From Sample to Insight: The Clinical Laboratory Chain of Responsibility | Webinar

Safeguarding Samples, Data, and Decisions Across the Clinical Biomarker Journey

Overview

A clinical laboratory does far more than process samples and report results.

Every patient-derived sample passes through a chain of interconnected processes before it becomes interpretable biomarker data. Sample collection and handling, traceability, laboratory operations, analytical performance, data interpretation, and final delivery can all influence whether a biomarker result ultimately provides meaningful information for a clinical study.

In this Nordic Bioscience webinar, we look beyond individual assays and laboratory technologies to examine the broader systems required to generate reliable, actionable biomarker insights.

Using the Chain of Responsibility as a framework, the webinar follows the clinical sample journey from collection through laboratory processing and biomarker measurement to data interpretation and its potential impact on clinical development.

The discussion will examine where risks can arise, how laboratories work to protect sample and data integrity, and why reliable biomarker measurement depends on much more than analytical performance alone.

What you can expect to learn

• Why the clinical laboratory’s responsibility extends beyond sample processing and biomarker measurement.
• How pre-analytical factors can influence the quality and interpretability of biomarker data before a sample reaches the analytical stage.
• Why accessioning, traceability, and controlled sample handling are essential throughout the clinical sample journey.
• How operational and analytical excellence work together to generate reliable biomarker measurements at scale.
• Why data interpretation and delivery are integral parts of the laboratory process rather than simply its final output.
• How clinically meaningful biomarkers connect laboratory measurements with questions relevant to clinical development and patient outcomes.
• Where risks can emerge across the sample journey and how an integrated laboratory framework can help reduce them.

Topics

1. Welcome and introduction

Prof. Dr. Morten Karsdal, CEO, Nordic Bioscience

An introduction to Nordic Bioscience, the speakers, and the central question of the webinar: what does it take to turn a patient-derived sample into biomarker data that can reliably support clinical research and decision-making?

2. The Chain of Responsibility: Five clinical laboratory processes essential for success

Charlotte Van Liedekerke, Senior Alliance Project Manager, Nordic Bioscience

The journey of a clinical sample does not begin when an assay is run, nor does it end when a result is generated.

This presentation introduces the Chain of Responsibility framework, following patient-derived samples through five interconnected areas that contribute to reliable and interpretable biomarker data:

• Pre-analytical integrity – protecting sample quality from collection onwards.
• Accessioning and traceability – maintaining control and visibility throughout the sample journey.
• Operational and analytical excellence – ensuring robust, reproducible, and scalable laboratory execution.
• Data interpretation and delivery – transforming analytical output into information that can be understood and used.
• Clinically meaningful biomarkers – ensuring that what is measured can address relevant biological and clinical questions.

The presentation will explore risks across these stages and demonstrate why the reliability of biomarker data depends on the integrity of the entire process rather than any single analytical step.

3. Scientific perspective: Connecting laboratory quality with clinical development

Dr. Asger Reinstrup Bihlet, CSO, NBCD

A broader scientific and clinical-development perspective on why biomarker data must be considered in the context in which it is generated and ultimately applied.

The discussion will connect laboratory processes with the requirements of clinical studies and examine how robust sample management, biomarker strategy, and interpretation contribute to generating data that can support meaningful development decisions.

4. Q&A and discussion

All speakers

Open discussion and audience questions on the clinical sample journey, laboratory processes, biomarker implementation, and the challenges involved in generating reliable and decision-ready biomarker data.

Speakers

Prof. Dr. Morten Karsdal

• Dr. Morten Karsdal joined Nordic Bioscience in 2001 and became CEO in June 2010, leading the company to significant advancements in biomarker development and disease biology.
• Dr. Karsdal is a KOL in extracellular matrix research, with more than 700 publication, 44,684 citations, and an impressive H-index of 106.
• Dr. Karsdal is an honorary professor of inflammation research at the University of Southern Denmark, where he continues to supervise PhD students, fostering the next generation of researchers.
• Dr. Karsdal chairs the Extracellular Matrix Pharmacology Congress, an important forum for advancing drug development by focusing on the extracellular matrix (ECM) as a key factor in most chronic diseases. He is renowned for his deep expertise in fibrosis, rheumatology (including rheumatoid arthritis and osteoarthritis), diabetes, and other chronic conditions, particularly in relation to ECM and biomarker research.
• Dr. Karsdal has led the development of FDA-approved and supported molecular diagnostics, as well as more than 100 commercialized biomarker assays, including ELISA assays and high precision automated platforms.
• He has extensive experience in clinical trial design and the clinical application of biochemical markers, often serving as a consultant to major pharmaceutical companies for the use of serological biomarkers in clinical trials.
• In 2016, he and his research team authored the first edition of “Biochemistry of Collagens, Laminins and Elastin,” published by Elsevier Science. The book, now in its 3rd edition as of 2023, is a key resource on collagens and structural proteins, with a focus on their applications in chronic diseases.

Charlotte Van Liedekerke

• Charlotte Van Liedekerke is Senior Alliance Project Manager at Nordic Bioscience, where she works at the intersection of biomarker science, clinical research, and strategic pharmaceutical partnerships.
• With a background in Biomedical Sciences from the KU Leuven and an MBA in Bio-Entrepreneurship from the Copenhagen Business School, she combines scientific expertise with business and project leadership.  
• She partners with global pharmaceutical and biotechnology companies to manage biomarker projects, facilitating collaboration between clinical teams, laboratories, and key stakeholders throughout drug development programs. 
• Prior to joining Nordic Bioscience, she conducted oncology research in Belgium, Austria, and Spain, providing her with hands-on experience across different research environments.  
• Recognized on the Forbes Belgium 30 Under 30 list in 2024, she represents a new generation of professionals shaping the future of life sciences through collaboration between science and industry. 

Dr. Asger Reinstrup Bihlet

• Dr. Reinstrup Bihlet is the Chief Scientific Officer of Sanos and is an internationally renowned expert in musculoskeletal drug development, pain, and clinical trial design.
• He holds a PhD for the University of Southern Denmark, and a master’s in Pharmaceutical Science (M.Sc. Pharm) from University of Copenhagen.
• During his 20+ years in the industry he has held several leading positions in pharma and clinical research organizations within regulatory affairs, medical affairs, and clinical science.
• Dr. Reinstrup Bihlet has a H-factor of 22, and has published more than 50 peer-reviewed papers, primarily on musculoskeletal clinical science, in high-ranking journals including The Lancet and JAMA.
• He is a frequent speaker at international MSK Conferences such as OARSI, EULAR, and ACR, where more than 100 original abstracts have been presented, in addition to invited speaker sessions on musculoskeletal trial design and placebo response mitigation.
• As Chief Scientific Officer, he currently leads the scientific and medical activities of Sanos and the subsidiaries CROs including the leading Global MSK niche-CRO NBCD.
• As chief scientist, has led of a long series of global trials totaling approximately 18,000 study participants evaluating experimental treatments in MSK conditions.
• Dr. Reinstrup Bihlet is actively researching in the fields of arthritis and osteoporosis, with a particular focus on optimizing clinical trial methodology and outcomes.

The webinar is organized exclusively by Nordic Bioscience.