Workshop on “The Value of Juvenile Animal Studies”

The HESI Developmental and Reproductive Toxicology (DART) Technical Committee sponsored a workshop entitled “The Value of Juvenile Animal Studies” in Washington, DC on May 5-6, 2010.  The workshop featured perspectives from industry and regulatory agencies, and offered highly interactive breakout sessions followed by open plenary discussions.

Workshop Presentations

Welcome and Workshop Objectives
Dr. Mark Hurtt, Pfizer Inc.
Dr. Luc de Schaepdrijver, Johnson & Johnson Pharmaceuticals R&D

A Pediatric Clinical Perspective
Dr. Klaus Rose, Granzer Regulatory Consulting & Services

European Union Regulatory Perspective
Dr. Jacqueline Carleer, Belgian Federal Agency for Medicines and Health Products

Japanese regulatory and industry perspective
Dr. Kazuhiro Shimomura, Daiichi Sankyo Co., Ltd.

U.S. Food and Drug Administration Regulatory Perspective
Dr. Melissa Tassinari, U.S. Food and Drug Administration

Industry Perspective – Preclinical Pediatric Drug Development in a Global Context
Dr. Shaun Maguire, GlaxoSmithKline R&D UK

Introduction and Warm-up
Dr. Graham Bailey, Johnson & Johnson Pharmaceuticals R&D

Juvenile animal studies – study design considerations and warm-up case study
Dr. Luc de Schaepdrijver, Johnson & Johnson Pharmaceuticals R&D

Please contact Dr. James Kim at jkim@hesiglobal.org for more information.