Workshop: From Research to Readiness

Advancing Research and Regulatory Acceptance of Microphysiological Systems for Infectious Disease Applications

May 31-June 1, 2023

Agenda (updated May 16)

Video from the workshop is available below.

While animal models can be useful in the study of infectious diseases, their susceptibility and manifestation of symptoms can differ substantially from humans. The emergence and global spread of COVID-19 underscores the need for human-based models of infection. NICEATM and partner organizations organized the Microphysiological Systems for COVID Research (MPSCoRe) working group to coordinate the use of microphysiological systems (MPS) to reduce animal use in studies of COVID-19 and other infectious diseases.

To support its continuing efforts to advance application of MPS in this area, MPSCoRe held a virtual workshop to facilitate discussion and collaboration about current regulatory approaches and to raise awareness of opportunities for accelerating the integration of MPS models in the regulatory framework. The workshop featured 14 presentations on MPS models for infectious disease research and where they are in terms of readiness as well as presentations from international regulators. Standardization of MPS models and demonstration of a model’s validity for a specific regulatory purpose were also identified as criteria for regulatory acceptance. Many presentations highlighted research applying MPS to improving evaluation of candidate drugs, highlighting their advantages over animal models in both evaluating safety and efficacy