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

Frank A Anania, MD, FAASLD, FACP, AGAF
Presenter

Frank A Anania, MD, FAASLD, FACP, AGAF

U.S. Food and Drug Adminstration
Mary E. Rinella, MD, FAASLD
Presenter

Mary E. Rinella, MD, FAASLD

The University of Chicago
Veronica Miller, PhD
Panelist

Veronica Miller, PhD

Forum for Collaborative HIV Research
Mazen Noureddin, MD, MHSc
Moderator

Mazen Noureddin, MD, MHSc

Houston Research Institute and Houston Methodist Hospital
Grace Su, MD, FAASLD
Moderator

Grace Su, MD, FAASLD

University of Michigan Medical Center

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
Nov 10 2025
Washington, D.C.

Introduction

Mazen Noureddin, MD, MHSc, Moderator
MASLD
9:50 AM - 10:00 AM
Nov 10 2025
Washington, D.C.

The FDA Update

Frank A Anania, MD, FAASLD, FACP, AGAF, Presenter
MASLD
10:00 AM - 10:10 AM
Nov 10 2025
Washington, D.C.

NIT as RSLE for MASH F2-F3 trials

Mazen Noureddin, MD, MHSc, Presenter
MASLD
10:10 AM - 10:20 AM
Nov 10 2025
Washington, D.C.

NIT as RSLE for MASH Cirrhosis Trials

Mary E. Rinella, MD, FAASLD, Presenter
MASLD
10:20 AM - 10:45 AM
Nov 10 2025
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