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

The Department of Health and Human Services through the National Institutes of Health has released a forecasted opportunity titled Accelerating Product Excellence in Innovation and for Clinical Adoption, known by its acronym APEx. This initiative is managed by the National Institute of Dental and Craniofacial Research in partnership with other NIH Institutes and Centers. The funding instrument type is a cooperative agreement under the U24 activity code, and no clinical trials are permitted within this award. The program falls under the category of Health and is supported by the Assistance Listing 93.121 for Oral Diseases and Disorders Research. The APEx program is designed to establish extramural Resource Centers that will support promising strategies and products in tissue engineering and regenerative medicine. These resource centers are expected to bring together clinical, scientific, industrial, regulatory, and commercialization expertise to guide interdisciplinary translational projects. The goal is to advance therapeutics such as adult stem cell-based treatments, as well as diagnostics and sensors, with an emphasis on validation, manufacturing, and preclinical testing. Products supported may address tissue damage from congenital conditions, trauma, or chronic disease, with priority placed on those that enable early detection, monitoring of biomarkers, or prevention of long-term damage. The outcome of this initiative is to ensure that products in tissue engineering and regenerative medicine have regulatory approvals in place for first-in-human studies. Awardees are expected to generate clinical study protocols and synthesis and manufacturing processes that will facilitate the initiation of clinical trials. By supporting the infrastructure and translational projects, NIH seeks to accelerate the pipeline from scientific discovery to clinical application. Eligibility for this program is broad and includes nonprofit organizations with IRS 501(c)(3) status other than institutions of higher education, Native American tribal governments that are federally recognized, for-profit organizations other than small businesses, county and state governments, independent school districts, public housing authorities, Indian housing authorities, public and private institutions of higher education, small businesses, and Native American tribal organizations other than federally recognized governments. This broad eligibility scope is designed to foster wide participation from multiple sectors that can bring value to the resource centers and translational projects. The program is currently in forecast status, with key dates provided to guide potential applicants in planning. The estimated post date for the Notice of Funding Opportunity is November 25, 2025, with an anticipated application due date of January 25, 2026. The estimated award date is December 1, 2026, and the project start date is set for the same day. This aligns the program with fiscal year 2027. At present, the total program funding, award ceiling, and award floor amounts have not yet been specified. Applications are not being solicited at this time, and the notice has been issued to provide sufficient lead time for potential applicants to build collaborations and design projects that are responsive to the program goals. Interested investigators are encouraged to begin developing ideas in tissue engineering and regenerative medicine that align with the stated purpose. For more information, potential applicants can contact Scott Verbridge, PhD, at the National Institute of Dental and Craniofacial Research by phone at 301-594-0676 or by email at scott.verbridge@nih.gov.