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

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.