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Translational Centers Using Microphysiological Systems for Infectious Diseases (U54 Clinical Trial Not Allowed)

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RFA-AI-28-012Grant

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The National Institute of Allergy and Infectious Diseases, under the National Institutes of Health, is soliciting proposals for the Translational Centers Using Microphysiological Systems for Infectious Diseases under solicitation number RFA-AI-28-012. This initiative aims to establish a consortium of centers focused on refining and validating human tissue models to study infectious diseases and test medical interventions. By leveraging New Approach Methodologies, the program seeks to create in vitro systems that capture human variability and patient-specific characteristics, ultimately accelerating the development of safer treatments while reducing costs and the reliance on laboratory animals. The primary objective is to advance these microphysiological systems to a level of regulatory qualification that encourages adoption by product developers and ensures regulatory acceptance. Interested parties must submit their responses by the deadline of January 30, 2027. This federal opportunity specifically focuses on bridging the gap between current research and regulatory use for infectious disease models, though it is noted that clinical trials are not allowed under this specific funding mechanism.

General Info

NIAID seeks proposals for infectious disease microphysiological systems centers by January 30, 2027.

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Organization & Contact Information

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AgencyNational Institutes Of Health → National Institute Of Allergy And Infectious Diseases
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OfficeUSA
Office AddressUSA
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Full Description

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The purpose of this notice of funding opportunity (NOFO) is to support a consortium of Translational Centers using Microphysiological Systems (MPS) for Infectious Diseases (TCMID). Recent efforts in the MPS fields are moving towards validation and regulatory use but have not focused upon models studying infectious diseases and testing of medical interventions. The NIH and FDA have recently issued guidance and established initiatives for enhancing use of New Approach Methodologies (NAMs) in research and product development. This includes in vitro systems that allow scientists to model human disease and capture human variability and patient-specific characteristics that will accelerate safer treatments for patients while reducing costs and sparing use of laboratory animals. To meet this need, the Centers will refine well validated human tissue models studying infectious diseases to a level consistent with regulatory qualifications that will promote their adoption for use by product developers, supporting regulatory acceptance.

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The National Institute of Allergy and Infectious Diseases (NIAID) has issued solicitation RFA-AI-28-012 to establish a consortium of Translational Centers Using Microphysiological Systems for Infectious Diseases (TCMID). The primary objective is to refine and validate human tissue models using Microphysiological Systems (MPS) to a level consistent with regulatory qualifications, thereby promoting their adoption by product developers and reducing reliance on laboratory animals. This initiative aligns with NIH and FDA guidance on New Approach Methodologies (NAMs) to accelerate the development of safer medical interventions by capturing human variability and patient-specific characteristics. The program is structured around an Administrative Core, a Qualification Core, and Scientific Cores, with a heavy emphasis on technical readiness, reproducibility, and regulatory acceptance. Key deliverables include the validation of assays for specific endpoints and the submission of regulatory packages. Applicants must be domestic entities, as foreign organizations and foreign subawards are strictly prohibited. Required personnel must possess deep expertise in infectious diseases, MPS platforms, bioinformatics, and FDA submission processes. Applications are due by January 29, 2027, and must be submitted via the NIH ASSIST system or approved institutional system-to-system solutions. Evaluation is based on an overall impact score considering the project's significance, the suitability of the investigators, and the quality of the institutional environment. Mandatory application components include a Data Management and Sharing Plan and a Benchmarks and Timeline PDF not exceeding six pages. Awardees must also adhere to strict cybersecurity incident reporting guidelines, notifying HHS within 48 hours of any discovery.
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