Biomarkers are increasingly central to modern clinical development. They can help identify the right patient population, demonstrate target engagement, monitor treatment response, assess safety and support the development of targeted therapies.
However, not every biomarker serves the same purpose. How a biomarker is intended to be used can have important implications for the design, regulation and delivery of a clinical trial.
Designed around practical workshops and interactive learning, this half-day session gives participants the opportunity to classify biomarkers, work through real-world case studies, discuss regulatory scenarios in breakout groups and review trial documents to identify practical gaps. Concise expert-led sessions will provide the essential scientific and regulatory context, followed by facilitated exercises that show how biomarker use translates into decisions for protocols, schedules of assessments, diagnostic strategy and study delivery.
Learning Objectives
By the end of the workshop, participants will be able to:
- Define and classify common biomarker types and explain how they are used across clinical development.
- Explain how biomarker purpose and assay use can influence the regulatory pathway.
- Recognise where CTR and IVDR considerations may affect trial design, documentation and delivery.
- Identify common gaps in biomarker and investigational diagnostic planning.
- Apply practical considerations to protocols, schedules of assessments and study-readiness activities.
Audience Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Who Should Attend?
Professionals responsible for designing, reviewing or delivering biomarker driven clinical trials in Europe, including:
- Regulatory affairs professionals working across medicinal products and IVDs
- Clinical development and clinical operations teams
- Biomarker and translational medicine leads
- Diagnostic and companion diagnostic teams
- Laboratory, quality and assay-development specialists
- Professionals supporting protocols, submissions or site activation
The workshop is particularly valuable for teams that need to understand where drug and diagnostic requirements intersect and what that means operationally for a development programme.
Agenda
1. Biomarkers Explained: What They Are and How They Shape Clinical Development
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Types and classification of biomarkers
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Use from early development through pivotal trials
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Applications in patient selection, treatment monitoring, safety and evidence generation
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Examples across oncology, rare disease and immunology
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Interactive biomarker-classification exercise
2. From Biomarker to Investigational Diagnostic: When Regulatory Requirements Change
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Exploratory versus regulated use
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Intended purpose and clinical decision-making
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RUO, CE-marked and investigational IVDs
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CTR and IVDR requirements in practice
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Classification case study
3. The Changing EU Landscape for Biomarker-Driven Trials
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Current challenges at the CTR and IVDR interface
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EC COMBINE and the direction of regulatory coordination
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Potential implications of emerging EU initiatives
4. Putting Biomarker Strategy into Practice
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Protocols and schedules of assessments
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Evidence and documentation requirements
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Bridging strategies and limitations
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Laboratory and site readiness
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Group protocol-review exercise
5. Making Your Next Biomarker-Driven Trial EU-Ready
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Common gaps and avoidable challenges
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Practical preparation across functions
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Diagnostic-readiness checklist
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Ten take-home considerations
Speakers
Vladimir Vujovic
Amber McNair BSc(Hons), RSci, BCMAS, mTOPRA
