Senior Editor

Jay H. Hoofnagle, M.D. is the senior editor and primary author of LiverTox, responsible for researching the scientific literature, writing drug chapters with overview of drug induced liver injury. Dr. Hoofnagle is a graduate of Yale Medical School and did post-graduate training in internal medicine, gastroenterology, and hepatology. He has been a senior investigator in liver disease in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) for more than 40 years and is currently Director of the Liver Disease Research Branch, Division of Digestive Diseases and Nutrition, NIDDK. In that capacity, he administers a portfolio of basic and clinical research grants that examine the cause, natural course, prevention, and treatment of liver diseases. He also oversees clinical research networks such as the Liver Cirrhosis Network, the NASH Clinical Research Network, and the Drug-Induced Liver Injury Network. Dr. Hoofnagle is a former president of the American Association for Liver Disease and is a recipient of the Association’s Distinguished Achievement Award. He is the author of more than 500 articles in the medical literature and has conducted both clinical and basic research on liver diseases including hepatitis A, B, C, D and E as well as acute liver failure, nonalcoholic steatohepatitis, autoimmune liver diseases, biliary atresia and drug induced liver disease.

Deputy Editor

James E. Knoben, Pharm. D., M.P.H. is the deputy editor of LiverTox, and he provides expertise in drug classification and ensures integrity of the data within LiverTox. Dr. Knoben is a graduate of the University of California and holds an M.P.H. degree from Yale University Medical School. He has extensive experience in biomedical writing, including serving 30 years as co-editor of a drug information handbook that was utilized worldwide in clinical education and practice. He served 12 years as director of the Division of Drug Information Resources in the Food and Drug Administration, and more recently as drug information consultant to the National Library of Medicine, NIH.

Administrator

Ms. Marge Worrest is the administrator in support of LiverTox. Ms. Worrest is a graduate of Keystone College and has served in program management positions for several government agencies, including the Department of Defense in Strategic Planning, Budget and Program Finance, and the Department of Homeland Security in Program Budget and Mission Support-Reimbursable Programs and is a Certified Greenbelt in Six Sigma Lean practices. Ms. Worrest is responsible for developing schedules of updating, editing and outside review of the LiverTox website. She is responsible for the management of the External Expert Review Committee and the flow of the Committee’s reviews and updates of LiverTox.

External Expert Review Committee

The LiverTox External Expert Review Committee is comprised of three non-federal experts in drug induced liver injury, hepatology, pharmacology and/or herbal supplement safety. The members are appointed by the NIDDK and serve 3-year, renewable terms. The review committee provides oversight of the LiverTox database with respect to assessing new content and revisions/updates of current content; advising on improvements to the accuracy, format, reliability, and usefulness of the site; and advising on policies governing the LiverTox website. The Expert Review Committee is also responsible for ensuring accurate peer review of all new material added to LiverTox. Currently, the review committee consists of the following individuals:

Adrian M. Di Bisceglie, M.D. received his medical degree from the University of Witwatersrand, Johannesburg, South Africa and completed his training in Internal Medicine at Baragwanath Hospital, Johannesburg before doing a research fellowship at the National Institutes of Health (NIH) where he went on to become chief of the Liver Diseases Section, NIDDK. He is currently a Professor of Internal Medicine at Saint Louis University where he served as department chairman from 2006 to 2017. Dr. Di Bisceglie served on the governing board of the American Association for the Study of Liver Disease (AASLD) and was President of that organization in 2014. He has served on the editorial boards of many journals including Hepatology, Liver Transplantation and as Section Editor on Hepatitis C for UpToDate. Dr. Di Bisceglie has received numerous awards including the AASLD Distinguished Service Award and Outstanding St. Louis Scientist Award from the Academy of Science of St. Louis.

