DoW Tuberous Sclerosis Complex, Clinical Translational Research Award

The Tuberous Sclerosis Complex Clinical Translational Research Award is offered by the Defense Health Agency through its Congressionally Directed Medical Research Programs as part of the Tuberous Sclerosis Complex Research Program. This program was established to fund high-impact research addressing tuberous sclerosis complex, a genetic disorder that can affect multiple organ systems and lead to neurological and developmental challenges. The Clinical Translational Research Award specifically focuses on advancing promising preclinical and clinical findings toward practical clinical applications that improve diagnosis, prognosis, and treatment of the condition. The initiative reflects a broader federal commitment to translational science that bridges laboratory discoveries with patient care improvements. The primary purpose of this funding opportunity is to support research projects that accelerate the translation of scientific discoveries into clinical use. Eligible studies may include those transitioning between preclinical and clinical stages, pilot clinical trials, and analyses of existing clinical data to improve understanding of disease mechanisms and therapeutic outcomes. Projects must demonstrate a clear clinical component and cannot be purely animal-based. Emphasis is placed on areas such as neuropsychiatric disorders associated with the condition, tumor prevention and treatment, epilepsy management, emerging diagnostic technologies, and maternal and reproductive health considerations. Funding for this award is structured to support substantial, multi-year research efforts. The program anticipates allocating approximately 3.5 million dollars to fund about two awards. Individual applications may request up to 1.6 million dollars for a single principal investigator or up to 1.9 million dollars for projects involving multiple principal investigators. The maximum period of performance is three years. Funds may be used for a range of allowable research costs, including collaboration travel and limited conference participation, but restrictions apply to ensure alignment with program priorities and efficient use of federal resources. Cost sharing is not required. Eligibility for this program is broad and inclusive. Both domestic and international organizations may apply, including academic institutions, nonprofit entities, for-profit organizations, and government-affiliated research bodies. Principal investigators must be independent researchers affiliated with an eligible organization, and individuals at all career stages are permitted to apply. The program also allows for collaborative applications involving multiple principal investigators, with defined roles and separate but coordinated submissions. Awards are made to institutions rather than individuals. The application process is a two-step submission requiring a pre-application followed by a full application. The pre-application consists of a letter of intent submitted through an electronic portal, which is used for planning purposes but does not require approval to proceed to the full application. The full application includes extensive documentation such as a project narrative, technical and lay abstracts, statement of work, impact and translation statements, and supporting documentation including data sharing and research plans. Submission portals differ depending on whether the applicant is affiliated with an intramural or extramural organization. Applications are evaluated through a two-tier review process. The first tier is peer review, where scientific and technical merit are assessed based on criteria such as translational potential, impact, feasibility, and research design. The second tier is programmatic review, which considers how well applications align with program priorities and overall portfolio balance. Reviewers also evaluate the qualifications of the research team, the strength of collaborations, and the likelihood that the proposed work will produce meaningful clinical outcomes. The timeline for this funding opportunity includes a pre-application deadline in late July and a full application deadline in early August. Peer review is expected to occur in November, followed by programmatic review in February of the following year. Awards are anticipated to be finalized by the end of the fiscal year. Applicants are advised to ensure that all required registrations and system accounts are active well in advance of submission deadlines. For assistance, applicants may contact the program’s technical support services via email or phone as outlined in the announcement documentation.

Emphasize strong translational pathway to clinical application; demonstrate feasibility with access to data and patients; align clearly with focus areas and show measurable impact on patient outcomes