Webcast Creative Brief:

Jakafi^TM: Rapid and Successful Use of a Patient Reported Outcome Endpoint to Support Product Labeling

KEY ISSUES FOR DISCUSSION

This webinar will focus on the type of work needed to develop an effective endpoint strategy when Patient Reported Outcomes (PRO) are used in clinical research and what is expected by regulators in defending that strategy. A case study will be presented on Incyte Corporation's recently approved Jakafi™ (ruxolitinib), the first drug to get symptom data on its approved label since the FDA issued its draft PRO Guidance in 2006. The speakers will review the key topics to consider when implementing PROs in new product development, based on Incyte's path to approval, which included:

• Early planning on the PRO component of their research,
• Working with patients to identify the most important and bothersome symptoms
• How a major global pharmaceutical company views the need for 'Intelligent pharmaceutical' to for the future of the industry
• Successfully collaborating with FDA on the development and administration of a new PRO instrument and data results

Key Learning Objectives:

• Learn how and why to plan early for the PRO components of research
• Learn the benefits of listening to patients to identify most bothersome symptoms
• Learn the best approach for collaborating with regulators early and often throughout development for best results

WHO SHOULD ATTEND

Should you not be able to attend the webinar, if you preregister you will receive the archived link 24 hours after the live broadcast.

Sponsored By:

Speaker:

Tom Hare, Vice President, Development Operations, Incyte Corporation
Jean Paty, Ph.D., Chief Scientist and Regulatory Advisor, Outcomes, ERT, inc.