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Building confidence for regulatory decision making with immune-competent liver models

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Discover how human liver models are building regulatory confidence in DILI risk assessment. How a continuously perfused, primary human Liver model, with immune-competent capabilities, can be leveraged to address a critical unmet need — capturing immune mediated toxicities associated with new drug modalities such as monoclonal antibodies (mAbs).

19 May 2026

08:00 (LA)| 10:00 (NY)| 15:00 (UK)

Virtual

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Evolving regulatory expectations are shifting how drug safety is assessed, with increasing focus on validated, human-relevant approaches that can support decision-making.

This webinar explores how liver microphysiological systems (MPS) are being benchmarked through cross-platform studies to build regulatory confidence in drug-induced liver injury (DILI) assessment. It also introduces emerging immune-competent models designed to address a key gap in predicting immune-mediated toxicity for newer therapies. Attendees will gain insight into how these advances are shaping regulatory acceptance and enabling more predictive, mechanism-driven safety evaluation.

Key Learning on how to build confidence for regulatory decision making with immune-competent liver models

• Understand how evolving regulatory expectations are shaping the adoption of human-relevant liver models
• Learn how cross-platform benchmarking is helping establish confidence in liver toxicity prediction
• Explore how advanced liver systems deliver more predictive, clinically relevant safety insights
• Discover how emerging models can uncover immune-mediated toxicity missed by traditional approaches

About the Presenter:

Dr. Emily Richardson

Biology Group Leader

Dr. Emily Richardson is driving development of MPS for toxicology and safety assessment. She led the development of CN Bio’s Lung and Lung/Liver models for infectious disease research and inhaled therapeutics, and spearheaded multiple other collaborative and grant-funded programmes, published peer-reviewed papers, and contributed to advancing regulatory acceptance of Organ-on-a-chip.
Her work bridges complex cell biology and real-world drug discovery, informed by a PhD from the University of Leicester in 3D cell culture for metastatic lung cancer and a BSc in Biochemistry and Molecular Medicine degree from the University of Nottingham.

Dr. Justina Then

Senior Scientist

Dr. Justina Then is a senior scientist at CN Bio, focusing on liver toxicology within the R&D team. Her academic foundation includes a PhD in experimental medicine and rheumatology and postdoctoral work at the William Harvey Research Institute (QMUL), where she spent her time investigating the potential of nanotechnology for drug development in rheumatoid arthritis and synovial fibroblasts.
With nine years in academia and three years in industry, she brings a wealth of expertise to advancing biological research and practical applications.