Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3) - Clinical Trial Optional | PAR 18 546

Opportunity Information: Apply for PAR 18 546

The Blueprint Neurotherapeutics Network (BPN) funding opportunity (PAR-18-546) is a National Institutes of Health (NIH) cooperative agreement designed to help neuroscience researchers push small-molecule drug projects further down the pipeline and, when appropriate, into first-in-human testing. The program targets disorders of the nervous system and is structured to bridge the common gap between academic discovery and the rigorous preclinical and early clinical work needed to start clinical development. Because it is a cooperative agreement (UG3/UH3), awardees should expect active collaboration and coordination with NIH and NIH-supported partners rather than a fully hands-off grant structure.

A central feature of BPN is the division of responsibilities between the applicant team and the program's external development resources. Investigators keep ownership of the disease-relevant scientific core of the project: they run the target- or disease-specific assays, models, and specialized research tools in their own laboratories, and the award provides funding for that work. At the same time, projects are strengthened by access to NIH-funded consultants and, critically, NIH contract research organizations (CROs). These CRO resources can cover many of the expensive, specialized, and highly regulated activities that often slow academic drug development, including medicinal chemistry support, pharmacokinetics (PK) and related ADME studies, toxicology, formulation development, chemical synthesis (including Good Manufacturing Practice, or GMP, production), and Phase I clinical testing. In practical terms, the program is set up so that a neuroscience lab does not need to independently build an industrial-scale development infrastructure to progress a credible small-molecule candidate.

The program allows entry at two different points depending on how mature the project is. Projects can enter at the Discovery stage, where the goal is to take promising hit compounds and optimize them through iterative medicinal chemistry and related testing to improve potency, selectivity, and drug-like properties. Alternatively, projects can enter at the Development stage, where a more advanced development candidate is ready to move toward Investigational New Drug (IND)-enabling work. For Development-stage projects, the emphasis is on completing the studies typically required to support an IND submission (notably formal toxicology and other regulatory-aligned packages) and potentially progressing into Phase I clinical testing. Importantly, Discovery-stage projects that successfully achieve their milestones can transition forward into the Development phase, creating a pathway from early optimization all the way to early clinical evaluation within the same program framework.

Milestones are a defining aspect of the UG3/UH3 structure. While the provided text does not list specific milestone requirements, the model implies a staged, go/no-go approach where continued support depends on meeting predefined technical and development objectives. This approach is intended to keep projects focused on producing decision-quality data and to ensure that only candidates with an acceptable balance of efficacy signals, safety margins, and developability move forward into costlier phases.

Intellectual property (IP) terms are another highlight of this opportunity and are structured to be attractive to applicants thinking about downstream translation and partnering. Awardee institutions retain their own IP rights, and they also receive assignment of IP rights generated by the BPN contractors for drug candidates developed within the program. This matters because it gives the awardee institution control over patent prosecution and licensing negotiations, which can be essential for attracting commercial partners or investors later, and helps avoid the fragmented ownership arrangements that can complicate drug development collaborations.

Eligibility is broad and includes many types of organizations that conduct biomedical research and development. Eligible applicants listed 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; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education institutions in those categories); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as Native American tribal organizations (other than federally recognized tribal governments). The announcement also explicitly calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, 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-U.S. entities (foreign organizations), signaling an intent to support a diverse set of applicants capable of contributing to neurotherapeutics development.

Administratively, the sponsoring agency is the NIH, and the opportunity falls under multiple CFDA program numbers (93.121, 93.213, 93.242, 93.273, 93.279, 93.853, 93.865, 93.866, 93.867), reflecting the cross-institute, cross-program nature of neuroscience and neurological disorder research within NIH. The original closing date in the provided record is 2020-03-03, and the posting was created on 2017-12-21. The award ceiling and expected number of awards are not specified in the source text, which suggests applicants would need to consult the full funding announcement or NIH contacts for budget limits, typical project sizes, and anticipated award counts.

Overall, BPN is best understood as a translation-focused program for small-molecule neurotherapeutics that combines investigator-driven biological validation and disease modeling with NIH-supported drug development expertise and infrastructure. It is designed to help move credible candidates from hit-to-lead optimization and candidate selection through IND-enabling studies and, when appropriate, Phase I clinical testing, while allowing awardee institutions to maintain meaningful control over resulting IP and commercialization decisions.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3) - Clinical Trial Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.242, 93.273, 93.279, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2017-12-21.
• Applicants must submit their applications by 2020-03-03. (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 18 546

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