STATBOLIC Program

Arun J. Sanyal, M.D.

Virginia Commonwealth University

Patient-centric paradigm for clinical trials of metabolic disorders: bonding clinical research and clinical practice

Scott Evans (George Washington University)

A novel design to evaluate multiple indications related to metabolic disorders in one outcome study

Yongming Qu (Eli Lilly and Company)

Panel discussion:

Arun Sanyal (Virginia Commonwealth University), Ramy (Massino) Younes (Boehringer Ingelheim), Godwin Yung (Genentech/Roche), Kuen Ying Cheung (Columbia University), Feifang Hu (George Washington University)

Fireside Chat:  Statistical Challenges and Opportunities in Development of Products Treating Metabolic Diseases

Statistical Challenges in Clinical Trials in Evaluating Cardiovascular, Kidney, and Liver Diseases

What does the future of clinical drug development in MASH look like? 

Peter Mesenbrink (Novartis)

Hierarchical composite endpoint – a new win-ratio endpoint in chronic kidney disease 

Julie Funch Furberg (Novo Nordisk)

Hierarchical Composite Endpoint – A New Win-Ratio Endpoint in Chronic Kidney Disease

Julie Funch Furberg (Novo Nordisk)

Emerging issues in designing clinical studies evaluating treatments for chronic weight management

Yu Du (Eli Lilly and Company), Bryan Goldman (Novo Nordisk)

Potential endpoints in evaluating medication in chronic weight management

Rachel Batterham (Eli Lilly and Company)

Panel Discussion

Rachel Batterham (Eli Lilly and Company), Christine Lee (Amgen), Mandy Fräßdorf (Boehringer Ingelheim), Tim Friede (University Medical Center Göttingen)

Keynote Speaker

Arun J. Sanyal, M.D., is a Professor of Medicine, Physiology, and Molecular Pathology in the Division of Gastroenterology at Virginia Commonwealth University (VCU) Medical Center in Richmond, Virginia. At VCU, he is currently the Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health. His research interests include all aspects of NAFLD and NASH as well as complications of end-stage liver disease. He has been continuously funded by the NIH since 1995 and is the principal investigator of four active NIH grants.  He has pioneered the development of diagnostics and therapeutics for end stage liver disease and fatty liver disease and currently leads multiple global trials for this condition.  He is the recipient of the Distinguished Mentorship Award from the American Gastroenterological Association and the Distinguished Scientific Achievement Award from the American Liver Foundation in 2017 and the Distinguished Achievement Award from the AASLD in 2018. 

Keynote Speaker

Mark Rothmann, Ph.D., is the Director of the Division of Biometrics II. He earned his Ph. D. in Statistics at the University of Iowa in 1990.  He then spent the next nine years as a professor at various universities before coming to the FDA in 1999. At the FDA, when he was a reviewer and team leader he was involved in the review on Oncology, Hematology, and Metabolism and Endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials. He has served on and led many committee and working groups including Office of Biostatistics committees on Bayesian Analysis, Drug Trials Snapshots and Pediatric Studies. In 2024, he was selected as a Fellow of the American Statistical Association.