Artificial Intelligence in Pre-clinical Drug Development for AD/ADRD (R01 Clinical Trial Not Allowed) | RFA AG 24 049

Opportunity Information: Apply for RFA AG 24 049

The National Institutes of Health (NIH) is soliciting R01 grant applications under funding opportunity RFA-AG-24-049, titled "Artificial Intelligence in Pre-clinical Drug Development for AD/ADRD (R01 Clinical Trial Not Allowed)." The main purpose of this opportunity is to speed up and strengthen early-stage Alzheimer disease (AD) and AD-related dementias (ADRD) therapeutic development by applying artificial intelligence and machine learning (AI/ML) methods across the drug discovery and preclinical pipeline. In practical terms, the NOFO is looking for projects that use existing AI/ML approaches or create new ones to improve how potential drug candidates are found, refined, prioritized, and ultimately selected for advancement, with the larger goal of increasing the chances that those candidates succeed later during clinical development. Importantly, this mechanism is explicitly "clinical trial not allowed," so the work is intended to stay on the discovery and preclinical side rather than testing interventions in human participants.

A central theme is acceleration and better decision-making in preclinical drug development for AD/ADRD, especially for novel targets where the field often struggles with uncertainty and high attrition. Applications are expected to show how AI/ML will be used to make the discovery process more efficient and more predictive, such as improving candidate identification, optimizing lead compounds, selecting the most promising molecules for preclinical advancement, or otherwise reducing time and cost while improving the quality of go/no-go decisions before clinical testing. The NOFO also emphasizes tool-building that can benefit the broader community, not just a single lab or company pipeline.

Another major deliverable is the creation of advanced open-source analytical tools. NIH indicates that this program should produce tools that are openly available to the wider research ecosystem, including academia and biotech/pharma, to support more effective AD/ADRD drug discovery campaigns. The intent is that funded projects contribute reusable methods, software, or analytical pipelines that others can adopt for new targets and programs, rather than keeping key capabilities proprietary or limited to one group. While the NOFO description does not list specific software requirements in the text provided, the repeated emphasis on "open-source" signals that accessibility, usability, and community impact are core expectations.

The award is a discretionary NIH grant using the R01 mechanism, with a funding activity category in health and CFDA number 93.866. The listed award ceiling is $1,000,000, and the original closing date is February 13, 2025. The posting indicates an expected awards field but does not provide a number in the provided source text, so applicants would typically check the full announcement for anticipated funding levels, budget guidance, and any institute-specific limits or preferences.

Eligibility is broad and includes many types of domestic U.S. organizations and certain non-U.S. entities. Eligible applicants include state, county, city or township, and 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses; and an "other" category that can cover additional organization types recognized by NIH policy. The announcement also explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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 non-domestic (non-U.S.) entities (foreign organizations). This breadth suggests NIH wants to encourage a wide range of teams with AI/ML expertise, neurodegeneration biology knowledge, and translational drug discovery capability to participate.

Overall, the opportunity is aimed at teams that can combine computational AI/ML innovation with preclinical drug discovery realities in AD/ADRD, producing both tangible advances in how candidates are discovered and selected and openly shared tools that raise the baseline capabilities of the broader field. Applicants should expect that strong proposals will clearly connect the AI/ML approach to specific pain points in AD/ADRD preclinical development, demonstrate how the method will improve candidate quality or predictability for downstream clinical success, and lay out a credible plan for delivering robust open-source tools that other researchers and developers can readily use.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Artificial Intelligence in Pre-clinical Drug Development for AD/ADRD (R01 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 2024-12-02.
• Applicants must submit their applications by 2025-02-13. (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 $1,000,000.00 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.

Apply for RFA AG 24 049

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: