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Pediatric Drug Development Workshop
Session 5: Making Innovative Infrastructure for Pediatric Product Development a Reality
Session Chair(s)
Edward Connor, MD, MS
- Professor Emeritus Pediatrics, Microbiology, Immunology, Tropical Medicine
- George Washington University School of Medicine and Health Sciences, United States
A major gap in the development of innovative drugs for children has been lack of a sustainable pediatric-focused clinical trials infrastructure. Over the past few years, significant progress has been made in making such infrastructure a reality on a global scale. This session will cover the challenges in execution of regulatory-grade clinical trials in children, public-private initiatives that are now being implemented in the US and Europe to address these challenges, and a view of the innovative capabilities and resources available to facilitate planning and execution of pediatric clinical trials.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand new and innovative opportunities for addressing the practical challenges in pediatric drug clinical trials
- Gain working knowledge of the major public-private initiatives, resources, and capabilities available to assist in planning, feasibility assessment, and execution of pediatric clinical trials
Speaker(s)
Ensuring Capability for Regulatory Grade Trials in Children Through Public Private Collaboration
Ronald Portman, MD
- Executive Director, Pediatric Development, Science and Innovation
- Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, United States
Pediatric Regulatory Considerations and the Need for Collaboration
Susan McCune, MD
- Vice President, Pediatrics and Clinical Pharmacology
- PPD, United States
Global Initiatives to Maximize Efficiency, Quality, and Impact of Pediatric Clinical Trials
Mark Turner, MD, PhD, MRCP, FFPM
- Professor of Neonatology and Research Delivery
- University of Liverpool, United Kingdom
Speaker
Edward Connor, MD, MS
- Professor Emeritus Pediatrics, Microbiology, Immunology, Tropical Medicine
- George Washington University School of Medicine and Health Sciences, United States
Real World Data: A Critical Element of Pediatric Trial Success
Vicki Seyfert-Margolis, PhD
- CEO
- My Own Med, Inc, United States
