Integrating real-world evidence (RWE) strategies during drug development and commercialization is critical to maximizing shareholder and stakeholder value. Biopharma executives need to know how to leverage RWE to accelerate clinical development, bolster regulatory strategy, optimize commercialization and market access, and drive down development costs. By highlighting their recent experiences with concrete examples, panelists will provide insights into how stakeholders, especially regulators, and payers, who are becoming increasingly sophisticated and willing to engage with companies early, are assessing the quality of RWE, whether it is “fit-for-purpose,” and if it can contribute to the “totality of evidence” required for a successful outcome, including a competitive advantage after approval. In particular, the panel will highlight where some companies have been successful and where others have not, and provide some “best practice” thinking on how to integrate and operationalize RWE into their plans.