Paul Hayashi | Associate Director, Drug-Induced Liver Injury, CDER/Office of New Drugs, Division of Hepatology and Nutrition
FDA

Dr. Hayashi is the Associate Director of DILI within the Division of Hepatology and Nutrition, FDA.  He received his Bachelor of Arts in microbiology at UCLA and MD at University of California (UC), San Diego.  After completing residency and gastroenterology fellowship at UC Davis in Sacramento, California, he completed a clinical research fellowship in the Liver Diseases Section, NIDDK, NIH.  He then completed a transplant fellowship at the University of Colorado, Denver. He completed a Master of Public Health at Saint Louis University (SLU), St. Louis, Missouri, while an assistant professor and transplant hepatologist there.  In 2006, he became Medical Director of Liver Transplantation at the University of North Carolina (UNC), Chapel Hill, serving in that capacity as associate and then full professor before joining the FDA in 2020.  His publications and research interests have been in cirrhosis epidemiology, transplant outcomes, and DILI, with the latter becoming his primary focus over the last 20 years. He was UNC’s Co-Principal Investigator for the NIH UO-1, Drug-Induced Liver Injury Network (DILIN) and remains Co-Chair of the DILIN’s Causality Committee.