Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Optional)

The Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment program, funded by the National Cancer Institute (NCI) under the National Institutes of Health (NIH), aims to accelerate the development and translation of scientific and engineering discoveries into practical tools, technologies, and methods for disease detection, prevention, diagnosis, treatment, and management. This initiative emphasizes collaborative partnerships between academic and industrial organizations, leveraging their combined strengths to address pressing biomedical challenges. Projects must include at least one academic and one industrial partner, forming an interdisciplinary, multi-institutional team capable of developing and validating technologies suitable for end-users. The partnerships are expected to translate innovations, such as diagnostic tools, imaging systems, molecular assays, bioinformatics tools, and disease-monitoring systems, from conceptual stages to functional and validated solutions ready for practical use. The program focuses on fostering innovation defined as the likelihood of delivering new capabilities to end-users. Supported projects may involve activities like optimizing diagnostic platforms, integrating imaging and spectroscopy systems, improving quality control measures, developing open-source tools, addressing affordability and accessibility challenges, and validating performance across multiple research sites. Additionally, the program will support clinical trials that test functionality or validate the performance of proposed solutions, provided these trials are translational in nature and not focused on late-stage phase III clinical trials. Projects must demonstrate readiness for translation, emphasizing feasibility, scalability, and alignment with user needs, including underserved or low-resource settings. Eligible applicants include higher education institutions (public and private), nonprofits, for-profit organizations (including small businesses), local and state governments, tribal organizations, and foreign institutions. International partnerships are also permitted, provided they align with NIH policies. Academic institutions affiliated with startup technology companies are eligible, provided financial conflicts of interest are properly managed. Applicants must meet federal registration requirements, including active registrations with SAM.gov, eRA Commons, and Grants.gov, before submitting proposals. Each application must include a clear governance plan detailing roles, responsibilities, and conflict resolution mechanisms among partners. The maximum project period is five years, with annual direct costs capped at $499,000. Applications must include specific aims, strategic plans for partnerships, detailed descriptions of project goals, performance metrics, and plans for validation and end-user adoption. Proposals will be evaluated based on three primary review criteria: the significance and innovation of the proposed research, the rigor and feasibility of the approach, and the expertise and resources of the research team. The review process will also consider additional factors such as human subjects' protections, inclusion plans for diverse populations, and the adequacy of data-sharing plans. Applications will follow the NIH standard submission deadlines, with cycles in February, June, and October each year until the program's expiration date on January 8, 2028. Applicants are encouraged to apply early to address potential submission errors. Funding decisions will be based on peer review scores, alignment with NCI priorities, and the availability of resources. Successful applicants must adhere to NIH policies for data management, reporting, and compliance with regulatory requirements, including adherence to FDA standards where applicable. For guidance, applicants are encouraged to contact NCI scientific program officials, grants management staff, or peer review administrators listed in the funding opportunity announcement. Comprehensive application instructions are available on the NIH Grants website, and additional resources can be accessed through the NIH Office of Extramural Research.