The NITs for RLSE workshop was held in Reston, VA on Friday, January 17, 2025

Materials

Agenda

Participant List

Session I: Introductory Remarks and Review of Goals

Introductory Remarks & Goals for the Check-In Meeting
Michelle Long, