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Session 2: Innovation Through Extrapolation: Improving the Efficiency and Effectiveness of Pediatric Drug Development
Session Chair(s)
Yeruk (Lily) Mulugeta, PharmD
Associate Director, Division of Pediatric and Maternal Health, CDER
FDA , United States
Robert "Skip" Nelson, MD, PhD
Senior Director, Pediatric Drug Development (CHILD)
Johnson & Johnson, United States
This session will explore the innovative use of extrapolation in pediatric drug development. A presentation of the conceptual, clinical, and ethical justification for the use of extrapolation will be followed by presentations exploring: (1) the use of modeling and simulation to establish and/or assess pediatric exposure and response for both small molecules and biologics and (2) innovative statistical approaches, including Bayesian designs, to borrowing source data to reduce the need for data from the target pediatric population. The presentations will be followed by a panel discussion.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the use of modeling and simulation to optimize the assessment of the pediatric exposure necessary to elicit a comparable clinical response
- Understand how a Bayesian statistical approach can be used in support of the extrapolation of source adult data to a target pediatric population
Speaker(s)
The Use of Extrapolation in Pediatric Drug Development
Robert "Skip" Nelson, MD, PhD
Johnson & Johnson, United States
Senior Director, Pediatric Drug Development (CHILD)
Speaker
Marc R Gastonguay, PhD
Metrum Research Group, United States
CEO
Speaker
Lisa Hampson, PhD
Novartis Pharma AG, Switzerland
Senior Director, Advanced Methodology & Data Science
Speaker
Nikolay Nikolov, MD
FDA, United States
Associate Director for Rheumatology
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