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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

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Integrating Liver-Chip data into pharmaceutical decision-making processes.

Daniel Levner¹, Lorna Ewart²

¹Chief Technology Officer, Emulate Inc, Boston, MA, USA.

Expert Opinion on Drug Discovery

|September 13, 2023

Summary

This summary is machine-generated.

Liver-Chip technology shows promise in reducing drug-induced liver injury (DILI) failures in clinical trials. New frameworks guide integrating Liver-Chip data for better drug development safety assessments.

Keywords:

Drug-induced liver injury Liver-Chip Organ-on-a-chip technology microphysiological systems patient safety preclinical safety assessment regulatory guidelines

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Area of Science:

Biotechnology
Drug Development
Toxicology

Background:

Drug-induced liver injury (DILI) poses significant risks, causing substantial drug withdrawal and clinical trial failures.
Current preclinical safety testing methods have limitations in accurately predicting DILI.
Liver-Chip technology offers a novel approach for enhanced DILI prediction.

Purpose of the Study:

To present decision-support frameworks for integrating Liver-Chip technology into drug development.
To guide drug developers and regulators on utilizing Liver-Chip data for DILI risk assessment.
To facilitate the adoption of Liver-Chip technology in preclinical safety testing.

Main Methods:

Performance assessment of the Emulate Liver-Chip for DILI prediction.
Development of a framework using quantitative Liver-Chip output for DILI severity analysis.
Integration of Liver-Chip data with traditional animal testing results for go/no-go decisions.

Main Results:

Liver-Chip technology demonstrates potential for accurate DILI prediction.
Quantitative Liver-Chip data enables nuanced risk analysis of DILI severity.
Integrated frameworks support informed decision-making throughout preclinical development.

Conclusions:

Liver-Chip technology can significantly reduce DILI-related failures in drug development.
Adoption of Liver-Chip technology is crucial for patient safety.
The proposed frameworks facilitate the incorporation of Liver-Chip data into drug safety assessment processes.