Herbert L. Bonkovsky, M.D. is Professor of Medicine and Molecular Medicine & Translational Research, and Director of the Liver and Metabolic Disorders Laboratory at Wake Forest University/NC Baptist Medical Center. He is a graduate of Case Western Reserve Medical School and did post-graduate training at Duke University, the National Institutes of Health and Dartmouth Medical School, and Liver and Gastroenterology fellowship training at Yale Medical School. He is board certified in internal medicine and gastroenterology. His research interests have been in porphyrin and heme metabolism, the effects of heme and iron on gene expression and intermediary metabolism and in drug and herbal induced liver injury.

Lily Dara, M.D. is an NIH-funded physician-scientist at the University of Southern California with a research interest in drug-induced liver injury and immune-mediated liver diseases. She is a graduate of Shahid Beheshti University of Medical Sciences in Tehran, Iran and completed an Internal Medicine Residency at Griffin Hospital, a Yale-affiliated program in Connecticut and Gastroenterology Fellowship at the University of Southern California in Los Angeles. She has served on the editorial boards of both Hepatology and Gastroenterology and is currently Vice Chair of the AASLD Hepatotoxicity SIG.

Dina Halegoua-De Marzio, M.D. is a transplant hepatologist and associate professor of medicine at Sidney Kimmel Medical College at Thomas Jefferson University (TJU). She completed her residency in internal medicine and fellowships in gastroenterology and transplant hepatology at TJU hospital. She developed the first adult Fatty Liver Center in the Delaware Valley and currently serves as its director. She also serves as the director of gastrointestinal research at TJU and is the associate chief for the Division of Gastroenterology and Hepatology. She been recognized “Teacher of the Year” for her specialty at TJU hospital and was placed on the Sidney Kimmel Medical College Education Honor Roll as an excellent educator. Her main areas of focus include nonalcoholic fatty liver disease and drug-induced liver injury. Her research has been presented internationally and published in numerous medical journals.

James H. Lewis, M.D., FAASLD, AGAF, FACG, FACP is Professor of Medicine on the Clinician-Scholar track of Georgetown University School of Medicine, Washington, DC, and Director of Hepatology in the Division of Gastroenterology, Med-Star Georgetown University Hospital, Washington, DC. A 1971 graduate of Oberlin College, he received his M.D. degree in 1975 from the State University of New York. Following a medical internship at Baylor College of Medicine and residency at Kings County Hospital-Downstate Medical Center in Brooklyn, NY, he completed his gastroenterology (GI) fellowship training (1978-1980) at George Washington University Medical Center in Washington, DC, where he remained on the faculty until 1985, under the mentorship of Hyman J. Zimmerman, M.D., with whom he worked for nearly 20 years in the field of drug-induced liver injury. He has held his present post at Georgetown University Medical Center since 1985, with a one year “sabbatical” to work at Glaxo Pharmaceuticals in drug development and medical affairs. He is a former voting member of the FDA GI Drugs Advisory Committee (1986-1990) and has served as a consultant hepatologist to the FDA. He remains an active consultant to the pharmaceutical industry in drug development and hepatic safety issues. He is the author of more than 450 journal articles, book chapters and abstracts, and the editor of three books. His principal clinical research interests are drug-induced liver disease and chronic viral hepatitis. He is the current Academic Lead for the IQ DILI Network.

External Review Committee Members, Years of Service

Herbert L. Bonkovsky, M.D. – 2019-present

Lily Dara, M.D. – 2023-present

Adrian M. Di Bisceglie, M.D. – 2019-present

Dina Halegoua-De Marzio, M.D. – 2024

James H. Lewis, M.D., FAASLD, AGAF, FACG, FACP – 2024

Raj Vuppalanchi, M.D. – 2019-2022

Ad Hoc Members of the External Expert Review Committee

The expert review committee may include ad hoc members, including other experts in drug induced liver injury from NIDDK and other NIH Institutes such as the National Library of Medicine and Office of Dietary Supplements as well as from the Food and Drug Administration and other Federal Agencies. The composition of the committee is subject to change as the database evolves.

