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Human biospecimens collection in the era of Personalized Medicine: challenges and perspectives

Why do we need your tissues? Modern biomedical research requires use of clinically characterized, high‐quality human biospecimens yielding high‐integrity analytes for development of novel medicines and companion diagnostic tests, biomarker assay development and, overall, achieving the goals of the personalized medicine. Effects of most important pre‐analytical biospecimen variables, significantly confounding human tissue research will be discussed: tissue collection specifications, processing materials and methods, storage and shipping procedures, molecular analyte preparation techniques, etc. Other issues include: collection of biospecimens using standard protocols versus project‐based collection protocols; using currently available biorepositories for future studies on the indicated subject; relevant regulatory and legal issues, including international disparities in regulations on using human materials for biomedical research.