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) initiative, funded by the National Institute of Dental and Craniofacial Research (NIDCR), a part of the National Institutes of Health (NIH), represents a strategic effort to drive forward the development and clinical readiness of technologies in tissue engineering and regenerative medicine (TE/RM). As a forecasted funding opportunity, APEx intends to support the formation of extramural Resource Centers (RCs) that are well-positioned to shepherd promising therapeutic innovations toward clinical implementation. These RCs will draw upon multidisciplinary expertise—including clinical, scientific, industrial, regulatory, and commercialization domains—to select and guide Interdisciplinary Translational Projects (ITPs) that show the highest potential for impact in diagnostics, therapeutics, and sensor-based innovations. The core objective of this opportunity is to facilitate the validation, manufacturing, and preclinical testing of high-potential TE/RM products. The projects supported under this initiative may span adult stem cell-based treatments, sensors for early detection, and technologies for diagnosing or treating tissue damage caused by congenital defects, injury, or chronic diseases. Emphasis will also be placed on projects that promote early detection of pathologies, monitor validated health biomarkers, and implement strategies aimed at reducing or preventing chronic tissue damage. Ultimately, the desired outcome of APEx is to prepare these products for clinical readiness with regulatory approvals secured and clinical trial protocols established. APEx will be administered through the U24 cooperative agreement mechanism, which typically involves substantial programmatic involvement from NIH staff. This mechanism supports the shared goals of the RCs and NIH to drive translational science while ensuring program integrity and alignment with public health priorities. The opportunity does not allow clinical trials within its scope. Instead, it emphasizes readiness for clinical studies through comprehensive preclinical preparation. This grant opportunity is currently in the forecast stage. The anticipated timeline includes an estimated post date of October 7, 2025, with applications due by November 7, 2025. The estimated award notification is expected by July 1, 2026, which is also the projected project start date. There is no information at this time regarding any earlier deadlines such as letters of intent or pre-applications. Matching funds are not required under this opportunity. Eligibility is broad and includes a range of public and private institutions. Eligible applicants include county and state governments, public and state-controlled as well as private institutions of higher education, independent school districts, public housing authorities, and federally and non-federally recognized tribal governments and organizations. Nonprofits with 501(c)(3) status, small businesses, and for-profit entities that are not small businesses are also eligible to apply. This suggests a diverse applicant pool and a collaborative focus on interdisciplinary innovation. For questions or to seek more details about the funding opportunity, interested applicants should contact Dr. Scott Verbridge at the National Institute of Dental and Craniofacial Research. He can be reached via email at scott.verbridge@nih.gov or by phone at 301-594-0676. While applications are not currently being accepted, this early notice is intended to help potential applicants prepare responsive proposals and establish strategic collaborations in anticipation of the official notice of funding opportunity.