The Evolution of Medical Affairs: How Real-World Evidence (RWE) Transformed Drug Development and Market Access

The medical affairs landscape has undergone a significant transformation, with RealWorld Evidence (RWE) playing a pivotal role in reshaping drug development and market access. This review explores the evolution of medical affairs from a traditional, supportive role to a strategic function driven by data, evidence, and value-based outcomes. By integrating RWE into clinical and commercial strategies, pharmaceutical companies now leverage insights from diverse sources, including electronic health records, registries, and patient-reported outcomes. The implications for regulatory decisions, payer negotiations, and clinical adoption are profound. This article provides a comprehensive overview of how RWE enhances decision-making, stakeholder engagement, and access to innovative therapies