Jose Serrano, M.D., Ph. D. is a physician scientist with postgraduate training in internal medicine, gastroenterology, and hepatology. As a Senior Scientific Officer in the Division of Digestive Diseases and Nutrition (NIDDK), he administers a basic and clinical research portfolio in a broad area of gastrointestinal diseases and since 2004 has been the Project Scientist for the Drug Induced Liver Injury Network (DILIN).

Mark Avigan, M.D., CM is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology at the Food and Drug Administration. As a clinical hepatologist with expertise in drug safety science, he served as a division director at FDA in drug safety from 2003 to 2011 and more recently as a consultant within the agency for the evaluation of drug-induced liver injury during the life cycle of drugs and biological agents. Dr. Avigan was a faculty member at the Georgetown University Medical Center until 1999 and was the principal investigator of NIH-funded grants in cell growth regulation. He is a long-standing member of the Drug Safety Oversight Board at the FDA’s Center for Drug Evaluation and Research and continues to have an active role in public-private partnerships that support the scientific and clinical analysis of hepatotoxicity.

Averell H. Sherker, M.D., FRCPC, FAASLD is Scientific Advisor for Viral Hepatitis and Liver Diseases in the NIDDK, NIH. He provides scientific guidance to the Division of Digestive Diseases and Nutrition as it focuses and accelerates research on liver disease at the NIDDK. He oversees a portfolio of research grants related to liver disease, including several clinical research networks. He acts as Program Official for the Drug-Induced Liver Injury Network. He received his MD from Queen’s University in Kingston, Canada and trained in medicine, gastroenterology, and hepatology at University of Toronto. He has molecular virology training from Stanford University and Chiba University, Japan. Previously, he was director of hepatology research at McGill University and subsequently was director of the Center for Liver Diseases at the Washington Hospital Center and attending physician and associate professor at Georgetown University School of Medicine.

Christopher Koh, M.D., MHSc, FACP, FAASLD is the Clinical Director for the Division of Intramural Research in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) and serves as investigator with the Liver Diseases Branch, NIDDK, NIH. As a clinical investigator, he has extensive experience in studying novel therapeutics in viral hepatitis, clinical biomarkers in liver disease, liver disease in rare populations, and drug induced liver injury. He also serves as the principal investigator for the NIH Clinical Center in the Drug Induced Liver Injury Network.

Paul H. Hayashi, M.D., MPH received his medical degree at the University of California (UC) San Diego and Master of Public Health at Saint Louis University. He completed fellowships at UC Davis, the National Institutes of Health, and University of Colorado. He is board certified in gastroenterology and transplant hepatology. He was Professor of Medicine and Medical Director of Liver Transplantation at the University of North Carolina (UNC) in Chapel Hill prior to joining the FDA in 2020 as a Medical Officer in the Center for Drug Evaluation and Research. While at UNC, he cared for patients across the spectrum of liver disorders including hepatotoxicity. He also served as Co-principal Investigator and Co-Chair of the Causality Committee for the Drug-Induced Liver Injury Network.

David Kleiner, M.D., Ph.D. is a graduate of the University of Chicago Medical School and earned a Ph.D. in Chemistry from the same institution. After a residency in Anatomic Pathology at the National Cancer Institute (NCI), he joined the faculty of the NCI’s Laboratory of Pathology. He is currently a Senior Research Physician and Chief of the Postmortem Section of the Laboratory of Pathology with expertise in hepatic pathology. His research has focused on chronic liver disease, with particular attention to assessing histological responses to therapy. Since 2005 he has served as the central pathologist for the Drug Induced Liver Disease Network of the National Institute of Diabetes and Digestive and Kidney Disease. He has authored over 400 articles in the medical literature and is the author of multiple book chapters and review articles on the histopathology of drug-induced liver injury.

