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.

Guest

1. Thierry Schulmann, Senior Director, Medical Affairs Strategy, Sumitomo Pharma (LinkedIn)

Episode Overview

This 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:

1. Why CRO selection should account for KOL expertise and therapeutic alignment
2. How to use KOL engagement to build patient-centered protocols and enhance feasibility, recruitment, and retention
3. The 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 Moments

00:02:10 – 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

00:10:40 – Regulatory navigation: How global KOL networks inform region-specific trial design and submission strategies

00:13:19 – Leveraging KOL and patient group relationships for evidence generation in rare and serious diseases

00:14:47 – Ensuring real-world effectiveness: The role of KOLs in validating trial design beyond controlled settings

00:18:30 – Lessons learned: When missed KOL input on comparator choice, unmet need assessment, or side effect profiles led to program failures

00:21:36 – When to engage KOLs: Practical recommendations for biotech and pharma, starting as early as Phase 1

Top 3 Takeaways

1. Proactive KOL engagement in early trial design is essential for successful clinical trial outsourcing and market access—don't wait until later phases to bring real-world and regulatory perspectives into protocol development.
2. Aligning clinical study endpoints and comparators with both therapeutic practice and payer requirements optimizes trial relevance and supports smoother regulatory acceptance—a key consideration in clinical operations best practices and CRO selection.
3. Building cross-functional collaboration with KOLs bridges gaps among sponsors, CROs, patient groups, and regulatory bodies, minimizing risk of costly rework and maximizing the practical value of clinical study optimization.

Quotes

"Making a study without launching it in the markets doesn’t make sense. Involve key opinion leaders early to ensure you’re not just building a study for science, but for real patient impact." — Thierry Schulmann

"Endpoints matter, but they must be clinically relevant. KOLs help ensure that what is statistically significant is also meaningful for adoption and payer acceptance." — Thierry Schulmann

"KOLs are not just scientific advisors—they bridge patient, regulatory, and market realities with sponsor strategy, reducing the risk of misaligned or commercially unviable trials." — Thierry Schulmann

"The reason products don’t launch isn’t always technical failure—it’s often weak alignment to the actual unmet need, pricing pressure, or irrelevance to local practice. KOL insight is the antidote." — Thierry Schulmann

"If you have a product, even in Phase 1, you should start discussing with KOLs. Don’t wait—disease awareness and unmet need education set the foundation for successful trial and market outcomes." — Thierry Schulmann

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