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

Webinar Series 9 Episode 2

Filed under: ADME, DILI, and Safety toxicology

S9E2 Thumbnail | regulatory confidence with immune-competent liver MPS

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 Learnings

How to build regulatory confidence with immune-competent liver MPS 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

View our Q&A document from the live event (coming soon…)

Webinar Transcript

Speaker

Emily USE THIS ONE | regulatory confidence with immune-competent liver MPS

Dr Emily Richardson

Biology Group Leader

Dr Emily Richardson is a Biology Group Leader at CN Bio, where she oversees the development and validation of microphysiological systems (MPS) for toxicology and safety assessment. She joined CN Bio in 2020 as a Senior Scientist and played a central role in creating the company’s Lung and Lung/Liver MPS models, advancing their use in infectious disease research and the evaluation of inhaled therapeutics.

Throughout her time at CN Bio, Dr Richardson has led multiple collaborative and grant funded programmes and acts as a key liaison across academic partners, pharmaceutical organisations, contract research organisations, regulatory bodies, and standardisation groups.

Her expertise sits at the intersection of complex cell biology and real world drug discovery, informed by industry experience in cellular therapeutics and specialism in complex in vitro modelling. She received her degree in Biochemistry and Molecular Medicine from the University of Nottingham and PhD from the University of Leicester, where she used 3D cell culture to uncover molecular mechanisms driving highly metastatic lung cancers – expertise that continues to shape her approach to developing more predictive and robust human relevant models today.
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    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.