04407nas a2200565   4500000000100000000000100001008004100002260001500043653001700058653003800075653002100113653002000134653001600154653001400170653002600184653001500210100001300225700001600238700001600254700002000270700001600290700001600306700002700322700002200349700001500371700001900386700001800405700002100423700001900444700001800463700001700481700001500498700002200513700002100535700001700556700001900573700001800592700002000610700002000630700002500650700003600675700002500711700001600736245012900752856005600881300001200937490000700949520287100956022001403827       2025                            d  c2025-04-1510adigital twin10adynamic microphysiological system10amulti-organ chip10aorgan-on-a-chip10aorganismoid10aorganoids10aregulatory acceptance10aValidation1 aUwe Marx1 aSonja Beken1 aZaozao Chen1 aEva-Maria Dehne1 aAnn Doherty1 aLorna Ewart1 aSuzanne C. Fitzpatrick1 aLinda G. Griffith1 aZhongze Gu1 aThomas Hartung1 aJames Hickman1 aDonald E. Ingber1 aSeiichi Ishida1 aJayoung Jeong1 aMarcel Leist1 aLisa Levin1 aDonna L. Mendrick1 aGiorgia Pallocca1 aStefan Platz1 aMarian Raschke1 aLena Smirnova1 aDanilo A. Tagle1 aMartin Trapecar1 aBas W. M. van Balkom1 aJanny van den Eijnden-van Raaij1 aAndries van der Meer1 aAdrian Roth00aBiology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare  uhttps://altex.org/index.php/altex/article/view/2869  a204-2230 v423 aThe 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.  a1868-8551