Immune-cell specific biomarker of early intestinal inflammation: Neutrophil elastase degraded fragment of type III collagen is elevated in patients with inflammatory bowel disease
Introduction
Inflammatory Bowel Disease (IBD) is characterized by epithelial barrier injury of the gastrointestinal (GI) tract and is driven by abnormal immune responses and excessive secretion of proteases from immune cells. Among these, neutrophils are the first to migrate into the inflamed interstitial matrix, where type III collagen is significantly deposited. Early detection of mucosal inflammation is crucial to prevent cumulative clinical damage, as a delayed diagnosis can hinder effective treatment.
In this study we aimed to develop a biomarker that reflects early intestinal inflammation prior to it becoming medically evident; allowing us to distinguish patients that would benefit from an anti-inflammatory treatment.
C3-HNE levels are elevated in patients with IBD compared with HD. This increase is also observed in conditioned media from primary neutrophils activated with lipopolysaccharide (LPS) for six hours. Importantly, C3-HNE reflects the early stages of clinically apparent mucosal damage in experimental models of colitis. As such, this biomarker holds promise for identifying early mucosal injury or acute inflammation in the gastrointestinal tract. Nevertheless, additional studies are needed to evaluate its clinical validity.
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Blood-based biomarkers of type III collagen remodeling as surrogate markers of endoscopic disease activity in patients with ulcerative colitis
Introduction
The chronic inflammation of Ulcerative Colitis (UC) causes excessive extracellular matrix (ECM) remodeling, resulting in clinical complications. Currently, endoscopic evaluation remains the gold standard method for determining disease activity. However, novel methods are wanted due to its invasiveness and accompanying patient discomfort.
As type III collagen is a major component of the intestinal ECM and a target for multiple proteases catalyzing its remodeling in IBD, we sought to investigate two blood-based neoepitope biomarkers of type III collagen degradation, and fibrosis resolution as surrogate markers of disease activity.
C3M was elevated at Week 0 in UC patients with severe endoscopic disease activity according to the Total Mayo Score. The fibrolysis biomarker, nordicCTX-III™, was significantly elevated in patients with moderate endoscopic disease at week 0 and numerically elevated in mild disease compared to severe disease activity.
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Watch this webinar focused on tissue remodeling, inflammation and biomarkers for pulmonary diseases. Our panel of experts will shed light on the tissue changes occurring in pulmonary diseases including idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease, and how this is affected by the intricate interplay between fibroblasts, epithelial cells, and immune cells.
Extracellular Matrix is an Active Agent in Lung fibrosis – Dr. Janette Burgess
The Role of the Epithelium in Pulmonary Fibrosis – Dr. Gisli Jenking
Prognostic and Pharmacodynamic Biomarkers for ECM Remodeling, Immune Cell Activity, and Endotyping – Dr. Jannie M. B. Sand
General discussion and questions
Scientific topics and speakers
The speakers will take you on a journey from discovering novel biomarkers to implementing them in clinical trials and clinical practice. They will discuss why blood-based biomarkers are needed for pulmonary diseases, and how biomarkers of ECM remodeling and immune cell activity may aid in the identification of novel endotypes and improvement of drug development.
Here’s a sneak peak of Dr. Janette Burgess’ talking points:
How changes in the composition of the ECM in lung fibrosis impact cellular function
How the ECM organization changes in lung fibrosis, and implications for disease driving processes
How matrix stiffness is altered in fibrosis and the cellular responses to these changes
How the above changes can be incorporated in model systems in vitro to expand our understanding of disease underlying mechanisms
Dr. Janette Burgess
Janette Burgess is a Professor of Extracellular Matrix in Disease Pathogenesis at the University Medical Center Groningen in the Netherlands.
She completed her Bachelor of Science (with honours) at the University of Adelaide, Australia, in 1991, and earned her PhD in Hematology at the University of New South Wales in 1998.
After a post-doctoral position at the University of Sydney focusing on the respiratory system’s structural changes in disease, she developed a keen interest in lung pathology.
In 2015, Janette was awarded a Rosalind Franklin Fellowship to join the University Medical Center Groningen, where she is now a tenured Professor.
