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    Drug Target Humanized Mice for IND-Enabling Toxicology Studies

    July 23, 2025
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    Title: Drug Target Humanized Mice for IND-Enabling Toxicology Studies 

    Webinar Description: 

    With rising ethical concerns, high costs, and extended timelines associated with the use of NHPs, the FDA has announced plans to reduce their use. There is a growing industry trend toward adopting drug-target humanized mouse models for IND-enabling toxicology studies. 

    This webinar will explore the evolving regulatory landscape and provide a practical guide to using humanized mice in toxicology studies. 

    We'll highlight lessons learned from recent case studies, including an innovative CNS gene delivery approach developed by Apertura Gene Therapy. By leveraging AAVs engineered to bind human TfR1, their work illustrates how humanized TfR1 mice can support the drug development pipeline—from early discovery through toxicology studies—reinforced by FDA INTERACT feedback that underscores the value of these models. 

    Don’t miss this opportunity to gain actionable insights into this growing industry trend and discover how integrating humanized models can strengthen your drug development pipeline.

    Speaker: 

    • Andrew Steinsapir, Acting Chief Technology Officer, Apertura Gene Therapy 
    • Jay Zhang, Regional BD Director, Biocytogen 
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