Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)

The Accelerating Product Excellence in Innovation and for Clinical Adoption program is a federal funding opportunity issued by the National Institutes of Health, specifically through participating institutes including the National Institute of Dental and Craniofacial Research, the National Eye Institute, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The program is structured as a cooperative agreement mechanism intended to support a single Resource Center that will coordinate and advance translational research in tissue engineering and regenerative medicine. This initiative builds upon prior consortium efforts and reflects NIH’s broader mission to translate scientific discoveries into clinical applications that improve health outcomes across populations. The primary purpose of this funding opportunity is to accelerate preclinical product development and readiness for clinical adoption in tissue engineering and regenerative medicine. The selected Resource Center will support interdisciplinary translational projects focused on therapeutics, including stem cell-based treatments, as well as sensors and diagnostic tools. The program emphasizes moving promising technologies through preclinical development stages toward regulatory approval for first-in-human studies. The Resource Center is expected to leverage expertise in clinical science, regulatory pathways, manufacturing, and commercialization to guide selected projects toward successful outcomes. Funding under this opportunity is designed to support both the infrastructure of the Resource Center and the portfolio of translational projects it manages. Applicants may request up to four million dollars in direct costs annually, with a maximum project period of five years. The NIH anticipates committing approximately six million dollars per year to fund one Resource Center and its associated projects. Funds may be used for a wide range of activities including preclinical testing, manufacturing scale-up, regulatory preparation, and development of clinical study protocols. Clinical trials themselves are not allowed under this funding mechanism, and projects must demonstrate sufficient maturity to advance toward clinical readiness. Eligibility for this program is broad and includes higher education institutions, nonprofit organizations, for-profit entities, and government agencies at the state, local, and tribal levels within the United States. Foreign organizations and foreign components are not eligible to apply. Applicants must demonstrate the capability to establish and manage a multidisciplinary Resource Center and support a portfolio of translational projects. Program directors and principal investigators must possess the necessary expertise and institutional support to carry out the proposed work. The application process requires submission through Grants.gov using approved systems such as NIH ASSIST or institutional system-to-system solutions. Applicants must complete all required registrations, including SAM, eRA Commons, and Grants.gov, prior to submission. The application must follow NIH’s Research Instructions and include detailed components such as a research strategy, organizational structure, project descriptions, and data management plans. The research strategy section is limited to thirty pages and must outline the operational plan for the Resource Center and its supported projects. Applications will undergo a rigorous peer review process based on criteria including significance, investigator qualifications, innovation, approach, and environment. Reviewers will assess the likelihood that the proposed Resource Center can effectively support translational projects and achieve regulatory milestones. Following initial peer review, applications will receive a second level of review by the National Advisory Council. Funding decisions will consider scientific merit, program relevance, and availability of funds. The timeline for this opportunity includes an opening date for submissions on June 10, 2026, and a final application deadline of July 10, 2026. Applications must be submitted by 5:00 PM local time of the applicant organization. The scientific merit review is scheduled for November 2026, followed by advisory council review in January 2027, and the earliest anticipated start date is April 2027. The funding opportunity expires on July 11, 2026, and does not indicate recurring cycles. Applicants are encouraged to submit early to allow time for corrections and ensure compliance with all submission requirements.

Focus on demonstrating translational readiness and regulatory pathway; ensure strong multidisciplinary team and clear commercialization strategy; align projects with FDA approval milestones