DoD Tuberous Sclerosis Complex, Clinical Translational Research Award | HT9425 23 TSCRP CTRA

Opportunity Information: Apply for HT9425 23 TSCRP CTRA

The Department of Defense Tuberous Sclerosis Complex (TSC) Clinical Translational Research Award (CTRA) is a funding opportunity intended to push strong, credible research findings closer to real-world clinical use for people living with TSC. The central purpose is translation: taking promising results from preclinical work and/or clinical research and moving them toward practical applications that improve diagnosis, sharpen prognosis, or lead to better treatments. The award is designed for projects that sit at the boundary between laboratory discovery and patient-facing medicine, with a clear emphasis on generating evidence or tools that can be used in clinical settings.

A key theme of this opportunity is moving research across the preclinical-to-clinical pipeline in either direction when it supports clinical impact. This can include studies that transition a well-supported preclinical discovery into a clinical research setting, or studies that use insights from clinical research to refine preclinical models or hypotheses. It can also include analysis of human anatomical substances (such as biospecimens) and/or data tied to completed clinical trials to better understand how an intervention works, clarify mechanisms of action, or identify ways to improve diagnosis, prognosis, or treatment strategies in TSC. In other words, the program is open to translational work that uses existing human trial materials and datasets, as long as the goal is to extract clinically meaningful conclusions.

Another major focus is improving "clinical trial readiness." The DoD is explicitly looking for studies that help the field run better, more informative trials in TSC by developing and validating elements like biomarkers and clinical endpoints. This can also include efforts to validate pharmacokinetics and pharmacodynamics (PK/PD), which are essential for understanding how a therapy behaves in the body and how it produces biological effects. Work in this area is meant to reduce uncertainty and increase the likelihood that subsequent trials are feasible, measurable, and capable of answering key clinical questions.

The CTRA also supports pilot clinical trials. These are smaller, limited clinical tests of a novel intervention that aim to generate early evidence on diagnostic or therapeutic effectiveness, safety, tolerability, and/or mechanism of action. The emphasis is on producing preliminary data that can justify and shape larger studies later, especially studies that could lead to interventions capable of improving outcomes for individuals with TSC. The program is therefore well-suited for early-stage clinical testing where the main goal is to learn enough to de-risk the next step rather than to deliver definitive proof of benefit.

Importantly, while preclinical work may be included, it must have a clinical component. Applications that are strictly animal research are not eligible under this mechanism and are directed to consider other funding options within the FY23 TSC Research Program (TSCRP). That requirement signals that the DoD wants funded projects to maintain a strong connection to human biology, patient data, clinical materials, and/or clinical testing, ensuring that the work is genuinely translational rather than purely exploratory.

Administratively, this opportunity was offered by the Department of Defense (Department of the Army, U.S. Army Medical Research Acquisition Activity, USAMRAA) under Funding Opportunity Number HT9425 23 TSCRP CTRA. The funding instrument types include both grants and cooperative agreements, meaning some awards may involve more active programmatic involvement from the sponsor depending on the specific instrument used. The activity falls under research and development (Science and Technology and other R&D) and is listed under CFDA 12.420. Eligibility is described as unrestricted (open to any type of entity), subject to any additional clarifications provided in the full announcement. The opportunity was created March 14, 2023, with an original closing date of July 7, 2023, and anticipated making about two awards. The award ceiling is listed as 0 in the provided record, which typically indicates that applicants need to refer to the full funding announcement for budget limits or that limits are defined in accompanying program guidance rather than in the summary field.

• 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 Mar 14, 2023.
• Applicants must submit their applications by Jul 07, 2023. (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 HT9425 23 TSCRP CTRA

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