Her research centers on understanding the role of the extracellular matrix (ECM) in lung pathology, investigating changes in lung tissue and airway structures during disease development.
Using primary human lung cells, tissue samples, and patient clinical information, her work aims to characterize ECM changes during lung diseases and uncover the underlying mechanisms.
Janette Burgess employs novel in vitro cell models, ex vivo human lung tissue models, and advanced microscopy imaging techniques to unravel the complex regulation of the ECM, exploring its potential as a therapeutic target for lung diseases.
Her research bridges basic science with the practical goals of preventing and treating human lung diseases that affect millions of people worldwide.
Dr. Jannie M. B. Sand
Dr. Jannie M. B. Sand is the head of the respiratory research department at Nordic Bioscience, having joined the company in 2010.
She holds a Master of Science in Molecular Biomedicine and a PhD in Clinical Research from the University of Copenhagen.
Dr. Sand’s research is dedicated to biomarker development and understanding lung tissue changes in chronic lung diseases, with a specific focus on pulmonary fibrosis and chronic obstructive pulmonary disease (COPD).
With over a decade of experience in biomarkers of lung tissue remodeling, she has authored over 50 articles, abstracts, and book chapters.
Her team at Nordic Bioscience focuses on developing non-invasive tools for specific lung disease processes, aiming to enhance understanding of pathologies and therapeutic effects.
The tools developed by Dr. Sand’s team include biomarkers for fibrogenesis, lung tissue destruction, basement membrane repair, and immune cell activity.
Their work spans both clinical and preclinical research, with a translational approach to bring tools to the broader community.
The team’s research has successfully identified prognostic and pharmacodynamic biomarkers and explores the identification of novel endotypes in chronic lung diseases.
Dr. Gisli Jenkins
Professor Gisli Jenkins is an NIHR Research Professor and holds the Margaret Turner-Warwick Chair of Thoracic Medicine at Imperial College London.
He serves as the Head of the Margaret Turner-Warwick Centre for Fibrosing Lung Diseases at the National Heart and Lung Institute, located at the Guy Scadding Building at the Brompton Campus.
Dr. Jenkins has honorary contracts with both the Royal Brompton and Harefield NHS Foundation Trust and the Imperial College Healthcare NHS Trust.
His primary research focus is on Interstitial Lung Diseases, with a particular emphasis on Pulmonary Fibrosis.
Prof Jenkins and his team strive to comprehend the biological foundations of pulmonary fibrosis, aiming to translate this understanding into improved outcomes for patients.
He is the Principal Investigator of several longitudinal observational studies, including the PROFILE study, the INJUSTIS Study, the UKILD Post COVID ILD study, and the DEMISTIFI Multi-Morbidity consortium.
Prof Jenkins serves as the pulmonary fibrosis working group lead for the Genomics England Clinical Interpretation Partnership in Respiratory Medicine, the PHOSP-COVID study, and the HEAL COVID platform study.
Recognitions include the ERS Gold Medal in Interstitial Lung Disease in 2020, Fellowship of the European Respiratory Society in 2022, and the role of President of Action for Pulmonary Fibrosis. He was also awarded the BTS Meritorious Service Award for 2022.
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Liver fibrosis is a progressive condition characterized by the excessive accumulation of scar tissue in the liver, often resulting from chronic liver diseases. Fibroblast activity plays a critical role in the progression of fibrosis, leading to organ function loss and liver-related complications. Liver fibrosis accounts for approximately 2 million deaths worldwide, while alcohol-related liver disease (ArLD) causes over 330,000 cirrhosis deaths globally every year.
In two recent studies, we investigated the fibrogenesis biomarker nordicPRO-C3™ in the context of advanced liver disease and full-spectrum fibrosis in alcohol-related liver disease. Our goal was to assess the nordicPRO-C3™ biomarker’s potential prognostic value and clinical utility as a predictor of outcome, and our results are very promising.
The nordicPRO-C3™ biomarker is capable of identifying advanced liver fibrosis and alcohol-related liver disease, providing a new clinical utility tool
In the first paper, published in JHEP Reports, we conducted investigations using two distinct cohorts of patients with compensated cirrhosis of mixed etiologies. In both cohorts, a 2-fold increase in nordicPRO-C3™ at baseline was associated with a significant hazard increase for liver-related events. Notably, nordicPRO-C3™ exhibited prognostic significance.
