Uwe Marx
TissUse GmbH, Berlin, Germany; Technische Universitaet Berlin, Germany
Takafumi Akabane
Stem Cell Evaluation Technology Research Association, Tokyo, Japan
Tommy B. Andersson
DMPK, Research and Early Development Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Elizabeth Baker
Physicians Committee for Responsible Medicine, Washington DC, USA
Mario Beilmann
Boehringer Ingelheim Pharma GmbH & Co. KG, Non-clinical Drug Safety, Biberach, Germany
Sonja Beken
Federal Agency for Medicines and Health Products, Brussels, Belgium
Susanne Brendler-Schwaab
BfArM, Bonn, Germany
Murat Cirit
Javelin Biotech, Inc, Woburn, MA, USA
Rhiannon David
Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK
Eva-Maria Dehne
TissUse GmbH, Berlin, Germany
Isabell Durieux
TissUse GmbH, Berlin, Germany
Lorna Ewart
Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK
Suzanne C. Fitzpatrick
US Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA
Olivier Frey
InSphero, Schlieren, Switzerland
Florian Fuchs
Novartis Institutes for BioMedical Research Chemical Biology & Therapeutics, Basel, Switzerland
Linda G. Griffith
Massachusetts Institute of Technology, Cambridge, MA, USA
Geraldine A. Hamilton
Emulate Inc., Boston, USA
Thomas Hartung
Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany; AxoSim, Inc., New Orleans, LA, USA
Julia Hoeng
Philip Morris International R&D, Neuchâtel, Switzerland
Helena Hogberg
Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
David J. Hughes
CN Bio Innovations Ltd., Welwyn Garden City, UK
Donald E. Ingber
Wyss Institute for Biology Inspired Engineering, Harvard University, Boston, USA
Anita Iskandar
Philip Morris International R&D, Neuchâtel, Switzerland
Toshiyuki Kanamori
National Institute of Advanced Industrial Science and Technology (AIST), Tokyo, Japan
Hajime Kojima
Japanese Center for Validation of Animal Methods, Tokyo, Japan
Jochen Kuehnl
Beiersdorf, Hamburg, Germany
Marcel Leist
Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany
Bo Li
National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing, P.R. China
Peter Loskill
Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Stuttgart, Germany; Faculty of Medicine, Eberhard Karls University Tübingen, Tübingen, Germany
Donna L. Mendrick
National Center for Toxicological Research, FDA, Silver Spring, MD, USA
Thomas Neumann
Nortis Inc., Seattle WA, USA
Giorgia Pallocca
CAAT-Europe at the University of Konstanz
Ivan Rusyn
Texas A&M University, College Station, TX, USA
Lena Smirnova
Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
Thomas Steger-Hartmann
Bayer, Investigational Toxicology, Berlin, Germany
Danilo A. Tagle
National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA
Alexander Tonevitsky
M.M. Shemyakin & Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, Russia; National Research University Higher School of Economics, Russia
Sergej Tsyb
Russian Ministry of Production and Trade, Moscow, Russia
Martin Trapecar
Massachusetts Institute of Technology, Cambridge, MA, USA
Bob van de Water
Universiteit Leiden, Leiden, The Netherlands
Janny van den Eijnden-van Raaij
Institute for Human Organ and Disease Model Technologies, Eindhoven, The Netherlands
Paul Vulto
MIMETAS BV, Leiden, The Netherlands
Kengo Watanabe
Daiichi Sankyo Co., Ltd., Tokyo, Japan
Armin Wolf
InSphero, Schlieren, Switzerland
Xiaobing Zhou
National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing, P.R. China
Adrian Roth
F. Hoffmann-La Roche Ltd, Roche Innovation Center Basel, Switzerland
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Abstract
The first microfluidic microphysiological systems (MPS) entered the academic scene more than 15 years ago and were considered an enabling technology to human in vitro (patho)biology and, therefore, to provide alternative approaches to laboratory animals in pharmaceutical drug development and academic research. Currently, the field generates more than a thousand scientific publications per year. Despite the MPS hype in academia and by platform providers, which say this technology is about to reshape the entire in vitro culture landscape in basic and applied research, MPS approaches neither have been widely adopted by the pharmaceutical industry yet nor have they reached regulated drug authorization processes.
Here, 46 leading international experts from all stakeholder groups – academia, MPS supplier industry, pharmaceutical and consumer products industries, and leading regulatory agencies – analyzed challenges and hurdles along the MPSbased assay life cycle in the second workshop of its kind in June 2019. The main findings were that the level of qualification of MPS-based assays for a given context of use and communication gaps between stakeholders are the major challenges slowing industrial adoption by end users, which in turn is causing a regulatory acceptance dilemma. This report elaborates on these findings and proposes solutions by providing recommendations and a roadmap towards regulatory acceptance of MPS-based models, which will benefit patients and further reduce laboratory animal use in drug development. Finally, the potential of MPS-based human disease models to feed back into laboratory animal replacement in basic life science research is discussed.
