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Hyatt Regency Bethesda

Oct 28, 2019 7:00 AM - Oct 29, 2019 12:15 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Pediatric Drug Development Workshop

Session 4: Leveraging Innovative Trials Design II

Session Chair(s)

Robert "Skip"  Nelson, MD, PHD

Robert "Skip" Nelson, MD, PHD

Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States

Christina  Bucci-Rechtweg, MD

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

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

Thomas Miller, PHD

Vice President and Global Head, Pediatrics, Bayer, United States

Speaker

Andrew  Mulberg, MD

Andrew Mulberg, MD

Senior Vice President, Neurogene, United States

Speaker

Yeruk (Lily)  Mulugeta, PHARMD

Yeruk (Lily) Mulugeta, PHARMD

Associate Director, Division of Pediatric and Maternal Health, CDER, FDA , United States

Speaker

Robert "Skip"  Nelson, MD, PHD

Robert "Skip" Nelson, MD, PHD

Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States

Speaker

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