With the greater use of electronic data, access to real-world data on patients, payers and the health system is exploding, bringing with it many opportunities to shape drug development, commercialization and access. Many significant initiatives with broad impact have been undertaken to shape how these types of data are being used to guide decision-making. How are these data being used to support safety and effectiveness? Does this information impact the payer landscape? What are the gaps and limitations? What are the standards, if any, available to guide good practice?

A short keynote address will set the groundwork and will be followed by a panel discussion that will examine pharma, safety, and patient perspectives on big data methodology and the need for real-world examples.