Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional) | PAR 21 163

Opportunity Information: Apply for PAR 21 163

The Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to move promising biologic therapies for nervous system disorders from late-stage discovery into early clinical development. In practical terms, it is meant for teams that already have a credible therapeutic concept and are ready to do the work needed to turn that concept into a development candidate, complete key preclinical packages, and, when appropriate, progress into Phase I clinical testing. The program is branded as BPN-Biologics and focuses specifically on biologic and biotechnology-product approaches rather than traditional small-molecule drugs.

The scope is broad across biologic modalities relevant to neurology and related nervous system conditions. Supported projects can include large biologic macromolecules such as proteins, antibodies, and peptides, as well as gene-based therapies including oligonucleotide-based and viral vector-based approaches. It also explicitly includes cell therapies and newer, emerging therapeutic concepts such as microbial or microbiome-based interventions. The emphasis is on preclinical discovery and development activities that de-risk a candidate and prepare it for clinical entry, while still allowing a path that can extend through Phase I clinical testing, depending on the project and readiness.

A defining feature of this opportunity is the built-in development infrastructure and hands-on collaboration model. Awardees do not work in isolation; they collaborate with NIH-funded consultants and can supplement their efforts with NIH contract research organizations (CROs). These CRO resources are positioned to cover specialized, expensive, and highly regulated development steps such as manufacturing and scale-up, pharmacokinetics, toxicology, and Phase I clinical testing. The idea is to provide not just money, but also access to experienced development expertise and operational capacity that many academic groups or early companies may not have in-house, especially for biologics where CMC (chemistry, manufacturing, and controls) and safety packages can be complex.

The award mechanism is a cooperative agreement, which generally signals substantial NIH involvement in the execution and oversight of the project compared with a standard grant. The FOA uses the UG3/UH3 structure and is labeled “Clinical Trial Optional,” meaning projects may remain preclinical or may advance into a clinical Phase I component if the program milestones and readiness criteria are met. In a typical UG3/UH3 arrangement, the UG3 phase supports early, milestone-driven development work, and successful completion of predefined milestones allows transition to the UH3 phase, which supports later-stage activities that can include clinical testing. This milestone-driven design is intended to keep projects tightly focused on measurable development progress and go/no-go decision points.

Intellectual property terms are also highlighted as a program advantage for applicants worried about losing control of commercial rights. Under BPN-Biologics, awardee institutions retain assignment of their own IP rights and also gain assignment of IP rights from BPN-Biologics contractors for biotherapeutic candidates developed within the program. As described, this structure is meant to ensure that the awardee controls patent prosecution and licensing negotiations for resulting candidates, which can be important for partnering, downstream investment, and eventual commercialization.

Eligibility is broad and includes a wide range of domestic organizations as well as certain non-U.S. entities. 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; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organization types. The opportunity also explicitly calls out additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (foreign) organizations.

From an administrative standpoint, the opportunity is cataloged as PAR-21-163, falls under the “Discretionary” opportunity category, and uses the cooperative agreement funding instrument type. It is associated with multiple CFDA listings (93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting NIH’s multiple participating institutes and programmatic areas that touch nervous system research and therapeutics. The source data notes an original closing date of 2024-08-19 and a creation date of 2021-03-11. Award ceiling and expected awards are not specified in the provided text, which often means applicants need to consult the full FOA or NIH guide notice for budget structure, milestone expectations, and the number of awards anticipated in a given cycle.

Overall, the BPN-Biologics program is best understood as a translational “bridge” for biologic therapies targeting nervous system disorders: it supports rigorous, milestone-based development from lead optimization and preclinical validation through IND-enabling work and potentially Phase I testing, while giving awardees access to NIH-affiliated consultants and CRO capabilities and allowing the originating institution to maintain meaningful control of IP and downstream 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): Biologic-based Drug Discovery and Development for 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, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2021-03-11.
• Applicants must submit their applications by 2024-08-19. (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 21 163

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