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European Biopharmaceutical Review

Essential Tools

Biomarkers play an important role in clinical trials, covering the whole spectrum of drug development from target identification and preclinical tests through Phase 1 studies into post-marketing. According to a recent report, around 12% of all trials registered in 2013 included biomarkers in outcome measures and/or inclusion criteria (1). They are primarily used in Phase 2 studies, helping to prove that the investigated product has the expected biological effect. Phase 1 trials assess the safety and tolerability of a new investigational drug and, although they are a starting point to identify the most valuable biomarkers for a subsequent Phase 2 study, the trial population is generally limited. Phase 3 studies usually include well-developed and characterised biomarkers, very often selected during Phase 2.

According to the FDA-NIH Biomarker Working Group definition, a biomarker is “a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions” (2). They can be molecular, histologic, radiographic or physiologic, including chemical and biochemical analyses from fluids and tissue biopsies, physiological assessments and medical image analysis. Each individual biomarker is part of one or more of the seven categories below, as defined by the Working Group:

  • Diagnostic
  • Monitoring
  • Pharmacodynamic (PD)/response
  • Predictive
  • Prognostic
  • Safety
  • Susceptibility/risk

Each category can have several contexts of use, describing the manner and the purpose of use for a given biomarker during development. For example, monitoring biomarkers can indicate drug-induced toxicity or detect changes in the extent of a disease, while those in the prognostic category could be used for enrichment strategies.

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Dr Mélanie Bodnar-Wachtel, PhD, is Scientific Expert for Biochemical Markers at Bioclinica Lab and is responsible for neurosciences and oncology projects. Drawing on her experience in academic and industry research, she is dedicated to bringing innovative solutions to the development of new technologies for biomarker assessment and in expanding Bioclinica Lab’s biomarker portfolio. She earned a PhD in Sciences, speciality Molecular, Integrative and Cellular Biology from Université de Lyon, France, and a Master’s degree in Biology and Health, speciality Oncogenesis, from École Pratique des Hautes Études, France.

Dr Tanja Schubert, PhD, is Vice President and General Manager of Biochemical Markers at Bioclinica Lab. She leads the Molecular Marker Lab division of the company and is responsible for all operational activities, including lab processes, service quality, study management, process improvements and regulatory compliance. She holds the accreditation of the College of American Pathologists for Bioclinica Lab and is a trained Pharmacist, with a PhD in Natural Sciences from Ludwig- Maximilians-Universität München, Germany.
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Dr Mélanie Bodnar-Wachtel
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Dr Tanja Schubert
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