CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional) | PAR 18 543

Opportunity Information: Apply for PAR 18 543

The CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR, clinical trial optional) is a National Institutes of Health funding opportunity designed to move a biologic therapy from an already-identified lead candidate into the set of studies needed to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration. It is aimed specifically at disorders that fall under the mission of the National Institute of Neurological Disorders and Stroke (NINDS), meaning applicants need to be developing treatments for neurological conditions within that scope. The program focuses on therapeutic biotechnology products and biologics, including (but not limited to) peptides, proteins, oligonucleotides, gene therapies, cell therapies, and other emerging therapeutic modalities.

A key expectation of this track is that applicants are not starting from scratch. To be appropriate for this FOA, the project needs to begin with a defined clinical candidate that already shows properties consistent with eventual use in patients. In practical terms, that means the candidate should have convincing bioactivity and a rationale for how it will work, along with supporting evidence for characteristics that matter when transitioning into regulated development. The announcement emphasizes readiness features such as stability, manufacturability, and bioavailability, plus in vivo efficacy and/or target engagement data when relevant. In other words, the program is structured for teams that have progressed beyond early discovery and are prepared to do the formal, regulator-facing work that turns a promising molecule or therapy into something that can legally enter human testing in the United States.

The core work supported by the FOA is IND-enabling development. While the specific studies will depend on the modality and indication, IND-enabling packages commonly include activities like establishing or scaling manufacturing approaches, setting product specifications, developing analytical assays, conducting formulation and stability work, and completing the preclinical safety and toxicology studies required for an IND submission. The intent is to fund the critical path items that reduce development risk and align the program with FDA expectations so that an IND can be submitted by the end of the award period. The stated milestone for a successful project is at least submission of an IND application to FDA, which signals that the program is outcome-driven and oriented around a clear regulatory deliverable.

In addition to preclinical development, the FOA allows an optional, small, delayed-onset first-in-human Phase I clinical trial. "Clinical trial optional" here means a company can propose a plan that includes a Phase I component, but it is not mandatory. The language about delayed onset indicates that clinical work is expected to occur only after key prerequisites are met (for example, manufacturing readiness, completion of required preclinical safety studies, and IND submission/clearance). This structure supports a realistic sequence: the award can carry a project through the regulatory gate and, if proposed and justified, into early human testing aimed at initial safety, tolerability, and possibly early pharmacology signals depending on the design.

From an administrative standpoint, this opportunity is an SBIR U44 cooperative agreement. SBIR indicates it is for small businesses, and the cooperative agreement mechanism generally implies substantial scientific or programmatic involvement by NIH staff compared with a standard grant. The listing identifies NIH as the agency and NINDS as the mission focus, with the activity category in health (CFDA 93.853). The opportunity number is PAR-18-543, and it was created on December 20, 2017, with an original closing date shown as May 7, 2021.

Eligibility is limited to small businesses, and there are specific restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, may be allowed in some cases. This distinction typically means the applicant organization itself must be U.S.-based and meet SBIR eligibility, but certain well-justified elements of the work might be performed abroad under NIH rules if they qualify as an allowable foreign component and are specifically approved.

Overall, the program is best understood as a translational, milestone-oriented bridge between a validated biologic clinical candidate and the point at which the therapy can enter the clinic under an IND, with the option to begin a tightly scoped Phase I study once the regulatory and development foundation is in place.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-12-20.
• 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 18 543

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