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Wednesday, June 26 • 2:00pm - 3:15pm
#371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-694-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Robert Meland Nelson, MD, PhD


The Use of Extrapolation in Pediatric Drug Development
Robert Meland Nelson, MD, PhD

Using Historical Data to Establish More Efficient Clinical Trials
Jeen Liu, PhD

Design and Analytic Strategies for Incorporating External Data in a Global Pediatric Trial
Margaret Gamalo-Stiebers, PhD


Margaret Gamalo-Stiebers

Principal Research Scientist, Eli Lilly and Company

Jeen Liu

Associate VP, Biostatistics, Allergan Inc.
I have worked in the Pharma industry for 20+ years as a statistician, currently responsible for biostatistics support of all the ophthalmology products for the company. Prior to joining Allergan, I have worked for Novartis, Astellas and Eisai. My experience in clinical trials covers... Read More →
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development and Pediatric Strategy Lead in Immunology at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session |   06: PreClin Dev-EarlyPhaseCR, Session
  • Level Beginner
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session