HUM-MOLGEN events: NASH Populations with Cirrhosis: Drug Development Challenges and Solution

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

Speakers

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.

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.

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.