Biomarker-Driven Therapy Launch Strategies for Global Success

Biomarkers, Biotech, Commercialization & HEOR, Drug Discovery & Development, Life Science, Pharma,
  • Tuesday, November 18, 2025 | 10am EST (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Launching a predictive biomarker-driven therapy is inherently complex, particularly when it is tied to companion diagnostics or lab-developed tests.

Teams often struggle to align scientific validation, market access and diagnostic readiness across global settings. 

Join this webinar, tailored for pharmaceutical professionals in Medical Affairs, Diagnostics, Precision Medicine and Commercialization, to explore actionable solutions that streamline rollout and improve patient access.

The featured speakers will explore the multidisciplinary steps required for a successful launch, focusing on the pivotal role of Medical Affairs in bridging scientific validation, clinical practice and stakeholder engagement.

Key topics include:

  • Scientific Validation and Evidence Generation: Learn how to ensure biomarker test reliability and reproducibility, which is critical for informed clinical decision-making and effective therapy adoption
  • Market Access Strategies: Discover approaches to expand global reach, including onboarding Key Opinion Leaders (KOLs) for market insights, designing early access programs and enabling labs for biomarker testing
  • Collaboration Between Stakeholders: Understanding the essential partnership between treating physicians and pathologists is crucial to ensure accurate result reporting and deliver the right therapy to the right patients
  • Overcoming Diagnostic Challenges: Gain insights into navigating scenarios where a companion diagnostic (CDx) is unavailable, relying instead on lab-developed tests

This webinar will provide practical guidance on aligning cross-functional teams, driving adoption among healthcare professionals and ensuring the broadest patient access to biomarker-driven therapies as early as possible. By addressing both scientific and commercial considerations, attendees will leave equipped to enhance the success of their therapy launch on a global scale.

Register for this webinar to learn how to launch biomarker-driven therapy with global access and diagnostic success.

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Speaker

Gudrun Baenfer, Discovery Life Sciences

Gudrun Baenfer, PhD, Client Relations and Business Expansion Manager, Peri and Post Approval Services, Discovery Life Sciences

Dr. Bänfer holds a PhD in Biology from the University of Kassel and a diploma from the Johann Wolfgang Goethe University in Frankfurt. With more than 16 years of experience in clinical trials, she has focused since 2010 on supporting oncology drug approvals through biomarker-driven strategies. Her expertise includes organizing educational programs for pathologists, coordinating reference testing, and leading concordance studies to generate real-world evidence for predictive biomarkers. Dr. Bänfer is passionate about identifying the best solutions for her clients to ensure the successful global launch of biomarker-based therapies. Her work bridges scientific rigor with strategic insight, making her a trusted partner in the evolving landscape of personalized medicine.

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Who Should Attend?

This webinar is designed for pharma teams responsible for market access and biomarker-driven therapy rollouts. Specifically:

  • Medical Affairs Professionals
  • Diagnostics Leads
  • Precision Medicine Specialists
  • Commercialization Teams

What You Will Learn

Attendees will gain insights into:

  • Maximizing Global Access: Engage Key Opinion Leaders (KOLs) for market insights and implement early access programs to enable labs worldwide for biomarker testing, ensuring broad patient reach
  • Launching with a Companion Diagnostic (CDx): Validate the CDx for reliability and reproducibility, and plan for scenarios where lab-developed tests are used when a CDx is unavailable
  • The Importance of Early Access Programs: Design compassionate use programs to provide early patient access, build real-world evidence and drive adoption among healthcare professionals
  • Enhancing Biomarker Accuracy: Foster collaboration with pathologists to ensure consistent and accurate biomarker assessments, optimizing patient identification and treatment outcomes

Xtalks Partner

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Discovery Life Sciences

Discovery Life Sciences is a global leader in biospecimens and specialty lab services, enabling the discovery and development of therapeutics and diagnostics that improve patient outcomes. Their extensive portfolio of biospecimens, cellular starting materials, and preclinical ADME-tox solutions accelerates research with reliable, high-quality products and expertise. Through a comprehensive suite of specialty lab services in genomics, proteomics, cell biology, and molecular pathology, Discovery delivers critical data and insights for biomarker discovery and both retrospective and prospective clinical trials. With a vision to be the most trusted partner in life science research and clinical development, Discovery Life Sciences is committed to advancing life sciences and transforming lives. Visit www.dls.com for more information.

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