Introduction: Drug-induced liver injury (DILI) is a potentially lethal condition that heavily impacts the pharmaceutical industry, causing approximately 21% of drug withdrawals and 13% of clinical trial failures. Recent evidence suggests that the use of Liver-Chip technology in preclinical safety testing may significantly reduce DILI-related clinical trial failures and withdrawals. However, drug developers and regulators would benefit from guidance on the integration of Liver-Chip data into decision-making processes to facilitate the technology's adoption.
Areas covered: This perspective builds on the findings of the performance assessment of the Emulate Liver-Chip in the context of DILI prediction and introduces two new decision-support frameworks: the first uses the Liver-Chip's quantitative output to elucidate DILI severity and enable more nuanced risk analysis; the second integrates Liver-Chip data with standard animal testing results to help assess whether to progress a candidate drug into clinical trials.
Expert opinion: There is now strong evidence that Liver-Chip technology could significantly reduce the incidence of DILI in drug development. As this is a patient safety issue, it is imperative that developers and regulators explore the incorporation of the technology. The frameworks presented enable the integration of the Liver-Chip into various stages of preclinical development in support of safety assessment.
Keywords: Drug-induced liver injury; Liver-Chip; Organ-on-a-chip technology; microphysiological systems; patient safety; preclinical safety assessment; regulatory guidelines.