Marc Ghany, M.D., M.H.Sc. is a Gastroenterologist and Investigator at the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases at the Clinical Center of the National Institutes of Health, Bethesda, Maryland. He started in the Liver Diseases Branch, NIDDK in 1996 as a Medical Staff Fellow and was made a Staff Physician in 2000 and promoted to a tenured Senior Investigator in 2022. His main areas of scientific focus include clinical research in liver disease and cirrhosis and the virology, epidemiology, and therapy of chronic viral hepatitis B and C. Dr. Ghany received his medical degree from the Royal College of Surgeons in Dublin, Ireland, completed his residency in Internal Medicine at St. Raphael’s Hospital in New Haven, a Yale-affiliated residency program, and finished a fellowship in Gastroenterology at Tulane University. From 1995-1996, he was a Clinical Instructor in the Department of Medicine, Section of Gastroenterology and Hepatology of Tulane University. He is board certified in Gastroenterology and Internal Medicine and has published over 200 original articles, editorials, and reviews on liver disease.

Martha C. Garcia, Ph.D. is a scientist with expertise on drug metabolism and liver toxicity. As a Program Officer in the Division of Digestive Diseases and Nutrition (NIDDK), she administers a basic and translational research portfolio in the areas of drug-induced liver injury and fatty liver disease.

Susan Yanovski, M.D. is co-director of the Office of Obesity Research at the NIDDK and the Senior Scientific Advisor for Clinical Obesity Research, Division of Digestive Diseases and Nutrition, NIDDK, NIH, Bethesda, Maryland. She coordinates obesity-related research activities across the Institute and serves as scientific lead for obesity within the Division of Digestive Diseases and Nutrition.

Gracia Viana Rodriguez, M.D. is a Fellow in the Division of Digestive Diseases and Nutrition (NIDDK), NIH, Bethesda, Maryland.

Milica Chernick, M.D. is a Medical Officer in the Kidney Disease Section of the Kidney Diseases Branch, Division of Digestive Diseases and Nutrition (NIDDK), NIH, Bethesda, Maryland. Areas of focus are: Clinical Research, Microbiology, and Infectious Diseases.

Maria Mironova, M.D. is a clinical hepatology fellow at the Liver Diseases Branch, NIDDK, NIH. Her research interests include non-cirrhotic portal hypertension and proteomics in metabolic dysfunction-associated steatotic liver disease.

Steven Casper, Ph.D. is a reviewer in the Office of Dietary Supplement Programs (ODSP) at CFSAN, FDA, College Park, Maryland. He reviews botanical dietary supplement ingredients in new dietary ingredient notifications submitted to ODSP and, as an Ethnobotanist, serves as a botany expert for FDA.

Frank A. Anania, M.D. is the Deputy Director of the Division of Hepatology and Nutrition (DHN) in the Office of New Drugs (OND) in CDER, FDA. He has extensive clinical and research experience related to Hepatology and helps to oversee reviews of drugs related to non-malignant, non-infectious liver diseases, including non-alcoholic steatohepatitis (NASH)/metabolic-associated dysfunction steatohepatitis (MASH).

Special Outside Reviewers

Special outside reviewers of content of LiverTox include experts on hepatotoxicity, pharmacology, herbal medicine, dietary supplements, and medical specialties such as cardiology, oncology, infectious diseases, neurology, gynecology and endocrinology. These include: Victor Navarro, M.D. [Thomas Jefferson University Hospital, Philadelphia, PA]; William Lee, M.D. [University of Texas, Southwestern, Dallas, TX]; Nazia Qazi, M.D. [Southshore University Hospital, Northwell Health Bayshore, NY]; Dwight Montgomery Bissell, M.D. [University of California, San Francisco, CA]; Andrew Stolz, M.D. [LAC University of Southern California Specialty Clinic, Los Angeles, CA]; Naga Chalasani, M.D. [Indiana University Health Physicians Gastroenterology, Indianapolis, Indiana]; A. Sidney Barritt IV, M.D. [The University of North Carolina at Chapel Hill, NC]; Craig Lammert, M.D. [Indiana University Health Physicians Digestive & Liver Disorders, Indianapolis, Indiana]; Robert Fontana, M.D., [University of Michigan Health System, Ann Arbor, MI], Gina Choi, M.D., [David Geffen School of Medicine at UCLA, Los Angeles, CA].

Editorial Support