Leveraging Key Opinion Leaders in Clinical Research Strategy and Execution With Thierry Schulmann

Discover how early engagement with key opinion leaders transforms clinical trial outsourcing decisions, reduces program risk, and optimizes clinical operations for higher-impact trial outcomes.

GuestThierry Schulmann, Senior Director, Medical Affairs Strategy, Sumitomo Pharma (LinkedIn)

Episode OverviewThis episode—recorded live at COG Europe—features Thierry Schulmann, Senior Director, Medical Affairs Strategy at Sumitomo Pharma, in a highly practical session focused on the operational value of engaging key opinion leaders (KOLs) early in clinical research.

Listeners will gain a clear framework for involving KOLs at each stage of clinical trial outsourcing, from initial design and feasibility to trial execution and market access. Drawing from real-world case studies, Thierry Schulmann illustrates how underestimating KOL input can lead to misalignment on endpoints, failed market launches, or unmet regulatory expectations—even in otherwise well-executed trials.

The discussion covers:

Why CRO selection should account for KOL expertise and therapeutic alignmentHow to use KOL engagement to build patient-centered protocols and enhance feasibility, recruitment, and retentionThe impact of KOLs on regulatory strategy, payer acceptance, guideline inclusion, and real-world implementation

For clinical operations professionals, outsourcing leads, and vendor managers, the episode provides actionable strategies to protect trial value, avoid program pitfalls, and ensure the commercial relevance of new therapies through smarter stakeholder engagement and clinical study optimization.

Key Moments00:02:10 – Framing the risks: Why approved products still fail to launch due to misaligned trial endpoints and weak stakeholder input

00:03:13 – Case study: The commercial impact of not localizing active comparators for European market expectations

00:04:58 – Why strategic KOL engagement is a form of "outsourcing" critical expertise beyond CRO selection

00:07:13 – Clinical operations best practice: Focusing on endpoints that drive real-world adoption, not just statistical significance

00:09:28 – Bridging gaps: KOLs as operational connectors between academic protocols, regulatory requirements, and patient needs