DoD Tuberous Sclerosis Complex, Clinical Translational Research Award | W81XWH 20 TSCRP CTRA

Opportunity Information: Apply for W81XWH 20 TSCRP CTRA

The Department of Defense, through the U.S. Army Medical Research Acquisition Activity (USAMRAA), offered the Tuberous Sclerosis Complex (TSC) Clinical Translational Research Award (CTRA) under funding opportunity number W81XWH 20 TSCRP CTRA. This program sits within the DoD Tuberous Sclerosis Complex Research Program (TSCRP) and is focused on translational work that can realistically push solid research findings closer to use in real-world clinical settings. In practical terms, the award is meant to bridge the gap between what has been discovered in the lab or early clinical research and what can be applied to improve how TSC is diagnosed, how outcomes are predicted (prognosis), or how the condition is treated.

The core emphasis is on projects that take promising, well-supported preclinical and/or clinical results and advance them toward clinical application. The opportunity explicitly supports studies that move from preclinical research into clinical research (for example, taking a therapeutic or diagnostic concept validated in models and preparing it for human study), as well as work that moves in the reverse direction (using insights from human data to refine mechanisms, targets, or intervention strategies in preclinical systems). The solicitation also highlights correlative and translational studies that use human anatomical substances (such as tissues, blood, or other biospecimens) and/or data tied to clinical trials. This includes analyses that can explain why a treatment works, identify which patients benefit, or uncover biological signatures associated with clinical outcomes.

A major priority area for this award is improving "clinical trial readiness." The program calls out the development of biomarkers, the identification and refinement of clinical endpoints, and validation of pharmacokinetics/pharmacodynamics (PK/PD) as particularly important. Biomarkers can include measurable biological indicators that help with patient selection, monitoring disease activity, predicting response, or tracking treatment effects. Clinical endpoints refer to the outcomes that trials measure to determine benefit, and the solicitation signals interest in endpoints that are meaningful, reliable, and feasible. PK/PD validation is aimed at confirming how an intervention behaves in the body (PK) and what biological effects it produces (PD), which is often essential for dose selection, interpreting trial results, and designing subsequent studies.

Beyond translational and readiness activities, the award encourages pilot clinical trials, including behavioral interventions. That means the program is open not only to drug or biologic development, but also to smaller, early-stage clinical studies designed to test feasibility, generate preliminary efficacy signals, refine protocols, or establish measures that would support larger, more definitive trials. Including behavioral interventions underscores that the program recognizes clinical needs in TSC that may be addressed through non-pharmacologic approaches, such as interventions targeting neurocognitive, psychiatric, or quality-of-life outcomes, provided the work is grounded in rigorous rationale and positioned to inform future clinical application.

From an administrative standpoint, the opportunity was listed as a discretionary funding program in the science and technology / research and development category (CFDA 12.420). Funding instruments included grants and cooperative agreements, indicating that awards could be structured either as more investigator-driven grants or as cooperative agreements with more substantial involvement from the funding agency during execution, depending on the project and program needs. Eligibility was described as unrestricted, meaning a wide range of entities could apply (such as universities, nonprofits, small businesses, or other organizations), subject to any additional eligibility clarifications that might be contained in the full announcement text. The posting was created on April 1, 2020, with an original closing date of July 9, 2020. The listing anticipated making about two awards, and the published award ceiling was shown as 0, which typically signals that applicants needed to rely on the full solicitation for specific budget guidance or that the ceiling was not represented in that summarized field.

Overall, this funding opportunity was designed for teams that can demonstrate a clear translational pathway: taking credible findings and packaging them into the kinds of tools, measures, and early clinical evidence that make later-stage clinical testing possible and more likely to succeed for people living with TSC.

• 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 Tuberous Sclerosis Complex, Clinical Translational Research 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 01, 2020.
• Applicants must submit their applications by Jul 09, 2020. (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.

Apply for W81XWH 20 TSCRP CTRA

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: