Mastermind: Navigating Seamlessly Through the Clinic

Time: 11:30 am
day: Immunogenicity Discussion Day

Details:

This mastermind session gives different groups the same set of questions to answer on designing clinical trials to support expedited approvals of gene therapies, exploring in-depth the below considerations. Following this, insights from different groups will be collated into a single document and circulated to the entire group.

Topics to be discussed include:

• Effectively navigating temporary holds: how can we take a collaborative with the FDA to amend protocols and swiftly lift a hold?
• Striking a balance between efficacy and safety when determining dosing in clinical trials to maximise chances of regulatory success
• Strategies for risk mitigation if safety signals are encountered during clinical trials
• Comparing the dosing regimens approaches used for systemic vs local gene therapy administration