Synopsis
Drug-induced liver injury (DILI) remains one of the most difficult safety challenges in drug development. Despite extensive preclinical testing, some drug candidates that appear safe in conventional models can still cause serious liver injury in patients, contributing to clinical-stage failures, regulatory setbacks, and post-market withdrawals. The major reason is simple: traditional preclinical models do not always reproduce the complex, human-specific biology that determines how the liver responds to a drug.
Emulate’s Human Liver-Chip was developed to help close that translational gap. In a landmark study evaluating 27 small molecule drugs with known clinical outcomes, the Liver-Chip identified DILI liabilities with 87% sensitivity and 100% specificity, including drugs associated with severe liver injury that had not been reliably predicted by animal testing.
That body of evidence has now reached an important regulatory milestone: Emulate recently submitted its Full Qualification Package to the FDA’s ISTAND program, advancing the Human Liver-Chip into the final stage of qualification as a Drug Development Tool for DILI assessment.
In this webinar, Daniel Levner, Ph.D., Chief Technology Officer at Emulate and lead author of the ISTAND application, will explain the scientific foundation behind the Liver-Chip, how it can complement existing approaches to liver safety assessment, and what FDA qualification could mean for drug developers seeking more human-relevant evidence earlier in development.
The webinar will also feature updated data from Emulate’s AVA™ Emulation System, demonstrating how Liver-Chip performance translates from the established Zoë® platform to an automated, higher-throughput format capable of supporting larger studies. As the Human Liver-Chip advances toward qualified Drug Development Tool status, researchers have an opportunity to incorporate the technology into their programs today, generating decision-grade, human-relevant data that can strengthen drug development decisions now and position teams for an evolving regulatory landscape.
Key Learning Points
- How the Human Liver-Chip models key aspects of liver physiology, including multicellular interactions, perfusion, and clinically relevant drug exposure.
- What the Liver-Chip’s predictive performance means for drug developers, including results demonstrating 87% sensitivity and 100% specificity across drugs with known clinical outcomes.
- How Liver-Chip data can strengthen safety decision-making, helping researchers identify liabilities earlier and generate additional human-relevant evidence alongside existing nonclinical approaches.
- How the science translates from Zoë to AVA, with updated data demonstrating consistent Liver-Chip performance in an automated, higher-throughput platform.
- Why now is the time to begin building Organ-Chip capabilities, as the Human Liver-Chip advances through the final stage of FDA qualification and the regulatory role of human-relevant methods continues to expand.
