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Building Trust in New Alternative Methods in Investigational New Drug Applications
Session Chair(s)
Rasika Kalamegham, PHD
Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
This forum will discuss practical experiences developing investigational new drug applications (IND) applications with new alternative methods (NAMs). Panelists will share lessons learned on how to build trust in NAMs for regulatory uses.
Learning Objective : Apply strategies to leverage new alternative methods (NAMs) in IND applications; Evaluate successful case studies; Identify gaps and opportunities to advance the use of NAMs for drug development.
Speaker(s)
Paul C. Brown, PHD
Associate Director for Pharmacology and Toxicology, OND, CDER, FDA, United States
FDA's Perspectives on the Current Use of NAMs in IND Applications
Christine Mayer-Nicolai, PHARMD
Vice President, Regulatory and Scientific Policy, Merck Healthcare Kgaa, Germany
Erin Greene, JD
US Lead, Global Regulatory Policy and Innovation, Takeda, United States
Speaker
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