Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) | PAR 24 294

Opportunity Information: Apply for PAR 24 294

The Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (PAR-24-294) is a National Institutes of Health (NIH) funding opportunity aimed at helping small businesses advance biologic-based treatments for nervous system disorders from relatively late discovery work into early clinical testing. It is a cooperative agreement (U44), meaning awardees do not just receive funds and work independently; they partner closely with NIH program staff and NIH-supported experts as the project moves through defined development milestones. The announcement is a reissue of PAR-21-233 and is designed to move promising biologic therapeutic candidates through lead optimization and key preclinical development activities, with the option to progress through Phase I clinical testing if the project is ready and achieves the required benchmarks.

The scope is specifically focused on biologic or biotechnology-derived therapeutics rather than traditional small molecules. The FOA explicitly includes large biologic macromolecules such as proteins, antibodies, and peptides, as well as gene-based approaches like oligonucleotide therapies and viral vector-based therapies. It also supports cell therapies and newer or emerging modalities, including microbial or microbiome-based therapeutics, as long as the goal is to develop an intervention for disorders of the nervous system. In practical terms, the program is meant to help a company take a credible therapeutic concept and turn it into a development-ready candidate by supporting the experiments and documentation needed to reach an Investigational New Drug (IND)-enabling package and potentially initiate first-in-human evaluation.

A defining feature of BPN-Biologics is the built-in development infrastructure that awardees can access. Applicants are expected to collaborate with NIH-funded consultants, and projects can be augmented using NIH contract research organizations (CROs) with specialized capabilities that are often expensive or hard for small businesses to assemble internally. These CRO resources can cover areas central to biologics development, including manufacturing and scale-up, pharmacokinetics, toxicology, and Phase I clinical testing. The intent is to reduce common bottlenecks that slow biologics programs down, while also improving the quality and regulatory readiness of the data package by using experienced development partners.

The intellectual property (IP) structure is also highlighted as a program benefit. Awardee institutions retain their existing IP rights, and they also receive assignment of IP rights from the BPN-Biologics contractors for biotherapeutic candidates developed under the program. This is positioned to give the awardee control over patent prosecution and licensing negotiations, which can be critical for small businesses seeking to raise investment, secure partnerships, or plan commercialization pathways.

Eligibility is limited to small businesses, aligning with the SBIR/STTR-style U44 mechanism. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, “foreign components” may be allowed under NIH policy, which generally means certain project elements could potentially be carried out abroad if they meet NIH requirements and receive appropriate approval, but the applicant organization itself must be U.S.-based and eligible as a small business.

From an administrative standpoint, the opportunity is listed under NIH with multiple CFDA numbers reflecting the NIH-wide nature of the Blueprint effort and the involvement of multiple institutes and centers that support neuroscience and neurological disorder research. The FOA has an original closing date of August 18, 2027, giving applicants a multi-year window to apply under the program’s submission schedule. While the notice provides no stated award ceiling or expected number of awards in the excerpt, the cooperative agreement structure and the described CRO access indicate the program is meant to support substantial translational work and milestone-driven development rather than early exploratory research.

Overall, PAR-24-294 is best understood as a translational “bridge” program for small companies building biologic therapeutics for nervous system disorders, offering both funding and hands-on development support to help push credible candidates through preclinical development and, when appropriate, into Phase I clinical testing, while allowing the awardee to maintain strong control over resulting IP.

• The National Institutes of Health in the education, environment, health 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): 93.113, 93.121, 93.213, 93.242, 93.273, 93.279, 93.853, 93.866, 93.867.
• This funding opportunity was created on 2024-10-01.
• Applicants must submit their applications by 2027-08-18.
• Eligible applicants include: Small businesses.

Apply for PAR 24 294

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