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

National Institutes of Health

RFA-DE-27-002

HHS-NIH11

General Information

$6,000,000
Est. Program Funding:
July 10, 2026
Closing Date:
N/a
Expected No. of Awards
$4,000,000
Award Ceiling

Opportunity Number:
RFA-DE-27-002

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

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.
Response Date Jul 10, 2026 12:00:00 AM EDT
Posting Date May 04, 2026 12:00:00 AM EDT
Archive Date Sep 08, 2026 12:00:00 AM EDT
Award Ceiling 4,000,000
Award Floor N/a
Cost Sharing No

Eligibility

Eligible Applicants City or township governments, Public housing authorities/Indian housing authorities, Private institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Small businesses, Special district governments, State governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Native American tribal organizations (other than Federally recognized tribal governments), Public and State controlled institutions of higher education, County governments, Independent school districts, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal governments (Federally recognized), For profit organizations other than small businesses
Additional Info on Eligibility: Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name National Institutes of Health
Link to Additional Information: N/a
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk
Phone: 301-402-2541

CFDA Program(s)

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