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
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