Biology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare

The regular workshops held by the Center for Alternatives to Animal Testing (CAAT) on biology-inspired microphysiological systems (MPS) taking place every four years, have become a reliable measure to assess fundamental scientific, industrial and regulatory trends for translational science in the MPS-field from a bird's eye view. The 2023 workshop participants at that time concluded that the technology as used within academia has matured significantly, underlined by the broad use of MPS and the steadily increasing number of high quality research publications - yet, broad industry adoption of MPS has been slow, despite strong interest. Academic research using MPS primarily aims to accurately recapitulate human biology in MPS-based organ models in areas where traditional models have been lacking key elements of human physiology, thereby enabling breakthrough discoveries for life sciences. Examples of these developments are summarized in the report presented here. In addition, we focus on key challenges identified during the previous workshop around progress made in bridging gaps between stakeholders between academia, regulatory agencies and industry on one hand, as well as overcoming hurdles to gain confidence in, and acceptance of MPS-derived data - the latter being of particular importance in a regulatory environment. The status of implementation of the recommendations detailed in the 2019 report have been reviewed. We conclude that communication between stakeholders has improved significantly, while recommendations related to regulatory acceptance still need to be implemented. Participants noted that the remaining challenges for increased translation of these technologies to industrial use and regulatory decision-making will not be fully solvable by basic academic research alone. Rather, more efforts into well-defined context-of-use qualifications are needed, together with increased standardization making MPS data more reliable and ultimately these novel tools economically more sustainable. The long-term roadmap from the 2015 workshop has been critically reviewed and updated. Recommendations for the next period and an outlook conclude the report.