Maximizing commercial performance by harnessing RWD and Clinical data

Late-phase clinical trials, post-market studies, and patient registries represent more than regulatory obligations—they are strategic assets that can dramatically enhance a drug's commercial trajectory and market potential. This presentation explores how pharmaceutical companies can transform these studies from cost centers to value drivers by implementing a comprehensive, data-driven approach to commercial strategy.

We’ve examined how rigorous, late-phase evidence generation provides critical insights into patient profiles in clinical practice settings, outcome variations across subpopulations, and comparative effectiveness against standard-of-care treatments. These insights become powerful tools for expanding indications, securing premium formulary positions, and enhancing market access with both public and private payers.

In this discussion, we demonstrate how pharmaceutical companies have successfully leveraged late-phase data to:

• Identify and validate new patient subgroups with enhanced response profiles
• Generate compelling comparative effectiveness evidence for payer negotiations
• Support label expansions that significantly extended product lifecycles
• Quantify economic value through critical metrics such as time to formulary approval, time to peak sales, and new market adoption
• Optimize future target population identification and segmentation strategies

The presentation provides a framework for cross-functional collaboration between clinical development, medical affairs, and commercial teams to design late-phase studies that simultaneously satisfy regulatory requirements while generating commercially valuable evidence. Particular emphasis is placed on designing studies with endpoints that resonate with payers, providers, and patients—transforming clinical data into compelling value narratives.