Opportunity Information: Apply for W81XWH 22 ALSRP TDA
Apply for W81XWH 22 ALSRP TDA
- 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 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.
- This funding opportunity was created on Mar 16, 2022.
- Applicants must submit their applications by Jul 28, 2022. (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 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 Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) is designed to push promising ALS treatments along the practical path toward the clinic. It funds studies that sit squarely in the middle-to-late preclinical development pipeline, starting with validating therapeutic leads and extending through key U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling work. The emphasis is strongly on empirical, product-driven research that moves a specific therapeutic candidate forward rather than on exploratory biology or early discovery.
This opportunity supports projects that already have a lead therapeutic in hand and are ready to do the kinds of experiments needed to confirm, refine, and de-risk that candidate. Typical supported work includes confirming candidate therapeutics that emerged from screening or other discovery approaches, then optimizing potency and drug-like properties while testing derivatives or closely related compounds. It also includes strengthening early findings by validating pilot studies, for example by reproducing preliminary results with additional time points, more dose levels, or across multiple ALS model systems to show the effect is robust and not model-specific. On the development side, the award can cover formulation and stability work that supports eventual Good Manufacturing Practice (GMP) production approaches. It also explicitly supports IND-enabling studies such as compound characterization and absorption, distribution, metabolism, and excretion (ADME) assessments, along with dose-response evaluations and toxicology studies in relevant systems. Overall, the program is aiming to fund the concrete steps that make a therapeutic package credible for regulatory consideration and clinical translation.
A key eligibility-like expectation is that applicants must come in with meaningful preliminary data appropriate to their stage of development. That includes basic evidence that the compound is what it is claimed to be (identity) and is sufficiently clean (purity), plus evidence of selectivity for the intended target compared with closely related targets, which helps reduce the risk of off-target effects. Applicants should also have primary and secondary in vitro bioactivity assays available, which are necessary for optimization work and structure-activity relationship efforts. In addition, the program expects proof-of-concept efficacy data in at least one ALS-relevant preclinical model system, which can include whole-animal models and cellular models. In other words, this is not a funding mechanism for someone who only has a hypothesis or a hit from a screen without follow-up data; it is meant for teams that are already past the earliest gate and can justify a focused development plan.
The award also makes biomarker work a central requirement, not an optional add-on. Applicants are expected to develop or further characterize validated biomarkers in parallel with the therapeutic program, specifically biomarkers that will make eventual clinical testing more informative and efficient. Examples include target engagement biomarkers that show the therapy is hitting its intended molecular target, pharmacodynamic biomarkers that reflect a biological effect of the investigational agent, and predictive or cohort-selective biomarkers that can help identify which patients or subgroups are most likely to respond. Importantly, biomarker efforts aimed only at diagnosis, prognosis, or measuring disease progression, without a clear tie to therapeutic development decisions, are not supported. Applicants must clearly define the biomarker and explain how it will improve the therapeutic development process, such as guiding dose selection, confirming mechanism in vivo, supporting go/no-go decisions, or enriching clinical trials with patients most likely to benefit.
From an applicant standpoint, the program signals that ALS domain expertise matters. Teams with limited experience in ALS are strongly encouraged to bring in collaborators who have substantial hands-on knowledge of ALS model systems, relevant endpoints, and ALS pathophysiology. This reflects the program goal of funding studies that are not only technically sound but also well-matched to the nuances and pitfalls of ALS translational research, where model selection, outcome measures, and interpretation can heavily influence whether a candidate is truly ready to advance.
Administratively, the opportunity is offered by the Department of Defense, Department of the Army, through USAMRAA, under Funding Opportunity Number W81XWH-22-ALSRP-TDA. The funding instrument type is listed as a cooperative agreement or grant, within the Science and Technology and other Research and Development category (CFDA 12.420). Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility clarifications in the full announcement. The posting indicates an expected three awards, with an award ceiling shown as 0 (which typically means applicants must rely on the full announcement for the actual cap or that a fixed ceiling is not stated in that field). The opportunity was created March 16, 2022, with an original closing date of July 28, 2022.
FAQs: DoD ALSRP Therapeutic Development Award (TDA)
What is the ALSRP Therapeutic Development Award (TDA)?
The Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) is a funding opportunity intended to advance promising ALS treatments along a practical, product-driven path toward clinical testing. It supports middle-to-late preclinical development work, from therapeutic lead validation through key FDA Investigational New Drug (IND)-enabling studies.
