Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) | PAR 21 233

Opportunity Information: Apply for PAR 21 233

The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) funding opportunity (PAR 21-233) is an NIH cooperative agreement (U44; clinical trial optional) aimed at helping small businesses move promising biologic-based treatments for nervous system disorders from late discovery through early clinical development. The program is set up to push projects past common development bottlenecks by pairing awardees with an organized NIH-supported development network, with the overall scope running from lead optimization and IND-enabling work through the option of Phase I clinical testing.

A key feature of this opportunity is the kind of products it is designed to support. It focuses specifically on biologic and biotechnology-based therapeutics rather than traditional small molecules. Examples called out in the announcement include large biologic macromolecules such as proteins, antibodies, and peptides; gene-based therapies including oligonucleotide-based and viral vector-based approaches; cell therapies; and newer or emerging modalities like microbial and microbiome-based therapies. In practical terms, the FOA is geared toward projects that need structured preclinical development (and potentially first-in-human planning) to become credible clinical candidates for neurological indications.

The support model goes beyond providing grant dollars. Because this is a cooperative agreement, recipients should expect substantial NIH involvement and active collaboration during the project. Awardees work with NIH-funded consultants and can also add capacity through NIH contract research organizations (CROs). Those CRO resources are meant to cover specialized and expensive development functions that many small businesses cannot easily build in-house, including manufacturing and scale-up, pharmacokinetics, toxicology, and Phase I clinical testing. The intent is to create a more streamlined, industry-style development path while still operating within an NIH-supported framework.

Intellectual property terms are also highlighted as a program advantage. The awardee institution keeps its own IP rights, and it also receives assignment of IP rights from BPN-Biologics contractors for biotherapeutic candidates developed through the program. That structure is meant to leave the small business in control of patent prosecution and later licensing negotiations, which can matter a lot for fundraising, partnerships, and commercialization planning.

Eligibility is limited to small businesses, and there are clear restrictions on foreign participation. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components may be allowed in some cases as defined under the NIH Grants Policy Statement, which typically means certain discrete elements of work might be performed abroad if well-justified and consistent with NIH policy, even though the applicant organization itself must be eligible and U.S.-based.

Administratively, the opportunity is run by the National Institutes of Health and is listed as a discretionary funding program. It falls under multiple CFDA numbers (93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the cross-institute nature of NIH neuroscience and neurological disease portfolios. The original closing date shown is 2024-08-19, and the FOA was created on 2021-04-23. Overall, the program is designed for small biotech companies with a biologic therapeutic concept for a nervous system disorder that is ready to be shaped into a developable candidate, with NIH providing a coordinated set of expertise and outsourced capabilities to help reach key preclinical milestones and potentially Phase I readiness.

• 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 (U44 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 2021-04-23.
• 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: Small businesses.

Apply for PAR 21 233

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