04147nas a2200901   4500000000100000000000100001008004100002260000900043653003200052653001900084653001200103653002100115653003300136653001800169653001100187653002600198653002300224653002400247653001700271653002700288653002400315653003100339653002100370653001800391653001400409653002600423100001300449700002100462700002300483700002000506700001900526700001600545700002900561700001600590700001900606700002000625700002000645700001600665700002700681700001700708700001800725700002200743700002600765700001900791700001600810700001900826700002000845700002100865700001900886700002300905700001800928700001800946700001700964700001000981700001800991700002201009700001901031700002101050700001501071700001801086700002701104700002001131700002501151700001601176700002001192700002101212700003601233700001501269700001901284700001501303700001801318700001601336245011401352300001201466490000701478520174601485022001403231       2020                            d  c202010aAnimal Testing Alternatives10aanimal welfare10aAnimals10aDrug development10aDrug Evaluation, Preclinical10aDrug Industry10aHumans10aLab-On-A-Chip Devices10aModels, Biological10aassay qualification10adrug testing10aiPSC-derived organoids10aindustrial adoption10amicrophysiological systems10amulti-organ-chip10aorgan-on-chip10aorganoids10aregulatory acceptance1 aUwe Marx1 aTakafumi Akabane1 aTommy B. Andersson1 aElizabeth Baker1 aMario Beilmann1 aSonja Beken1 aSusanne Brendler-Schwaab1 aMurat Cirit1 aRhiannon David1 aEva-Maria Dehne1 aIsabell Durieux1 aLorna Ewart1 aSuzanne C. Fitzpatrick1 aOlivier Frey1 aFlorian Fuchs1 aLinda G. Griffith1 aGeraldine A. Hamilton1 aThomas Hartung1 aJulia Hoeng1 aHelena Hogberg1 aDavid J. Hughes1 aDonald E. Ingber1 aAnita Iskandar1 aToshiyuki Kanamori1 aHajime Kojima1 aJochen Kuehnl1 aMarcel Leist1 aBo Li1 aPeter Loskill1 aDonna L. Mendrick1 aThomas Neumann1 aGiorgia Pallocca1 aIvan Rusyn1 aLena Smirnova1 aThomas Steger-Hartmann1 aDanilo A. Tagle1 aAlexander Tonevitsky1 aSergej Tsyb1 aMartin Trapecar1 aBob van de Water1 aJanny van den Eijnden-van Raaij1 aPaul Vulto1 aKengo Watanabe1 aArmin Wolf1 aXiaobing Zhou1 aAdrian Roth00aBiology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development  a365-3940 v373 aThe 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.  a1868-8551