Opportunity Information: Apply for W81XWH 18 ALSRP TDA
The DoD Amyotrophic Lateral Sclerosis (ALS) Therapeutic Development Award is a Department of Defense funding opportunity designed to push promising ALS treatments closer to the clinic. It supports work that starts after an initial drug or biologic lead already exists and extends through advanced preclinical development, including the types of studies typically needed to justify filing an FDA Investigational New Drug (IND) application. The program is clearly aimed at practical, product-driven development rather than exploratory biology: proposed studies are expected to be empirical, focused on generating decision-quality data, and organized around advancing a specific therapeutic candidate toward human testing.
The kinds of projects this award supports sit in the middle-to-late stages of preclinical development. That includes confirming and strengthening candidate therapeutics that may have emerged from screening campaigns or earlier discovery efforts, optimizing potency and pharmacological properties, and testing related variants such as derivatives or sister compounds. It also includes validating early pilot findings by replicating preliminary results more rigorously, adding time points, expanding dose ranges, and testing across multiple ALS model systems (cellular and whole-animal), so that the evidence base is stronger and more reproducible. On the development side, the award can fund formulation and stability work that leads toward Good Manufacturing Practice (GMP) production methods, as well as IND-enabling packages such as compound characterization, ADME studies (absorption, distribution, metabolism, and excretion), and dose-response and toxicology studies in relevant models.
A notable feature of the opportunity is its encouragement of translational validation using human biospecimens, as long as those specimens already exist and are de-identified. Applicants are encouraged to use appropriately powered and well-controlled analyses with biological correlates of disease activity and progression, leveraging specimens from well-characterized patient cohorts such as controlled clinical trials, observational studies, or registries. The announcement specifically points to resources like the CDC National ALS Registry and Biorepository. A key restriction is that collecting new specimens is not allowed under this award; any specimens must be in hand by the time the application is submitted. The DoD also emphasizes considering active duty military and Veteran patient populations or related resources, aligning the program with military and public health relevance.
This award is not meant for very early discovery efforts, and it sets a relatively high bar for readiness. Applications must begin with lead compounds already in hand and must include preliminary data appropriate to the development stage being proposed. Examples of expected readiness evidence include proof of identity and purity, selectivity for the intended target relative to closely related targets, and established in vitro bioactivity assays (primary and secondary) that can support optimization and structure-activity relationship work. Applicants are also expected to have proof-of-concept efficacy data in relevant ALS preclinical models (both cellular and animal models) or, in some cases, informative clinical data from a related human disease that helps justify the therapeutic approach. For investigators who are still at the earlier, basic discovery stage and do not yet have that preliminary package, the notice points them toward a separate mechanism (the Therapeutic Idea Award) that is intended for drug discovery and does not require preliminary data.
For FY18, the program introduced an optional add-on called the Therapeutically Relevant Marker Option. This option provides an avenue for applicants to co-develop a marker alongside the therapeutic program, with additional funding available for marker work that directly improves drug development. The intent is not general biomarker discovery for its own sake; it is specifically focused on markers that make the therapeutic development pathway more efficient or more informative. Examples include pharmacodynamic biomarkers that objectively show whether the investigational therapy is having its intended biological effect, or predictive/cohort-selective biomarkers that help identify which patients (or subgroups) are more likely to respond. In contrast, marker development aimed only at diagnosis, prognosis, or measuring disease progression, without a direct tie to the therapeutic development process, is explicitly not supported. Applicants pursuing this option must submit a Therapeutically Relevant Marker Statement describing the marker and how it will enhance therapeutic development, and the announcement encourages alignment with FDA and ALS community guidance documents on ALS drug development.
Administratively, this opportunity was issued by the Department of Defense, Department of the Army (USAMRAA) under Funding Opportunity Number W81XWH-18-ALSRP-TDA. It was offered as a discretionary program using grant and cooperative agreement funding instruments under CFDA 12.420, with eligibility listed as unrestricted (open to many entity types, subject to any additional eligibility clarifications in the full announcement). The posting indicates an expected three awards, with an award ceiling listed as 0 in the extracted metadata (typically meaning applicants must refer to the full program announcement for exact budget limits and any option-related caps). The original posting date was April 10, 2018, with an original closing date of October 11, 2018. Above all, funded projects must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public, reinforcing the program’s mission to accelerate meaningful ALS therapeutics with real-world impact.Apply for W81XWH 18 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, 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 Apr 10, 2018.
- Applicants must submit their applications by Oct 11, 2018. (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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FAQs: DoD ALS Therapeutic Development Award (W81XWH-18-ALSRP-TDA)
What is the DoD ALS Therapeutic Development Award?
The DoD Amyotrophic Lateral Sclerosis (ALS) Therapeutic Development Award is a Department of Defense funding opportunity intended to move promising ALS therapies closer to clinical testing. It supports advanced, product-driven preclinical development work that is typically used to justify filing an FDA Investigational New Drug (IND) application.
What stage of research does this award support?
This program supports mid-to-late stage preclinical development, starting after an initial drug or biologic lead already exists. It is designed for projects that are beyond early discovery and are focused on generating decision-quality data needed to advance a specific therapeutic candidate toward human testing.
Is this funding meant for exploratory or basic ALS biology studies?
