How to Implement a Real-World Data Study for Regulatory Decision-Making Following the New FDA Draft Guidance

The FDA has issued two new draft guidance documents on the use and structure of real-world data in regulatory decision-making. While real-world data has been around for many years, the speakers on this webinar will recap the guidance and discuss what this means for the use of real-world data going forward. In particular, they will discuss the key requirements for real-world data to be suitable for regulatory decision-making and how those requirements differ from traditional uses of real-world data.

They will use real examples from their own proprietary dataset as exemplars of how real-world data can be collected in a manner that enables data studies that are fit for regulatory decision-making.

Register for this webinar to:

• Understand the new FDA draft guidance on real-world data in regulatory decision-making and implications of the guidance
• Determine what data should look like in order to meet FDA guidance
• Learn how to best apply the draft guidance to run studies on a real-world data sample with the intent of submitting to the FDA
• Recognize what a study would look like that meets the FDA guidance

Speakers

Mark Shapiro, Chief Operating Officer, xCures, Principal investigator, XCELSIOR

For two decades, Mark has been driving growth and innovation programs in clinical research. Mark also acts as Principal Investigator at XCELSIOR, a patient-powered real-world data and outcomes registry in cancer. Prior to joining xCures, Mr. Shapiro was Senior Vice President of Operations at a global CRO where he was responsible for a team of about 500 drug development professionals in 30 countries and a portfolio of more than 100 active clinical trials.

Message Presenter

Max Goldstein, Vice President of Research Partnerships, xCures

Max leads business development efforts and commercial strategy at xCures. Prior to xCures, Max was Director of Business Development at Certara Evidence and Access. Max brings nearly 10 years of evidence, value, and access strategy experience across various roles in consulting and business development. Max is currently pursuing a Master’s in Healthcare Administration at NYU and holds a BS in Health: Science, Society, and Policy from Brandeis University.

Message Presenter

Bryan Federowicz, Vice President of Clinical Operations, xCures

Bryan is a seasoned clinical operations leader with experience running global clinical programs through all phases in oncology. Prior to joining xCures, Bryan led a global team at a mid-market CRO focused on driving innovation and getting trials initiated at record pace while ensuring regulatory compliance was maintained.

Message Presenter