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Building Confidence for Regulatory Decision Making With Immune-Competent Live Models

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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, including work accepted into the FDA ISTAND program, 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.

Attend this webinar to:
  • 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
Speakers
Greyscale Headshot of Emily Richardson, PhD
Emily Richardson, PhD
Biology Group Leader
CN Bio
Greyscale headshot of Justina Then
Justina Then, PhD
Senior Scientist
CN Bio
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