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Saturday, June 19 • 12:00pm - 1:00pm
#529 OD: A Collaborative Cross-Company Pediatric Platform Trial in Pediatric Crohn’s Disease Using an Innovative Bayesian Analysis

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Component Type: Session
Level: Intermediate

Innovative approaches to pediatric drug development are needed to reduce the delay between adult and pediatric marketing approval. This session presents a cross-company pediatric platform trial in Crohn's disease using a Bayesian analysis.

Learning Objectives

Identify some of the recruitment challenges in pediatric drug development; Identify the role of platform trials in addressing these challenges; Discuss the clinical, scientific, regulatory, and operational challenges in designing and implementing a cross-company pediatric platform trial.

Chair

Robert Nelson, MD, PhD

Speaker

Industry Update
Laurie Conklin, DrMed, MD

Industry Update
Wendy Komocsar

Industry Update
Forrest Williamson, PhD



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 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 →
LC

Laurie Conklin

Director, Pediatric Immunology, Janssen, United States
Laurie Conklin joined the Pediatric Development Team at Janssen in September 2020. Her primary responsibilities are leading regulatory strategy in pediatric inflammatory bowel disease (IBD), and trials of Stelara in pediatric IBD. Prior to joining Janssen, Dr. Conklin worked with... Read More →
avatar for Wendy Komocsar

Wendy Komocsar

Research Advisor, Immunology, Eli Lilly and Company , United States
Wendy Komocsar, BSMT (ASCP) SI is currently a Research Advisor with the Immunology Platform at Eli Lilly & Company in Indianapolis, IN. As part of the medical team, she leads pediatric development for an asset being studied in both ulcerative colitis and Crohn’s disease. This work... Read More →
FW

Forrest Williamson

Senior Research Scientist, Statistics Data and Analytics, Eli Lilly and Company, United States


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session