Opportunity Information: Apply for RFA DE 27 002
The Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) funding opportunity (RFA-DE-27-002) is a National Institutes of Health (NIH) cooperative agreement (U24) designed to push promising tissue engineering and regenerative medicine (TE/RM) ideas beyond the early research stage and into a state where they are realistically ready to enter first-in-human testing. The program is built to close common translational gaps that slow TE/RM technologies down, such as incomplete preclinical evidence packages, manufacturing and scale-up barriers, unclear regulatory paths, and lack of practical commercialization planning. Although the end goal is to enable clinical trials, this particular announcement is explicitly "Clinical Trial Not Allowed," meaning supported activities must remain in the preclinical and translational development space rather than running human studies under this award.
APEx is structured around two linked elements: Resource Centers (RCs) and Interdisciplinary Translational Projects (ITPs). The Resource Centers are meant to act as hubs of specialized expertise and infrastructure, bringing together multidisciplinary capabilities that TE/RM teams typically need but often cannot assemble on their own. That includes clinical perspective (to ensure the product targets a real use case), scientific and engineering expertise (to strengthen performance and reproducibility), industrial know-how (to address manufacturability and quality systems), and regulatory and commercialization support (to align the development plan with FDA expectations and downstream adoption realities). In practical terms, RCs are expected to provide hands-on technical support, access to research capacity and shared resources, administrative coordination, and guidance on regulatory documentation and commercialization strategy, while helping the associated ITPs execute the work needed to complete preclinical development.
The Interdisciplinary Translational Projects represent the specific products or strategies being advanced within the program, and they can fall into therapeutics (including adult stem cell-based treatments), sensors, or diagnostics. The emphasis is on maturing products that have strong promise but still need rigorous validation, manufacturing development, and preclinical testing before they can credibly move to a first-in-human study. The NOFO highlights applications focused on detecting or treating tissue damage associated with congenital defects, traumatic injuries, or chronic diseases. It also calls out, as particularly encouraged, products and approaches that enable early detection of chronic pathologies, monitoring of validated biomarkers of health or disease, and strategies intended to reduce or prevent damage before it becomes irreversible. In other words, APEx is not limited to therapies alone; it also prioritizes measurement technologies and diagnostics that can change clinical decision-making earlier in the disease course or improve monitoring over time.
A central theme of this program is readiness for clinical entry rather than basic discovery. During this funding cycle, APEx-supported teams are expected to complete the types of activities that make a technology credible to regulators and future clinical partners, such as analytical and functional validation, establishment or refinement of synthesis and manufacturing methods, and generation of preclinical testing packages appropriate for the intended use. The stated outcome is not simply a promising prototype, but TE/RM products that have the necessary regulatory groundwork in place for first-in-human studies, along with accompanying clinical study protocols (prepared for later use), and manufacturing and synthesis protocols that are sufficiently mature to support the initiation of clinical trials after this award ends or under a different funding mechanism.
From an administrative standpoint, the award mechanism is a cooperative agreement, which generally means NIH expects to have substantial programmatic involvement compared to a standard research project grant. The funding opportunity is categorized as discretionary and falls under the health activity category, with CFDA numbers 93.121, 93.846, and 93.867. The award ceiling is listed as $4,000,000, and the application deadline (original closing date) is 2026-07-10, with the opportunity created on 2026-05-04. While the number of expected awards is not clearly specified in the provided excerpt, the structure implies a programmatic set of RCs and ITPs rather than a collection of unrelated single-investigator projects.
Eligibility is broad across U.S.-based organizations and includes state and local governments, tribal governments and eligible tribal organizations, public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), small businesses, and other eligible entities as defined in the NOFO. At the same time, restrictions on foreign involvement are strict: non-U.S. organizations cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. This effectively confines project activities and organizational participation to domestic U.S. entities and components.
Overall, APEx is aimed at teams that already have a credible TE/RM therapeutic, sensor, or diagnostic concept and need a highly structured translational environment to finish the most demanding preclinical and development steps. The program is designed to turn strong candidates into clinically actionable products by pairing them with Resource Centers that can supply real-world translational support, with the explicit end point being regulatory readiness and practical protocols for manufacturing and first-in-human study launch, without conducting the clinical trial itself under this award.Apply for RFA DE 27 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.846, 93.867.
- This funding opportunity was created on 2026-05-04.
- Applicants must submit their applications by 2026-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $4,000,000.00 in funding.
- Eligible applicants include: 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.
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APEx (RFA-DE-27-002) Funding Opportunity FAQs
What is the APEx funding opportunity (RFA-DE-27-002)?
Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) is a National Institutes of Health (NIH) cooperative agreement opportunity (U24) intended to move promising tissue engineering and regenerative medicine (TE/RM) technologies beyond early research and into a stage where they are realistically prepared to enter first-in-human testing.
What is the main purpose of APEx?
APEx is designed to close common translational gaps that slow TE/RM technologies down, including incomplete preclinical evidence packages, manufacturing and scale-up barriers, unclear regulatory paths, and lack of practical commercialization planning. The emphasis is on clinical-entry readiness rather than basic discovery.
Does APEx fund clinical trials or studies in humans?
No. The announcement is explicitly "Clinical Trial Not Allowed." Supported work must remain in the preclinical and translational development space. The goal is to make products ready for first-in-human testing later, under a different mechanism or after the award ends, without running human studies under this award.
What kinds of technologies or projects are supported?
