Uwe Marx
TissUse GmbH, Berlin, Germany
Tommy B. Andersson
AstraZeneca, Cardiovascular and Metabolic Diseases, Innovative Medicines and Early Development Biotech Unit, Mölndal, Sweden; Section of Pharmacogenetics, Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden
Anthony Bahinski
Wyss Institute for Biologically Inspired Engineering at Harvard University, Boston, MA, 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
Flemming R. Cassee
National Institute for Public Health & the Environment, Bilthoven, The Netherlands; Institute for Risk Assessment Science, Utrecht University, The Netherlands
Murat Cirit
Massachusetts Institute of Technology, Cambridge, MA, USA
Mardas Daneshian
Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany
Susan Fitzpatrick
US Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA
Olivier Frey
ETH Zurich, Dept. Biosystems Science and Engineering, Bio Engineering Laboratory, Basel, Switzerland
Claudia Gaertner
microfluidic ChipShop GmbH, Jena, Germany
Christoph Giese
ProBioGen AG, Berlin, Germany
Linda Griffith
Massachusetts Institute of Technology, Cambridge, MA, USA
Thomas Hartung
Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany; Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
Minne B. Heringa
National Institute for Public Health & the Environment, Bilthoven, The Netherlands
Julia Hoeng
Philip Morris International R&D, Neuchâtel, Switzerland
Wim H. de Jong
National Institute for Public Health & the Environment, Bilthoven, The Netherlands
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
Andreas Luch
German Federal Institute for Risk Assessment, Department of Chemicals and Product Safety, Berlin, Germany
Ilka Maschmeyer
TissUse GmbH, Berlin, Germany
Dmitry Sakharov
Scientific Research Centre Bioclinicum, Moscow, Russia
Adrienne J. A. M. Sips
National Institute for Public Health & the Environment, Bilthoven, The Netherlands
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
National Center of Medical Radiological Research, Moscow, Russia
Tewes Tralau
German Federal Institute for Risk Assessment, Department of Chemicals and Product Safety, Berlin, Germany
Sergej Tsyb
Russian Ministry of Production and Trade, Moscow, Russia
Anja van de Stolpe
The Institute for Human Organ and Disease Model Technologies, Leiden, The Netherlands
Rob Vandebriel
National Institute for Public Health & the Environment, Bilthoven, The Netherlands
Paul Vulto
MIMETAS BV, Leiden, The Netherlands
Jufeng Wang
Chinese National Center for Safety Evaluation of Drugs, Beijing, China
Joachim Wiest
cellasys GmbH, Kronburg, Germany
Marleen Rodenburg
National Institute for Public Health & the Environment, Bilthoven, The Netherlands
Adrian Roth
F. Hoffmann-La Roche Ltd, Roche Innovation Centre Basel, Switzerland
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Abstract
The recent advent of microphysiological systems – microfluidic biomimetic devices that aspire to emulate the biology of human tissues, organs and circulation in vitro – promises to enable a global paradigm shift in drug development. An extraordinary US government initiative and various dedicated research programs in Europe and Asia recently have led to the first cutting-edge achievements of human single-organ and multi-organ engineering based on microphysiological systems. The expectation is that test systems established on this basis will model various disease stages and predict toxicity, immunogenicity, ADME profiles and treatment efficacy prior to clinical testing. Consequently, this technology could significantly affect the way drug substances are developed in the future. Furthermore, microphysiological system-based assays may revolutionize our current global programs of prioritization of hazard characterization for any new substances to be used, for example, in agriculture, food, ecosystems or cosmetics, thus replacing the use of laboratory animal models. Here, thirty-six experts from academia, industry and regulatory bodies present the results of an intensive workshop (held in June 2015, Berlin, Germany). They review the status quo of microphysiological systems available today against industry needs, and assess the broad variety of approaches with fit-for-purpose potential in the drug development cycle. Feasible technical solutions to reach the next levels of human biology in vitro are proposed. Furthermore, key organ-on-a-chip case studies as well as various national and international programs are highlighted. Finally, a roadmap into the future towards more predictive and regulatory-accepted substance testing on a global scale is outlined.
