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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
Executive 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)
Robert "Skip" Nelson, MD, PhD
Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
The Use of Extrapolation in Pediatric Drug Development
Marc R Gastonguay, PhD
CEO, Metrum Research Group, United States
Speaker
Lisa Hampson, PhD
Senior Director, Advanced Methodology & Data Science, Novartis Pharma AG, Switzerland
Speaker
Nikolay Nikolov, MD
Director, Office of Immunology and Inflammation, OND, CDER, FDA, United States
Speaker
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