The identification of nordicPRO-C3™ as an independent prognostic factor for liver-related clinical outcomes has important implications for both drug development and clinical practice. By understanding the dynamic range of nordicPRO-C3™, researchers can improve its utility as a predictive marker in drug trials, enabling the development of targeted therapies to mitigate fibrosis progression and improve patient outcomes.
In a clinical setting, the integration of nordicPRO-C3™ measurement alongside established markers such as fibrosis-4 index (FIB-4) or transient elastography (TE) may enhance risk stratification and inform treatment decisions. Early identification of patients at higher risk for liver-related events can facilitate timely interventions, such as disease monitoring, lifestyle modifications, and appropriate therapeutic interventions.
In the second paper, published in Liver International, we assessed nordicPRO-C3™ models to predict liver-related events in patients with a history of excessive alcohol use but without a confirmed diagnosis of chronic liver disease. Our findings our promising for improving risk stratification and clinical outcomes in alcohol-related liver disease.
A prospective cohort study involving patients with alcohol-related Liver Disease (ArLD), was conducted and divided into a derivation cohort of secondary care patients and a validation cohort of primary care patients. Baseline variables, including nordicPRO-C3™, were utilized to develop a prediction model known as the ALPACA score. The prognostic accuracy of the ALPACA score was compared to existing tools such as the enhanced liver fibrosis (ELF) test, FIB-4, TE, and the ADAPT score (developed for fatty liver disease).
The ALPACA score demonstrated excellent discriminative accuracy in both the derivation and validation cohorts, comparable to TE and the ELF test, and superior to FIB-4, nordicPRO-C3™ alone, and the ADAPT score. Importantly, the ALPACA score provided reliable prognostic performance independent of the baseline fibrosis stage. This breakthrough has the potential to revolutionize risk stratification and patient management in primary and secondary care settings.
NordicPRO-C3™ has recently become available on the Roche-COBAS high-precision platform, paving the way for its commercial availability worldwide in the near future. This accessibility will enable widespread adoption of nordicPRO-C3™-based scores, leading to improved risk prediction and better outcomes for individuals.
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This webinar focuses on the intricate interplay between fibroblasts and arthritic diseases. Our panel of experts will unravel mechanisms behind tissue damage and repair, discussing fibroblast activation, collagen overproduction, and scar tissue formation.
Discover how blood-based biomarkers of extracellular matrix destruction offer insights into treatment effectiveness and patient well-being. Our speakers will also give insights into PRIME cells’ role in heralding rheumatoid arthritis flare-ups and delve into the molecular underpinnings of symptoms like pain and morning stiffness.
Agenda
Fibroblast Activation in Arthritis – Dr. Adam Croft
PRIME cells in Rheumatoid Arthritis Flares – Dr. Dana Orange
Identification of Fibrotic and Fibrolytic Endotypes in Rheumatic Disease Cohorts – Dr. Anne Bay-Jensen
We will explore how measuring tissue damage through blood markers can offer insights into treatment effectiveness and patient experiences. A segment is dedicated to PRIME cells, fibroblast-like entities in blood that signal rheumatoid arthritis flares. We will also delve into the molecular basis of symptoms like pain, morning stiffness, and flares in rheumatoid arthritis.
This webinar spotlights the buzz around developing fresh therapies targeting fibroblasts and fibrosis in arthritic diseases. By sharing the latest research, we aim to shed light on the specific roles and types of fibroblasts driving disease progression and outcomes.
Scientific topics and speakers
In this edition of the ECM Pharmacology Symposium Series, we’re diving into the realm of fibroblasts and their relevance in arthritic diseases. These cells are key players in disease progression, responsible for crafting collagen and extracellular matrix proteins that build the foundation of tissues. In arthritic conditions, activated fibroblasts kick into overdrive, generating excess matrix components, leading to the formation of scar tissue, or fibrosis, with potential impact on joints and tissues.
