Biology-Inspired Dynamic Microphysiological System Approaches to Revolutionize Basic Research, Healthcare and Animal Welfare

The regular t⁴ workshops on biology-inspired microphysiological systems (MPS) have become a reliable benchmark for assessing fundamental scientific, industrial, and regulatory trends in the MPS field. The 2023 workshop participants concluded that MPS technology as used in academia has matured significantly, as evidenced by the steadily increasing number of high-quality research publications, but that broad industrial adoption of MPS has been slow. Academic research using MPS is primarily aimed at accurately recapitulating human biology in MPS-based organ models to enable breakthrough discoveries. Examples of these developments are summarized in the report. In addition, we focus on key challenges identified during the previous workshop. Bridging gaps between academia, regulators, and industry is addressed. We also comment on overcoming barriers to trust and acceptance of MPS-derived data - the latter being particularly important in a regulatory environment. The status of implementation of the recommendations detailed in the 2020 report was reviewed. It is concluded that communication between stakeholders has improved significantly, while the recommendations related to regulatory acceptance still need to be implemented. Participants noted that the remaining challenges for increased translation of these technologies into industrial use and regulatory decision-making will require further efforts on well-defined context of use qualifications, together with increased standardization. This will make MPS data more reliable and ultimately make these novel tools more economically sustainable. The long-term roadmap from the 2015 workshop was critically reviewed and updated. Recommendations for the next period and an outlook conclude the report.