Session Details

This session will provide guidance to researchers on how to design and implement preclinical studies in order to gain information needed to support the development of clinical trials. It is necessary to learn the appropriate design and conduct of preclinical studies that will lead to regulatory decisions defining the safe administration of investigative new cell and gene therapy products.

Learning Objectives:

• Translation of gene and cell therapies from bench to bed
• When to assess therapies in animal models
• Choosing the appropriate model for disease context
• How to relay in vivo data for pre-clinical trials