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Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation
Session Chair(s)
Robert "Skip" Nelson, MD, PhD
Executive Director, Pediatric Drug Development (CHILD)
Johnson & Johnson, United States
The ICH E11A guidance advances use of pediatric extrapolation in three areas: (1) role of exposure-response; (2) statistical implications of using external data; and (3) extrapolation of safety. After an overview, these three areas will be explored.
Learning Objective : Define pediatric extrapolation and three components of extrapolation concept; Describe role of exposure-response in supporting data extrapolation from reference to target pediatric population; Examine the impact of extrapolation on false positive rate of a pediatric clinical trial; Outline impact of pediatric extrapolation on generation of safety data in the target pediatric population.
Speaker(s)
FDA Update on ICH E11A EWG on Pediatric Extrapolation
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
Industry Update
Forrest Williamson, PhD, MS
Eli Lilly and Company, United States
Director of Pediatrics, Statistical Innovation Center
Industry Update on ICH E11A EWG on Pediatric Extrapolation
Brenda Cirincione, PhD, MS
Vertex, United States
Vice President, Clinical and Quantitative Pharmacology
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