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Lorna C. Ewart, Athanasia P. Apostolou, Skyler A. Briggs, Christopher V. Carman, Jake T. Chaff, Anthony R. Heng, Sushma Jadalannagari, Jeshina Janardhanan, Kyung‐Jin Jang, Sannidhi R. Joshipura and 22 more
BACKGROUND: Conventional preclinical models often miss drug toxicities, meaning the harm these drugs pose to humans is only realized in clinical trials or when they make it to market. This has caused the pharmaceutical industry to waste considerable time and resources developing drugs destined to fail. Organ-on-a-Chip technology has the potential improve success in drug development pipelines, as it can recapitulate organ-level pathophysiology and clinical responses; however, systematic and quantitative evaluations of Organ-Chips' predictive value have not yet been reported. METHODS: 870 Liver-Chips were analyzed to determine their ability to predict drug-induced liver injury caused by small molecules identified as benchmarks by the Innovation and Quality consortium, who has published guidelines defining criteria for qualifying preclinical models. An economic analysis was also performed to measure the value Liver-Chips could offer if they were broadly adopted in supporting toxicity-related decisions as part of preclinical development workflows. RESULTS: Here, we show that the Liver-Chip met the qualification guidelines across a blinded set of 27 known hepatotoxic and non-toxic drugs with a sensitivity of 87% and a specificity of 100%. We also show that this level of performance could generate over $3 billion annually for the pharmaceutical industry through increased small-molecule R&D productivity. CONCLUSIONS: The results of this study show how incorporating predictive Organ-Chips into drug development workflows could substantially improve drug discovery and development, allowing manufacturers to bring safer, more effective medicines to market in less time and at lower costs.
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Ewart, L. C., Apostolou, A. P., Briggs, S. A., Carman, C. V., Chaff, J. T., Heng, A. R., Jadalannagari, S., Janardhanan, J., Jang, K., Joshipura, S. R., Kadam, M. M., Kanellias, M., Kujala, V. J., Kulkarni, G., Le, C. Y., Lucchesi, C., Manatakis, D. V., Maniar, K. K., Quinn, M. E., … Levner, D. (2022). Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Communications Medicine, 2(1), 154. https://doi.org/10.1038/s43856-022-00209-1
Ewart, Lorna C., et al. "Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology." Communications Medicine, vol. 2, no. 1, 2022, pp. 154, https://doi.org/10.1038/s43856-022-00209-1.
Ewart, Lorna C., Athanasia P. Apostolou, Skyler A. Briggs, Christopher V. Carman, Jake T. Chaff, Anthony R. Heng, Sushma Jadalannagari, et al. "Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology." Communications Medicine 2, no. 1 (2022): 154. https://doi.org/10.1038/s43856-022-00209-1.
Ewart L. C., Apostolou A. P., Briggs S. A. [и др.] Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology // Communications Medicine. — 2022. — Vol. 2, № 1. — P. 154. — URL: https://doi.org/10.1038/s43856-022-00209-1
@article{ewart2022performance,
title = {{Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology}},
author = {Lorna C. Ewart and Athanasia P. Apostolou and Skyler A. Briggs and Christopher V. Carman and Jake T. Chaff and Anthony R. Heng and Sushma Jadalannagari and Jeshina Janardhanan and Kyung‐Jin Jang and Sannidhi R. Joshipura and Mahika M. Kadam and Marianne Kanellias and Ville J. Kujala and Gauri Kulkarni and Christopher Y. Le and Carolina Lucchesi and Dimitris V. Manatakis and Kairav K. Maniar and Meaghan E. Quinn and Joseph S. Ravan and Ann Catherine Rizos and John F. K. Sauld and Josiah D. Sliz and William Tien-Street and Dennis Ramos Trinidad and James Velez and Max Wendell and Onyi Irrechukwu and Prathap Kumar S. Mahalingaiah and Donald E. Ingber and Jack W. Scannell and Daniel Levner},
journal = {Communications Medicine},
year = {2022},
volume = {2},
number = {1},
pages = {154},
doi = {10.1038/s43856-022-00209-1},
url = {https://doi.org/10.1038/s43856-022-00209-1}
}TY - JOUR AU - Ewart, Lorna C. AU - Apostolou, Athanasia P. AU - Briggs, Skyler A. AU - Carman, Christopher V. AU - Chaff, Jake T. AU - Heng, Anthony R. AU - Jadalannagari, Sushma AU - Janardhanan, Jeshina AU - Jang, Kyung‐Jin AU - Joshipura, Sannidhi R. AU - Kadam, Mahika M. AU - Kanellias, Marianne AU - Kujala, Ville J. AU - Kulkarni, Gauri AU - Le, Christopher Y. AU - Lucchesi, Carolina AU - Manatakis, Dimitris V. AU - Maniar, Kairav K. AU - Quinn, Meaghan E. AU - Ravan, Joseph S. AU - Rizos, Ann Catherine AU - Sauld, John F. K. AU - Sliz, Josiah D. AU - Tien-Street, William AU - Trinidad, Dennis Ramos AU - Velez, James AU - Wendell, Max AU - Irrechukwu, Onyi AU - Mahalingaiah, Prathap Kumar S. AU - Ingber, Donald E. AU - Scannell, Jack W. AU - Levner, Daniel TI - Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology JO - Communications Medicine VL - 2 IS - 1 SP - 154 PY - 2022 DA - 2022/12/06 DO - 10.1038/s43856-022-00209-1 UR - https://doi.org/10.1038/s43856-022-00209-1 ER -
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