Drug Safety Sciences

Institute for Drug Safety Sciences


Paul Watkins, M.D., is the Verne S. Caviness Distinguished Professor of Medicine, Professor of Toxicology, and Professor of Experimental Therapeutics at The University of North Carolina at Chapel Hill (UNC). 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.

For more than a decade, Dr. Watkins has also been among a handful of hepatologists worldwide who have consistently advised industry and government agencies on drug development and regulatory issues related to DILI. Currently, he is chair of the scientific advisory boards for two FDA critical path research initiatives involving DILI: the Liver Toxicology Biomarker Study and the Computer Models for Human DILI Project. Dr. Watkins also serves as a scientific consultant for the Severe Adverse Events Consortium and the Preclinical Safety Testing Consortium. In addition, Dr. Watkins is now leading an Institute of Medicine initiative to craft a research agenda for the development of clinical biomarkers for DILI.

Dr. Watkins also chairs the steering committee for the Drug Induced Liver Injury Network (DILIN) which has been funded by the National Institutes of Health since 2004, and was expanded in 2008 to include 8 major academic institutions. A primary goal of the network is to collect complete clinical data and biospecimens (genomic DNA, plasma, urine, lymphocytes, and liver tissue when available) for mechanistic studies. Identity links are maintained, and subjects will be approached in the future and invited to participate in additional studies.

The Science Advisory Board

The Science Advisory Board, consisting of executives from five leading biopharmaceutical companies, academic scientists, and two members of FDA, shapes the strategic scientific direction of the Center for Drug Safety Sciences and will monitor its research progress.

Research Collaborations

The Istitute for Drug Safety Sciences is developing a number of formal agreements with key partners. For example, the Center and Entelos, Inc., a preeminent computational software company, are finalizing an agreement to create a new virtual liver model to assess DILI, for which FDA is providing seed funding. Using Hamner agreements with China Medical City and the Shanghai CDC, the Center is also looking at innovative ways to assess the safety of drugs used to treat tuberculosis patients. A memorandum of collaboration was recently signed with Risk Sciences, Inc., a postmarketing surveillance company with access to 17 million electronic medical records. Additional agreements are underway with one of the top tissue-engineering experts in the U.S. as well as a major pharmaceutical company that is assigning rights to a novel biomarker strategy that can be used to diagnose liver damage based on circulating RNA.