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European Biopharmaceutical Review

Pinpointing the Problem

EBR: Biomarkers are fast becoming an essential part of drug discovery and development. How did we get here and what advantages do they bring?

Dr Mario L Rocci Jr: A biomarker is a tool we use to assess a bodily process or function. This can define what is abnormal or characteristic when a disease is present, and how this improves after the disease is ameliorated through some form of therapeutic treatment. For instance, biomarkers can involve the measurement of a specific substance in a blood, urine or tissue sample, or might be scans resulting from imaging evaluations.

So there are several ways that they can best be used in drug discovery and development. Efficacy biomarkers can be utilised as an indicator of whether a drug being manufactured is likely to be efficacious in improving disease. Good examples include the use of serum glucose measurements or the ability to reduce HbA1C levels when developing drugs to treat diabetes, and the use of serum cholesterol and low-density lipoprotein levels when creating therapies for atherosclerotic disease.

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Dr Mario L Rocci Jr, a Senior Vice President at ICON Laboratories, has authored over 150 publications including a book on regulated bioanalysis due out in 2017. He is a past president of the American Society for Clinical Pharmacology and Therapeutics and the American Association of Pharmaceutical Scientists (AAPS), where he received the AAPS Distinguished Service Award. Mario is a member of an External Advisory Board at the University of Kentucky, US, a fellow of the American College of Clinical Pharmacology, US, and a fellow and past Board member of the International Pharmaceutical Federation.
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