Global healthcare decision-makers are developing real-world evidence (RWE) guidance and capabilities so that this evidence, where applicable, can be incorporated into decision-making. Decision-makers' movement toward RWE broadens the evidence landscape that biopharma sponsors can provide to support regulatory and reimbursement submissions. In addition, RWE has become a central element of product lifecycle management and support, providing vital information on, for example, clinicians’ prescribing patterns and patient-selection criteria, and patient outcomes. However, the RWE capabilities among biopharma sponsors can vary widely, as do the challenges they may face; for example, large biopharma companies often have licenses to commercial real-world datasets and have created RWE centers of excellence for their RWE study needs. In comparison, small biopharma companies often have limited-to-no RWE capabilities and might not even have internal HEOR or medical-affairs groups.

This Forum session will highlight lessons learned and key strategies for RWE development within each biopharma segment (i.e., large, mid-size, small). The speakers will represent each segment and discuss how they have integrated RWE into their evidence-development strategies.