Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease worldwide. Globally, the incidence of liver cirrhosis caused by NAFLD increased from 178,430 cases in 1990 to 367,780 cases in 2017 — a 106 percent increase — and the incidence is expected to continue growing. Consequently, there is a coming tsunami of patients with cirrhosis secondary to NAFLD and its complications. It is imperative that we find ways to change the natural history for these patients and slow progression of the disease. Treatment for patients with early NAFLD will need to focus on the underlying metabolic disease. However, for patients with cirrhosis, treatment will need to focus on reversing and/or slowing progression of fibrosis. Treatment in patients with portal hypertension may be more challenging as it is not clear at what point fibrosis is no longer reversible in this group, and will require addressing the hemodynamic changes (e.g., shunting) in portal hypertension.
Drug development sponsors face several challenges in conducting clinical trials in patients with cirrhosis secondary to NAFLD. This seminar will review the pathophysiology of cirrhosis and portal hypertension. We will discuss patient populations for drug development, the importance of the placebo response and screen failures, as well as clinical trial designs, drug development pathways and potential biomarkers that may be used in these clinical trials.
Register for this webinar to gain insights on liver cirrhosis from a key opinion leader, John M. Vierling, MD, FACP, FAASLD, AGAF, Professor of Medicine and Surgery, Chief of Hepatology, Director of Baylor Liver Health, Baylor College of Medicine. Dr. Vierling will be joined by Labcorp’s leading NASH scientists, Dr. Claudia Filozof, Dr. Joanne C. Imperial and Dr. Lara Dimick-Santos.
Claudia Filozof, MD, PhD, Vice President, Liver Therapeutic Area Head, Global Clinical Development, Labcorp Drug Development
Dr. Claudia Filozof joined Labcorp Drug Development in 2014 and consults on nonalcoholic fatty liver disease and nonalcoholic 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.
Joanne C. Imperial, MD, FAASLD, Senior Medical Director, Cardiovascular, Metabolic, Endocrine, Renal Therapeutic Area, LabCorp Drug Development
Joanne C. Imperial, MD, joined Labcorp as a Senior Medical Director in the Cardiovascular, Metabolic, Endocrine, Renal (CVMER) therapeutic area in September 2020. After obtaining her MD degree from New York Medical College, she pursued fellowships in Nutrition and Metabolism, Gastroenterology and Transplant Hepatology. She spent most of her career in academic medicine and was an Associate Professor at Stanford University Medical Center and Lucille Packard Children’s Hospital where she served as PI in many clinical trials in her specialty area of transplant hepatology, with special interests in autoimmune liver diseases, chronic viral hepatitis and nonalcoholic steatohepatitis/fibrosis.
Joanne was involved in the multidisciplinary Liver Forum since its inception and served as co-chair of the NASH Data Standardization Committee from 2014 to 2016 and co-authored the Forum’s first publication in Gastroenterology in 2017. She is an ongoing member of the Liver Forum cirrhosis working groups and the PSC Forum.
John M. Vierling, MD, FACP, FAASLD, AGAF, Professor of Medicine and Surgery, Chief of Hepatology, Director of Baylor Liver Health, Baylor College of Medicine
John M. Vierling, MD, FACP, FAASLD, AGAF, is Professor of Medicine and Surgery, Chief of Hepatology and Director of Baylor Liver Health at the Baylor College of Medicine in Houston, Texas. He also serves as Director of Advanced Liver Therapies (a clinical research unit) and Program Director of the Hepatology and Liver Transplantation Fellowship. He obtained his undergraduate degree in Biology with Great Distinction from Stanford University and his MD degree from Stanford University School of Medicine.
His honors include: Phi Beta Kappa, Alpha Omega Alpha, Best Doctors in America for the past 21 years, Top 1% physician rating by U.S. News and World Report, Who’s Who in America, in the World, in Science and Engineering, in Healthcare, the Albert Nelson Marquis Lifetime Achievement Award and the 2021 AASLD Distinguished Service Award. He currently serves on the NIH NIDDK Liver Tissue and Cell Distribution System Coordinating Committee and on the DILI Network’s DSMB. He is a former President of the American Association for the Study of Liver Diseases, Secretary-Treasurer of Digestive Disease Week® and Chairman of the National Board of Directors of the American Liver Foundation.
Lara Dimick-Santos, MD, Executive Medical Director in the Liver Indications Group, LabCorp Drug Development
Dr. Dimick worked at the US Food and Drug Administration (FDA) from 2009 to June 2021. She initially reviewed indications for gastrointestinal diseases and for inborn errors of metabolism (rare diseases). However, eventually she gravitated to review of liver disease indications and has been a major driver in the promotion of drug development for liver diseases since that time. Dr. Dimick was pivotal in the development of surrogate endpoints for clinical trials in nonalcoholic steatohepatitis (NASH) that facilitated the expansion of drug development for NASH. She was the main driver of the development of the clinical outcome endpoint of “progression to cirrhosis” on histopathology, which reduced the length of the clinical trials for many liver diseases by several years, making them feasible. This allowed a large expansion of drug development in liver diseases.
Who Should Attend?
This webinar is intended for biopharmaceutical professionals involved in NASH drug development, including roles as:
- Chief Medical Officer
- Chief Executive Officer
- Senior Medical Director
- Medical Director
- Clinical Development Director
- Research and Development Director
- Operational Director
- Senior Operational Director
- Clinical Director
- Senior Clinical Director
- Research Director
- Academic Investigator and Researcher
- Government Regulator
What You Will Learn
In this webinar, participants will:
- Learn about the definition and identification of the correct population for NASH-related cirrhosis clinical trials
- Review how to determine if NASH is the primary underlying etiology of liver disease
- Gain understanding on regulatory guidelines for accelerated approval and clinical benefit trials
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