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Hyatt Regency Bethesda

Oct 28, 2019 7:00 AM - Oct 29, 2019 12:15 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

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 "Skip"  Nelson, MD, PhD

Robert "Skip" Nelson, MD, PhD

Senior 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


Robert "Skip"  Nelson, MD, PhD

The Use of Extrapolation in Pediatric Drug Development: Robert "Skip" Nelson, MD, PhD

Senior Director, Pediatric Drug Development (CHILD)

Johnson & Johnson, United States

Marc R Gastonguay, PhD

Speaker: Marc R Gastonguay, PhD


Metrum Research Group, United States

Lisa  Hampson, PhD

Speaker: Lisa Hampson, PhD

Senior Director, Advanced Methodology & Data Science

Novartis Pharma AG, Switzerland

Nikolay  Nikolov, MD

Speaker: Nikolay Nikolov, MD

Associate Director for Rheumatology

FDA, United States

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