Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective

Abstract

Tissue chips are poised to deliver a paradigm shift in drug discovery. By emulating human physiology, these chips have the potential to increase the predictive power of preclinical modeling, which in turn will move the pharmaceutical industry closer to its aspiration of clinically relevant and ultimately animal-free drug discovery. Despite the tremendous science and innovation invested in these tissue chips, significant challenges remain to be addressed to enable their routine adoption into the industrial laboratory. This article describes the main steps that need to be taken and highlights key considerations in order to transform tissue chip technology from the hands of the innovators into those of the industrial scientists. Written by scientists from 13 pharmaceutical companies and partners at the National Institutes of Health, this article uniquely captures a consensus view on the progression strategy to facilitate and accelerate the adoption of this valuable technology. It concludes that success will be delivered by a partnership approach as well as a deep understanding of the context within which these chips will actually be used. Impact statement The rapid pace of scientific innovation in the tissue chip (TC) field requires a cohesive partnership between innovators and end users. Near term uptake of these human-relevant platforms will fill gaps in current capabilities for assessing important properties of disposition, efficacy and safety liabilities. Similarly, these platforms could support mechanistic studies which aim to resolve challenges later in development (e.g. assessing the human relevance of a liability identified in animal studies). Building confidence that novel capabilities of TCs can address real world challenges while they themselves are being developed will accelerate their application in the discovery and development of innovative medicines. This article outlines a strategic roadmap to unite innovators and end users thus making implementation smooth and rapid. With the collective contributions from multiple international pharmaceutical companies and partners at National Institutes of Health, this article should serve as an invaluable resource to the multi-disciplinary field of TC development.

Applications of the microphysiology systems database for experimental ADME-Tox and disease models

“…Though the model used here is a microfluidic human liver model, the MPS-Db can capture and aggregate quantitative data from any MPS experimental model, ranging from static microplate models to integrated, multi-organ microfluidic models, as well as MPS that model animal systems. The importance of species-specific MPS is recognized in the field, 46 and the MPS-Db is able to accommodate data from these models as well. The MPS-Db continues to evolve to meet the needs of the users, and we encourage users to provide feedback on the current functionality and what functionality would be useful.…”

Improved Ocular Tissue Models and Eye-On-A-Chip Technologies Will Facilitate Ophthalmic Drug Development

“…This working group has now been transformed into an Affiliate group, reflecting the growing interest from pharmaceutical industry tissue chip end-users. 38 There are other institutes leveraging the progress of the NCATS tissue-on-a-chip efforts. To stimulate basic research to develop next-generation human cell-derived MPS that more closely recapitulates the cornea, lens, retina, RPE, and/or elements of the central visual pathway, the NEI has joined 4 other institutes to support a funding opportunity announcement for ''Engineering Next-Generation Human Nervous System Microphysiological Systems'' (https:// grants.nih.gov/grants/guide/pa-files/PAR-16-398.html).…”

Tissue chips – innovative tools for drug development and disease modeling

“…To begin this early translational and face validity testing, the National Center for Advancing Translational Sciences at the National Institutes of Health in the US is currently funding a Tissue Chip Testing Centers initiative, for tissue chip developers funded under a larger Tissue Chip for Drug Screening program. The creation of centralized testing centers, in partnership with the US Food and Drug Administration (FDA) and the IQ Consortium (a group of pharmaceutical industry representatives), will allow broader testing of chip capability 98 . Throughput capabilities of platforms can be independently assessed, producing realistic readouts of intra- and inter-laboratory reproducibility, and collating and integrating operating procedures and processes for wider use.…”