Institute for Drug Safety Sciences
Integrate clinical medicine with cutting-edge systems biology and in silico modeling platforms to make drugs safer and advance drug development.
Dr. Janet Woodcock (second from left), Director of the FDA Center for Drug Evaluation and Research, cuts the ribbon to mark the opening of The Hamner-University of North Carolina Institute for Drug Safety Sciences on June 11, 2009.
The Institute for Drug Safety Sciences (IDSS) is a unique partnership between the Hamner Institutes for Health Sciences, a private, nonprofit, translational research organization with over 30 years of experience in small molecule safety, and The University of North Carolina at Chapel Hill (UNC) Schools of Medicine and Pharmacy. The Hamner-UNC Institute for Drug Safety Sciences is committed to understanding, predicting, and preventing adverse reactions to drugs. Researchers implement innovative approaches to investigate the underlying mechanisms for rare or “idiosyncratic” toxicities that are often not discovered until late in the clinical development pipeline. The Institute’s goal of incorporating safety earlier in the drug development process is integral to The Hamner’s mission to improve public health outcomes. Hamner scientists are building computational models of toxicity pathways, in collaboration with industry and the FDA, to create a platform capable of predicting rare, drug-induced liver toxicities. The Institute is also developing new in vivo models to identify genes that are associated with drug-induced toxicities.
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The Hamner-University of North Carolina Institute for Drug Safety Sciences
Paul B. Watkins, M.D., Director
Paul B. Watkins, M.D., is the Professor of Medicine, Professor of Toxicology, and Professor of Experimental Therapeutics at The University of North Carolina at Chapel Hill (UNC), and serves as Director of the Institute for Drug Safety Sciences. As an internationally recognized expert in drug safety, Dr. Watkins has extensive research experience in drug-induced liver injury (DILI), which includes basic investigation in drug metabolism and transport, clinical studies, causation assessment, and regulatory affairs. He has been continuously funded for over 20 years by the National Institutes of Health for basic and translational research, and he is one of the most frequently cited authors in the field of pharmacology.
Dr. Watkins gave a presentation as part of the FDA Center for Drug Evaluation Research (CDER) Seminar Series, on October 26, 2011 in Washington, DC. His talk was entitled, "When Good Drugs Are Bad for the Liver." [Click here to view the recorded presentation]