• Lisette Hoogendoorn, Epidemiology Director, Global Epidemiology and Database Studies team, IQVIA Real World Solutions

• Jamie Geier, Global Head of Quantitative Safety and Epidemiology (QSE) at Novartis

• Nick Honig, Executive Director, Highlander Health

Leaning Objectives:

• Explain the requirements for LTFU studies to study the safety and effectiveness of cell and gene therapies after their approval.
• Explain the role RWD can play in such LTFU studies and illustrate challenges that can be encountered during the design and conduct of RWD-based LTFU studies.
• Provide perspective on and examples of studies that applied novel data collection approaches to capture crucial data for the study of safety and effectiveness of CGT.