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Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
Session Chair(s)
Robert "Skip" Nelson, MD, PhD
Senior Director, Pediatric Drug Development (CHILD)
Johnson & Johnson, United States
Pediatric drug development for adult indications is mandated. Yet children should be protected from unnecessary risks. This session discusses innovative techniques using extrapolation from adult data as an efficient way to study drugs in children.
Learning Objective : Explain the regulatory and ethical context of pediatric drug development; Discuss the role, assumptions, and data needed for using extrapolation from adult data; Identify innovative approaches using Bayesian methodologies to demonstrate the efficacy of drugs in pediatrics; Discuss ways to integrate pediatric into adult drug development.
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)
Using Historical Data to Establish More Efficient Clinical Trials
Jeen Liu, PhD
Regeneron, United States
Head of Biostatistics and Data Management
Incorporating External Information in a Global Pediatric Trial in the Context of Extrapolation
Margaret Gamalo, PhD
Pfizer Inc, United States
Vice President, Statistics Therapeutic Area Head
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