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The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
Session Chair(s)
Christopher Mathes, PhD, MBA
Chief Commercial Officer
AnaBios, United States
This session will discuss how human-focused translational technologies help ensure the safety and efficacy of novel therapies, reduce product development costs, shorten time to market and provide an unprecedented opportunity to unlock new possibilities for preclinical drug discovery.
Learning Objective : Discuss the importance of human cells and/or tissue in early drug discovery for success in clinical trials; Identify strategies for using human cells and/or tissue in every stage of preclinical research (i.e., from target identification to lead optimization and into phase 1; Identify from case studies that describe how data from human cells/tissues can be more predictive than in vivo animal studies.
Speaker(s)
Industry Perspective
Andre Ghetti, PhD
AnaBios, United States
Chief Executive Officer
PMDA Update
Satoshi Tsunoda
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Specialist, Office of New Drug IV
Translation of Safety Pharmacology Testing to Human Trials: What Do We Know?
Hugo Vargas, PhD
Amgen Inc., United States
Executive Director
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