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

Key Facts

Status: Forecasted

Posted date: May 4, 2026

Archive date: September 8, 2026

Close date: July 10, 2026

Opportunity ID: 359128

Opportunity number: RFA-DE-27-002

Opportunity category: Discretionary

Agency name: National Institutes of Health

Agency code: HHS-NIH11

Award floor: $0

Award ceiling: $4,000,000

Cost sharing required: No

Funding Instrument Types
  • Cooperative Agreement
Category of Funding Activity
  • Health
Eligible Applicants
  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Tools
Categories (use these for quoted searches)
  • agency_code:hhs_nih11
  • category_of_funding_activity:health
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:city_or_township_governments
  • eligible_applicants:county_governments
  • eligible_applicants:for_profit_organizations_other_than_small_businesses
  • eligible_applicants:independent_school_districts
  • eligible_applicants:native_american_tribal_governments_federally_recognized
  • eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
  • eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:others
  • eligible_applicants:private_institutions_of_higher_education
  • eligible_applicants:public_and_state_controlled_institutions_of_higher_education
  • eligible_applicants:public_housing_authoritiesindian_housing_authorities
  • eligible_applicants:small_businesses
  • eligible_applicants:special_district_governments
  • eligible_applicants:state_governments
  • funding_instrument_type:cooperative_agreement
  • opportunity_category:discretionary
  • status:forecasted
Description

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.

Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)
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.
[Forecasted] Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)
Forecasted
National Institutes of Health
Health
Cooperative Agreement
State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
Others
2026-05-04