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Monday, June 17 • 2:15pm - 3:15pm
#131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-531-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Robert "Skip" Nelson, MD, PhD

Speaker

FDA Update on ICH E11A EWG on Pediartic Extrapolation
Lynne Yao, MD

Industry Update
Forrest Williamson, PhD

Industry Update on ICH E11A EWG on Pediatric Extrapolation
Brenda Cirincione, PhD, MS


Speakers
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 in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →
BC

Brenda Cirincione

Vice President, Clinical and Quantitative Pharmacology, Vertex, United States
Brenda Cirincione has over 20 years of research experience in Clinical Pharmacology and Pharmacometrics. She received a PhD in pharmaceutical sciences and a MA in statistics from the University of Buffalo, State University of New York, and has experience working in businesses across... Read More →
FW

Forrest Williamson

Director of Pediatrics, Statistical Innovation Center, Eli Lilly and Company, United States
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session