All Times EDT
In this panel, Dr. Peter Mensenbrink and Dr. Shein-Chung Chow will share their insights and experiences from the clinical development of treatments for non-infectious chronic liver disease. There are many challenges due to the lack of qualified and validated biomarkers despite this, the improvement in histology from paired biopsies has been established as a surrogate endpoint for establishing initial regulatory approval conditional on the demonstration of efficacy on long-term clinical outcomes. There have not been any well-controlled trials that have established this link and there are difficulties in identifying the best treatments to Phase 3 due to the lack of validated biomarkers of early efficacy. The discussion will include possible scenarios for better regulatory strategies and more efficient designs, including analysis of two-stage adaptive seamless design to evaluate treatments in this disease area. The FDA speakers will also join the panel discussion.