AASLD/EASL: Primary Biliary Cholangitis (PBC) Endpoint
Nov
10
2025
Convention Center: Room 145, Level 1
11:00 AM - 12:30 PM
Description
The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) have jointly led a multi-stakeholder Consensus Process focused on the use of surrogate endpoints and real-world evidence in the design of clinical trials for Primary Biliary Cholangitis (PBC).This collaborative initiative culminated in a Consensus Conference held during the 2025 EASL Congress in Amsterdam, bringing together global experts, regulatory authorities, patient representatives, and industry stakeholders.
The final recommendations from this Consensus Process will be presented in the current session.
Journey Maps
Presentations
11:00 AM - 11:05 AM
Nov
10
2025
Washington, D.C.
Opening
Cynthia Levy, MD, FAASLD, Moderator
Acute Liver Failure
Acute-on-Chronic Liver Failure
Trainee
11:20 AM - 11:30 AM
Nov
10
2025
Washington, D.C.
Consensus Recommendations on Endpoints
Marco Carbone, Presenter
Acute Liver Failure
Acute-on-Chronic Liver Failure
Trainee
11:40 AM - 11:50 AM
Nov
10
2025
Washington, D.C.
Consensus Recommendations on Use of Real-World Data
Bettina Hansen, Presenter
Acute Liver Failure
Acute-on-Chronic Liver Failure
Trainee
12:00 PM - 12:10 PM
Nov
10
2025
Washington, D.C.
Conclusions - Next steps
Gideon M Hirschfield, MB BChir, PhD, FRCP (Lon), Presenter
Acute Liver Failure
Acute-on-Chronic Liver Failure
Trainee
12:10 PM - 12:30 PM
Nov
10
2025
Washington, D.C.
Q&A/Panel Discussion
Ana Lleo, MD, PhD, FAASLD, Moderator
Acute Liver Failure
Acute-on-Chronic Liver Failure
Trainee
Objectives
- To identify the key scientific, clinical, and regulatory needs to advance the development of reliable surrogate endpoints
- To reach a consensus on how to use real world evidence to design confirmatory clinical trials in PBC