The current, but imperfect, gold standard for diagnosis of NASH fibrosis is the liver biopsy. While liver biopsy allows pathologists to directly observe liver tissue, its utility in both clinical trials and clinical practice is limited. For example, in clinical development, primary endpoint data relies on just a small portion of the liver and is subject to sampling and central reader variability. In clinical practice, the invasive, costly and potentially painful and risky biopsy procedure is unlikely to gain widespread acceptance and use in the routine diagnosis of NASH fibrosis. With several therapeutics expected to reach the market soon, there is an urgent need to develop non-invasive biomarkers for the identification of patients at high risk for NASH fibrosis to ensure the right patients get the right treatment, at the right time.
While there is no shortage of promising blood- and imaging-based biomarker leads, the application of a non-invasive biomarker in NASH is still largely under development. With the potential to revolutionize clinical trial design and patient access to new treatments, the race is on to find markers that not only have diagnostic potential but prognostic and treatment-monitoring utility. This expert-led webinar will review the most promising biomarkers for NASH fibrosis including their performance, advantages and limitations in both clinical development and in daily clinical practice.
Speakers
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 Nonalcoholic 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, 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.
Message Presenter
Kenneth Cusi, MD, FACP, FACE, Professor of Medicine, Chief, at The University of Florida at Gainesville
Dr. Kenneth Cusi has studied the role of defects in insulin secretion and insulin resistance to the development of type 2 diabetes mellitus (T2DM), as well as complications associated with T2DM, focusing on the underlying mechanisms of non-alcoholic fatty liver disease (NAFLD) in T2DM and its impact on dyslipidemia, diabetes control and cardiovascular disease. He is a professor of medicine in the Division of Endocrinology, Diabetes and Metabolism at The University of Florida.
Dr. Cusi published the first randomized, controlled trial on the role of pioglitazone for the treatment of NASH for patients with prediabetes or T2DM (Belfort et al, NEJM 2006). His current work centers on discovering the mechanism(s) leading to NASH and searching for novel treatments. He frequently lectures at meetings to discuss the role of obesity and NAFLD in T2DM. Dr. Cusi is a member of the National Institute of Health (NIH) Clinical and Integrative Diabetes and Obesity (CIDO) study section. He contributed to the panel of the 2012 and 2018 NASH guidelines of the American Association for the Study of Liver Diseases.
Message Presenter
Claudia Filozof, MD, PhD, Vice President, Liver Therapeutic Area Head, Global Clinical Development, Covance
Dr. Claudia Filozof joined Covance in 2014 and consults on nonalcoholic 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, diabetes and four recent review articles in clinical development in NASH.
Message PresenterWho Should Attend?
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Scientists
- Clinical Development Manager
- Procurement Manager
What You Will Learn
- Current and potential biomarkers including performance, advantages and limitations in clinical development and daily clinical practice setting
- A summary of the increasing number of trials aiming to validate blood tests, imaging modalities and combinations
- The critical role of the endocrinologist in the identification of NASH
- The use of non-invasive biomarkers in clinical development in NASH
Xtalks Partner
Covance Inc
Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®.
Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Information on Covance’s solutions can be obtained through its website at www.covance.com.
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