SBIR FY27 BAA Topic 1: Development andRefinement ofComplex In VitroModels (CIVM) as New Approach Methodologies (NAMs)forInfectiousDiseaseProductDevelopment
Forecast New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $7,000,000 to $13,000,000
- Set-aside
- Total Small Business
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health (NIH) forecasts a new requirement under Topic 1 of its FY27 SBIR BAA to develop and refine complex in vitro models (CIVM) as New Approach Methodologies (NAMs) for infectious disease product development, with an estimated solicitation release date of May 1, 2027. Platforms must accurately model infectious diseases in humans to support drug development and related medical countermeasures in early to mid developmental stages, including pathogen testing, under a total small business set-aside in NAICS 541715. The forecast ties the work to NIH's establishment of the Office of Research Innovation, Validation, and Application, and the estimated award date is October 1, 2027.
The estimated award value range is $7 million to $13 million. Contracting Officer Callie Prassinos (callie.prassinos@nih.gov, +1 240-669-5155) and Candace Kerr (candace.kerr@nih.gov) are the listed points of contact, both at the National Institutes of Health.
Forecast text
The goal of this solicitation is to develop and/or refine New Approach Methodologies (NAMs) complex in vitro platform technologies that accurately model infectious diseases in humans for the purpose of supporting infectious disease product development.
If not approved, NIH will not be able to fulfill one of this Administration's priorities for Alternative testing models under the Unified Strategy for infectious disease research: "NIH is establishing the Office of Research Innovation, Validation, and Application under the Division of Program Coordination, Planning, and Strategic Initiatives, to develop, validate, and scale the use of human-biology-based new approach methodologies (NAMs) to complement animal models and enhance investigations. "
No other effort or service exists at NIH that is specifically leveraging small business interests and technology to develop NAM products that can support infectious disease research drug development and related medical countermeasures in early to mid developmental stages.
NIAID has previously invested billions of dollars over time developing small business technologies based on animal studies that are flawed or insufficient to mimic the human disease state. As such the NAMs field is lacking for drug development and infectious disease research.
Absence or significant delay in this work puts at risk these critical accomplishments in NAM technology that could be deployed or refined to support product development and testing efforts for infectious disease research and drug development. Most importantly, it risks that these novel platforms will not be developed or refined for uses such as pathogen testing which are not commonly shared in the NAMs community in drug discovery efforts and regulatory submissions. For this purpose, NIAID fills a unique gap at these early stages of business development compared to NIAID collaborations with multiple USG agencies including BARDA and FDA.
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