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


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.

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How to Cite
Marx, U., Akabane, T., Andersson, T., Baker, E., Beilmann, M., Beken, S., Brendler-Schwaab, S., Cirit, M., David, R., Dehne, E.-M., Durieux, I., Ewart, L., Fitzpatrick, S., Frey, O., Fuchs, F., Griffith, L., Hamilton, G., Hartung, T., Hoeng, J., Hogberg, H., Hughes, D., Ingber, D., Iskandar, A., Kanamori, T., Kojima, H., Kuehnl, J., Leist, M., Li, B., Loskill, P., Mendrick, D., Neumann, T., Pallocca, G., Rusyn, I., Smirnova, L., Steger-Hartmann, T., Tagle, D., 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. doi: 10.14573/altex.2001241.
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