Opportunity Information: Apply for W81XWH 16 ALSRP TDA
Apply for W81XWH 16 ALSRP TDA
- The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "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 01, 2016 and posted on Mar 01, 2016.
- Applicants must submit their applications by Jul 21, 2016. (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 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 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award is a Department of Defense funding opportunity designed to move promising ALS treatment candidates through key stages of preclinical development, from validating an existing therapeutic lead all the way toward preparation for a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) submission. The program is explicitly product-driven and expects hands-on, empirical development work rather than exploratory or purely hypothesis-generating studies. A central requirement is that applicants must already have lead compounds in hand at the time of application, meaning this award is intended for teams that are beyond early discovery and are ready to do the practical work needed to advance a candidate toward human testing.
Supported activities cover much of the standard preclinical drug development pipeline. This includes secondary validation of lead compounds that may have come from screening or other discovery approaches, with the goal of demonstrating target selectivity and clarifying mechanism of action. The award also supports medicinal chemistry and optimization work, such as improving potency and pharmacologic properties, building structure-activity relationship (SAR) maps through synthesis, and testing related analogs (derivatives and sister compounds). In addition, it can fund formulation development and stability studies, development of good manufacturing practice (GMP) production methods, and generation of the kinds of data that typically feed into an IND package. IND-enabling work called out in the announcement includes compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose-response and toxicology studies.
While the award focuses on lead validation and development, it also pushes applicants to connect the drug development plan to meaningful biological outcomes in ALS. In parallel with chemistry and preclinical package-building, applicants are strongly encouraged to demonstrate in vivo efficacy or show target engagement in relevant preclinical ALS model systems. Target engagement is described in practical terms as measuring target binding or proximal downstream effects, emphasizing the expectation that the therapy is doing what it is supposed to do in a living system, not just in a dish.
Applications must include preliminary data and supporting evidence appropriate to the development stage being proposed. The funding notice highlights several specific expectations: background data supporting the proposed mechanism of action as a credible therapeutic strategy; identification of a bioactive compound or a small, defined set of lead molecules; proof of identity and purity; evidence of selectivity for the intended target over closely related targets when the target is known; availability of primary and secondary in vitro assays that can support optimization and SAR work; and access to appropriate ALS preclinical animal models to evaluate either in vivo efficacy or mechanism-specific activity at the intended target. Researchers who are still at an earlier, more basic drug discovery stage (and may not yet have preliminary data) are directed instead to a separate opportunity, the ALSRP Therapeutic Idea Award.
Collaboration is treated as a practical necessity rather than a nice-to-have. Because preclinical development often requires specialized infrastructure and expertise, the program encourages partnerships across institutions and with biotechnology or pharmaceutical companies. Industry applicants are encouraged to contribute their own resources alongside grant funding. The announcement also makes it clear that collaborations should be set up to succeed by addressing intellectual property and material transfer issues early and removing organizational barriers that could slow progress. Teams without strong ALS-specific experience are strongly encouraged to partner with investigators who have deep ALS expertise and access to ALS model systems, and letters confirming or supporting collaborations are required as part of the application.
Administratively, this opportunity was issued by DOD-AMRAA under Funding Opportunity Number W81XWH-16-ALSRP-TDA. The eligible applicant pool is described as unrestricted (open to any entity type, subject to any additional eligibility language in the full notice). The instrument types include grants and cooperative agreements, reflecting that some projects may involve more active programmatic involvement. The opportunity was posted March 1, 2016, with a closing date of July 21, 2016, and it anticipated making about two awards. The award ceiling is not specified in the provided excerpt. Overall, the award is aimed at teams that already have credible lead molecules and want to do the concrete preclinical work needed to move an ALS therapeutic candidate closer to an IND and, ultimately, clinical testing.
ALSRP Therapeutic Development Award (TDA) FAQs
What is the ALSRP Therapeutic Development Award (TDA)?
The Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award is a U.S. Department of Defense funding opportunity intended to advance promising ALS treatment candidates through key stages of preclinical development, from validating an existing therapeutic lead through preparation toward a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) submission.
What is the main goal of this award?
The goal is to push an ALS therapeutic candidate forward in a product-driven way by completing practical, empirical preclinical development activities that typically support an IND package and readiness for human testing.
Is this opportunity focused on basic research or product development?
It is explicitly product-driven. The program expects hands-on development work (validation, optimization, formulation, IND-enabling studies) rather than exploratory, hypothesis-generating, or purely discovery-focused studies.
Do applicants need to already have a therapeutic lead to apply?
Yes. A central requirement is that applicants must already have lead compounds in hand at the time of application. This award is intended for teams beyond early discovery that are ready to advance a candidate through practical preclinical steps.
What kinds of projects are a good fit for this award?
Projects that already have credible lead molecules and propose concrete preclinical development plans, such as secondary validation, medicinal chemistry optimization, formulation and stability work, GMP method development, and IND-enabling studies, are aligned with the intent of the award.
What kinds of activities can be supported (in general)?
