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.
Regulatory submissions such as NDAs, BLAs, and PMAs are the culmination of years of research and investment, yet their success depends on how clearly and strategically the data are communicated. This Solutions Circle will explore key decisions sponsors face when preparing clinical data for FDA review. During this interactive session, participants will gain insights into the importance of early and effective engagement with regulators, the role of clear messaging and visuals, and how to avoid common mistakes in submission planning. The session will highlight practical strategies to ensure data are presented in a way that supports FDA’s understanding and maximizes the chance of a favorable outcome.
Learning Objectives:
Importance of communicating and collaborating with the FDA early and often as they prepare their submission
Strategic considerations/decisions sponsors will face while planning for a submission
Reasons why sponsors should simplify their data into messages and visuals in the submission that will resonate with regulators
Understand the common mistakes sponsors make when preparing clinical submissions
