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Pediatric Product Development in the 21st Century: Developing Research Networks to Get the Job Done
Session Chair(s)
Lynne Yao, MD
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
FDA, United States
Efficient pediatric drug development in the 21st century will require effective collaboration between industry, academia, patients, and government. This forum will gather stakeholders from these groups to explore use of pediatric research networks.
Learning Objective : Recognize successful approaches to pediatric product development based on permanent pediatric legislative efforts; Identify challenges to successful pediatric product development; Formulate novel, innovative, and collaborative pathways for the successful development of pediatric therapies.
Speaker(s)
Why a Pediatric Clinical Trials Network?
Samuel Maldonado, MD, MPH
Janssen Research & Development, LLC , United States
Vice President, Head of Child Health Innovation Leadership Department
Successful Clinical Research Networks in Europe: Strengths and Opportunities
Mark Turner, MD, PhD, MRCP, FFPM
University of Liverpool, United Kingdom
Chief Executive Officer of the c4c- Stichting (c4c-S) & Professor of Neonatology
Global Paradigm Shift: Getting It Done!
Pamela Lyncee Simpkins, MBA
Mezzopointe. LLC, United States
Managing Partner
How CROs can Work Successfully with a Global Pediatric Research Network
Earl Seltzer, MBA
CTI, United States
Senior Director, Partnerships and Innovation