Emulate Validates Organ-on-a-Chip Technology for Predictive Toxicology in Preclinical Drug Development

12.07.22. Boston-based biotech company Emulate, published a first-of-its-kind predictive study demonstrating the superior capability of their human cell-based Liver-Chip technology at predicting drug-induced liver toxicity in preclinical studies relative to animal models. Researchers assessed the performance of 870 Emulate human Liver-Chips on 27 known hepatotoxic and non-toxic drugs. The Liver-Chip was able to correctly identify 87% of the tested drugs that caused drug-induced liver injury in human patients despite passing preclinical animal testing studies.

Government agencies funding drug development have a responsibility to the public and to research scientists to expand the regulatory options for testing safety and efficacy of drugs to include non-animal approaches, and to prioritize public funding to develop and improve these methods to eventually replace animal models. At the present time, application of non-animal models in biomedical research and product testing is limited, and being conducted primarily in conjunction with animal studies, where data are comparatively evaluated for predictability and validity. Given the extremely low translatability of most animal models to human drug trials, the high cost of using animals in research, and the needless suffering they endure, it is time to accelerate the transition to non-animal models through investment, education, and advocacy. The Aisling Center is advocating for the passage of the FDA Modernization Act 2.0, which will be a key step toward this end.