Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed) | PAR 21 123

Opportunity Information: Apply for PAR 21 123

The NIH grant opportunity PAR 21-123, titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)," supports projects that build and rigorously validate model systems for neurological or neuromuscular disorders with the explicit aim of making early-stage neurotherapeutic discovery more predictive and clinically meaningful. The central emphasis is on improving how well preclinical models and ex vivo tissue systems mirror real disease biology, so that future therapeutic testing has a better chance of translating into patient benefit. This is positioned within the IGNITE program, which is designed to accelerate exploratory and early drug discovery efforts by providing resources for foundational enabling tools, in this case, better disease-relevant models.

The FOA specifically encourages two broad categories of model platforms: animal models and human/animal tissue ex vivo systems. In both cases, the expectation is that the proposed system should recapitulate key phenotypic and physiologic characteristics of a clearly defined disorder, rather than offering only superficial similarity or limited face validity. In practical terms, this means applicants are expected to design models that capture important disease-relevant features such as measurable functional impairments, relevant cellular or circuit-level dysfunction, and physiological readouts that map onto what is observed in patients. A major theme is translational relevance, meaning the model should not only be scientifically interesting, but should also enable testing that is informative for therapeutic development decisions.

A key goal of the program is to produce models that can support feasible and meaningful assessments of efficacy following therapeutic intervention. In other words, the model should be able to detect treatment effects using endpoints that are robust, interpretable, and preferably aligned with measures used or usable in clinical contexts. The FOA is aimed at strengthening the bridge between preclinical and clinical development by improving the quality of the testbed used to evaluate whether a candidate therapeutic is working. By funding development and validation work, NIH is signaling that model creation itself is a critical translational bottleneck, and that better models can reduce late-stage failures by improving early go/no-go decisions.

The mechanism is an R61/R33 phased innovation award, reflecting an expectation of milestone-driven progression. While the source text does not provide the detailed milestone structure, this paired mechanism generally supports an initial phase focused on development and early validation activities, followed by a subsequent phase that expands validation once predefined performance and rigor criteria are met. The "Clinical Trial Not Allowed" designation indicates that the supported work should not include clinical trials; the focus is on preclinical model systems and ex vivo validation activities that enable later therapeutic development rather than testing interventions in human participants as clinical trials.

From an administrative standpoint, the opportunity is a discretionary grant under the NIH, within the health funding activity category, and is associated with CFDA number 93.853. The original closing date listed is 2024-10-21. The source information provided does not specify an award ceiling or the anticipated number of awards, so applicants would need to consult the full FOA and any associated NIH notices for current budget and award quantity details.

Eligibility includes, at minimum, nonprofits with 501(c)(3) status other than institutions of higher education, and the FOA also notes a broad range of other eligible applicant types. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); eligible federal agencies; faith-based or community-based organizations; Hispanic-serving institutions; historically Black colleges and universities (HBCUs); Indian/Native American tribal governments (other than federally recognized); foreign (non-U.S.) entities; regional organizations; tribally controlled colleges and universities (TCCUs); and U.S. territories or possessions. This breadth signals NIH interest in drawing innovative model-development capacity from diverse organizational settings and geographies, including international contributors where appropriate.

Overall, this FOA is best understood as targeted support for creating the kind of validated, disease-relevant experimental systems that neurotherapeutic programs rely on but often lack. The intended output is not a clinical study, and not necessarily a therapeutic candidate itself, but a demonstrably improved model or ex vivo system that can be used downstream to test interventions with endpoints and biology that meaningfully correspond to human disease.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 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): 93.853.
• This funding opportunity was created on 2021-03-11.
• Applicants must submit their applications by 2024-10-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education.

Apply for PAR 21 123

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