Opportunity Information: Apply for W81XWH 09 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 Research Program 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 27, 2009 and posted on May 27, 2009.
  • Applicants must submit their applications by Oct 15, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 3 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 Research Program (ALSRP) Therapeutic Development Award (TDA) is a U.S. Department of Defense funding opportunity designed to move potential ALS treatments forward through preclinical development. Its central purpose is to improve treatment options for amyotrophic lateral sclerosis by supporting research that is directly tied to developing or advancing therapeutic candidates. In practice, this means the program is looking for studies that generate concrete, decision-making data about a therapeutic agent, such as whether it is promising enough to justify further development. The award is explicitly restricted to ALS-focused work, and projects must stay tightly aligned with therapeutic development rather than general neuroscience or broad mechanistic exploration.

A key theme of the opportunity is that proposed projects should be empirical and product-driven. Applicants are encouraged to test both novel and existing agents in preclinical settings, with an emphasis on producing actionable outputs that can push a therapy along a development pathway. While hypothesis-driven research is not prohibited, the hypothesis must serve a therapeutic-development goal rather than basic science discovery for its own sake. The program anticipates that funded efforts will yield agents and/or datasets that enable meaningful advancement toward ALS therapeutics, such as preclinical efficacy signals, dose and regimen insights, pharmacology or toxicology indicators, or other development-enabling evidence. By contrast, basic science studies that do not directly inform therapeutic development are described as outside the intent of this mechanism.

The funding instrument is listed as a Cooperative Agreement/Grant under the Department of the Army (USAMRAA), reflecting the program’s placement within military medical research and development (CFDA 12.420). The opportunity category is discretionary, and it falls under science and technology and other research and development activities. The announcement projected an expected three awards, with an estimated total funding amount of $5,000,000. There is no cost-sharing or matching requirement stated for applicants, which means proposals are not expected to include institutional matching funds as a condition of eligibility.

Eligibility is described as “unrestricted,” meaning it is broadly open to different types of applicant entities, subject to any additional clarifications that may appear in the full announcement text. The posted date and creation date were May 27, 2009, and the application closing date was October 15, 2009, with an archive date of November 14, 2009. Importantly, the scope boundaries include a clear prohibition on clinical trials: even though the goal is to improve treatments, the work supported under this award must remain in the preclinical space and cannot be structured as a clinical trial.

For support and administrative questions, the announcement provides multiple help contacts, including assistance for accessing the full announcement (PA HELP at 301-619-7079 and cdmrp.pa@amedd.army.mil) and electronic submission support (eReceipt HELP at 301-682-5507, help@cdmrp.org), as well as the CDMRP Help Desk. Overall, this opportunity is best understood as a translational preclinical funding mechanism aimed at generating the kind of evidence and development-ready outputs that can meaningfully accelerate ALS therapeutic candidates, while excluding projects that are primarily basic research or any work that crosses into clinical trial territory.

FAQs: DoD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA)

What is the ALSRP Therapeutic Development Award (TDA)?

The ALSRP Therapeutic Development Award (TDA) is a U.S. Department of Defense funding opportunity intended to move potential ALS treatments forward through preclinical development. The focus is on research that directly develops or advances therapeutic candidates for amyotrophic lateral sclerosis (ALS).

What is the primary goal of this award?

The central purpose is to improve treatment options for ALS by supporting work that produces concrete, decision-making data about a therapeutic agent. The expectation is that the results help determine whether a candidate is promising enough to justify further development.

What type of research is the program trying to fund?

The program emphasizes empirical, product-driven preclinical research tied to therapeutic development. Projects should generate actionable outputs that push a therapeutic agent along a development pathway (for example, data that inform next-step development decisions).

Does the award allow both novel and existing therapeutic agents?

Yes. Applicants are encouraged to test both novel and existing agents in preclinical settings, as long as the work is designed to produce development-relevant evidence.

Is hypothesis-driven research allowed under this award?

Hypothesis-driven work is not prohibited, but the hypothesis must serve a therapeutic-development goal. The program does not support hypothesis-driven work when it is primarily aimed at basic science discovery rather than advancing a therapeutic candidate.

What kinds of outcomes or data does the program expect from funded projects?

Funded efforts are expected to yield agents and/or datasets that enable meaningful advancement toward ALS therapeutics. Examples described include preclinical efficacy signals, dose and regimen insights, pharmacology or toxicology indicators, and other development-enabling evidence.

What research is considered outside the intent of this mechanism?

Basic science studies that do not directly inform therapeutic development are described as outside the intent. Projects that are broadly mechanistic or general neuroscience without a clear therapeutic-development trajectory are not aligned with the award purpose.

Is the award restricted to ALS-focused projects?

Yes. The award is explicitly restricted to ALS-focused work. Projects must stay tightly aligned with developing or advancing therapeutic candidates specifically for ALS.

Are clinical trials allowed?

No. The opportunity includes a clear prohibition on clinical trials. Even though the goal is to improve treatments, supported work must remain in the preclinical space and cannot be structured as a clinical trial.

What is the funding instrument for this opportunity?

The funding instrument is listed as a Cooperative Agreement/Grant under the Department of the Army (USAMRAA). The opportunity is associated with military medical research and development and is identified under CFDA 12.420.

What category of funding opportunity is this?

The opportunity category is discretionary, and it falls under science and technology and other research and development activities.

How many awards were expected and what was the estimated total funding?

The announcement projected an expected three awards, with an estimated total funding amount of $5,000,000.

Is cost sharing or matching required?

No cost-sharing or matching requirement is stated. Proposals are not expected to include institutional matching funds as a condition of eligibility based on the information provided.

Who is eligible to apply?

Eligibility is described as "unrestricted," meaning it is broadly open to different types of applicant entities, subject to any additional clarifications that may be included in the full announcement text.

What were the key dates for this opportunity?

The posted date and creation date were May 27, 2009. The application closing date was October 15, 2009, and the archive date was November 14, 2009.

What kind of help is available for applicants who need the full announcement or submission support?

For assistance accessing the full announcement, the contact listed is PA HELP at 301-619-7079 or cdmrp.pa@amedd.army.mil. For electronic submission support, the contact listed is eReceipt HELP at 301-682-5507 or help@cdmrp.org. The announcement also references the CDMRP Help Desk for support.

What should an applicant keep in mind when aligning a project to this award?

Projects should be tightly aligned with therapeutic development for ALS and designed to generate practical, decision-enabling preclinical data about a therapeutic candidate. The work should avoid drifting into broad basic research aims or anything that would constitute a clinical trial.

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