Microphysiological Systems to Advance Precision Medicine for AD/ADRD Treatment and Prevention (U54 Clinical Trial Not Allowed) | RFA AG 24 040

Opportunity Information: Apply for RFA AG 24 040

The National Institutes of Health (NIH) funding opportunity RFA-AG-24-040, titled "Microphysiological Systems to Advance Precision Medicine for AD/ADRD Treatment and Prevention (U54 Clinical Trial Not Allowed)," supports the creation of multi-component Translational Centers focused on Microphysiological Systems (MPS) for Alzheimers disease (AD) and Alzheimers disease-related dementias (AD/ADRD). The award mechanism is a U54 Cooperative Agreement, which means funded projects are expected to operate as centers with multiple coordinated components and to work in close collaboration with NIH program staff under a cooperative, milestone-driven structure. The overall intent is not to fund clinical trials, but to strengthen preclinical and translational capabilities by building robust human-relevant model platforms that can accelerate therapeutic discovery and development.

The central goal of the program is to develop and validate reproducible, scalable 2D and 3D AD/ADRD model systems that capture key aspects of human disease biology. These platforms are envisioned as precision medicine research tools, meaning they should be useful for studying the heterogeneity of AD/ADRD (for example, differences tied to genetic risk factors, cellular states, or other patient-linked features) and for investigating complex disease mechanisms in ways that conventional models often cannot. In practice, the NOFO is oriented toward building model systems that better recapitulate human pathophysiology and that can be used to support multiple stages of the drug discovery pipeline, including target identification and validation, mechanistic studies, and preclinical drug development activities such as screening and early evaluation of candidate therapeutics.

A major emphasis is on microphysiological systems as platforms, which typically refers to engineered in vitro human tissue models that may include organ-on-a-chip approaches, microfluidic systems, or other advanced culture methods designed to mimic tissue microenvironments, multicellular interactions, and functional outputs. By calling for both 2D and 3D models, the opportunity leaves room for a spectrum of technologies, from advanced co-culture systems to complex 3D tissue constructs, as long as they are reproducible, scalable, and meaningfully reflective of AD/ADRD biology. The translational center concept also implies that awardees are expected to go beyond proof-of-concept prototypes and move toward standardized platforms that can be broadly useful for the research community and for translational applications.

Administrative details in the source information indicate the opportunity falls under the Health activity category (CFDA 93.866) and uses a discretionary funding mechanism. The posted award ceiling is $2,500,000, and the original application closing date was 2024-02-15. Because it is a center-style cooperative agreement, applicants should expect that the program is designed to support coordinated, team-based science with defined goals, integration across components, and active programmatic engagement from NIH.

Eligibility is broad and includes many types of U.S. organizations and institutions, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits not classified as small businesses); and other eligible entities. The opportunity also explicitly highlights additional eligible applicants and institution types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-domestic (non-U.S.) entities/foreign organizations. This broad eligibility signals an interest in drawing from diverse technical strengths and institutional contexts, including communities and organizations that may contribute distinct expertise, resources, or perspectives to AD/ADRD translational modeling.

Taken together, the opportunity is best understood as an NIH-led push to build a network of AD/ADRD-focused MPS Translational Centers that can produce reliable, scalable human-relevant model systems. The expected payoff is better precision medicine research capability for AD/ADRD and faster, more informative preclinical decision-making in drug discovery and development, without supporting clinical trials under this specific announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Microphysiological Systems to Advance Precision Medicine for AD/ADRD Treatment and Prevention (U54 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): 93.866.
• This funding opportunity was created on 2023-10-19.
• Applicants must submit their applications by 2024-02-15. (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 $2,500,000.00 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.

Apply for RFA AG 24 040

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