Getting Biomarkers Right: Strategy, Execution, and Clinical Relevance in Early Drug Development

Biomarkers can play a critical role in early drug development, helping teams understand biological activity, identify the right patient populations and make more informed decisions about which programs to advance.

But developing an effective biomarker strategy requires more than selecting the right assays. Decisions made early in development must account for scientific relevance, operational feasibility and regulatory requirements, while ensuring the data generated can ultimately inform clinical development.

This panel will explore how sponsors can build biomarker strategies that are both scientifically meaningful and practical to execute. Experts spanning early development strategy, regulated laboratory testing and translational research will discuss where biomarker programs commonly encounter challenges, how testing can be implemented reliably within a regulated environment, and how translational approaches can help connect laboratory findings to clinically relevant questions. Drawing on examples from cardiometabolic and respiratory disease programs, the discussion will highlight practical considerations and lessons that can help teams strengthen biomarker planning and execution across early development.

Key takeaways:

• How to build a biomarker strategy that aligns scientific objectives with broader early development goals
• What sponsors should consider when moving biomarker testing into a regulated laboratory environment
• How translational research can help connect biomarker data to clinically meaningful decisions
• Common challenges that can undermine biomarker programs — and how teams can address them earlier
• Practical lessons from cardiometabolic and respiratory development programs