Biology-inspired microphysiological systems to advance medicines for patient benefit and animal welfare.
Biology-inspired microphysiological systems to advance medicines for patient benefit and animal welfare.
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受生物学启发的微生理系统可促进患者利益和动物福利的药物发展。
DOI：
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
A. Roth
中科院分区：
文献类型：
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作者：
U. Marx;T. Akabane;T. Andersson;Elizabeth Baker;M. Beilmann;S. Beken;S. Brendler;M. Cirit;Rhiannon David;Eva;Isabell Durieux;L. Ewart;S. Fitzpatrick;O. Frey;Florian Fuchs;L. Griffith;G. Hamilton;T. Hartung;J. Hoeng;H. Hogberg;D. Hughes;D. Ingber;A. Iskandar;T. Kanamori;H. Kojima;Jochen Kuehnl;M. Leist;Bo Li;P. Loskill;D. Mendrick;T. Neumann;G. Pallocca;I. Rusyn;Lena Smirnova;T. Steger;D. Tagle;A. Tonevitsky;Sergej Tsyb;M. Trapecar;B. van de Water;J. van den Eijnden;P. Vulto;Kengo Watanabe;A. Wolf;Xiao;A. Roth
第一个微流控微生理系统（MPS）在15年前进入学术界，被认为是体外人类（病理）生物学的一种使能技术，因此为药物开发和学术研究中的实验室动物提供了替代方法。如今，该领域每年产生一千多份科学出版物。尽管MPS在学术界和平台提供商中大肆宣传，称这项技术即将重塑基础和应用研究中的整个体外培养景观，但MPS方法尚未被制药行业广泛采用，也没有达到受监管的药物授权流程。在2019年6月举行的第二次此类研讨会上，来自全球所有利益相关者（学术界、MPS供应商行业、制药和消费品行业以及领先的监管机构）的46位领先专家分析了基于MPS的检测生命周期沿着的现有挑战和障碍。他们发现，特定使用环境下基于MPS的测定的资格水平以及利益相关者之间的沟通差距是最终用户在工业上采用的主要挑战。最后，在这种背景下，存在着监管接受的困境。这份t4报告详细阐述了这些发现，并总结了如何克服障碍的解决方案。它为监管机构接受的基于MPS的模型和测定提供了建议和路线图，以造福患者并进一步减少药物开发中的实验室动物。最后，专家们强调了基于MPS的人类疾病模型反馈到基础生命科学研究中实验室动物替代的潜力。
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.