Opportunity Information: Apply for HT942524ALSRPTDA
The FY24 DOD Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (Funding Opportunity Number HT942524ALSRPTDA) is a discretionary federal grant opportunity run through the Department of the Army, USAMRAA, under CFDA 12.420. Its purpose is to move promising ALS therapeutics forward along a practical development path, supporting work that spans from preclinical validation of a therapeutic lead up through FDA Investigational New Drug (IND)-enabling studies. The program is explicitly product-driven and empirical, meaning it is designed to generate the kinds of data packages that can credibly support progression toward clinical testing rather than exploratory, hypothesis-only science.
A central requirement is that applicants must already have lead compounds in hand. In addition, the application must include proof-of-concept efficacy data in at least one preclinical ALS model system, which can include whole-animal models and cellular models. Because ALS models, endpoints, and disease biology can be technically demanding and easy to misapply, teams that do not have strong ALS-specific experience are strongly encouraged to bring in collaborators who have demonstrated expertise with relevant ALS model systems, outcome measures, and pathophysiology.
The award is intended to fund later-stage preclinical activities that strengthen confidence in a therapeutic candidate and prepare it for the regulatory steps that precede human trials. Supported efforts can include confirming candidate therapeutics identified through screening or other discovery approaches, along with medicinal chemistry and optimization work to improve potency and pharmacological properties, including testing derivative or closely related compounds. It can also support validation and expansion of early pilot efficacy findings, such as follow-on studies that replicate initial results more rigorously, add time points, test additional doses, and extend testing into additional ALS model systems. Beyond efficacy validation, the opportunity covers IND-enabling development tasks such as compound characterization and ADME work (absorption, distribution, metabolism, and excretion), formulation and stability studies, and the steps needed to reach Good Manufacturing Practice (GMP) production methods. It also anticipates dose-response characterization and toxicology studies in relevant model systems, reflecting the kind of integrated preclinical package typically needed to justify an IND submission.
A distinctive and emphasized feature of this award is the expectation that biomarker strategy is not optional or peripheral. The program states that mechanism-specific, predictive or cohort-selective biomarkers, target engagement measures, and pharmacodynamic biomarkers should be developed in parallel with the therapeutic work as a critical component of the project. If relevant biomarkers already exist or are being developed elsewhere, the application needs to clearly explain how those biomarkers will tangibly improve clinical trial design, patient selection, and the efficiency or interpretability of eventual trials for the proposed therapeutic approach. At the same time, the opportunity draws a firm boundary around what it will not support: biomarker work aimed only at diagnosis, prognosis, or tracking general disease progression, without a clear link to the therapeutic development plan, is considered out of scope for this mechanism.
The announcement also clarifies where earlier-stage or separate work should go. Applicants who are primarily pursuing basic ALS drug discovery and do not yet have preliminary efficacy data are directed instead to the FY24 ALSRP Therapeutic Idea Award (TIA), which does not require preliminary data. Likewise, applicants seeking biomarker development that is independent of a specific therapeutic development effort are encouraged to apply to the FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA), rather than trying to fit a standalone biomarker project into this Therapeutic Development Award.
Administratively, the opportunity lists eligibility as unrestricted and indicates an expected four awards. The original closing date is July 10, 2024, and the posting was created March 25, 2024. The award ceiling is not specified in the provided source data. Overall, the mechanism is best suited for teams that already have a credible ALS therapeutic lead with initial in-model efficacy, and that are ready to execute a tightly planned set of preclinical and IND-enabling studies, paired with a biomarker approach that directly supports patient stratification, target engagement confirmation, and decision-making for eventual clinical testing.Apply for HT942524ALSRPTDA
- 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.
- This funding opportunity was created on 2024-03-25.
- Applicants must submit their applications by 2024-07-10. (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 4 candidate(s).
- Eligible applicants include: Unrestricted.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FY24 DOD ALSRP Therapeutic Development Award (HT942524ALSRPTDA) - FAQs
What is the FY24 DOD ALSRP Therapeutic Development Award?
The FY24 Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (Funding Opportunity Number HT942524ALSRPTDA) is a discretionary federal grant opportunity intended to move promising ALS therapeutics forward along a practical development path. It supports work ranging from preclinical validation of a therapeutic lead through FDA Investigational New Drug (IND)-enabling studies.
Which agency runs this funding opportunity?
This opportunity is run through the Department of the Army, USAMRAA (U.S. Army Medical Research Acquisition Activity) under the ALSRP.
What is the CFDA number for this program?
The CFDA listing associated with this opportunity is 12.420.
What is the main goal or purpose of this award?
The purpose is to advance an ALS therapeutic candidate toward clinical testing by generating a credible, practical, and empirical preclinical data package that can support progression to IND-related regulatory steps rather than exploratory, hypothesis-only research.
