Solutions Circles Know Before You Go: • Tickets are required and can be picked up at the Solutions Circle check-in desk 20 minutes before start (first-come, first-served). • Max 30 participants per session. Seats cannot be held in between sessions. • Arrive early. Your seat is only held for 3 minutes after a session starts, then released to standby attendees. • Open to full conference registrants only - have your badge ready. • Located in the Exhibit Hall, booth 200.
Description: Recently in oncology trials, FDA has given a lot of importance to survival benefit and data. Especially as we are moving towards targeted therapies and in cases where accelerated approvals have not resulted in OS confirmatory benefit, FDA has evolved their thinking and made these criteria more stringent for sponsors seeking approval in earlier lines of therapy. For most companies, the perception is that oncology trials are quicker and approvals do not take a long time; however with recent shift in FDA thinking, there is a lot of Regulatory nuance that needs to be thought through to ensure successful filing with OS data. My session would bring my own experience from FDA interactions and provide possible solutions to participants in navigating this evolving thinking.
Learning Objectives:
Identify appropriate level of OS data needed for studies in oncology and carve out more robust Regulatory strategies
Understand how FDA thinking has evolved and how FDA guidance can be used to achieve higher regulatory success
Identify areas of risk and possible mitigation solutions
