Real-World Evidence (RWE) is transforming the landscape of data that influences clinical decision-making and even regulatory approvals. Here, MAPS speaks with Cerise James, member of the MAPS Evidence Generation Focus Area Working Group about applications of Real World Evidence including FDA criteria for accepting RWE, types of data, RWE study designs and the Totality of Evidence approach. To learn more about the emerging uses of Real World Evidence, plan to attend Cerise's session at the MAPS 2022 Global Annual Meeting, March 20-23 in New Orleans, titled "Real World Evidence Applications and How it can Change Medicine and Biopharma."