Is this award focused on basic research or product development?
This award is explicitly product-driven and empirical. It is designed to support studies that strengthen a therapeutic candidate and prepare it for the regulatory pathway leading to human trials.
Do applicants need to already have a therapeutic lead or compound?
Yes. A central requirement is that applicants must already have lead compounds in hand.
Is preliminary efficacy data required to apply?
Yes. The application must include proof-of-concept efficacy data in at least one preclinical ALS model system. The eligible model types described include whole-animal models and cellular models.
What types of ALS model systems can be used for proof-of-concept efficacy?
The opportunity indicates that proof-of-concept efficacy data may come from at least one preclinical ALS model system, which can include whole-animal models and cellular models.
What if a team does not have strong ALS-specific experience with models and endpoints?
The announcement strongly encourages teams without strong ALS-specific experience to include collaborators with demonstrated expertise in relevant ALS model systems, outcome measures, and ALS pathophysiology, since ALS models and endpoints can be technically demanding and easy to misapply.
What stage of work is this award intended to support?
It is intended to fund later-stage preclinical activities that increase confidence in a therapeutic candidate and prepare it for IND-enabling development and related regulatory steps that precede human trials.
What kinds of therapeutic development activities are supported?
Supported efforts can include confirming candidate therapeutics identified through screening or other discovery approaches, medicinal chemistry and optimization to improve potency and pharmacological properties (including derivative or closely related compounds), and more rigorous validation and expansion of early efficacy findings.
Can the award support medicinal chemistry and optimization work?
Yes. The opportunity specifically describes support for medicinal chemistry and optimization work to improve potency and pharmacological properties, including testing derivative or closely related compounds.
Can the award support follow-on studies to replicate and strengthen pilot efficacy results?
Yes. The award can support validation and expansion of early pilot efficacy findings, such as follow-on studies that replicate initial results more rigorously, add time points, test additional doses, and extend testing into additional ALS model systems.
Does the award support IND-enabling studies?
Yes. The scope includes IND-enabling development tasks to prepare a therapeutic for the steps needed prior to initiating clinical testing.
What specific IND-enabling tasks are mentioned as in scope?
The announcement describes eligible IND-enabling tasks including compound characterization and ADME (absorption, distribution, metabolism, and excretion) work, formulation and stability studies, steps needed to reach Good Manufacturing Practice (GMP) production methods, dose-response characterization, and toxicology studies in relevant model systems.
Are ADME studies included in the supported scope?
Yes. ADME (absorption, distribution, metabolism, and excretion) work is explicitly listed as part of the IND-enabling development tasks that can be supported.
Are formulation and stability studies included?
Yes. Formulation and stability studies are included among the IND-enabling development tasks described as within scope.
Does the opportunity mention GMP-related work?
Yes. It anticipates work needed to reach Good Manufacturing Practice (GMP) production methods as part of the overall therapeutic development pathway.
Are toxicology and dose-response studies part of this award?
Yes. The opportunity anticipates dose-response characterization and toxicology studies in relevant model systems as components of the integrated preclinical package needed to justify an IND submission.
Is a biomarker plan required?
Yes. A distinctive and emphasized feature of this award is that a biomarker strategy is expected as a critical component of the project and should be developed in parallel with the therapeutic work.
What types of biomarkers does the program expect applicants to address?
The program emphasizes mechanism-specific, predictive or cohort-selective biomarkers, target engagement measures, and pharmacodynamic biomarkers as part of the therapeutic development plan.
If relevant biomarkers already exist, how should they be handled in the application?
If relevant biomarkers already exist or are being developed elsewhere, the application needs to clearly explain how those biomarkers will tangibly improve clinical trial design, patient selection, and the efficiency or interpretability of eventual trials for the proposed therapeutic approach.
What biomarker work is considered out of scope for this award?
Biomarker work aimed only at diagnosis, prognosis, or tracking general disease progression, without a clear link to the therapeutic development plan, is considered out of scope for this mechanism.
Is standalone biomarker development a fit for this Therapeutic Development Award?
No. The opportunity draws a firm boundary that biomarker efforts must be directly tied to the therapeutic development plan. Applicants seeking biomarker development independent of a specific therapeutic development effort are directed to a different mechanism.
If a project is mainly basic ALS drug discovery without preliminary efficacy data, is this the right award?
No. Applicants who are primarily pursuing basic ALS drug discovery and do not yet have preliminary efficacy data are directed instead to the FY24 ALSRP Therapeutic Idea Award (TIA), which does not require preliminary data.
Where should applicants apply if they want biomarker development independent of a therapeutic program?
