Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) | PAR 21 162

Opportunity Information: Apply for PAR 21 162

The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) funding opportunity (PAR-21-162) is an NIH cooperative agreement (U44, clinical trial optional) aimed at helping small businesses move biologic-based therapeutics for nervous system disorders from late discovery into early clinical development. In practical terms, the program is designed to bridge the common gap between having a promising biologic concept and having a development-ready candidate that can enter Phase I testing, with NIH providing not just money but hands-on, milestone-driven support typical of a cooperative agreement.

The scope is focused on biologic and biotechnology therapeutic modalities for disorders of the nervous system. The FOA explicitly includes large biologic macromolecules such as proteins, antibodies, and peptides, as well as gene-based therapies (including oligonucleotide-based and viral vector-based approaches), cell therapies, and newer or emerging platforms like microbial or microbiome-based interventions. The supported pipeline spans lead optimization and the preclinical package needed for an IND-enabling pathway, and it can extend through Phase I clinical testing, depending on the maturity of the project and the proposed plan.

A defining feature of BPN-Biologics is the structured collaboration model. Awardees work with NIH-funded consultants and can also tap into NIH contract research organizations (CROs) that have specialized capabilities that small companies often need but may not have in-house. These CRO-supported functions can include manufacturing and scale-up, pharmacokinetics, toxicology, and Phase I clinical testing. The intent is to reduce technical and operational bottlenecks by giving awardees access to experienced development partners, while still keeping the small business in the driver seat for the asset and its overall strategy.

The program also highlights intellectual property terms that are meant to be attractive to companies building a commercial product. Awardee institutions retain their existing IP rights, and they also receive assignment of IP rights arising from the work performed by BPN-Biologics contractors for the biotherapeutic candidates developed under the program. This structure is important because it allows the awardee to control patent prosecution decisions and licensing negotiations, rather than having key rights remain with outside contractors.

Eligibility is limited to small businesses, consistent with the U44 mechanism. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, may be permitted in some cases, which generally means discrete elements of a project might be allowable if they meet NIH policy requirements and are well justified.

Administratively, the opportunity is offered by the National Institutes of Health under a discretionary funding category, with activity aligned to health-related research and development. The original closing date listed for the opportunity was April 23, 2021, and the FOA is associated with multiple CFDA program numbers (93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the broader NIH and neuroscience-related funding landscape connected to Blueprint and participating institutes. Overall, BPN-Biologics is positioned as a translational, development-oriented program for small businesses advancing biologic therapies for neurological disorders, with a strong emphasis on de-risking candidates through NIH-supported expertise, CRO resources, and a clear path toward 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 2021-03-29.
• Applicants must submit their applications by 2021-04-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 21 162

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