Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development

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Uwe Marx
Takafumi Akabane
Tommy B. Andersson
Elizabeth Baker
Mario Beilmann
Sonja Beken
Susanne Brendler-Schwaab
Murat Cirit
Rhiannon David
Eva-Maria Dehne
Isabell Durieux
Lorna Ewart
Suzanne C. Fitzpatrick
Olivier Frey
Florian Fuchs
Linda G. Griffith
Geraldine A. Hamilton
Thomas Hartung
Julia Hoeng
Helena Hogberg
David J. Hughes
Donald E. Ingber
Anita Iskandar
Toshiyuki Kanamori
Hajime Kojima
Jochen Kuehnl
Marcel Leist
Bo Li
Peter Loskill
Donna L. Mendrick
Thomas Neumann
Giorgia Pallocca
Ivan Rusyn
Lena Smirnova
Thomas Steger-Hartmann
Danilo A. Tagle
Alexander Tonevitsky
Sergej Tsyb
Martin Trapecar
Bob van de Water
Janny van den Eijnden-van Raaij
Paul Vulto
Kengo Watanabe
Armin Wolf
Xiaobing Zhou
Adrian Roth

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.

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How to Cite
Marx, U., Akabane, T., Andersson, T. B., Baker, E., Beilmann, M., Beken, S., Brendler-Schwaab, S., Cirit, M., David, R., Dehne, E.-M., Durieux, I., Ewart, L., Fitzpatrick, S. C., Frey, O., Fuchs, F., Griffith, L. G., Hamilton, G. A., Hartung, T., Hoeng, J., Hogberg, H., Hughes, D. J., Ingber, D. E., Iskandar, A., Kanamori, T., Kojima, H., Kuehnl, J., Leist, M., Li, B., Loskill, P., Mendrick, D. L., Neumann, T., Pallocca, G., Rusyn, I., Smirnova, L., Steger-Hartmann, T., Tagle, D. A., Tonevitsky, A., Tsyb, S., Trapecar, M., van de Water, B., van den Eijnden-van Raaij, J., Vulto, P., Watanabe, K., Wolf, A., Zhou, X. and Roth, A. (2020) “Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development”, ALTEX - Alternatives to animal experimentation, 37(3), pp. 364-394. doi: 10.14573/altex.2001241.
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