We will explore how measuring tissue damage through blood markers can offer insights into treatment effectiveness and patient experiences. A segment is dedicated to PRIME cells, fibroblast-like entities in blood that signal rheumatoid arthritis flares. We will also delve into the molecular basis of symptoms like pain, morning stiffness, and flares in rheumatoid arthritis.
This webinar spotlights the buzz around developing fresh therapies targeting fibroblasts and fibrosis in arthritic diseases. By sharing the latest research, we aim to shed light on the specific roles and types of fibroblasts driving disease progression and outcomes.
Dr. Adam Croft
Dr. Adam Croft is a Professor of Translational Rheumatology at the University of Birmingham and also serves as a Consultant Rheumatologist at University Hospitals Birmingham.
He holds a senior research fellowship from the Kennedy Trust for Rheumatology Research.
Dr. Croft’s research program encompasses the entire spectrum of inflammatory arthritis, spanning from children to adults.
His goal is to establish connections between synovial tissue pathology and specific disease outcomes and treatment responses.
He places a strong emphasis on the discovery of novel and actionable therapeutic targets, leveraging cutting-edge single-cell profiling technologies.
Dr. Croft’s research is particularly focused on understanding the role of tissue resident fibroblasts in perpetuating inflammation in immune-mediated inflammatory diseases and finding therapeutic strategies to target these cells effectively.
Dr. Dana Orange
Dr. Dana Orange, MD, MSc, holds the position of Associate Professor of Clinical Investigation at Rockefeller University and serves as an Assistant Attending of Rheumatology at the Hospital for Special Surgery.
She earned her medical degree from Weill Cornell Medical College, Cornell University, and obtained her MSc from Rockefeller University.
Dr. Orange completed her Internal Medicine Residency at New York Presbyterian Hospital and her Rheumatology Fellowship at the Hospital for Special Surgery.
Her research is dedicated to unraveling the molecular mechanisms behind symptoms associated with rheumatoid arthritis, including pain, morning stiffness, and flares.
Dr. Anne Bay-Jensen
Dr. Anna Bay-Jensen serves as the Chief Technology Officer (CTO) and Director of ImmunoScience at Nordic Bioscience, where she has been part of the team since 2008, starting as a post-doc and advancing to leadership roles.
She is recognized for her hard work, innovative thinking, and leadership in the development of novel biomarkers that support precision medicine, an ongoing journey.
Dr. Bay-Jensen’s research primarily focuses on biomarkers related to rheumatic diseases, with a particular emphasis on joints and rheumatoid arthritis, a field she has dedicated two decades to.
She has an impressive academic record with 10,459 citations, an h-index of 60, and an i10-index of 191, reflecting her significant contributions to the field.
Her research has highlighted the importance of extracellular matrix remodeling as a common denominator in connective tissue diseases and the development of novel combinations of post-translational modification (PTM) neo-epitopes as tissue-specific biochemical markers.
We have collected some of our best publications that we and our collaborators worked on in the second quarter of 2023—in no particular order. We invite you to browse and read according to your interests!
Hepatology
Alcohol-related liver disease (ArLD) leads to progressive liver-related outcomes and death, necessitating vigilant monitoring. Examining patients with ArLD over an average of 5.2 years, the PRO-C3-based score known as ALPACA (PRO-C3/AST/ALT, Platelets) demonstrated remarkable prognostic capability for liver-related events.
Comparatively, FIB-4, single markers like PRO-C3, ADAPT, ELF, and liver stiffness measures were all surpassed by the predictive efficacy of the ALPACA score in assessing outcomes for ArLD patients.
Fibronectin is a key protein for matrix organization and has been described as the glue of the extracellular matrix. The novel biomarker FN-EDB targets a degradation fragment of cellular fibronectin and showed to be elevated in patients with idiopathic pulmonary fibrosis.
This new biomarker enables quantification of a vital matrix embedded protein – laying the groundwork for important future studies.
In this study, we explored three collagen type III markers in the kidney’s interstitial matrix. These markers exhibited varied expressions and associations with inflammation, kidney function, and fibrosis in IgA nephropathy patients.
These findings emphasize the significance of selecting appropriate epitopes for distinct organs and diseases. Notably, urinary C3M emerges as a potential non-invasive fibrosis biomarker, complementing kidney biopsies in IgA nephropathy.