No. The award is clearly aimed at practical, empirical, candidate-focused development rather than exploratory biology. Proposed studies are expected to be organized around advancing a specific therapeutic candidate and producing data that directly supports development decisions.
Do applicants need to already have a therapeutic lead in hand?
Yes. Applications must begin with lead compounds (or biologic leads) already in hand. The opportunity sets a high bar for readiness and expects a preliminary package appropriate to the proposed development stage.
What kinds of preliminary data are expected for readiness?
Examples of readiness evidence mentioned include proof of identity and purity, selectivity for the intended target relative to closely related targets, and established in vitro bioactivity assays (primary and secondary) that can support optimization and structure-activity relationship work. Applicants are also expected to have proof-of-concept efficacy data in relevant ALS preclinical models (cellular and animal) or, in some cases, informative clinical data from a related human disease that justifies the therapeutic approach.
What types of therapeutic development activities are supported?
Supported activities include confirming and strengthening candidate therapeutics from screening or earlier discovery efforts, optimizing potency and pharmacological properties, and testing related variants such as derivatives or sister compounds. The program also supports replicating and strengthening pilot findings by adding time points, expanding dose ranges, and testing across multiple ALS model systems (cellular and whole-animal) to improve reproducibility.
Does the award support IND-enabling studies?
Yes. The award can support IND-enabling development packages such as compound characterization, ADME studies (absorption, distribution, metabolism, and excretion), and dose-response and toxicology studies in relevant models, consistent with work typically needed to support an IND submission.
Can the award fund formulation, stability, and manufacturing-related work?
Yes. The opportunity includes formulation and stability work that leads toward Good Manufacturing Practice (GMP) production methods as part of advancing a candidate toward clinical readiness.
Are applicants encouraged to use human biospecimens?
Yes. The announcement encourages translational validation using human biospecimens, provided the specimens already exist and are de-identified. It emphasizes appropriately powered, well-controlled analyses using biological correlates of disease activity and progression.
Can applicants collect new human biospecimens under this award?
No. Collecting new specimens is not allowed. Any biospecimens proposed for use must already be in hand at the time the application is submitted.
What sources of human biospecimens are specifically referenced?
The announcement points to well-characterized patient cohorts such as controlled clinical trials, observational studies, or registries, and specifically references resources like the CDC National ALS Registry and Biorepository.
Is there an emphasis on military relevance?
Yes. Funded projects must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The opportunity also emphasizes considering active duty military and Veteran patient populations or related resources.
What should applicants focus on when designing studies?
Studies are expected to be empirical and tightly focused on generating decision-quality data that advances a specific therapeutic candidate toward human testing. The program emphasizes rigorous validation, reproducibility, and practical development milestones rather than open-ended exploration.
Is there an alternative mechanism for earlier-stage discovery projects?
Yes. The notice points earlier-stage investigators (who do not yet have the required lead and preliminary package) toward a separate mechanism called the Therapeutic Idea Award, which is intended for drug discovery and does not require preliminary data.
What is the "Therapeutically Relevant Marker Option"?
Introduced in FY18 as an optional add-on, the Therapeutically Relevant Marker Option provides an avenue to co-develop a marker alongside the therapeutic program, with additional funding available for marker work that directly improves therapeutic development.
What kinds of markers are supported under the Therapeutically Relevant Marker Option?
The option is focused on markers that make the therapeutic development pathway more efficient or informative. Examples include pharmacodynamic biomarkers that objectively show whether the therapy is having its intended biological effect, and predictive/cohort-selective biomarkers that help identify patient subgroups more likely to respond.
What marker work is explicitly not supported under the Marker Option?
Marker development aimed only at diagnosis, prognosis, or measuring disease progression is not supported if it does not directly tie to improving the therapeutic development process.
Is any special document required if applying for the Marker Option?
Yes. Applicants pursuing the option must submit a Therapeutically Relevant Marker Statement describing the marker and how it will enhance therapeutic development.
Does the opportunity mention alignment with external guidance?
Yes. The announcement encourages alignment with FDA and ALS community guidance documents on ALS drug development, particularly for applicants pursuing the marker-related work.
Who issued this funding opportunity?
This opportunity was issued by the Department of Defense, Department of the Army (USAMRAA).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is W81XWH-18-ALSRP-TDA.
What CFDA number is associated with this opportunity?
The opportunity is listed under CFDA 12.420.
What funding instruments are used?
The posting indicates it was offered as a discretionary program using grant and cooperative agreement funding instruments.
Who is eligible to apply?
Eligibility is listed as unrestricted, meaning it is open to many entity types, subject to any additional eligibility clarifications that may be included in the full program announcement.
How many awards were expected?
The posting indicates an expectation of three awards.
What is the award ceiling?
The extracted metadata lists an award ceiling of 0, which typically indicates that applicants should refer to the full program announcement for the actual budget limits and any caps related to optional components.
When was this opportunity originally posted and when did it close?
The original posting date was April 10, 2018, and the original closing date was October 11, 2018.
What is the overall goal of the program?
The overall goal is to accelerate meaningful ALS therapeutics with real-world impact by advancing a specific therapeutic candidate through advanced preclinical development and toward clinical testing, while maintaining relevance to military and public health needs.
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