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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

Speaker

Edward Connor, MD, MS

George Washington University School of Medicine and Health Sciences, United States

Professor Emeritus Pediatrics, Microbiology, Immunology, Tropical Medicine

Thomas  Miller, PhD

Speaker

Thomas Miller, PhD

Bayer, United States

Vice President and Global Head, Pediatrics

Andrew  Mulberg, MD

Speaker

Andrew Mulberg, MD

Neurogene, United States

Senior Vice President

Yeruk (Lily)  Mulugeta, PharmD

Speaker

Yeruk (Lily) Mulugeta, PharmD

FDA , United States

Associate Director, Division of Pediatric and Maternal Health, CDER

Robert "Skip"  Nelson, MD, PhD

Speaker

Robert "Skip" Nelson, MD, PhD

Johnson & Johnson, United States

Executive Director, Pediatric Drug Development (CHILD)

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