@article{5516,
  keywords = {digital twin, dynamic microphysiological system, multi-organ chip, organ-on-a-chip, organismoid, organoids, regulatory acceptance, Validation},
  author = {Uwe Marx and Sonja Beken and Zaozao Chen and Eva-Maria Dehne and Ann Doherty and Lorna Ewart and Suzanne C. Fitzpatrick and Linda G. Griffith and Zhongze Gu and Thomas Hartung and James Hickman and Donald E. Ingber and Seiichi Ishida and Jayoung Jeong and Marcel Leist and Lisa Levin and Donna L. Mendrick and Giorgia Pallocca and Stefan Platz and Marian Raschke and Lena Smirnova and Danilo A. Tagle and Martin Trapecar and Bas W. M. van Balkom and Janny van den Eijnden-van Raaij and Andries van der Meer and Adrian Roth},
  title = {Biology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare},
  abstract = {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.
Plain language summary The regular t4 workshops on biology-inspired microphysiological systems (MPS) have become a reliable benchmark for assessing trends in the field. Participants at the 2023 workshop concluded that the technology as used in academia has matured significantly, but that broad industry adoption of MPS has been slow. The primary goal of academic research is to accurately recapitulate human biology in MPS-based organ models to enable breakthrough discoveries. Participants commented on overcoming barriers to trust and acceptance of MPS-derived data, the latter being particularly important in a regulatory environment. They reviewed the status of implementation of the recom­mendations detailed in the 2020 report and conclude that communication between stakeholders has improved significantly, while recommendations related to regulatory acceptance still need to be implemented. Participants highlighted the need for further qualification and standardization. The long-term roadmap from the 2015 workshop was updated. Recommendations for the next period conclude the report.},
  year = {2025},
  journal = {ALTEX - Alternatives to animal experimentation},
  volume = {42},
  pages = {204-223},
  month = {2025-04-15},
  issn = {1868-8551},
  url = {https://altex.org/index.php/altex/article/view/2869},
  doi = {10.14573/altex.2410112},
  language = {en},
}