Applicants seeking biomarker development that is independent of a specific therapeutic development effort are encouraged to apply to the FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA).
What is the eligibility for this funding opportunity?
The opportunity lists eligibility as unrestricted.
How many awards are expected to be made?
The opportunity indicates an expected four awards.
What is the application closing date?
The original closing date listed is July 10, 2024.
When was this opportunity posted?
The posting was created on March 25, 2024.
What is the maximum award amount (funding ceiling)?
The award ceiling is not specified in the provided source information.
What types of teams are best suited for this opportunity?
This mechanism is best suited for teams that already have a credible ALS therapeutic lead with initial in-model efficacy data and are ready to execute a tightly planned set of preclinical and IND-enabling studies, paired with a biomarker approach that supports patient stratification, target engagement confirmation, and decision-making for eventual clinical testing.
Browse more opportunities from the same category: Science and Technology and other Research and Development
Next opportunity: NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required)
Previous opportunity: NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for HT942524ALSRPTDA
Applicants also applied for:
Applicants who have applied for this opportunity (HT942524ALSRPTDA) also looked into and applied for these:
| Funding Opportunity |
|---|
| DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award Apply for HT942524ALSRPPCTA Funding Number: HT942524ALSRPPCTA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Vision Research, Mentored Clinical Research Award Apply for HT942524VRPMCRA Funding Number: HT942524VRPMCRA Agency: Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Cooperative Agreement for CESU-affiliated Partner of the Chesapeake Watershed Cooperative Ecosystem Studies Unit Apply for G24AS00323 Funding Number: G24AS00323 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $300,000 |
| Cooperative Agreement for CESU-affiliated Partner with Great Lakes – Northern Forest Cooperative Ecosystem Studies Unit Apply for G24AS00322 Funding Number: G24AS00322 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $70,000 |
| Cooperative Agreement for CESU-affiliated Partner with Gulf Coast Cooperative Ecosystem Studies Unit Apply for G24AS00321 Funding Number: G24AS00321 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $149,050 |
| Accelerating Federal Technology Transfer (AFTT) Program Apply for 2024 NIST AFTT 01 Funding Number: 2024 NIST AFTT 01 Agency: National Institute of Standards and Technology Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Small Business Innovation Research (SBIR) Program Phase II Apply for 2024 NIST SBIR 02 Funding Number: 2024 NIST SBIR 02 Agency: National Institute of Standards and Technology Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Development Innovation Ventures: Stage 4 Awards Annual Program Statement (APS) Apply for 7200AA24APS00003 Funding Number: 7200AA24APS00003 Agency: Agency for International Development Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Office of Naval Research Science and Technology for Advanced Manufacturing Projects (STAMP) Apply for N0001424SB002 Funding Number: N0001424SB002 Agency: Office of Naval Research Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Alpine Monitoring and Research in Western National Parks Apply for P24AS00330 Funding Number: P24AS00330 Agency: National Park Service Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Probability Apply for PD 18 1263 Funding Number: PD 18 1263 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Cooperative Agreement for CESU-affiliated Partner with Californian Cooperative Ecosystem Studies Unit Apply for G24AS00334 Funding Number: G24AS00334 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $475,000 |
| NIJ FY24 Community-Based Violence Intervention and Prevention Initiative (CVIPI) Research and Evaluation Apply for O NIJ 2024 172060 Funding Number: O NIJ 2024 172060 Agency: National Institute of Justice Category: Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Early Stage Innovations Apply for NNH24ZTR001N 24ESI B2 Funding Number: NNH24ZTR001N 24ESI B2 Agency: NASA Headquarters Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Commercial Supersonic Technology (CST) Project Apply for NNH24ZEA001N CST Funding Number: NNH24ZEA001N CST Agency: NASA Headquarters Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Funding Opportunity Announcement ONR STEM Program Apply for N0001424SF005 Funding Number: N0001424SF005 Agency: Office of Naval Research Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Cooperative Agreement for CESU-affiliated Partner with Pacific Northwest Cooperative Ecosystem Studies Unit Apply for G24AS00343 Funding Number: G24AS00343 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $900,000 |
| Cooperative Agreement for CESU-affiliated Partner with Southern Appalachian Mountains Cooperative Ecosystem Studies Unit Apply for G24AS00342 Funding Number: G24AS00342 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $59,000 |
| Cooperative Agreement for CESU-affiliated Partner with Colorado Plateau Cooperative Ecosystem Studies Unit Apply for G24AS00341 Funding Number: G24AS00341 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $30,000 |
| Cooperative Agreement for CESU-affiliated Partner with Californian Cooperative Ecosystem Studies Unit Apply for G24AS00340 Funding Number: G24AS00340 Agency: Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $13,576 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "HT942524ALSRPTDA", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.