In our second renal publication, We examined whether collagen type III fragment C3M relates to inflammation markers and endothelial dysfunction, predicting chronic kidney disease (CKD) progression in type 2 diabetes patients with microalbuminuria.
Inflammatory markers and select endothelial indicators correlated with baseline serum C3M. Doubling serum C3M predicted CKD progression (accounting for mortality risk) post-conventional factor adjustment. These findings highlight serum C3M’s dual role as a CKD risk predictor and inflammation marker in type 2 diabetes.
Biomarkers aren’t just confined to different omics categories; various classes are referring to the types of serological measurements.
Consider cytokines, growth factors, receptors, kinases, transcription factors, intracellular proteins, extracellular proteins, and a subset within that—Extracellular Matrix (ECM) proteins. The common denominator in most pathologies is a loss of balance between different ECM proteins, especially collagens.
Biomarkers are more than just omics categories
This excessive destruction and deposition of proteins significantly propel the progression of end-stage diseases, culminating in organ dysfunction, failure, and, ultimately, death.
Diverse cytokines and growth factors orchestrating via specific receptors and kinases lead to ECM destruction and deposition, making ECM the converging pathway for multiple stimuli.
By the end of the day, what matters is to reverse ECM deterioration, or even undo, organ damage and function decline. Reversing organ damage can be achieved by stopping ECM deterioration. To truly reverse organ damage and restore organ functionality in patients, we need to repair the ECM to its normal balance.
We at Nordic Bioscience believe that the answer lies in effecting change at the tissue level—the key to reversing organ damage and, in turn, revitalizing organ function.
Have you considered if your treatment or pathway is affecting tissue formation or degradation? If so, feel free to browse our unique ECM biomarker portfolio.
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Nordic Bioscience’s extracellular matrix-based dermatology biomarkers offer a unique approach that sets them apart from competitors, providing deeper insights into tissue formation, degradation, immune cell activity, and resolution processes related to skin diseases. Unlike wide-range proteomics arrays, our biomarkers are fundamentally different and more specific, offering a higher level of clarity and precision.
Nordic Bioscience’s ECM-based dermatology biomarkers offer a unique approach
A clear connection
The clear connection between our dermatology biomarkers and skin diseases lies in the fact that immune cell activity, skin tissue remodeling and genetic mutations of collagens are known to cause these conditions. By identifying pathology specific biomarkers, we not only indicate the presence of a disease in a patient but also highlight the local manifestation of an underlying systemic cause. This genetic link and visible manifestation on the skin create a relatable narrative for stakeholders and pharmaceutical companies, potentially paving the way towards a better understanding of the disease.
A key advantage of our skin disease biomarkers is the limited competition in the market, and no approved biomarkers for skin diseases. With no competitors in the tissue-based biomarker space, we have the opportunity to position ourselves as leaders in this area. Supported by compelling data that demonstrates pathology specificity, disease activity, disease progression, and pharmacodynamic response, there is a rare chance for pharmaceutical partners to be among the first movers and pioneers in this field.
Moreso, we have observed that skin aging and cross-linking collagens are correlated. Our biomarkers can quantify the age of collagens by measuring alpha and beta CTX-III together with the ECM of the epidermis and dermis.
Nordic Bioscience can quantify specific pathological fragments from the different compartments of the skin
Implications for precision medicine
Precision medicine is a crucial aspect empowered by our dermatology biomarkers. By providing information about ongoing pathological processes within the tissue, such as damage and repair, we enable targeted treatments and therapies that enhance patient outcomes. This personalized medicine approach is far more effective than relying on proteomic providers’ hope of hitting the right target by chance. Our markers aid in drug development by specifically identifying target populations and reducing costs, ultimately expediting the development process.
Our skin disease biomarkers play a vital role in elucidating the mechanism of action (MoA) of treatments. Here, we can also shed light on the speed at which a compound modulates tissue and fibroblast derived biomarkers, providing essential information on the efficacy and responsiveness of the treatment.
