WORKSHOP F: Strategizing for Regulatory Approval when Designing Clinical Trials for Neurological Gene Therapies
Time: 1:00 pm - 4:00 pm
day: CLINICAL TRACK PM
Details:
Many drug developers require clarity on acceptable clinical trial design and in utilizing optimal endpoints that will be accepted by the FDA. With so many gene therapies being placed on an accelerated timeline, it’s important to gain insights on strategies that will help you to gain successful regulatory approval.
Join this workshop to learn:
- Understanding how to set up your clinical trial design to please regulators
- Identifying novel biomarkers to CNS indications to utilize in clinical monitoring
- Accelerating clinical studies with endpoints to show disease modifying effects at a faster rate
