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Pediatric Drug Development Workshop


Session 4: Leveraging Innovative Trials Design II

Session Chair(s)

Robert  Nelson, MD, PhD

Robert Nelson, MD, PhD

  • Senior 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 Pharmaceuticals Corporation, 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

  • President, Clinical Research Alliance; Chairman and President
  • I-ACT for Children, United States
Thomas  Miller, PhD

Speaker

Thomas Miller, PhD

  • Vice President and Global Head, Pediatrics
  • Bayer, United States
Andrew E. Mulberg, MD

Speaker

Andrew E. Mulberg, MD

  • Senior Vice President, Global Regulatory Affairs
  • Amicus Therapeutics , United States
Yeruk (Lily)  Mulugeta, PharmD

Speaker

Yeruk (Lily) Mulugeta, PharmD

  • Associate Director, Division of Pediatric and Maternal Health, CDER
  • FDA , United States
Robert  Nelson, MD, PhD

Speaker

Robert Nelson, MD, PhD

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