Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed) | PAR 18 763

Opportunity Information: Apply for PAR 18 763

The National Institutes of Health (NIH) funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)" supports early, translational work that makes neurotherapeutic discovery more practical and more predictive of what will happen in people. The emphasis is on creating and rigorously validating research tools, rather than running human clinical trials, with the larger aim of improving how researchers evaluate whether a potential therapy is actually working in a way that matters for neurological disease.

The FOA invites projects in two main categories. The first category focuses on developing and validating animal models and human tissue-based ex vivo systems that better reproduce the key traits of a specific neurological disorder. That includes reproducing relevant phenotypic features (what the disease looks like in terms of symptoms or measurable outcomes) and physiologic characteristics (how the disease functions biologically). The idea is to move beyond models that are convenient but poorly predictive, and instead build systems that capture the aspects of disease biology that drive clinical outcomes. These could include improved animal models, organotypic or slice cultures, patient-derived tissue systems, or other ex vivo approaches, as long as the end result is a model system that is demonstrably tied to the human disorder in a meaningful way.

The second category supports the development of pharmacodynamic (PD) markers that are clinically feasible for therapies targeting neurological diseases. Pharmacodynamic markers are measurements that indicate a biological response to a drug or intervention, such as evidence that a target is engaged, a pathway is modulated, or a disease-relevant process is shifting in the intended direction. A key expectation here is feasibility in clinical settings, meaning the marker should be measurable in ways that could realistically be used in human studies (for example, using imaging, electrophysiology, biofluids, or other clinically accessible readouts). Strong proposals under this FOA are expected to show that the PD marker is not just measurable, but informative for decisions about therapeutic efficacy and translation from preclinical work to clinical development.

Across both categories, the core goal is to produce tools that substantially improve translational relevance. In practical terms, NIH is looking for models, ex vivo systems, and PD markers that can provide feasible and meaningful assessments of efficacy after a therapeutic intervention, and ideally ones that can bridge preclinical and clinical research. That translational bridge is central: the FOA aims to reduce the common gap where a treatment looks promising in a lab model but fails in humans because the model or readout was not sufficiently representative of the human condition.

This opportunity sits within the broader IGNITE program, which is described as a suite of efforts designed to enable the exploratory and early stages of drug discovery. Rather than funding late-stage development or clinical testing, IGNITE FOAs generally concentrate on removing early bottlenecks: better models, better measures, and better go/no-go decision tools that can make downstream therapeutic development more efficient and credible.

Mechanistically, the award uses an R61/R33 structure. This is typically a phased approach in which the initial phase supports early, milestone-driven development (R61), and the later phase supports expanded validation or implementation work (R33) once predefined progress criteria are met. While the FOA title explicitly notes "Clinical Trial Not Allowed," it still supports clinically oriented tool development, as long as the work does not cross into conducting a clinical trial.

Eligibility is broad and includes many types of organizations: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly highlights additional eligible applicants such as 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), eligible federal agencies, faith-based or community-based organizations, foreign (non-U.S.) entities, regional organizations, and U.S. territories or possessions. This broad eligibility signals NIH interest in drawing strong model and biomarker development ideas from a wide range of research and community settings.

Key administrative details included in the source information are that the agency is NIH, the funding instrument is a grant, the activity category is health, and the CFDA number is 93.853. The opportunity number is listed as PAR 18 763, with a creation date of April 19, 2018, and an original closing date of March 12, 2021. The award ceiling and expected number of awards are not specified in the provided data, which usually means applicants need to consult NIH budget guidance for the mechanism and any FOA-specific limits when preparing an application.

• 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 and/or Pharmacodynamic Markers 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 2018-04-19.
• Applicants must submit their applications by 2021-03-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 PAR 18 763

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