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Pediatric Drug Development Workshop

Session 5: Making Innovative Infrastructure for Pediatric Product Development a Reality

Session Chair(s)

Edward Connor, MD, MS

Edward Connor, MD, MS

  • President, Clinical Research Alliance; Chairman and President
  • I-ACT for Children, United States
A major gap in the development of innovative drugs for children has been lack of a sustainable pediatric-focused clinical trials infrastructure. Over the past few years, significant progress has been made in making such infrastructure a reality on a global scale. This session will cover the challenges in execution of regulatory-grade clinical trials in children, public-private initiatives that are now being implemented in the US and Europe to address these challenges, and a view of the innovative capabilities and resources available to facilitate planning and execution of pediatric clinical trials.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand new and innovative opportunities for addressing the practical challenges in pediatric drug clinical trials
  • Gain working knowledge of the major public-private initiatives, resources, and capabilities available to assist in planning, feasibility assessment, and execution of pediatric clinical trials

Speaker(s)

Ronald Portman, MD

Ensuring Capability for Regulatory Grade Trials in Children Through Public Private Collaboration

Ronald Portman, MD

  • Executive Director, Pediatric Development, Science and Innovation
  • Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, United States
Susan McCune, MD

Pediatric Regulatory Considerations and the Need for Collaboration

Susan McCune, MD

  • Vice President, Pediatrics and Clinical Pharmacology
  • PPD, United States
Mark Turner, MD, PhD, MRCP, FFPM

Global Initiatives to Maximize Efficiency, Quality, and Impact of Pediatric Clinical Trials

Mark Turner, MD, PhD, MRCP, FFPM

  • Co-Director International Neonatal Consortium
  • NIHR Clinical Research Network Children's, Theme Liverpool Women's Hospital, United Kingdom
Edward Connor, MD, MS

Speaker

Edward Connor, MD, MS

  • President, Clinical Research Alliance; Chairman and President
  • I-ACT for Children, United States
Vicki Seyfert-Margolis, PhD

Real World Data: A Critical Element of Pediatric Trial Success

Vicki Seyfert-Margolis, PhD

  • CEO
  • My Own Med, Inc, United States

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