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 (APEx) funding opportunity, issued by the National Institutes of Health (NIH) through its National Institute of Dental and Craniofacial Research (NIDCR), is designed to promote the advancement of tissue engineering and regenerative medicine (TE/RM) products. The primary aim of this grant is to establish extramural Resource Centers (RCs) that will serve as hubs of expertise, supporting Interdisciplinary Translational Projects (ITPs) focusing on therapeutics, sensors, and diagnostics relevant to TE/RM. These RCs are expected to leverage their capabilities in scientific research, clinical application, industrial practices, regulatory pathways, and commercialization strategies to support the development and validation of promising TE/RM products. The APEx initiative particularly emphasizes the translation of innovative products intended to address tissue damage resulting from congenital conditions, traumatic injuries, or chronic diseases. It also supports the development of technologies aimed at the early detection of chronic pathologies, monitoring of biomarkers, and strategies to mitigate or prevent long-term damage. Selected projects should be poised to proceed through stages of validation, manufacturing, and preclinical testing with the objective of achieving regulatory readiness for first-in-human studies. Final deliverables should include approved protocols for clinical studies and standardized manufacturing procedures. Although this is a forecasted funding opportunity, and formal applications are not currently being accepted, it provides sufficient lead time for prospective applicants to form strategic collaborations and prepare robust project proposals. The grant will utilize the U24 Cooperative Agreement mechanism, which supports resource-related research projects contributing to NIH’s mission. Eligibility for this opportunity is broad and includes a range of public and private entities, including public housing authorities, non-profit organizations with 501(c)(3) status, tribal organizations, state and local governments, independent school districts, higher education institutions (both public and private), and certain for-profit organizations. Notably, small businesses and Federally recognized tribal governments are also eligible to apply. The estimated post date for this opportunity is October 7, 2025, with an application due date of November 7, 2025. Awards are projected to be announced by July 1, 2026, which is also the anticipated project start date. There are no stated minimum or maximum award amounts at this time, and cost sharing or matching is not required. For more information, potential applicants can contact Dr. Scott Verbridge at the National Institute of Dental and Craniofacial Research. He can be reached at 301-594-0676 or via email at scott.verbridge@nih.gov.