Global Liver Institute Externally-Led Patient Focused Drug Development Meeting Nonalcoholic Steatohepatitis (NASH)
On November 4th at 10 AM ET, Global Liver Institute led an Externally Led Patient-Focused Drug Development Meeting on NASH for the FDA. This online event is open to the public with registration required.
Up to 444 million people worldwide, including 40 million in the United States, are estimated to be living with the progressive, chronic liver condition nonalcoholic steatohepatitis (NASH), the advanced form of fatty liver disease (NAFLD). Current estimates show that more than 1 in 4 adults have NAFLD, and up to 6% have NASH. Yet, these conditions are under recognized, under diagnosed, and undertreated.
There are several reasons people may develop NASH including genetic predisposition and the presence of metabolic disorders, obesity, diabetes, chronic kidney disease, and cardiovascular disease. NASH is projected to rise in parallel to these diseases and to increase in prevalence by over 50% by 2030.
With these harrowing statistics in mind, we are excited to work with the liver advocacy community and invite you to join the first NASH EL-PFDD. An EL-PFDD meeting of this magnitude will allow the U.S. Food and Drug Administration (FDA) and other stakeholders across the medical field to obtain a wide range of patients' and caregivers' input on NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies.
Have you been impacted by NASH? The Liver Action Network and GLI urge you to help to educate the medical community about the priorities and preferences for addressing NASH by participating in this important EL-PFDD NASH survey. Data collected in this survey will only be shared in an anonymized fashion and the survey organizers will not contact you about your responses.
The NASH EL-PFDD Meeting is a critical first step in providing the medical community with a deeper understanding of NASH directly from the patients and caregivers that have been impacted most. In case you missed it, watch it below:
Our Agenda:
10:00 a.m. – 10:10 a.m. Welcome, Opening Remarks & Introductions
Donna Cryer, CEO and Founder of Global Liver Institute
10:10 a.m. – 10:15 a.m. EL-PFDD Overview and FDA Role
Director Joe Toerner, Division of Hepatology and Nutrition
10:15 a.m. – 12:00 p.m. Patient Panel 1: Testimonies
12:00 p.m. – 12:15 p.m. Q&A for Panel 1
12:45 p.m. – 2:30 p.m. Patient Panel 2: Testimonies
2:30 p.m. – 2:45 p.m. Q&A for Panel 2
2:45 p.m – 3:00 p.m. Concluding Remarks