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European Biopharmaceutical Review

Hidden Treasures

Nowadays, both the EMA and FDA want to see treatments based on solid evidence, but how can we document this? For many different diseases, therapeutic effects seem to be poorly defined and challenging to monitor. Fighting a symptom, such as lowering the body’s temperature during a fever, does not count. Truly desirable effects that should be assessed or monitored would include killing bad bacteria in case of an infection, thus lowering the body’s bacterial load.

Usual Matrix Used

Each individual biomarker is part of one or more of seven categories, as defined by the FDA and National Institutes of Health Working Group, including diagnostic, monitoring, prognostic and safety. Biomarkers are endogenous substances, usually easiest to determine in blood plasma, saliva or urine. These bodily fluids are not difficult to obtain and derived from or connected to the bloodstream, which nourishes all organs and is also in contact with the central nervous system and the cerebrospinal fluid. This blood-brain barrier protects our control centre from the detrimental influences of a great number of large molecular substances, which are not able to cross it.

Historically, many may first think of protein biomarkers. Proteins may indeed be closer to the body’s reaction to a disease than small molecules. However, detecting these specific proteins in the blood is not always easy. We have many thousands of proteins in the body which consist of amino acids, and the sequence of the connected amino acids is responsible for the function of the protein.

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Professor Hermann Mascher, founder and Bioanalytical Consultant at pharm-analyt Labor, has more than 100 publications in peer-reviewed journals, including two books by Wiley-VCH. He is also the inventor of three patents for biomarkers in the area of rare lysosomal storage diseases: Gaucher, NPC and metachromatic leukodystrophy.
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Professor Hermann Mascher
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