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YouTube

From Animal Models to NAMs - How the FDA Modernization Act 2.0 is Shaping Clinical Trials and Cancer Research

Labroots via YouTube

Overview

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Explore how the FDA Modernization Act 2.0 is revolutionizing cancer research and clinical trials by transitioning from traditional animal models to New Approach Methodologies (NAMs) in this 30-minute webinar presented by medical writer and cannabis journalist Lydia Kariuki. Discover the critical challenges facing oncology drug development, where nearly 90% of drugs successful in animal studies fail in human trials due to poor translatability of preclinical data. Learn about the groundbreaking regulatory shift that now allows non-animal testing methods including microphysiological systems (organs-on-a-chip), induced pluripotent stem cells, and in silico modeling to replace animal models in preclinical research. Understand how these human-relevant models more accurately reflect tumor biology and patient diversity, promising to reduce attrition in cancer drug pipelines while enabling more personalized and predictive translational research. Gain practical insights into what this regulatory change means for cancer research and translational medicine, how NAMs are reshaping preclinical pipelines, and strategies for clinical labs to position themselves competitively by embracing modern informatics tools. Acquire actionable approaches for operationalizing regulatory change while improving efficiency, compliance, and translational outcomes in the evolving landscape of oncology research.

Syllabus

From Animal Models to NAMs: How the FDA Modernization Act 2.0 is Shaping Clinical Trials and...

Taught by

Labroots

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