Nonalcoholic fatty liver disease (NAFLD) is a growing cause of chronic liver disease globally, both in children and adult populations. As the rate of increase in obesity and diabetes begins to level off, we anticipate a concomitant slowing of the incidence of NAFLD cases, but still to a level of circa 20% increase in total new cases in the next 15 years. At the same time, many current NAFLD patients will continue to progress to more advanced stages of NASH leading to a projected 100-140% increase in HCC, liver cirrhosis, new cases of decompensated cirrhosis and liver related death.
While liver biopsy remains the gold standard for staging of disease, complications of this procedure and other well-recognized limitations make it impractical for widespread use given the overall NAFLD disease burden. Non-invasive imaging modalities are increasingly being applied to evaluate and stage NAFLD in patients given the wide spectrum of disease, with a potential to discern underlying inflammation and staging of fibrosis. The objective of this presentation is to discuss the role of these new and promising non-invasive imaging modalities to assess disease severity in NAFLD.
NAFLD in children has rapidly evolved into the most common liver disease in the pediatric population and is a management challenge for general pediatric practitioners. Pediatric NASH often displays a histologic pattern distinct from that found in adults. Liver biopsy remains the gold standard for diagnosis of NASH. The objective of this presentation is to discuss the challenges in clinical development in NASH and future directions in the diagnosis of this disease.
Claudia Filozof, MD, PhD
Executive Medical Director, CVMER (cardiovascular, metabolic, endocrine, renal) group
Dr. Filozof joined Covance in 2014 and is responsible for medical oversight and consulting on NAFLD/NASH projects. She is board-certified in nutrition and metabolism and has broad expertise in diabetes, obesity and related metabolic disorders. Her career spans almost 20 years in academia and 13 years of service in the pharmaceutical industry. Dr. Filozof has led multiple development programs in obesity, lipids, diabetes and her work has been focused on NASH since 2011. She is a member of the liver forum, the AASLD steatohepatitis working group and the EASD NAFLD group. She has recently published a number of papers in prominent Hepatology journals on medical needs, drug development opportunities in NASH and the design of flexible / adaptive clinical trial paradigms for NASH drugs.
Stephen Harrison, MD
Visiting Professor of Hepatology, University of Oxford, UK
Dr. Harrison has served as a Professor of Medicine at the Uniformed Services University of the Health Sciences and is currently a Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford. He is a past Associate Editor for Hepatology and is currently an Associate Editor for Alimentary Pharmacology and Therapeutics. He is a peer-reviewer for over 20 medical journals and internationally known for studies in hepatitis C and non-alcoholic fatty liver disease with over 170 peer reviewed publications in these fields. Dr. Harrison most recently served as a Colonel in the United States Army. Retiring in 2016, he concluded 20 years of dedicated service to his country. During his army tenure, he served as the Director of Graduate Medical Education at Brooke Army Medical Center, Associate Dean for the San Antonio Uniformed Services Health Education Consortium and Gastroenterology Consultant to the Army Surgeon General. Currently, Dr. Harrison serves as the Medical Director for Pinnacle Clinical Research.
Miriam Benedicta Vos, MD
Associate Professor of Pediatrics at Emory University School of Medicine
Dr. Vos is an Associate Professor of Pediatrics at Emory University School of Medicine, Director of Transplant Wellness at Children’s Healthcare of Atlanta and Director of Graduate Studies for Nutrition and Health Sciences in the Laney Graduate School, Emory University. Dr. Vos is an expert in pediatric liver diseases, childhood obesity and nutrition science and has over 15 years of experience in clinical and translational research for pediatric diseases. Her overall goals are to advance care for children with metabolic disease and liver disease through clinical studies addressing mechanisms, natural history, therapeutics development and prevention strategies. She has extensive clinical trial experience in pediatric liver diseases and has been the PI or site PI for 4 FDA regulated treatment trials in children with NAFLD and 4 mechanistic clinical trials including 24 hour, 4 week and 8 week feeding studies in children. She has been continuous NIH funded during her faculty career and has leadership roles in 4 NIH clinical research networks. She has multiple national and international leadership roles in the NAFLD field including serving as Pediatric Chair for the large Target NASH cohort study and on the steering committee of the Liver Forum.
- To understand the magnitude of the NASH health burden both in adults and children
- To learn how to apply non-invasive imaging techniques in clinical development in NASH
- To understand the challenges in the diagnosis, treatment and clinical development in children with NASH
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