NINDS CREATE Bio Optimization Track for Biologics (U44) | PAR 17 457

Opportunity Information: Apply for PAR 17 457

The NINDS CREATE Bio Optimization Track for Biologics (U44) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity designed to help small companies move promising biologic-based therapeutics from an encouraging early stage into a more mature, optimized drug candidate that is ready for the next step of development. Run by the National Institute of Neurological Disorders and Stroke (NINDS), the program specifically targets therapeutic approaches that fit within the NINDS mission, meaning the intended disease or condition should be neurological in nature and aligned with NINDS priorities. The award mechanism is a cooperative agreement (U44), which generally means NIH staff are expected to have substantial involvement during the project compared to a standard grant, often through active project stewardship, milestone tracking, and coordinated problem-solving to keep the program on a development-focused path.

This FOA focuses on biologics and biotechnology-derived therapeutic products rather than small-molecule drugs. Examples explicitly highlighted include peptides, proteins, oligonucleotides, gene therapies, and cell therapies, as well as newer or emerging therapeutic modalities. The key point is that projects applying to this track should not be speculative discovery efforts. Instead, they should already have a therapeutic agent that has shown credible promise in vivo, supported by relevant, rigorous, and convincing animal efficacy data (or other appropriate in vivo models). In other words, the program is intended for teams that have already crossed an important proof-of-concept threshold and now need resources to refine the candidate into something more development-ready.

The core purpose of the Optimization Track is to support additional characterization and optimization work that increases confidence the candidate can realistically progress toward clinical development. By the end of the funding period, successful projects are expected to have produced an optimized therapeutic candidate with demonstrated performance across several practical, development-critical attributes. Those attributes include bioactivity (the candidate does what it is supposed to do biologically), stability (it remains intact and active under relevant storage and physiological conditions), manufacturability (it can be produced reproducibly and at a quality level consistent with development needs), bioavailability (it reaches the intended site at sufficient levels, as appropriate for the modality and route of administration), and in vivo efficacy (continued evidence that it works in living systems). The program is structured so that a strong outcome is not just more data, but a refined candidate package that is positioned to advance directly into the NINDS CREATE Bio Development track, which is implied to be the next stage in the CREATE Bio pipeline.

Eligibility is limited to small businesses, consistent with SBIR rules, and the FOA is explicitly not open to non-U.S. (foreign) institutions as applicants. In addition, non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components may be allowed under NIH policy as defined in the NIH Grants Policy Statement, which typically means that certain discrete elements of work might be performed outside the U.S. if they are well-justified and compliant, even though the applicant organization itself must be an eligible U.S. small business. The opportunity is listed under CFDA 93.853 and is categorized as a discretionary health funding program administered by NIH. The funding opportunity number is PAR-17-457, it was created on 2017-08-11, and the original closing date shown is 2021-05-07.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Bio Optimization Track for Biologics (U44)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-08-11.
• Applicants must submit their applications by 2021-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 17 457

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