Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)
Closed Posted
- Opportunity number
- RFA-DE-27-002
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $4,000,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Non-501(c)(3) Nonprofits
- County Governments
- Public or Indian Housing Auth.
- City/Township Governments
- State Governments
- Independent School Districts
- Other
- For Profit Organizations
- Special District Governments
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Public)
- Tribal Governments (Federally Recognized)
- 501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- Small Businesses
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Dental and Craniofacial Research (NIDCR), in partnership with the National Eye Institute (NEI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), seeks applications to establish one Resource Center (RC) that will support Interdisciplinary Translational Projects (ITPs) in tissue engineering and regenerative medicine (TE/RM), including therapeutics with adult stem cell-based treatments, sensors, and diagnostics. Applicants must demonstrate clinical, scientific, industrial, regulatory, and commercialization expertise to provide infrastructure and support services to guide ITPs through preclinical development toward FDA approval for first-in-human clinical trials. Key objectives include completing validation, manufacturing, and preclinical testing of promising products that detect or treat tissue damage from congenital defects, traumatic injury, or chronic disease, with particular emphasis on early detection, biomarker monitoring, and damage prevention approaches. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, and tribal organizations; however, clinical trials are not permitted under this funding mechanism. The application deadline is June 10, 2026, with an anticipated earliest start date of July 10, 2026, and all applicants must complete required registrations in SAM, obtain a Unique Entity Identifier (UEI), register with eRA Commons, and register with Grants.gov.
The total funding available is $6 million per year to support one RC and associated ITPs, with individual award budgets limited to $4 million in direct costs annually over a maximum 5-year project period. The RC must propose an initial cohort of 4-6 ITPs with plans to expand to approximately 10 ITPs, establish clear milestones for success and graduation, and balance projects from within and outside the RC institution while engaging industrial partners. Program Directors/Principal Investigators must collectively contribute at least 3 person-months (25% FTE) effort and be registered with ORCID. Research will be performed at recipient organizations' facilities across the United States, and the expected outcome is TE/RM products with regulatory approvals in place for first-in-human studies, along with associated clinical study protocols and synthesis and manufacturing protocols ready for clinical trial initiation.
Synopsis
This Notice of Funding Opportunity (NOFO) solicits cooperative agreement research applications to support a multidisciplinary program titled "Accelerating Product Excellence in Innovation and for Clinical Adoption" (APEx), that will facilitate advancement of promising strategies and products for tissue engineering and regenerative medicine (TE/RM). APEx will be composed of Resource Centers (RCs) and associated Interdisciplinary Translational Projects (ITPs) in the area of therapeutics (including adult stem cell-based treatments), sensors, and diagnostics. RCs will capitalize on their available clinical, scientific, industrial, regulatory and commercialization expertise, to deliver technical support, research capacity, administrative infrastructure and regulatory and commercialization support to the ITPs and guide them to complete pre-clinical studies toward initiation of clinical trials. During this funding cycle, APEx will complete validation, manufacturing, and preclinical testing of the most promising products, which may include, but are not limited to products for detecting or treating tissue damage caused by congenital defect, traumatic injury, or chronic disease. Products that support early detection of chronic pathologies, monitoring of validated biomarkers of health or disease, as well as approaches to reduce or prevent resulting damage, are especially encouraged. The outcome of APEx will be TE/RM products with their regulatory approvals in place for first-in-human studies, along with associated clinical study protocols, and synthesis and manufacturing protocols ready for initiation of clinical trials.
Files
| File | Type | Posted |
|---|---|---|
| RFA-DE-27-002-Full-Announcement.html | HTML file |
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