SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional) | RFA CA 23 034

Opportunity Information: Apply for RFA CA 23 034

The SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44, Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity from the National Cancer Institute (NCI) designed to help small businesses move cancer-focused innovations past the SBIR/STTR Phase II stage and into real-world commercialization. The intent is to provide additional, targeted support for the next development steps that often require substantial resources, clear regulatory planning, manufacturing readiness, clinical validation, or other late-stage activities that can be difficult to finance with public funding alone. While the award is structured as an SBIR grant (Funding Opportunity Number RFA-CA-23-034; CFDA 93.394 and 93.395), the central goal is practical: reduce the gap between a promising Phase II result and a product or service that can be launched, adopted, and sustained in the market to improve cancer prevention, diagnosis, treatment, or related care.

This NOFO is specifically geared toward small business concerns (SBCs) that already hold a prior SBIR or STTR Phase II award from any federal agency, and now need additional funding to complete the capital-intensive work that makes commercialization possible. It is not meant for brand-new concepts or early feasibility alone; it is meant for projects with a credible foundation from Phase II and a defined development path that leads to a commercial endpoint. Proposed work can cover either preclinical or clinical stages of development depending on what is appropriate for the technology and the remaining risk. Clinical trials are allowed but not mandatory, meaning applicants can propose studies involving human subjects when justified, but they can also focus on preclinical validation, engineering, scale-up, regulatory preparation, or other non-trial milestones if those are the key barriers to commercialization.

A defining feature of the Phase IIB Bridge Award is the emphasis on partnerships and private-sector commitment. NCI expects applicants to bring in independent third-party funding from investors and/or strategic partners (for example, venture investors, corporate partners, foundations that qualify as third-party funders, or other non-federal sources), and the application must include a Commercialization Plan describing how the project will be financed and brought to market. The plan should explain the business case, market need, competitive landscape, intellectual property strategy, regulatory and reimbursement considerations when relevant, manufacturing and quality planning, and a realistic route to revenue and adoption. Importantly, the NOFO states an expectation that third-party funding during the project period will be equal to or greater than the NCI funds requested, effectively making this a matching or leveraging mechanism intended to ensure that the project has market validation and sufficient capital to complete the final steps toward launch.

Eligibility is limited to U.S. small businesses; non-U.S. (foreign) institutions cannot apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components may be allowed in certain cases as defined under the NIH Grants Policy Statement, which generally means a project may include some foreign involvement if it is clearly justified and permitted under NIH policy, but the applicant organization itself must be an eligible U.S. small business. The funding instrument is a grant under the SBIR program, and the activity category is listed under education and health, reflecting NIH program classifications rather than limiting the technical scope to educational projects.

Key administrative details provided in the source include an original closing date of 2023-08-21 and a creation date of 2023-04-21. The opportunity listing does not specify an award ceiling or the expected number of awards in the provided fields, so applicants would need to confirm budget limits, project period, and award volume directly in the full NOFO text. Overall, this program is best understood as an NCI commercialization accelerator for SBIR/STTR Phase II graduates: it funds the final development stretch while pushing companies to secure substantial outside capital and to present a concrete, investor-aligned commercialization plan that demonstrates a credible path to market impact in oncology.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
• This funding opportunity was created on 2023-04-21.
• Applicants must submit their applications by 2023-08-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA CA 23 034

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