Breaking News in MASH: FDA’s Pathway for NIT-Driven Endpoints
Nov
10
2025
Convention Center: Ballroom A, Level 3
9:45 AM
- 10:45 AM
World Class Speakers
Description
This program is designed to explore the recent FDA announcement and HEPATOLOGY publication regarding the role of non-invasive tests (NITs) in MASH clinical trials. The session will review the regulatory perspectives, scientific evidence, and clinical implications of these developments. It will also provide a forum for open dialogue and audience engagement, highlighting both opportunities and challenges for integrating NITs into practice and research. Attendees will leave with a clearer understanding of how these updates may shape the future landscape of hepatology and drug development.Journey Maps
Presentations
9:45 AM
- 9:50 AM
Apr
29
2026
Washington, D.C.
Introduction
Mazen Noureddin
, Moderator
MASLD
9:50 AM
- 10:05 AM
Apr
29
2026
Washington, D.C.
NIT as RSLE for MASH F2-F3 trials
Mazen Noureddin
, Presenter
MASLD
10:05 AM
- 10:20 AM
Apr
29
2026
Washington, D.C.
NIT as RSLE for MASH Cirrhosis Trials
Mary E. Rinella, MD, FAASLD
, Presenter
MASLD
10:20 AM
- 10:45 AM
Apr
29
2026
Washington, D.C.
Q&A/Panel Discussion (All Presenters and Panelists)
Grace Su, MD, FAASLD
, Moderator
MASLD
Objectives
- Evaluate the recent FDA announcement and HEPATOLOGY publication on the use of non-invasive tests (NITs) in MASH clinical trials, with emphasis on regulatory and clinical implications.
- Discuss the opportunities, limitations, and future directions of NITs in MASH through interactive dialogue with peers and experts.
Chair
Alina M. Allen, MD
Mayo Clinic Rochester
Chair
Mazen Noureddin
Houston Research Institute and Houston Methodist Hospital