What stage of research is this award meant to fund?
This award targets projects in the middle-to-late preclinical development pipeline. It is designed for teams that already have a specific therapeutic lead and need to perform the experiments required to confirm, optimize, and de-risk that candidate for eventual regulatory consideration and clinical translation.
What types of projects are not a good fit for this award?
The emphasis is on empirical, product-driven research that advances a specific therapeutic candidate. The opportunity is not intended for exploratory biology, early discovery efforts, or projects that only have a hypothesis or an initial screening hit without meaningful follow-up and proof-of-concept data.
Does an application need to focus on a specific therapeutic candidate?
Yes. The program prioritizes work that moves a specific therapeutic candidate forward rather than broad, exploratory studies. Projects are expected to be centered on confirming, refining, and developing a defined therapeutic lead.
What kinds of lead validation activities does the award support?
Supported work can include confirming candidate therapeutics that emerged from screening or other discovery approaches, validating early/pilot results, and strengthening confidence in the candidate by reproducing preliminary findings with additional time points, more dose levels, or across multiple ALS model systems.
Does the award support optimization of potency and drug-like properties?
Yes. The opportunity includes optimizing potency and drug-like properties, including testing derivatives or closely related compounds to support structure-activity relationship and refinement activities.
Can applicants use the award to validate results in more than one ALS model system?
Yes. The program explicitly describes strengthening early findings by validating pilot studies across multiple ALS model systems to demonstrate that effects are robust and not limited to a single model.
What development-focused studies are supported (formulation, stability, manufacturing readiness)?
The award can support formulation and stability work that helps prepare for eventual Good Manufacturing Practice (GMP) production approaches. This aligns with the program goal of building a credible therapeutic development package.
Does the award support FDA IND-enabling work?
Yes. The TDA explicitly supports IND-enabling studies such as compound characterization, absorption/distribution/metabolism/excretion (ADME) assessments, dose-response evaluations, and toxicology studies in relevant systems.
What is the overall goal of the funded work?
The overall aim is to fund concrete steps that make a therapeutic package credible for regulatory consideration and clinical translation, helping move an ALS therapeutic candidate toward the clinic.
What preliminary data are expected for an application to be competitive or appropriate?
Applicants are expected to come with meaningful preliminary data appropriate to their stage of development. The opportunity describes expectations including evidence of compound identity and purity, evidence of selectivity for the intended target compared with closely related targets, availability of primary and secondary in vitro bioactivity assays, and proof-of-concept efficacy in at least one ALS-relevant preclinical model system (which may include whole-animal and cellular models).
Are compound identity and purity data expected?
Yes. The opportunity notes that applicants should have basic evidence that the compound is what it is claimed to be (identity) and is sufficiently clean (purity).
Is target selectivity evidence expected?
Yes. The program expects evidence of selectivity for the intended target compared with closely related targets to reduce the risk of off-target effects.
Do applicants need established in vitro bioactivity assays?
Yes. The opportunity expects that applicants have primary and secondary in vitro bioactivity assays available, which support optimization work and structure-activity relationship efforts.
Is proof-of-concept efficacy in an ALS-relevant model required or expected?
Yes. The opportunity states an expectation for proof-of-concept efficacy data in at least one ALS-relevant preclinical model system, which can include animal models and cellular models.
Is biomarker work optional under this award?
No. Biomarker work is described as a central requirement, not an optional add-on. Applicants are expected to develop or further characterize validated biomarkers in parallel with the therapeutic program.
What kinds of biomarkers does the program want applicants to develop or characterize?
Examples provided include target engagement biomarkers (showing the therapy is hitting its intended molecular target), pharmacodynamic biomarkers (reflecting a biological effect of the investigational agent), and predictive or cohort-selective biomarkers (helping identify which patients or subgroups are most likely to respond).
Are diagnosis-only or prognosis-only biomarkers supported?
No. Biomarker efforts aimed only at diagnosis, prognosis, or measuring disease progression are not supported if they are not clearly tied to therapeutic development decisions.
How should applicants justify biomarker work in the proposal?
Applicants are expected to clearly define the biomarker and explain how it will improve the therapeutic development process. The opportunity gives examples such as guiding dose selection, confirming mechanism in vivo, supporting go/no-go decisions, or enriching clinical trials with patients most likely to benefit.
Does the program emphasize ALS-specific expertise on the project team?
