@article{2566,
  keywords = {Animal Testing Alternatives, animal welfare, Animals, Drug development, Drug Evaluation, Preclinical, Drug Industry, Humans, Lab-On-A-Chip Devices, Models, Biological, assay qualification, drug testing, iPSC-derived organoids, industrial adoption, microphysiological systems, multi-organ-chip, organ-on-chip, organoids, regulatory acceptance},
  author = {Uwe Marx and Takafumi Akabane and Tommy B. Andersson and Elizabeth Baker and Mario Beilmann and Sonja Beken and Susanne Brendler-Schwaab and Murat Cirit and Rhiannon David and Eva-Maria Dehne and Isabell Durieux and Lorna Ewart and Suzanne C. Fitzpatrick and Olivier Frey and Florian Fuchs and Linda G. Griffith and Geraldine A. Hamilton and Thomas Hartung and Julia Hoeng and Helena Hogberg and David J. Hughes and Donald E. Ingber and Anita Iskandar and Toshiyuki Kanamori and Hajime Kojima and Jochen Kuehnl and Marcel Leist and Bo Li and Peter Loskill and Donna L. Mendrick and Thomas Neumann and Giorgia Pallocca and Ivan Rusyn and Lena Smirnova and Thomas Steger-Hartmann and Danilo A. Tagle and Alexander Tonevitsky and Sergej Tsyb and Martin Trapecar and Bob van de Water and Janny van den Eijnden-van Raaij and Paul Vulto and Kengo Watanabe and Armin Wolf and Xiaobing Zhou and Adrian Roth},
  title = {Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development},
  abstract = {The first microfluidic microphysiological systems (MPS) entered the academic scene more than 15 years ago and were considered an enabling technology to human (patho)biology in vitro and, therefore, provide alternative approaches to laboratory animals in pharmaceutical drug development and academic research. Nowadays, the field generates more than a thousand scientific publications per year. Despite the MPS hype in academia and by platform providers, which says this technology is about to reshape the entire in vitro culture landscape in basic and applied research, MPS approaches have neither been widely adopted by the pharmaceutical industry yet nor reached regulated drug authorization processes at all. Here, 46 leading experts from all stakeholders - academia, MPS supplier industry, pharmaceutical and consumer products industries, and leading regulatory agencies - worldwide have analyzed existing challenges and hurdles along the MPS-based assay life cycle in a second workshop of this kind in June 2019. They identified that the level of qualification of MPS-based assays for a given context of use and a communication gap between stakeholders are the major challenges for industrial adoption by end-users. Finally, a regulatory acceptance dilemma exists against that background. This t4 report elaborates on these findings in detail and summarizes solutions how to overcome the roadblocks. It provides recommendations and a roadmap towards regulatory accepted MPS-based models and assays for patients' benefit and further laboratory animal reduction in drug development. Finally, experts highlighted the potential of MPS-based human disease models to feedback into laboratory animal replacement in basic life science research.},
  year = {2020},
  journal = {ALTEX},
  volume = {37},
  pages = {365-394},
  month = {2020},
  issn = {1868-8551},
  doi = {10.14573/altex.2001241},
  language = {eng},
}