Failure in late stages of the drug development pipeline is one of the major challenges the pharmaceutical industry faces today. Human organ-on-a-chip (Organ-Chip) technology has the potential to disrupt preclinical drug discovery, as it has been shown to recapitulate organ-level pathophysiology and clinical responses. Additionally, industrial guidelines have been published that describe the criteria for qualifying preclinical models for a particular use application; however, systematic and quantitative evaluation of Organ-Chips’ predictive value has not been conducted to date. To explore how this challenge might be approached, 780 human Liver-Chips were analyzed to determine their ability to predict drug-induced liver injury caused by small molecules. Across a blinded set of 27 known hepatotoxic and non-toxic drugs, the Liver-Chip demonstrated a sensitivity of 87% and a specificity of 100%. A computational economic value analysis suggests that, with this performance, the Liver-Chip could generate $3 billion per year to small-molecule drug development by driving an increase in research and development productivity.
In this webinar, we discussed:
- Why preclinical models with greater predictive validity will improve clinical success and productivity
- How the Emulate Liver-Chip performed against the IQ MPS guidelines
- How the Emulate Liver-Chip compared to animal models and hepatic spheroids
- What the economic impact of the Liver-Chip in routine use of small-molecule liver toxicity could be
- Where the Emulate Liver-Chip can be implemented into the drug development process
A preprint of this study is currently available on BioRXiv: LE. 2022. Qualifying a human Liver-Chip for predictive toxicology: Performance assessment and economic implications. bioRxivdoi: https://doi.org/10.1101/2021.12.14.472674