This funding opportunity, issued by the National Institute of Mental Health (NIMH) within the National Institutes of Health (NIH), seeks applications for the National Cooperative Drug/Device Discovery/Development Groups (NCDDG) program. The initiative aims to accelerate the translation of innovative therapies for mental disorders from discovery to early human studies. The program will support the development of pharmacological and neuromodulatory tools, innovative therapeutic candidates, and early-stage human trials. Focus areas include drug and device-based interventions targeting mental health disorders, development of novel ligands, and tools to validate new therapeutic targets. Partnerships between academia, industry, and other stakeholders are strongly encouraged to leverage multidisciplinary expertise.

The purpose of this funding opportunity is to support the discovery, preclinical development, and testing of innovative therapeutic agents and devices, including biotechnology products like proteins, antibodies, gene-based therapies, and emerging interventions such as microbiome therapies. Projects may range from ligand discovery to human Phase I studies, emphasizing safety, tolerability, and pharmacodynamics. The program also aims to validate novel targets for drug and device therapies and to develop tools that enhance basic and clinical research capabilities, such as imaging agents and biomarkers. The initiative emphasizes addressing unmet medical needs in psychiatric disorders and leveraging the strengths of academic-industrial collaborations.

Funding is available through cooperative agreements, with project budgets and periods not exceeding five years. Applications may include basic or clinical research; clinical trials are optional. Eligible applicants include institutions of higher education, nonprofit organizations, for-profits, state and local governments, and certain foreign organizations. Applicants must demonstrate expertise and resources to execute proposed projects and adhere to NIH application instructions. Registration with multiple systems, including SAM.gov and eRA Commons, is required prior to submission.

Applications will be reviewed based on scientific merit, innovation, feasibility, and relevance to program goals. Priority will be given to projects addressing significant unmet needs in mental health, offering novel approaches, and demonstrating strong collaborative frameworks. The review process involves initial peer review, advisory council review, and subsequent funding decisions. Key criteria include scientific rigor, innovation, the strength of the investigative team, and the availability of resources. Applications may also be evaluated on their plans for data sharing, recruitment of diverse populations, and compliance with human subject protection regulations.

Applications are accepted on a rolling basis with due dates on February 25, June 25, and October 25 annually through 2027. Letters of intent are encouraged 30 days before submission. Proposals must include a comprehensive research strategy, letters of collaboration, and plans for data management and sharing. Clinical trial applications require additional documentation, including milestone plans, data monitoring strategies, and common data elements.

The NCDDG program represents a significant opportunity for collaborative, multidisciplinary research to address critical challenges in mental health therapeutics. For further details or assistance with applications, prospective applicants are encouraged to contact designated NIH representatives listed in the announcement.