes that companies are expected to leverage their own resources alongside award funding, whether applying alone or as part of a partnership.
Is cost sharing or matching required?
No. The opportunity states that no cost sharing or matching is required.
What is the funding instrument and CFDA number?
The funding instrument is listed as a cooperative agreement/grant under CFDA 12.420 (Military Medical Research and Development).
How much total funding is expected and how many awards are anticipated?
The estimated total funding amount is $4.8 million, and the program expects approximately two awards for this cycle.
What are the key dates for this opportunity?
The opportunity was posted May 3, 2013, with a closing date of September 18, 2013, and it was archived October 18, 2013.
Who should applicants contact for access issues?
For access issues, the listing directs applicants to the CDMRP Help Desk at 301-682-5507.
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