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Session 4: Leveraging Innovative Trials Design II
Session Chair(s)
Robert "Skip" Nelson, MD, PHD
Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Christina Bucci-Rechtweg, MD
Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
This session will explore the use of innovative trial designs that have the strong potential to accelerate approval of new pediatric therapeutics.
Panelists will be challenged to reflect on strategies that are being discussed with regulatory agencies, and employed across small, focused biotech companies and large pharma to address varying pipeline needs within today’s complex development environment.
Speaker(s)
Edward Connor, MD, MS
Professor Emeritus Pediatrics, Microbiology, Immunology, Tropical Medicine , George Washington University School of Medicine and Health Sciences, United States
Speaker
Thomas Miller, PHD
Vice President and Global Head, Pediatrics, Bayer, United States
Speaker
Andrew Mulberg, MD
Senior Vice President, Neurogene, United States
Speaker
Yeruk (Lily) Mulugeta, PHARMD
Associate Director, Division of Pediatric and Maternal Health, CDER, FDA , United States
Speaker
Robert "Skip" Nelson, MD, PHD
Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Speaker
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