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

FAQs: NINDS CREATE Bio Optimization Track for Biologics (U44) - PAR-17-457

1) What is the NINDS CREATE Bio Optimization Track for Biologics (U44)?

It is an NIH Small Business Innovation Research (SBIR) funding opportunity run by the National Institute of Neurological Disorders and Stroke (NINDS). The goal is to help small companies move a promising biologic-based therapeutic from an early-but-encouraging stage into a more mature, optimized drug candidate that is ready for the next step of development.

2) What does the program mean by an "Optimization Track"?

The Optimization Track is meant for projects that already have a therapeutic agent with credible in vivo promise. The funding supports additional characterization and optimization work to make the candidate more development-ready, rather than supporting speculative discovery research.

3) Who administers this opportunity?

The program is administered by the National Institutes of Health (NIH) and run by NINDS (the National Institute of Neurological Disorders and Stroke).

4) What type of award mechanism is used?

This opportunity uses a cooperative agreement mechanism (U44). In general, this means NIH staff are expected to have substantial involvement during the project compared to a standard grant, including active project stewardship, milestone tracking, and coordinated problem-solving to keep the project on a development-focused path.

5) Is this opportunity for small molecules or biologics?

This FOA focuses on biologics and biotechnology-derived therapeutic products, not small-molecule drugs.

6) What kinds of therapeutic modalities are explicitly included?

Examples explicitly highlighted include peptides, proteins, oligonucleotides, gene therapies, and cell therapies, as well as newer or emerging therapeutic modalities.

7) What disease areas are expected to be a fit?

Projects should align with the NINDS mission and priorities. That means the intended disease or condition should be neurological in nature and aligned with NINDS priorities.

8) Is this program intended for discovery-stage projects?

No. Projects applying to this track should not be speculative discovery efforts. Applicants are expected to already have a therapeutic agent that has shown credible promise in vivo.

9) What level of evidence is expected before applying?

The opportunity description emphasizes relevant, rigorous, and convincing animal efficacy data (or other appropriate in vivo models). The intent is that teams have already crossed an important proof-of-concept threshold.

10) What is the main goal of the funding period?

By the end of the funding period, successful projects are expected to produce an optimized therapeutic candidate that is positioned to move forward in development, rather than simply generating additional research data.

11) What attributes should the optimized candidate demonstrate by the end of the project?

The optimized candidate is expected to show strong performance across development-critical attributes, including:

• Bioactivity
• Stability
• Manufacturability
• Bioavailability (as appropriate for the modality and route of administration)
• In vivo efficacy

12) What does "bioactivity" mean in this context?

Bioactivity refers to evidence that the candidate does what it is supposed to do biologically (i.e., it produces the intended biological effect consistent with the therapeutic concept).

13) What does "stability" mean for a biologic candidate in this track?

Stability refers to the candidate remaining intact and active under relevant storage and physiological conditions, consistent with practical development needs.

14) What does "manufacturability" mean in this opportunity description?

Manufacturability refers to the ability to produce the therapeutic candidate reproducibly and at a quality level consistent with development needs.

15) What does "bioavailability" mean here?

Bioavailability refers to the candidate reaching the intended site at sufficient levels, as appropriate for the therapeutic modality and route of administration.

16) Why does the FOA emphasize in vivo efficacy?

The program is designed for candidates that already show credible in vivo promise and need optimization. Continued in vivo efficacy evidence helps maintain confidence that improvements to the candidate still translate into meaningful performance in living systems.

17) What is the expected "next step" after this Optimization Track?

A refined candidate package from this track is expected to be positioned to advance directly into the NINDS CREATE Bio Development track, described as the next stage in the CREATE Bio pipeline.

18) Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR rules.

19) Are non-U.S. (foreign) institutions allowed to apply?

No. The FOA is explicitly not open to non-U.S. (foreign) institutions as applicants.

20) Are non-U.S. components of U.S. organizations eligible to apply?

No. Non-U.S. components of U.S. organizations are not eligible to apply.

21) Can any part of the work be done outside the United States?

Foreign components may be allowed under NIH policy as defined in the NIH Grants Policy Statement. This typically means discrete elements of work might be performed outside the U.S. if well-justified and compliant, even though the applicant organization itself must be an eligible U.S. small business.

22) What is the funding opportunity number for this FOA?

The funding opportunity number is PAR-17-457.

23) What is the CFDA number associated with this opportunity?

The opportunity is listed under CFDA 93.853.

24) How is this program categorized?

It is categorized as a discretionary health funding program administered by NIH.

25) When was this funding opportunity created?

It was created on 2017-08-11.

26) What closing date is shown for this opportunity?

The original closing date shown is 2021-05-07.