Liver biopsy (LB) sample evaluation is an essential part of clinical studies in non-alcoholic steatohepatitis (NASH). However, LB remains a vastly controversial and debated subject. Histologic lesions of NASH are unevenly distributed throughout the liver parenchyma. Therefore, sampling error in liver biopsy can result in substantial misdiagnosis and staging inaccuracies. Additionally, though previous data suggested substantial or moderate concordance for some key histological NASH features (e.g fibrosis, ballooning degeneration), poor concordance in these components were reported in a recent trial.
The panel will present available data assessing reproducibility of liver biopsy reading in NASH, methodological aspects in the interpretation of data and potential limitations, discuss how to leverage lessons learned from other liver indications, brainstorm about potential central reading options and evaluate potential mitigation strategies to minimize the inter- and intra-subject variability.
Claudia Filozof, MD, PhD, Vice President, Liver Therapeutic Area Head, Global Clinical Development, Covance
Dr. Claudia Filozof joined Covance in 2014 and consults on non-alcoholic fatty liver disease and steatohepatitis (NAFLD/NASH) research projects, as well as provides medical oversight. She is board-certified in nutrition and metabolism and has broad expertise in diabetes, obesity and related metabolic disorders, including in NAFLD/NASH. Her career spans almost 20 years in academic research, as well as 15 years of experience in the pharmaceutical industry.
Dr. Filozof led multiple drug development programs in obesity and other metabolic diseases and has been actively involved in NASH clinical development since 2011. She is an active member of the Liver Forum, member of the American Association for the Study of Liver Diseases steatohepatitis working group and the European Association for the Study of Diabetes NAFLD group. She has published multiple manuscripts on obesity, lipids and diabetes as well as four recent review articles in Clinical Development in NASH.Message Presenter
Troy Johnson, MS, Statistical Fellow, Biostatistics, Covance
Troy Johnson has been with Covance since 2015 and has been in the pharmaceutical industry for 30 years, supporting all aspects of drug development from pre-clinical to post-marketing. He currently provides statistical consulting on optimal study design and DMC support for NASH clinical trials of various sponsors. He also has therapeutic experience in Alzheimer’s Disease and bone disorders and has served as lead statistician for many large studies leading to regulatory approval.Message Presenter
Pierre Bedossa, MD, PhD, Professor of Pathology, Liverpat
Dr. Pierre Bedossa is the leader of several national and European liver pathology consortia and is central pathologist for major international clinical trials in non-alcoholic fatty liver diseases. In 2018, he founded LIVERPAT, a company providing consultancy in liver pathology and he is a Visiting Professor at the Institute of Cellular Medicine, Newcastle University, UK.
After medical school at Paris University, Dr. Bedosso moved to the University of California, San Diego for a post-doctoral fellowship on molecular pathology of fibrosis. Back in Paris, he was nominated full professor and director of the department of pathology at Paris-Sud University. Then he served as Head of the Department of Pathology, Physiology, Nuclear Medicine and Imaging at the academic hospitals of Paris Nord-Val de Seine, France and was chairman of the Department of Pathology at Beaujon Hospital, Clichy, France. During that time, he led a research group at CNRS (Centre National de la Recherche Scientifique) then at INSERM (Institut National de la Santé et Recherche en médicine) focusing on pathophysiology of liver diseases and collaborated with several research teams around the world. He served European Society of Pathology as a member of the executive committee and then had the honor to be nominated President of ESP (2015-2017).Message Presenter
Arun Sanyal, MD, Professor of Medicine at Virginia Commonwealth University (VCU) School of Medicine, Richmond, VA
Dr. Arun Sanyal serves as chairman of the National Institutes of Health’s Non-alcoholic Steatohepatitis (NASH) Clinical Research Network. He is also chairman of the Gastroenterology Division at VCU. He is a member of the Scientific and Clinical Advisory Boards at Galmed Pharmaceuticals Ltd. Additionally, Dr. Sanyal is a member of the Scientific Advisory Board for Hepatic Clinical Medicine for Cardax Pharmaceuticals Inc. and at Exalenz Bioscience Ltd. He has authored more than 100 articles in publications including Gastroenterology, Hepatology and the Journal of Infectious Diseases.Message Presenter
Who Should Attend?
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Clinical Development Manager
- Procurement Manager
What You Will Learn
In this webinar, participants will learn:
- Available data assessing reproducibility of liver biopsy reading in NASH
- How to leverage lessons learned from other liver indications
- Potential mitigation strategies to minimize the inter- and intra-subject variability
- How training standards can be implemented
- Statistical strategies to maximize power and minimize the impact of this variability
- The potential use of new technology
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