Lessons Learned from Completed Trials in NAFLD/NASH, PBC and PSC
Sponsored by: Covance
- Liver Diseases
- Non Alcoholic Steatohepatitis
Date: 13 February
Time: 3PM London/10AM New York
The first pivotal study in NASH was posted on clinicaltrials.gov only three years ago. Now, five Phase III trials are underway with one- and two-year Phase II data already published or communicated. These trials have helped shape and refine approaches in trial design, patient identification and operational conduct, which are key factors for enabling more efficient trials in the future.
In the case of Primary Biliary Cholangitis (PBC), it took nearly two decades after the approval of ursodeoxycholic acid (UDCA) before a second drug, obeticholic acid (OCA), was approved. However, it is unlikely that the development of additional therapies will be as protracted. Currently, one compound is in Phase III and several others are being evaluated in Phase II trials.
In this webinar, we will discuss key lessons learned in clinical development over the past three years in NAFLD, PBC and PSC.
Claudia Filozof, MD, PhD,
Executive Medical Director, CVMER (cardiovascular, metabolic, endocrine, renal) group, Covance
Dr. Filozof joined Covance in 2014 and consults on NAFLD/NASH research projects, as well as provides medical oversight. Her career spans almost 20 years in academic research and 15 years in the pharmaceutical industry. Dr. Filozof has led multiple drug development programs in obesity, lipids, diabetes and NAFLD, and has been actively involved in clinical development in NASH since 2011.
Arun Sanyal, MD,
Professor of Medicine and Chairman of Gastroenterology Division at Virginia Commonwealth University (VCU) School of Medicine, Richmond, VA
Dr. Sanyal serves as chairman of the National Institutes of Health Nonalcoholic Steatohepatitis (NASH) Clinical Research Network. He is a member of the Scientific and Clinical Advisory Boards at Galmed Pharmaceuticals Ltd. Additionally, he 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.
Naga Chalasani, MD, FACG,
Professor of Medicine and Cellular & Integrative Physiology, Associate Dean of Clinical Research, Indiana University School of Medicine
In a series of translational studies, Dr. Chalasani has characterized the role of leptin, adiponectin, cytochrome P450 2E1, GPI-PLD and FADS1 in NASH. His studies also observed that patients with NAFLD have a higher risk for cardiovascular disease, a common cause of death in NAFLD patients. He helped develop an Ossabaw swine model for NASH, and he has published over 180 articles, as well as co-edited a textbook titled Alcoholic & Nonalcoholic Fatty Liver Disease - Bench to Bedside (Springer 2015).
Gideon Hirschfield, MA, MB, BChir, FRCP, PhD,
Lily and Terry Horner Chair in Autoimmune Liver Disease, Professor of Medicine, University of Toronto and Staff Physician, Toronto Centre for Liver Disease, University Health Network
Professor Hirschfield is an internationally trained clinician scientist committed to discovery and translational science in liver disease. His research seeks to understand, manage and provide individualized treatment to patients with immune/inflammatory-mediated liver diseases by bridging discovery science, clinical trials and development of risk-stratified clinical care pathways. He has published numerous studies as an expert in hepatology and liver diseases.
Key Learning Objectives
- Leverage lessons learned to create more efficient study designs
- Discuss patient populations and study endpoints
- Learn how to reduce screen failure rates, as well as manage unpredictable placebo behavior
- Understand new developments in non-invasive biomarkers and PRO instruments
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Clinical Development Manager
- Procurement Manager