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 MPS-based 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.
Highlights
1.1 Definitions and terminology Microphysiological systems (MPS) are microfluidic devices capable of emulating human biology in vitro at the smallest biologically acceptable scale, defined by purpose
Once a new model or assay is considered qualified by the FDA for a specific context of use, industry and other stakeholders can use it for the qualified purpose during product development, and FDA reviewers can be confident in applying it without needing to review the underlying supporting data again.”1 For the sake of simplicity, we have used the terms academia, MPS suppliers, end users and regulators for the four interested MPS stakeholder groups
Having a universal physiological template (UPT) with self-sustained organismal homeostasis opens up wide opportunities to replace animal testing in basic research, foster personalized therapies and shift the drug development paradigm, ethical principles should be followed to define the scope of a study and its specific context
Summary
1.1 Definitions and terminology Microphysiological systems (MPS) are microfluidic devices capable of emulating human (or any other animal species’) biology in vitro at the smallest biologically acceptable scale, defined by purpose. Once a new model or assay is considered qualified by the FDA for a specific context of use, industry and other stakeholders can use it for the qualified purpose during product development, and FDA reviewers can be confident in applying it without needing to review the underlying supporting data again.” For the sake of simplicity, we have used the terms academia, MPS suppliers, end users and regulators for the four interested MPS stakeholder groups. Of four elements: i) academic invention and model development, ii) tool creation and model qualification by supplier industries, iii) qualification of a fit-for-purpose assay and its adoption for candidate testing by pharmaceutical industries, and iv) regulatory acceptance of the predictive results of validated assays for a drug candidate for a specific context of use.
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