Discussing How The FDA’s New Approach Methodologies Initiative Could Transform Drug Testing and Development

Executed on:Sep 10, 2025 10:00 AM EDT

Call Duration:30 minutes

Expert Profile

ExpertBlinded Expert

Institution: University of Minnesota Professor and Dietrich Chair in Biochemistry, Molecular Biology, and Biophysics at the University of Minnesota, specializing in molecular mechanisms of muscle function and disorders.
Directs the Minnesota Muscle Training Program, leading interdisciplinary training in muscle biophysics and physiology to advance research on heart failure and muscular dystrophy.
Pioneers translational research with over 300 publications on muscle proteins and develops novel therapies for muscle-related disorders.

Interview Goal

This call will explore the implications of the FDA's New Approach Methodologies initiative, focusing on the shift away from mandatory animal testing in drug development. It will cover the role of innovative technologies like organoids, organ-on-chip systems, and AI-driven models in advancing safer and more efficient preclinical research and their effects on drug development.

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