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

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.