Biomarkers in medicine
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Individualized medicine provides a powerful engine revolutionizing the practice of clinical pharmacology, tailoring genetic and molecular profiles of patients to improve therapeutic specificity, reduce treatment variability and minimize adverse drug events. In that context, advances in individualized medicine have transformed the science of clinical pharmacology and therapeutics from drug discovery through identification of drugable targets, development through stratification of disease risk, regulation through identifying pathways mediating off-target effects and utilization through personalizing drug regimens. ⋯ Insights in the mechanistic basis of cell, tissue and organ function, and their interface with the environment are being translated to define disease risk, identify processes mediating disease susceptibility, target mechanism-based therapies, and tailor prevention and control paradigms, providing previously unanticipated opportunities for patient-specific disease management. The emerging field of individualized medicine is transforming the practice of clinical pharmacology, driving the leading edge of discovery from the laboratory bench to the evidence basis of practice in the clinic, extending to populations, to transform healthcare and create predictive, personalized and pre-emptive solutions for tailored patient-specific therapeutic strategies.
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Biomarkers in medicine · Dec 2009
Interview with Janet Woodcock: progress on the FDA's critical path initiative.
Janet Woodcock is the Director of the US FDA's Center for Drug Evaluation and Research. Dr Woodcock has held various positions within the FDA's Office of the Commissioner from October 2003 until 1 April, 2008, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director of the Critical Path Programs. She oversaw scientific and medical regulatory operations for the FDA. ⋯ She previously served in other positions at the FDA including Director of the Office of Therapeutics Research and Review and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr Woodcock received her MD from Northwestern Medical School (IL, USA), and completed further training and held teaching appointments at the Pennsylvania State University (PA, USA)and the University of California in San Francisco (CA, USA). She joined the FDA in 1986.