Dr. Cynthia Guy Presents at FDA Workshop on Using AI/Machine Learning in Clinical Trials

Duke Liver Pathology Division Chief Cynthia Guy, MD, presented at a virtual workshop sponsored by the U.S. Food and Drug Administration (FDA) on Sept. 18th-19th, 2023, titled “Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic Metabolic Syndrome Dysfunction-Associated Steatohepatitis (MASH) Clinical Trials.”

MASH is the most common form of chronic liver disease in the United States and many other countries due to the rising rates of obesity, diabetes, hypertension and dyslipidemia. Guy’s talk addressed the strengths and limitations of AI/Machine Learning in liver biopsy scoring for MASH clinical trials. Medical therapies are urgently needed to ease the high burden of disease and the risk of advancement to cirrhosis - a condition in which the liver is scarred and likely permanently damagedand to hepatocellular carcinoma, or liver cancer.

The workshop assembled leading experts from many fields to discuss knowledge gaps related to improvement in MASH clinical trials endpoints development. It featured updates about state-of-the-art use of biomarkers and noninvasive tests (NITs) based on recent advances in nonalcoholic steatohepatitis (NASH)/MASH clinical trials. Read more about the workshop here.

Guy is a gastrointestinal and liver pathologist with more than 20 years of clinical diagnostic experience, and is active in translational research. She has a special interest in NASH/MASH). She is a longstanding member of the NIH-sponsored NASH Clinical Research Network Pathology Committee, and a member of the International NAFLD Pathology Group. She received her MD degree from the Medical University of South Carolina, completed Anatomic and Clinical Pathology residency training at Emory University, and completed her fellowship at Duke University.