Bio: Dr. Eunice Musvasva is currently head of Translational Safety Assessment, Roche Pharma Research & Early Development. She currently leads regulatory toxicology project team members in defining and implementation of the nonclinical safety strategies for drug development approaches across multiple therapeutic areas and multiple modalities. She obtained PhD in Toxicology at Northeastern University, Boston MA.
Abstract: Transgenic animal models have transformed safety assessment by enabling genetic modifications that mimic human biological responses. By incorporating or altering human genes, these models more accurately replicate human metabolic processes and immune responses, improving predictions of drug toxicity and safety. This is especially important for novel therapeutics like biologics and gene therapies, where traditional models may not suffice due to lack of cross-reactivity. These models help identify potential adverse effects early, reducing late-stage failures. Developing transgenic animals is complex and resource-intensive, and full characterization of the models is needed for safety assessment. However, they offer significant ethical and scientific benefits: they reduce reliance on non-human primates by providing models more closely aligned with human biology, making them crucial in modern toxicology for reliable safety assessments in new therapeutic development.
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Date | Time | Local Time | Room | Forum | Session | Role | Topic |
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2025-10-17 | 14:00-14:30 | 2025-10-17,14:00-14:30 | Room 6 - Guoxing Hall | Symposium Program (Session) |
Session 25: Novel Strategies for Safety Assessment: A Paradigm Shift for the Future |
Speaker | Transgenic animal models for safety assessment |