Mastermind Session: Understanding ‘’What is Durability?’’ and Finding the Middle Ground for Demonstrating Durability to Regulatory Bodies

Time: 12:30 pm
day: Day One AM


This mastermind will give each group the same set of questions surrounding this idea, and then answers will be collated at the end of the session and distributed to all attendees post-conference to gain insights into current perspectives in the field, and suggestions and ideas of relevant actions we can take as a collective to navigate misconceptions in gene therapy

• Determining a definition for durability

• Discovering FDA/EMA insights

• Navigating what clinically measurable indictors the FDA want to see

• Understanding how to gather durability data without a trial needing to last 10 years

• Support for following up with patients’ long term