Paul B. Watkins, M.D.
Director, Hamner-UNC Institute for Drug Safety Sciences
B.A., physical chemistry, Cornell University, Ithaca, NY, 1975.
M.D., Cornell Medical College, New York, NY, 1979.
Internship (Internal Medicine), The New York Hospital - Cornell Medical Center, July 1979 - July 1980.
Residency (Internal Medicine), The New York Hospital - Cornell Medical Center, July 1980 - July 1982.
Clinical Fellow, Medical College of Virginia, McGuire Veterans Administration Medical Center, July 1982 - July 1983.
Research Fellow, NIH Training Grant, Medical College of Virginia, Division of Environmental Medicine and Clinical Toxicology, July 1983 - July 1984.
Fellowship (Gastroenterology/Hepatology), July 1982 - July 1984.
Admission Ward Physician, Khao-I-Dang Cambodian Refugee Camp, Thailand, April 1982 - July 1982.
Paul 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). 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]
Selected Publications - click to view
Winnike, JH, Pediaditakis, P, Wolak, J, McClelland, R, Watkins, PB, Macdonald, JM. Stable Isotope Resolved Metabolomics of Primary Human Hepatocytes Reveals a Stressed Phenotype. In Press, Metabolomics.
Robertson, DG, Watkins, PB and Reily, MD. Metabolomics in toxicology: preclinical and clinical applications. Toxicol Sci 120(supp; 1): S146-S170, 2011.
Watkins PB, Desai M, Berkowitz S, Peters G, Horsmans Y, Larrey D, and Maddrey W. Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH): Application of This Data Organization Tool to Phase III Clinical Trials of Rivaroxaban after Total Hip or Knee Replacement Surgery. Drug Safety 34 (3)243-252, 2011.
O’Connell, TM and Watkins, PB. The application of Metabolomics to predict drug-induced liver injury. Clin Pharmacol Ther 88 (3):394-9, 2010.
Stewart JD, Horvath R, Baruffini E, Ferrero I, Bulst S, Watkins PB, Fontana RJ, Day CP, Chinnery PF. Common POLG genetic variants increase the risk of sodium valproate induced liver injury and failure. In press, Hepatology.
Wetmore BA, Brees DJ, Singh R, Watkins PB, Andersen ME, Loy J, and Thomas RS. Quantitative Analyses and Transcriptomic Profiling of Circulating mRNAs as Biomarkers of Rat Liver Injury. Hepatology 52 (6):2127-2139, 2010.
Winnike J H, LiZ, Wright FA, Macdonald JM, O’Connell TM, and Watkins PB. Use of Pharmaco-Metabonomics for Early Prediction of Acetaminophen-InducedHepatotoxicity in Humans.Clin Pharmacol Ther, Clin Pharmacol Ther, 88(1):45-51, 2010.
Fannin RD, Russo M, O’Connell TM, Gerrish k, Winnike JH, Macdonald J, JNewton J, Malik S, Sieber SO, Parker J, Shah R, Zhou T, Watkins PB, Paules RS. Acetaminophen dosing of humans results in blood transcriptome and metabolome changes consistent with impaired oxidative phosphorylation. Hepatology51(1):227-36, 2010.
Winnike J H, Busby MG, Watkins PB, and O’Connell TM. Effects of a prolonged standardized diet on normalizing the human metabolome. Am. J. Clin Nutr 90:1-6, 2009.
Harrill AH, Watkins PB, Su S, Ross PK, Harbourt DE, Stylianou IM, Boorman GA, Russo MW, Sackler RS, Harris SC, Smith PC, Tennant R, Bogue M, Paigen K, Harris C, Contractor T, Wiltshire T, Rusyn I, Threadgill DW. Mouse Model of the Human Population Reveals that Variants in CD44 Contribute to Acetaminophen-Induced Liver Injury in Humans. Genome Research (9):1507-15. 2009.
Zhou T, Chou J, Watkins PB, Kaufmann WK. Toxicogenomics: transcriptomic profiling for toxicology assessment. EXS, 99:325-66, 2009.
Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J. Rationale, Design and Conduct of the Drug Induced Liver Injury Network (DILIN) Prospective study. Drug Safety 32(1):55-68, 2009.
Hayashi, PH, Watkins, PB. Progress in our understanding of severe drug-induced liver injury. Liver Transplantation 15 (7):675-6, July 2009.
