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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)
FDA's Perspectives on the Current Use of NAMs in IND Applications
Paul C. Brown, PhD
FDA, United States
Associate Director for Pharmacology and Toxicology, OND, CDER
Christine Mayer-Nicolai, PharmD
Merck Healthcare KGaA, Germany
Vice President, Regulatory and Scientific Policy
Speaker
Erin Greene, JD
Takeda, United States
US Lead, Global Regulatory Policy and Innovation
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