National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Award Program - Fiscal Year 2025
Contract Overview
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The National Cancer Institute is seeking proposals from small business concerns to develop transformative technologies, including therapeutics, preventatives, diagnostics, and digital health tools, specifically targeting pediatric and rare cancers. This initiative focuses on rare cancers with a five-year survival rate below 50 percent and requires a clear development path toward a specific product, supported by a sound scientific premise. Beyond technical proof-of-concept and de-risking experiments, awardees must develop commercialization plans and enhance their entrepreneurship skills. This Concept Award program is designed to serve as a pipeline for the federal Small Business Innovation Research program. The current contract, held by Cloverleaf Bio, Inc. with a value of 355,000 dollars, is projected to end on September 14, 2026. There is a high confidence level that this will result in a full recompete under a firm fixed price structure. The opportunity is designated as a total small business set-aside and will be conducted via full and open competition after the exclusion of sources. Managed by the Department of Health and Human Services, the solicitation falls under NAICS code 541715.
General Info
Place of Performance
MD, 065112690, USASet-Aside
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Organization & Contact Information
Full Description
Current Contract: 75N91025C00020 Incumbent: CLOVERLEAF BIO, INC. Contract Value: $355,000 Potential End Date: 2026-09-14T00:00:00.000Z Competition: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES Pricing: FIRM FIXED PRICE Classification: full-recompete (Confidence: high - 90/100)
The National Cancer Institute is soliciting proposals from small business concerns to perform key activities to demonstrate technical feasibility and proof-of-concept for the development of highly innovative and potentially transformative technologies in the following areas: Development of therapeutic or preventative technologies for treatment or prevention of Pediatric Cancers and/or Rare Cancers. Development of devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis of Pediatric Cancers and/or Rare Cancers. For this solicitation rare cancers with a 5-year survival rate of less than 50 % are encouraged and rare cancers would be defined as including all the cancers listed by the NIH Genetics and Rare Diseases Information Center. The list can be found here: https://rarediseases.info.nih.gov/search-result?category=Cancer. Access the NCI Surveillance, Epidemiology, and End Results Program (SEER) database (https://seer.cancer.gov/) for more information regarding 5-year cancer survival rates. Preliminary data is not required; however, the ideas should have sound scientific premise either based on the offeror's own research or literature evidence. Proposals will need to identify an anticipated product that will be developed and clearly lay out the anticipated development path. Proposals will need to clearly identify the clinical problem and cancer type(s) that the proposal will focus on with adequate justification. In addition, the offerors should propose experiments to obtain initial de-risking and proof-of-concept data. Awards will also include requirements to enhance entrepreneurship skills and to develop or refine a business model and commercialization plan. This solicitation is a Concept Award program that could serve as a pipeline for the federal Small Business Innovation Research (SBIR) program. Background for the SBIR program can be found in the Small Business Administration's policy directive found here: https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf
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