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Session 4: Leveraging Innovative Trials Design II
Session Chair(s)
Robert "Skip" Nelson, MD, PhD
Senior 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)
Speaker
Edward Connor, MD, MS
George Washington University School of Medicine and Health Sciences, United States
Professor Emeritus Pediatrics, Microbiology, Immunology, Tropical Medicine
Speaker
Thomas Miller, PhD
Bayer, United States
Vice President and Global Head, Pediatrics
Speaker
Andrew Mulberg, MD
Neurogene, United States
Senior Vice President
Speaker
Yeruk (Lily) Mulugeta, PharmD
FDA , United States
Associate Director, Division of Pediatric and Maternal Health, CDER
Speaker
Robert "Skip" Nelson, MD, PhD
Johnson & Johnson, United States
Senior Director, Pediatric Drug Development (CHILD)
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