Interdisciplinary Translational Projects (ITPs) can include TE/RM therapeutics (including adult stem cell-based treatments), sensors, or diagnostics. The program is not limited to therapies; it also prioritizes measurement technologies and diagnostics that can affect early clinical decision-making or improve monitoring over time.
What disease areas or use cases does the NOFO emphasize?
The NOFO highlights applications focused on detecting or treating tissue damage associated with congenital defects, traumatic injuries, or chronic diseases.
Are early detection and monitoring technologies encouraged?
Yes. Particularly encouraged are products and approaches that enable early detection of chronic pathologies, monitoring of validated biomarkers of health or disease, and strategies intended to reduce or prevent damage before it becomes irreversible.
What is meant by "translational gaps" in the context of APEx?
In this program, translational gaps refer to practical barriers that keep a promising TE/RM technology from being credible and usable in a clinical setting, such as missing preclinical evidence, manufacturing/scale-up challenges, unclear regulatory strategy, and weak commercialization planning.
What is the difference between Resource Centers (RCs) and Interdisciplinary Translational Projects (ITPs)?
APEx is structured around two linked elements. Resource Centers (RCs) serve as hubs of specialized expertise and infrastructure. Interdisciplinary Translational Projects (ITPs) are the specific products or strategies being advanced (for example, a therapy, sensor, or diagnostic) that are supported and enabled by the RC capabilities.
What do Resource Centers (RCs) do in practice?
RCs are expected to provide hands-on technical support, access to research capacity and shared resources, administrative coordination, and guidance on regulatory documentation and commercialization strategy. They help associated ITPs execute the work needed to complete preclinical development and improve readiness for clinical entry.
What kinds of expertise are Resource Centers expected to bring together?
RCs are intended to integrate multidisciplinary capabilities that TE/RM teams often cannot assemble alone, including clinical perspective, scientific and engineering expertise, industrial know-how for manufacturability and quality systems, and regulatory and commercialization support to align plans with FDA expectations and downstream adoption realities.
What types of activities are APEx-funded teams expected to complete?
During this funding cycle, teams are expected to complete the types of activities that make a technology credible to regulators and future clinical partners. Examples called out include analytical and functional validation, establishment or refinement of synthesis and manufacturing methods, and generation of preclinical testing packages appropriate for the intended use.
What is the intended outcome at the end of an APEx-supported project?
The stated outcome is TE/RM products that have the necessary regulatory groundwork in place for first-in-human studies, along with accompanying clinical study protocols prepared for later use, and manufacturing and synthesis protocols sufficiently mature to support initiation of clinical trials after this award ends or under a different funding mechanism.
If clinical trials are not allowed, why does APEx mention first-in-human readiness?
APEx is designed to prepare technologies for first-in-human testing by completing preclinical and translational development work and by producing the supporting protocols and groundwork. The award supports readiness activities, not the conduct of human studies.
What does it mean that this is a cooperative agreement (U24)?
A cooperative agreement indicates NIH expects substantial programmatic involvement compared to a standard research project grant. This aligns with APEx being a structured program built around coordinated Resource Centers and linked Translational Projects rather than unrelated standalone projects.
What is the maximum award amount listed for this opportunity?
The award ceiling listed is $4,000,000.
When is the application deadline?
The original closing date provided is 2026-07-10.
When was this funding opportunity created?
The opportunity creation date provided is 2026-05-04.
What is the activity category and funding type?
The opportunity is categorized as discretionary and falls under the health activity category.
What CFDA numbers are associated with APEx?
The CFDA numbers listed are 93.121, 93.846, and 93.867.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and includes state and local governments, tribal governments and eligible tribal organizations, public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), small businesses, and other eligible entities as defined in the NOFO.
Are non-U.S. organizations eligible to apply?
No. Non-U.S. organizations cannot apply under this opportunity.
Can a U.S. organization include a non-U.S. component on the application?
No. Non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed in any form?
No. Foreign components (as defined by NIH policy) are not allowed, which confines project activities and organizational participation to domestic U.S. entities and components.
Is APEx intended for early-stage discovery research?
No. A central theme is readiness for clinical entry rather than basic discovery. APEx is aimed at teams that already have a credible TE/RM concept and need a structured translational environment to complete demanding preclinical and development steps.
Does APEx focus only on regenerative medicine therapies?
No. While TE/RM therapeutics are included, the program also supports sensors and diagnostics, especially those that enable earlier detection, biomarker monitoring, and prevention of irreversible damage.
Does the excerpt specify how many awards NIH expects to make?
No. The number of expected awards is not clearly specified in the provided excerpt, though the described structure implies a programmatic set of Resource Centers and Interdisciplinary Translational Projects.
How does APEx address manufacturing and scale-up challenges?
The program emphasizes establishment or refinement of synthesis and manufacturing methods and draws on industrial know-how through Resource Centers to address manufacturability, quality systems, and scale-up barriers that can prevent clinical entry.
How does APEx address regulatory readiness?
APEx includes regulatory support through Resource Centers, including guidance on regulatory documentation and aligning development plans with FDA expectations, with the intended endpoint being regulatory groundwork in place for first-in-human studies (without conducting them under this award).
What role does commercialization planning play in APEx?
Commercialization planning is a stated gap APEx intends to close. Resource Centers are expected to provide commercialization support to align development with downstream adoption realities and help ensure the product is practical to move forward after the award period.
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