Yes. The opportunity signals that ALS domain expertise matters. Teams with limited ALS experience are strongly encouraged to include collaborators with substantial hands-on knowledge of ALS model systems, endpoints, and ALS pathophysiology.
Who is offering this funding opportunity?
The opportunity is offered by the Department of Defense, Department of the Army, through USAMRAA.
What is the Funding Opportunity Number (FON) for this award?
The Funding Opportunity Number is W81XWH-22-ALSRP-TDA.
What funding instrument is used for this opportunity?
The funding instrument type is listed as a cooperative agreement or grant.
What program category and CFDA number are associated with this opportunity?
The opportunity is listed under the Science and Technology and other Research and Development category, with CFDA 12.420.
Who is eligible to apply?
Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility clarifications in the full announcement.
How many awards are expected?
The posting indicates an expected three awards.
What is the maximum award amount (award ceiling)?
The award ceiling field is shown as 0, which typically indicates applicants should rely on the full announcement for the actual cap or that a fixed ceiling is not stated in that field.
When was this opportunity created and what was the closing date?
The opportunity was created March 16, 2022, with an original closing date of July 28, 2022.
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| Funding Opportunity |
|---|
| DoD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award Apply for W81XWH 22 ALSRP PCTA Funding Number: W81XWH 22 ALSRP PCTA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Amyotrophic Lateral Sclerosis, Therapeutic Idea Award Apply for W81XWH 22 ALSRP TIA Funding Number: W81XWH 22 ALSRP TIA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Investigator-Initiated Translational Research Award Apply for W81XWH 22 LCRP IITRA Funding Number: W81XWH 22 LCRP IITRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Clinical Translational Research Partnership Award Apply for W81XWH 22 LCRP CTRPA Funding Number: W81XWH 22 LCRP CTRPA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD PRMRP Discovery Award Apply for W81XWH 22 PRMRP DA Funding Number: W81XWH 22 PRMRP DA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Concept Award Apply for W81XWH 22 LCRP CA Funding Number: W81XWH 22 LCRP CA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Career Development Award Apply for W81XWH 22 LCRP CDA Funding Number: W81XWH 22 LCRP CDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Idea Development Award Apply for W81XWH 22 LCRP IDA Funding Number: W81XWH 22 LCRP IDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD PRMRP Investigator-Initiated Research Award Apply for W81XWH 22 PRMRP IIRA Funding Number: W81XWH 22 PRMRP IIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD PRMRP Clinical Trial Award Apply for W81XWH 22 PRMRP CTA Funding Number: W81XWH 22 PRMRP CTA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD PRMRP Technology/Therapeutic Development Award Apply for W81XWH 22 PRMRP TTDA Funding Number: W81XWH 22 PRMRP TTDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD PRMRP Focused Program Award Apply for W81XWH 22 PRMRP FPA Funding Number: W81XWH 22 PRMRP FPA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Geobiology and Low-Temperature Geochemistry (GG) Apply for 22 578 Funding Number: 22 578 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Spinal Cord Injury Model Systems (SCIMS) Multi-Site Collaborative Research Project Apply for HHS 2022 ACL NIDILRR SIMS 0025 Funding Number: HHS 2022 ACL NIDILRR SIMS 0025 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $900,000 |
| Willamette Valley Prairie Pollinator Studies Apply for W81EWF 22 SOI 0012 Funding Number: W81EWF 22 SOI 0012 Agency: Department of Defense, Engineer Research and Development Center Category: Science and Technology and other Research and Development Funding Amount: $95,000 |
| “Natural Resources and Endangered Species Research and Support at Fort Hood, Texas” Apply for W81EWF 22 SOI 0011 Funding Number: W81EWF 22 SOI 0011 Agency: Department of Defense, Dept. of the Army -- Corps of Engineers Category: Science and Technology and other Research and Development Funding Amount: $977,000 |
| Sea Cadet Program Apply for N00244 22 S SEA FO01 Funding Number: N00244 22 S SEA FO01 Agency: Department of Defense, Naval Supply Systems Command Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DOD Ovarian Cancer Investigator-Initiated Research Award Apply for W81XWH 22 OCRP IIRA Funding Number: W81XWH 22 OCRP IIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DOD Ovarian Cancer Pilot Award Apply for W81XWH 22 OCRP PA Funding Number: W81XWH 22 OCRP PA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Ovarian Cancer Proteogenomics Research Award Apply for W81XWH 22 OCRP PGRA Funding Number: W81XWH 22 OCRP PGRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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