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Juvenile Animal Studies and Pediatric Nonclinical Development

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 17, 10:30AM - 11:30AM (Pacific Standard Time)

Session Number:
233

Room Number:
7B

Level:
Intermediate

Type:
Session

Title:
Juvenile Animal Studies and Pediatric Nonclinical Development

Chair(s):
Dinah Duarte, PharmD, MSc
Head, Scientific Evaluation Unit, Directorate of Medicinal Products
INFARMED, Portugal

Description:
The need for early consideration of pediatric populations in the investigational development of medicines, to support an indication in pediatric populations, has led to an increased focus on the strategy in relation to nonclinical aspects of the pediatric development and the relevance of nonclinical studies in juvenile animals. General considerations for determining whether juvenile toxicity studies are necessary to support pediatric drug development are in EU and US Guidelines (juvenile animal guidance). This session will explore the importance of nonclinical juvenile animal guidance in pediatric drug development, share real world experience from available historical data on juvenile animal studies, and examine if juvenile animal studies in nonclinical support for pediatric drug development has significantly changed.

Learning Objective(s):
Discuss the importance of nonclinical juvenile animal guidance in pediatric drug development; Share real world experience from available historical data on juvenile animal studies; Examine if juvenile animal studies in nonclinical support for pediatric drug development has significantly changed.

Presentation(s) & Speaker(s):
Juvenile Animal Studies and Pediatric Nonclinical Development: EU Perspective
Dinah Duarte, PharmD, MSc
Head, Scientific Evaluation Unit, Directorate of Medicinal Products
INFARMED, Portugal

Juvenile Animal Studies and Pediatric Nonclinical Development: Industry Perspective
Mark E Hurtt, PhD
Executive Director and Global Head, DSRD Centers of Emphasis
Pfizer Inc, United States