TY - JOUR
KW - Animal Testing Alternatives
KW - animal welfare
KW - Animals
KW - Drug development
KW - Drug Evaluation, Preclinical
KW - Drug Industry
KW - Humans
KW - Lab-On-A-Chip Devices
KW - Models, Biological
KW - assay qualification
KW - drug testing
KW - iPSC-derived organoids
KW - industrial adoption
KW - microphysiological systems
KW - multi-organ-chip
KW - organ-on-chip
KW - organoids
KW - regulatory acceptance
AU - Uwe Marx
AU - Takafumi Akabane
AU - Tommy B. Andersson
AU - Elizabeth Baker
AU - Mario Beilmann
AU - Sonja Beken
AU - Susanne Brendler-Schwaab
AU - Murat Cirit
AU - Rhiannon David
AU - Eva-Maria Dehne
AU - Isabell Durieux
AU - Lorna Ewart
AU - Suzanne C. Fitzpatrick
AU - Olivier Frey
AU - Florian Fuchs
AU - Linda G. Griffith
AU - Geraldine A. Hamilton
AU - Thomas Hartung
AU - Julia Hoeng
AU - Helena Hogberg
AU - David J. Hughes
AU - Donald E. Ingber
AU - Anita Iskandar
AU - Toshiyuki Kanamori
AU - Hajime Kojima
AU - Jochen Kuehnl
AU - Marcel Leist
AU - Bo Li
AU - Peter Loskill
AU - Donna L. Mendrick
AU - Thomas Neumann
AU - Giorgia Pallocca
AU - Ivan Rusyn
AU - Lena Smirnova
AU - Thomas Steger-Hartmann
AU - Danilo A. Tagle
AU - Alexander Tonevitsky
AU - Sergej Tsyb
AU - Martin Trapecar
AU - Bob van de Water
AU - Janny van den Eijnden-van Raaij
AU - Paul Vulto
AU - Kengo Watanabe
AU - Armin Wolf
AU - Xiaobing Zhou
AU - Adrian Roth
AB - 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.
BT - ALTEX
DA - 2020
DO - 10.14573/altex.2001241
IS - 3
LA - eng
N2 - 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.
PY - 2020
SP - 365
EP - 394
T2 - ALTEX
TI - Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development
VL - 37
SN - 1868-8551
ER -