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Frequently Asked Questions (FAQs) - DoD ALS Therapeutic Development Award (TDA) (FY15)

1) What is the DoD ALS Therapeutic Development Award (TDA)?

The ALS Therapeutic Development Award (TDA) is a Department of Defense funding opportunity, administered by the Department of the Army through USAMRAA under the CDMRP ALS Research Program. It is designed to push promising ALS drug candidates through the key preclinical steps needed to become viable therapeutic products.

2) What is the main goal of this award mechanism?

The central goal is translation. Projects are expected to generate practical, actionable preclinical data packages that reduce risk ("de-risk") for a specific drug candidate and move it toward clinical readiness, rather than pursuing broad exploratory biology without a clear development endpoint.

3) Who is this opportunity intended for?

This opportunity is intended for teams that already have one lead molecule, or a small, clearly defined set of lead molecules, with demonstrated biological activity in a pathway tied to ALS onset and/or disease progression.

4) Does the TDA support early-stage discovery work?

No. For FY15, the TDA is positioned after discovery. Applicants are expected to come in with credible leads already in hand and a plan focused on advancing those leads through the next development stages.

5) What changed in FY15 regarding project duration?

For FY15, the maximum period of performance is limited to 2 years. This reinforces the expectation that projects will be execution-focused and milestone-oriented.

6) What activities will the TDA NOT fund in FY15?

The FY15 TDA no longer supports development of models or screening systems, and it does not support performing screening campaigns. Those discovery-enabling activities were redirected to a different mechanism: the ALSRP FY15 Therapeutic Idea Award.

7) What kinds of preclinical activities are supported?

The scope can cover a range of preclinical development tasks from follow-up validation through preparation for an FDA Investigational New Drug (IND) submission. Supported activities include secondary validation of leads, medicinal chemistry and optimization, formulation and stability work, GMP-aligned manufacturing method development, and generating preclinical datasets commonly expected for an IND package (such as compound characterization, ADME, dose-response, and toxicology/safety studies).

8) Does the award support secondary validation of lead compounds?

Yes. Examples given include confirming target selectivity, clarifying mechanism of action, and verifying that observed activity is robust and reproducible.

9) Is medicinal chemistry and lead optimization allowed?

Yes. The announcement supports medicinal chemistry and optimization work aimed at improving potency and pharmacological properties, as long as it is tightly tied to improving a nominated lead.

10) Does the opportunity mention structure-activity relationship (SAR) work?

Yes. It explicitly mentions generating SAR maps through synthesis and testing of derivatives or closely related compounds, indicating that iterative chemistry plus testing is an appropriate use of funds when aligned with lead improvement.

11) Can funding be used for formulation and stability studies?

Yes. The scope includes formulation and stability studies as part of the practical development work often required to advance a candidate.

12) Can funding support manufacturing method development consistent with GMP?

Yes. The opportunity supports development of manufacturing methods consistent with Good Manufacturing Practice (GMP).

13) What IND-enabling datasets are within scope?

The award is intended to help generate preclinical datasets typically expected by the FDA for an IND submission, including compound characterization, ADME (absorption, distribution, metabolism, and excretion), and dose-response, toxicology, and related safety studies.

14) Are biomarkers included in the scope of work?

Yes. The opportunity expresses interest in biomarker work, specifically validation of existing biomarkers and development of biomarkers as indicators of mechanism-specific drug activity and/or clinical progression.

15) Can biomarker work be proposed as a standalone project?

No. Biomarker efforts are described as something to pursue in parallel with validating and advancing the therapeutic lead, not as a standalone biomarker discovery program. Biomarker work should strengthen the development case for the nominated candidate (for example, by demonstrating target engagement, pharmacodynamic activity, or relevance to disease trajectory).

16) When was this FY15 opportunity posted, and when did it close?

The opportunity was posted on March 18, 2015, and the application closing date was August 20, 2015.

17) What type of funding is this categorized as?

It is categorized as discretionary funding for science and technology and other research and development.

18) What is the funding instrument type?

The funding instrument type is listed as a cooperative agreement/grant.

19) Is cost sharing or matching required?

No. The listing states there was no cost sharing or matching requirement.

20) How many awards were anticipated, and what was the estimated total funding?

The program anticipated making about 2 awards, with an estimated total funding amount of $3.2 million.

21) Who is eligible to apply?

Eligibility was described as unrestricted, meaning it was open to essentially any type of applicant organization, subject to any additional eligibility clarifications in the full announcement.

22) What is the CFDA number associated with this opportunity?

The CFDA listing associated with the opportunity is 12.420 (Military Medical Research and Development).

23) Who administers this award?

The opportunity is administered by the Department of the Army through USAMRAA under the Congressionally Directed Medical Research Programs (CDMRP) ALS Research Program.

24) Where should applicants go for access issues or administrative help?

The listing points applicants to the CDMRP Help Desk at 301-682-5507 for access issues or administrative support.

25) How should proposals be structured to fit this mechanism?

Based on the description, proposals should be empirical and product-driven, with a tightly focused plan to produce actionable development data for a specific lead (or small set of leads). The work should emphasize execution, milestones, and progress toward preclinical readiness and potential IND preparation within the 2-year performance period.