Furthermore, by analyzing the objective disease activity, we can determine how the compound affects specific factors associated with the patient’s profile, such as neutrophil activity, mast cell activity, macrophage activity, soft tissue destruction, systemic fibroblast activity, and more. This holistic evaluation enables a deeper understanding of how the compound influences different aspects of the disease process, ultimately facilitating the development of more effective and targeted therapies for patients.
Robust technology
Our laboratory technology is robust and meets CLSI validation guidelines, ensuring reliability and accuracy. Moreover, our derma markers can be seamlessly integrated into Roche automated platforms, making them easily accessible worldwide. This scalability and dependability are vital for the development of reliable clinical research tools, further solidifying the value of our biomarkers in the field of dermatology.
A potential case for melanoma studies
While our dermatology markers have broad applicability, there is a particularly intriguing potential use in melanoma. By understanding the tissue formation, degradation, and repair processes specific to this type of skin cancer, we can offer valuable insights for diagnosis and management.
For clients involved in ongoing metastatic melanoma research, we can help establish a connection between extracellular matrix remodeling and melanoma, positioning our biomarkers as a valuable resource for further investigation and improving patient care.
Nordic Bioscience’s ECM-based biomarkers provide a relatable and comprehensive narrative by connecting genetic links, visible skin manifestations, and in-depth insights into ongoing pathological processes. With unparalleled clarity and understanding, our biomarkers empower precision medicine in skin diseases. Supported by robust technology, validated methodologies, and a potential application in melanoma, our biomarkers offer an unprecedented opportunity for stakeholders and pharmaceutical companies.
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This webinar focuses on the intriguing interplay between inflammatory bowel diseases (IBD) and neutrophil activity, with a special emphasis on the insights provided by the unique CPa9-HNE serum calprotectin.
Our experts will unravel the biological processes of mucosal damage and healing in inflammatory bowel disease (IBD), and how it relates to neutrophil activity and the extracellular matrix (ECM). Specifically, we will delve into the role of mucosal damage, intestinal fibrosis, and fibro-inflammation, and how they impact ECM remodeling and integrity.
The role of neutrophil activity in tissue destruction – Dr. Morten A. Karsdal
Mucosal damage and intestinal fibrosis in IBD – Dr. Florian Rieder
Fibro-inflammation in IBD a new frontier and how to quantify it – Dr. Joachim Høg Mortensen
Questions from the chat
Scientific topics and speakers
In this edition of the ECM Pharmacology Symposium Series, we will address the mechanisms of neutrophil activity in chronic diseases, in particular on fibro-inflammation in inflammatory bowel diseases, focusing in particular on fibro-inflammation and mucosal damage.
We will also present the latest methods for quantifying fibro-inflammation in IBD, such as the novel serum calprotectin biomarker CPa9-HNE, and discuss the implications of these findings for patients. In addition, we will look at current and future treatment options for IBD and the potential impact of these advances on patient outcomes.
This webinar is an excellent opportunity for researchers, clinicians, and healthcare professionals to gain valuable insight into the latest developments in IBD research and treatment, and to gain a deeper understanding of the intricate interplay of neutrophil activity, mucosal damage and fibro-inflammation in IBD.
Dr. Rieder’s clinical focus is patients with IBD with a special emphasis on the field of pathogenesis, prediction, and therapy of intestinal fibrosis.
Dr. Rieder has published over 150 articles (h-index 52) and book chapters and he has been awarded the Sherman Emerging Leaders award.
He is the lead author of the ECCO guidelines on Ulcerative colitis and the first ECCO clinical consensus on ‘Diagnosis and Management of Intestinal Fibrosis’. He is a past associate editor of Clinical and Translational Gastroenterology.
Dr. Rieder serves as an abstract reviewer for all major GI conferences and on several editorial boards of medical journals.
Dr. Rieder has significant ties to the ECCO, having served as the chair of Y-ECCO, a member of the ECCO operational board, a prior Y-ECCO committee member, and a member of the scientific committee.
He was the past chair of REACH-IBD and is currently the Co-Chair of the Professional Education Committee of the Crohn’s and Colitis Foundation.
Dr. Rieder is the leading Principal Investigator (PI) of the international Stenosis Therapy and Research (STAR) Consortium, which aims to test anti-fibrotic medications in stricturing Crohn’s disease.
