Transform and Accelerate Pediatric Drug Development
Pediatric drug development is at a critical juncture with growing regulatory demands and trial recruitment challenges. But there is exciting innovation today and in our horizon that we will help us get crucial medicines to children faster. Join our 2-day virtual symposium to bring together thought leaders and innovators in pediatric drug development to share and collaborate on ideas and new developments that are advancing pediatric drug development into a new era.
The 2-day agenda of virtual talks, discussions, and roundtables covers a range of topics, including:
- Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development
- Reaching Agreement with Regulators on Global Approach to Pediatric Drug Development
- Neonatal Research Insights
- Novel Clinical Trial Design
- Multifaceted Approach to Patient Engagement in Pediatric Clinical Research
About the Organizers
The organizing committee members of the Symposium have designed a program to encourage robust dialogue and share ideas.
- Amy Cheung, Certara
- Lynne Georgopoulos, Certara (Symposium Co-Chair)
- Barry Mangum, Paidion Research
- Solange Corriol Rohou, AstraZeneca
- Mark Shapiro, xCures
- Patrick Smith, Certara (Symposium Co-Chair)
Featured Speakers
We are excited to feature discussions led by key thought leaders in pediatric drug development from industry, regulatory agencies, and academia.
Lynne Yao, MD
Director at Division of Pediatric and Maternal Health at US FDA, CDER; Keynote Speaker
Jeff Barrett, PhD
Senior Vice President at Critical Path Institute
Hannah Batchelor, PhD
Professor at Strathclyde Institute of Pharmacy and Biomedical Science
Alex Bliu, PhD
Senior Biostatistician with the Office of Biostatistics, Health Canada
Amy Cheung, PhD
Senior Director of Integrated Drug Development at Certara
Christopher Copland
Co-chair of Fostering Age Inclusive Research Trials (FAIR Trials)
Solange Corriol-Rohou, MD
Sr. Director of Regulatory Affairs & Policy for Europe, AstraZeneca
Elin Haf Davies, PhD
CEO of Aparito
Nathalie Gaspar, MD
Paediatric Oncologist at Gustave Roussy Cancer Campus
Lynne Georgopoulos, RN, MSHS
VP, Regulatory Strategy at Certara
Jing Liu, PhD
Sr. Director of Clinical Pharmacology at Pfizer
Barry Mangum, PharmD
CEO, Paidion Research
Lily Mulugeta, PharmD
Associate Director for Policy and Research, FDA
Robert Nelson, MD, PhD
Senior Director, Pediatric Drug Development, Child Health Innovation Leadership Department at Johnson & Johnson
Amy Ohmer
Director, iCAN Research and Advocacy
Gregory Reaman, MD
Associate Director for Oncology Sciences at Center for Drug Evaluation and Research, US FDA
Theresa Shalaby, MSN, RN
Senior Regulatory Services Manager at Certara
Mark Shapiro, MBA, MA
Chief Operating Officer at xCures
Patrick Smith, PharmD
Senior Vice President of Integrated Drug Development at Certara
Mark Turner, BSc, PhD, MBChB, DRCOG, MRCP(UK), FRCPCH, FFPM(Hon)
Professor of Neonatology and Research Delivery at University of Liverpool
John van den Anker, MD, PhD
Chair of Pediatric Clinical Pharmacology at Children's National Medical Center
Max Williamson
Cancer Patient and Advocate
Karen Rowland Yeo, PhD
Senior Vice President of Client and Regulatory Strategy at Certara
Dominik Karres, MD
Scientific Officer at European Medicines Agency
Collin Hovinga, Pharm.D., MS, FCCP
Senior Vice President of Clinical and Scientific Development at the Institute for Advanced Clinical Trials for Children
Tanja Andrea Gruber
Chief of Pediatric Hematology Oncology Stem Cell Transplant and Regenerative Medicine at Stanford University