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European Biopharmaceutical Review

Validated Biomarkers: The Holy Grail

 

There is little doubt that biomarkers will be one of the major drivers of pharmaceutical and diagnostics research and development (R&D) in the next decade. The post-genomic sciences have identified numerous potential drug targets, opening the door to many novel therapeutics. However, this has made bridging the gap between drug discovery and clinical development more challenging than ever. By predicting the potential success of therapies in clinical trials, biomarkers have the potential to improve research efficiency, save on development costs and provide organisations with a valuable advantage over competitors. Increasingly, biomarkers will be used in decision-making throughout the development pipeline and in disease management once therapies are in the clinic. However, before the full benefits of biomarkers can be realised, there are various challenges to overcome.

A biomarker is defined as “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention” (1). Many types of biomarkers exist, including RNA, DNA, metabolites and proteins. For any particular research and development programme, the type of biomarker that best fits the purpose is often easy to identify, but the exact biomarker (or, indeed biomarkers) to use must first be discovered and then validated. Although the terms diagnostic and diagnostic test are frequently used interchangeably with biomarker and biomarker testing, biomarkers can only become diagnostics following the collection of much qualifying data, and the development of an easy-to-use testing kit.

Using biomarkers is considered a key approach to increasing productivity and decreasing costs in the pharmaceutical industry. Biomarkers have roles spanning all aspects of drug discovery and development, from research tools to clinical endpoints. Some biomarkers can help diagnose the state of a person’s biology and others have prognostic potential. In addition, biomarkers are vital to realising the goal of personalised medicine.


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Dr Ruth A VanBogelen is Director of Biomarkers and Proteomics at NextGen Sciences. She has 30 years’ experience using proteomics technologies to generate and test hypotheses for preclinical and clinical programmes, in both industry and academia, and has also led research into microbial proteomics at the University of Michigan Medical Centre. Ruth has published over 30 peer-reviewed scientific papers and has authored numerous review articles and book chapters on proteomics. She currently serves on the Editorial Board for Proteomics, Proteomics Clinical Applications and the Journal of Proteomics and Bioinformatics.

Dr M Walid Qoronfleh is Vice President of Business Development at NextGen Sciences. He has over 20 years’ commercial experience, with responsibilities including strategic planning, scientific direction, business development and marketing and sales strategy. Walid has held several senior management and executive positions with an emphasis on product development, commercialisation and portfolio management, as well as scientific, R&D and technology appointments. Walid received an MBA from Penn State University and has a Marketing certificate from the University of Wisconsin- Madison.

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Ruth A VanBogelen
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M Walid Qoronfleh
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