Rethinking Risk: Why Early Evidence Strategy Matters for Emerging Biotechs

For emerging biotech companies, development success is often measured by clinical milestones, safety, and efficacy. However, demonstrating an asset’s value extends beyond regulatory approval. Understanding patient needs and treatment experiences, as well as evolving stakeholder expectations, early in development plays an important role in shaping a more informed evidence strategy.

In this podcast, Ashwin Rai, Director of Data Science and Advanced Analytics, and Gale Harding, Senior Research Leader, from the PPD clinical research business of Thermo Fisher Scientific, discuss how integrating real-world data and patient-centered insights earlier in development can help developers address evidence gaps, inform critical decisions, and build a stronger foundation for demonstrating treatment value.

What the Podcast Explores
• Why evidence planning should begin early in asset development, rather than closer to commercialization
• How real-world data can help identify unmet needs, understand patient journeys, and inform development decisions, and why more data doesn’t necessarily mean better data
• The importance of capturing patient experiences and outcomes beyond traditional clinical endpoints
• How patient-centered research can help address evidence gaps and strengthen an asset’s value story
• Why evidence strategies must evolve alongside changing stakeholder expectations and development priorities