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European Biopharmaceutical Review

The Road to Success

When thinking of biomarkers and their role in delivering personalised medicine, most will picture recent advances in oncology and, in particular, those that have arisen following seminal developments in human genomics, including the publishing of the human genome sequence in 1999. However, in reality, biomarkers have been around for much longer and have been driving a move to a more personalised approach to medicine for many years. This article examines both historical and modern groundbreaking examples to explain and exemplify the different types of biomarkers and their use in medicine.

Defining Biomarkers

There are many definitions of biomarkers, but this article will focus on one from a WHO collaborative study which defined a biomarker as “any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence of outcome or disease” (1). If this definition is extended to include the effects of treatments, interventions, and exposure to environmental agents such as chemicals or nutrients, the possibilities are endless.

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Dr Karen Hills is Director of Marketing and Medical Affairs at PredictImmune, focussing on the launch of new products and clinical studies. Her background includes medical and marketing roles in both startup companies and Big Pharma. Karen has a PhD from the University of Cambridge and an Executive MBA from London Business School, UK.

Professor Ken Smith is Professor of Medicine and Head of the Department of Medicine at the University of Cambridge and is Chief Medical Officer at PredictImmune. He trained in nephrology and clinical immunology and completed a PhD at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia. His lab runs a translational programme in autoimmune disease (particularly IBD, vasculitis, and SLE) that has led to the discovery of a novel prognosis-predicting biomarker currently in clinical trials and the identification of genes and pathways involved in disease pathogenesis.
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Dr Karen Hills
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Professor Ken Smith
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