Supported activities cover much of the preclinical drug development pipeline, including:
- Secondary validation of lead compounds (including demonstrating target selectivity and clarifying mechanism of action)
- Medicinal chemistry and optimization (potency and pharmacologic property improvements)
- Structure-activity relationship (SAR) development through synthesis and testing of analogs (derivatives and sister compounds)
- Formulation development and stability studies
- Development of good manufacturing practice (GMP) production methods
- Generation of data that typically feed into an IND submission package
What specific IND-enabling studies are mentioned?
The notice calls out several categories of IND-enabling work, including compound characterization, absorption/distribution/metabolism/excretion (ADME) studies, and dose-response and toxicology studies.
Does the award support validating leads that came from screening?
Yes. The award supports secondary validation of lead compounds that may have originated from screening or other discovery approaches, with the goal of demonstrating selectivity and clarifying mechanism of action as part of moving toward development readiness.
Does the program expect evidence tied to ALS biology, not just chemistry?
Yes. While it focuses on lead validation and development, applicants are strongly encouraged to connect the development plan to meaningful biological outcomes in ALS, including demonstrating in vivo efficacy or target engagement in relevant ALS preclinical model systems.
What does "target engagement" mean in this opportunity?
Target engagement is described in practical terms as measuring target binding or proximal downstream effects in a living system. The emphasis is on showing the therapy is doing what it is intended to do in vivo, not only in vitro.
Are in vivo studies required?
The announcement strongly encourages applicants to demonstrate in vivo efficacy or show target engagement in relevant preclinical ALS models. The opportunity also expects access to appropriate ALS preclinical animal models to evaluate either in vivo efficacy or mechanism-specific activity at the intended target.
What preliminary data are expected in an application?
Applications must include preliminary data and supporting evidence appropriate to the proposed development stage. The notice highlights expectations such as:
- Background data supporting the proposed mechanism of action as a credible therapeutic strategy
- Identification of a bioactive compound or a small, defined set of lead molecules
- Proof of identity and purity of the lead compound(s)
- Evidence of selectivity for the intended target over closely related targets (when the target is known)
- Availability of primary and secondary in vitro assays to support optimization and SAR work
- Access to appropriate ALS preclinical animal models to evaluate in vivo efficacy or mechanism-specific activity/target engagement
If a team is still in early discovery and does not have preliminary data, is this the right award?
No. Teams that are earlier in the drug discovery process (and may not yet have preliminary data or lead compounds in hand) are directed to a different opportunity: the ALSRP Therapeutic Idea Award.
How many lead compounds can be proposed?
The notice indicates applicants should identify a bioactive compound or a small, defined set of lead molecules. This suggests the program is designed around advancing a focused lead or narrow lead set rather than broad, early-stage discovery libraries.
Is medicinal chemistry work like SAR and analog testing supported?
Yes. The award supports medicinal chemistry and optimization activities, including building structure-activity relationship (SAR) maps through synthesis and testing related analogs such as derivatives and sister compounds.
Can formulation and stability work be included?
Yes. Formulation development and stability studies are specifically listed among the supported development activities.
Can GMP-related work be included?
Yes. The award can support development of good manufacturing practice (GMP) production methods as part of the work that moves a candidate toward IND readiness.
Does this opportunity encourage collaboration?
Yes. Collaboration is treated as a practical necessity. The program encourages partnerships across institutions and with biotechnology or pharmaceutical companies, reflecting the specialized infrastructure and expertise often required for preclinical development.
Are industry partnerships allowed or encouraged?
They are encouraged. The notice encourages collaborations with biotechnology or pharmaceutical companies and also encourages industry applicants to contribute their own resources alongside grant funding.
Does the announcement say anything about intellectual property (IP) or material transfer?
Yes. It emphasizes setting collaborations up to succeed by addressing intellectual property and material transfer issues early and removing organizational barriers that could slow progress.
If a team lacks ALS-specific expertise, can it still apply?
The notice strongly encourages teams without strong ALS-specific experience to partner with investigators who have deep ALS expertise and access to ALS model systems.
Are letters of collaboration required?
Yes. Letters confirming or supporting collaborations are required as part of the application.
Who issued this funding opportunity?
It was issued by DOD-AMRAA (Department of Defense - U.S. Army Medical Research Acquisition Activity).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number listed is W81XWH-16-ALSRP-TDA.
Who is eligible to apply?
The eligible applicant pool is described as unrestricted, meaning it is open to any entity type (subject to any additional eligibility language that may exist in the full notice).
What funding mechanisms are used for this opportunity?
The instrument types include grants and cooperative agreements. This indicates that some projects may involve more active programmatic involvement under a cooperative agreement structure.
When was the opportunity posted, and what was the closing date?
The opportunity was posted on March 1, 2016, and the closing date was July 21, 2016.
How many awards were anticipated?
The announcement anticipated making about two awards.
Is the maximum award amount (ceiling) provided in the excerpt?
No. The award ceiling is not specified in the provided excerpt.
What is the expected endpoint of the funded work?
The program is designed to move a candidate toward preparation for an FDA IND submission by generating the kinds of validation, optimization, formulation, manufacturing-method, and IND-enabling data typically needed to support that step.
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