- Patrick Smith, President of Integrated Drug Development at Certara
Post-Symposium Materials
2021 Video recordings, Presentations and Q&A
Keynote – Accelerating Global Pediatric Drug Development – Challenges and Opportunities
- Lynne P. Yao, Director, Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research (CDER)
Session 1 – Innovative Techniques Toward Extrapolation and Efficient Drug Development
- Evidence to support pediatric approval through extrapolation Robert “Skip” Nelson, (Johnson & Johnson)
- Pediatric formulations, considerations for BA/BE studies Hannah Batchelor, (Strathclyde Institute of Pharmacy and Biomedical Sciences)
- Panel discussion moderated by: Lily Mulugeta (FDA), Solange Corriol Rohou (AstraZeneca), Amy Cheung (Certara)
Break (15 min)
Session 2 – Reaching Agreement with Regulators on Global Approach to Pediatric Drug Development
- Changing Regulatory Landscape and Pediatric Oncology Development Greg Reaman (FDA)
- European Perspective/Global Collaboration Dominik Karres (EMA)
- Fostering Age Inclusive Research (FAIR) Nathalie Gaspar (Gustave Roussy Cancer Campus) and Chris Copland (Unite2 Cure)
- Panel discussion moderated by: Lynne Georgopoulos (Certara); Lynne Yao (FDA) and Max Williamson
Closing Remarks
- Lynne Georgopoulos, Vice President, Regulatory Strategy at Certara
Session 1 – Neonatal Research Insights
- Challenges in planning and conducting successful trials in infants/neonates John van den Anker (Children’s National Medical Center)
- PBPK – Applications of modeling and simulation – infants and neonates Karen Yeo (Certara)
- Panel discussion moderated by: Barry Mangum (Paidion), and Dr. Tanja Gruber (Stanford University)
Session 2 – Study Methodologies in Pediatric Trials
- Best practices to assembling Real World Data Jeff Barrett (Critical Path Institute)
- Novel Approaches to Pediatric Trial Design Collin Hovinga (IACT)
- Statistical Methodologies in Pediatric Trials Alex Bliu (Health Canada)
- Panel discussion moderated by: Amy Cheung (Certara), Jing Liu (Pfizer) and Mark Shapiro (Chief Operating Officer at xCures), Solange Corriol Rohou (AstraZeneca)
Break (15 min)
Session 3 – Multifaceted Approach to Patient Engagement in Pediatric Clinical Research
- International Children’s Advisory Network (iCAN) Amy Ohmer (iCAN)
- Research Networks Mark Turner (University of Liverpool)
- Enhancing Family/Patient Engagement Through Technology Elin Haf Davies (Aparito)
- The Patient Experience Max Williamson
- Panel discussion moderated by: Theresa Shalaby (Certara|Synchrogenix) and Begonya Nafria Escalera (Patient Engagement in Research Coordinator at Sant Joan de Déu Chidren’s Hospital (Spain))
- Lynne Georgopoulos, Vice President, Regulatory Strategy at Certara