Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed) | PAR 19 289

Opportunity Information: Apply for PAR 19 289

Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (PAR-19-289) is an NIH R01 grant opportunity focused on strengthening the early, preclinical stage of treatment development for mental illnesses. The central aim is to develop and validate in vivo assays in animal models that can reliably measure neural circuit engagement, using neurophysiological readouts (for example, electrophysiology or other real-time measures of brain activity) alongside behavioral measures. Rather than supporting clinical studies, the announcement is explicitly limited to preclinical work (clinical trials are not allowed), with the intent of improving how well animal research can inform therapeutic decisions before candidates move further down the pipeline.

The FOA is designed around the idea that many promising therapeutic targets fail because preclinical studies do not adequately demonstrate whether a candidate treatment is actually affecting the brain mechanisms that matter for psychiatric symptoms. To address this, NIH is seeking projects that optimize, standardize, and evaluate neurophysiological and behavioral measures that can serve as surrogate markers of neural processes that are clinically relevant. In practical terms, applicants are expected to build assays that reflect current knowledge of systems neurobiology and clinical neuroscience and that can be used as screening tools to test whether a target, pathway, or treatment candidate changes circuit function in a way that is meaningful for mental health conditions.

A key emphasis is assay development for the screening phase of therapeutic development, meaning the work should be geared toward measures that are practical and informative for early go/no-go decisions. The measures should be grounded in what is known about the neurobiology of mental illnesses, and they should help quantify engagement of specific neural circuits or processes implicated in psychiatric disorders. The broader goal is to increase the scientific value and translational relevance of preclinical animal data by linking interventions to neurobiological mechanisms of interest, not merely to broad behavioral outcomes.

The funding mechanism is an R01 research project grant, categorized under Health (CFDA 93.242). The opportunity is discretionary and administered by the National Institutes of Health. The original closing date listed for the opportunity was September 7, 2022, and the provided source data does not specify an award ceiling or the expected number of awards.

Eligibility is broad and includes many common U.S. applicant types 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 tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations), as well as Indian/Native American Tribal Governments that are not federally recognized.

Overall, this FOA is aimed at advancing preclinical neuroscience tools that directly measure circuit-level effects of interventions, with the expectation that better assays of circuit engagement will make early therapeutic development more informative and more likely to translate into clinically useful treatments for mental illnesses.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (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): 93.242.
• This funding opportunity was created on 2019-05-29.
• Applicants must submit their applications by 2022-09-07. (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 19 289

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