Dr. Joachim Høg Mortensen
Dr. Mortensen joined Nordic Bioscience in 2013 and currently serves as Head of Department of Gastrointestinal Diseases.
The group’s research activities span from biomarker discovery to preclinical and clinical trial exploration focusing on the development and validation of blood-based biomarkers to quantify fibro-inflammation which covers neutrophil activity, mucosal damage and intestinal fibrosis in serum of patients with gastrointestinal diseases e.g. inflammatory bowel disease.
The group’s primary focus is to evaluate pharmacodynamics changes, efficacy and monitoring of response to various treatments using biomarkers reflecting fibro-inflammation.
Biomarkers are developed to support and understand fibro-inflammation-associated IBD disease progression and response to treatment, where the biomarkers are applied from target selection to clinical trial monitoring.
Dr. Morten A. Karsdal
Dr. Karsdal chairs the Extracellular Matrix Pharmacology Congress, an influential forum dedicated to advancing drug development by identifying changes in the ECM as common denominators in chronic diseases.
Dr. Morten Karsdal joined Nordic Bioscience in 2001 and has been serving as CEO since June 2010.
He is a prolific author, with more than 650 peer-reviewed articles to his name, accumulating over 34,000 citations and an h-index of 95.
He is renowned for his expertise and commitment to biomarker development, extracellular matrix biology, and disease research, particularly in fibrosis, rheumatology, and diabetes. He possesses extensive experience in clinical trial design and the clinical application of biochemical markers, consulting for major pharmaceutical companies.
As an honorary professor of inflammation research at the University of Southern Denmark, Dr. Karsdal supervises PhD students and contributes to advancing scientific knowledge in the field.
In 2016, he authored the first edition of “Biochemistry of Collagens, Laminins and Elastin,” published by Elsevier Science, which is now in its 3rd edition, providing a comprehensive overview of structural proteins and their relevance in chronic diseases.
Dr. Karsdal’s leadership and contributions to the Nordic Life Science community were recognized with the Arthur D. Little Nordic Life Science Award in 2023, highlighting his outstanding management and leadership achievements.
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In the field of clinical trials, accuracy and reliability are critical to success. For this reason, Nordic Bioscience Laboratory is dedicated to providing the highest quality laboratory services, with a strong focus on data integrity, customer satisfaction, and scientific excellence.
Our clinical laboratory offers central lab and specialty lab services, including a wide range of diagnostic and exploratory tests that are essential for meeting patients’ care needs and advancing drug development efforts. We use state-of-the-art equipment and technology, as well as a team of highly skilled laboratory professionals, to deliver fast, accurate and reliable results without sacrificing quality.
Nordic Bioscience Clinical Laboratory offers central and specialty lab services
Compliance at every step of the way
We pride ourselves on ensuring that biomarker validation complies with European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. In addition, we provide access to a team of scientific experts who have the experience and expertise to help you navigate the complexities of biomarker research, interpret data, and make informed decisions about your studies.
Our Clinical Laboratory is accredited by the College of American Pathologists (CAP) and all aspects of laboratory services are performed in accordance with international Good Clinical Practice (GCP) and Good Clinical laboratory Practices (GCLP) standards. Our accreditation reflects our unwavering commitment to providing the highest quality laboratory services that adhere to the most rigorous industry standards.
Commitment to improvement
As part of our ongoing commitment to continuous improvement, our processes, and procedures are regularly reviewed and audited by numerous external auditors and accreditation bodies. These audits enable us to continuously improve and innovate our laboratory services to meet the latest regulatory requirements. We also invest in the continuous education and training of our staff to stay abreast of the latest laboratory science. These efforts allow us to maintain our high-quality standards and ensure that our customers receive the best possible laboratory services, as well as scientific excellence that can help them interpret data.
At Nordic Bioscience Laboratory, we hold ourselves to the highest standard of quality and place a high value on providing a personalized experience for clinical testing. We are committed to serving as your trusted partner in delivering accurate and reliable laboratory services that help advance the field of clinical trials.
We hope that you will consider partnering with Nordic Bioscience for your clinical laboratory needs. We look forward to the opportunity to work with you and support your research activities.
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