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Session 5, Track B: Advancing Pediatric Clinical Trials: Innovation, Regulation, and Operational Excellence
Session Chair(s)
Katalin Bertenyi, MSc
Manager, Centre for Blood, Blood Products and Biotherapeutics, Health Canada, Canada
Foo-Lim Yeh, MS
Allergan Aesthetics and Specialty Head, Regulatory Affairs, AbbVie Corporation, Canada
This session will provide an overview of current perspectives on pediatric clinical trials, with emphasis on the regulatory, operational, and scientific considerations that shape study design and delivery. It will bring together perspectives on pediatric platform trial design, an update on Health Canada’s Pediatric Drug Action Plan and its relevance to ongoing pediatric drug development efforts, and practical challenges and opportunities across the pediatric trial landscape. The overall goal is to share strategies that can make pediatric trials more efficient, feasible, and better aligned with practical study execution.
Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Initiative
Elisa Koppelman, Brigham & Women's Hospital
Bringing More Pediatric Clinical Trials to Canada: Challenges, Capacity and Solutions
Thierry Lacaze-Masmonteil, Maternal Infant Child and Youth Research Network (MICYRN)
Natasha Rastogi, Health Canada
Pediatric Standard of Care Clinical Trials Pilot
Eden Story, Health Canada
Learning Objective : At the conclusion of this session, participants should be able to: - Summarize the role of pediatric platform trials and other study approaches in advancing pediatric drug development
- Identify common barriers to pediatric trial execution and strategies to address them
- Explain the relevance of Health Canada’s Pediatric Drug Action Plan to ongoing pediatric development efforts
Speaker(s)
Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Initiative
Elisa Koppelman, MPH
Team & Program Director, MRCT Center, United States
Bringing More Pediatric Clinical Trials to Canada: Challenges, Capacity and Solutions
Thierry Lacaze-Masmonteil, MD, FRCPC
Scientific Director, Maternal Infant Child and Youth Research Network (MICYRN), Canada
Speaker
Natasha Rastogi, MS
Senior Policy Analyst, Health Canada, Canada
Pediatric Standard of Care Clinical Trials Pilot
Eden Story
, Health Canada, Canada