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Pediatric Drug Development Workshop


Session 2: Innovation Through Extrapolation: Improving the Efficiency and Effectiveness of Pediatric Drug Development

Session Chair(s)

Yeruk (Lily)  Mulugeta, PharmD

Yeruk (Lily) Mulugeta, PharmD

  • Associate Director, Division of Pediatric and Maternal Health, CDER
  • FDA , United States
Robert  Nelson, MD, PhD

Robert Nelson, MD, PhD

  • Senior Director, Pediatric Drug Development
  • 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  Nelson, MD, PhD

The Use of Extrapolation in Pediatric Drug Development

Robert Nelson, MD, PhD

  • Senior Director, Pediatric Drug Development
  • Johnson & Johnson, United States
Marc R Gastonguay, PhD

Speaker

Marc R Gastonguay, PhD

  • CEO
  • Metrum Research Group, United States
Lisa  Hampson, PhD

Speaker

Lisa Hampson, PhD

  • Associate Director
  • Statistical Methodology & Consulting, Novartis Pharma AG, Switzerland
Nikolay  Nikolov, MD

Speaker

Nikolay Nikolov, MD

  • Associate Director for Rheumatology
  • FDA, United States