Watkins PB, Seligman PJ, Pears JS, Avigan MI, Senior JR. Using controlled clinical trials to learn more about acute drug-induced liver injury. Hepatology 48(5):1680-9, 2008.
Chalasani N, Fontana R, Bonkovsky H, Watkins PB, Davern T, Serrano J, Yang H, Rochon J. Causes, Clinical Features, and Outcomes From a Prospective Study of Drug-Induced Liver Injury in the United States. Gastroenterology 135(6):1924-34, 2008.
Rochon J, Protiva P, Seeff LB, Fontana RJ, Liangpunsakul S, Watkins PB, Davern T, Mc Hutchinson JG. The reliability of the RUCAM for assessing causality in drug-induced liver injury. Hepatology 48(4)1175-83, 2008.
Chaluda PC, Vahdat HL, Sharp RR, Delosier TC, Watkins PB, Pusek SN, Blackshear PJ. The Environmental Polymorphism Registry: a DNA resource to study genetic susceptibility loci. Human Genet. 123(2):207-14, 2008.
Poonkuzhali B, Lamba J, Strom S, Sparreboom A, Thummel K, Watkins PB, and Erin G. Schuetz. Association of BCRP/ABCG2 Phenotypes with Novel promoter and intron1 SNPs. Drug Metabo. Dispo. 36(1):146-54, 2008.
Olanow, CW, Watkins PB. Tolcapone: an efficacy and safety review. Clin Neuropharmacol 30(5):287-94, 2007.
Bushel, PR, Heinloth AN, Li J, Huang L, Chou, JW, Boorman, GA, Malarkey, DE, Houle CD, Ward S.M, Wilson RE, Fannin RD, Russo MW, Watkins PB, Tennant RW, and Paules RS. Blood gene expression signatures predict exposure levels. Proc. Natl. Acad Sci. 104(46):18211-6, 2007.
Isoherranen N, Ludington SR, Givens RC, Pusek SN, Dees EC,Blough D, Iwanaga K, Hawke RL, Schuetz EG, Watkins PB, Thummel KE, and Paine MF. The influence of CYP3A5 expression on the extent of hepatic CYP3A inhibition is substrate dependent: an in vitro-in vivo evaluation. Drug Metab Dispo. 36(1):146-54, 2007.
Wilke RA, Lin DW, Roden DM, Watkins PB, Flockhart D, Zineh I, Giacomini KM, Krauss R. Identifying genetic risk factors for serious adverse drug reactions: Current progress and future challenges. Nature Drug Discovery Reviews, 6(11):904-16, 2007.
Watkins PB, Dube LM, Walton-Bowen K, Cameron CM, Kasten LE. Clinical pattern of zileuton-associated liver injury: Results of a 12-month study in patients with chronic asthma. Drug Safety 30(9):805-15, 2007.
Leslie EM, Watkins PB, Kim RB, Brouwer KL. Differential inhibition of rat and human Na+-dependent taurocholate co-transporting polypeptide (NTCP/SLC10A1) by bosentan: A mechanism for species differences in hepatotoxicity. J. Pharmacol. Exp. Ther. 321(3):1170-8, 2007.
Watkins PB, Kaplowitz N, Slattery J T, Colucci SV Colonnese C, Stewart P, Harris SC. High incidence of ALT elevations in healthy subjects receiving 4 grams acetaminophen daily: Results of a randomized, placebo controlled, single blind trial. JAMA 5:296(1):87-93, 2006.
- Alison H. Harrill, Ph.D.
- Barbara A. Wetmore, Ph.D.
- Brett A. Howell, Ph.D.
- Darol E. Dodd, Ph.D., DABT
- Edward L. LeCluyse, Ph.D.
- Harvey J. Clewell III, Ph.D., DABT
- Jeffrey L. Woodhead, Ph.D.
- Jerry Campbell, Jr., Ph.D.
- Jingbo Pi, M.D., Ph.D.
- Joshua A. Harrill, Ph.D.
- Kyoungju Choi, Ph.D.
- Melvin E. Andersen, Ph.D., DABT, CIH
- Miyoung Yoon, Ph.D.
- O. Joe Trask, B.S.
- Paul B. Watkins, M.D.
- Qiang Zhang, M.D., Ph.D.
- Rebecca A. Clewell, Ph.D.
- Russell S. Thomas, Ph.D.
- Sudin Bhattacharya, Ph.D.
- Yuching Yang, Ph.D.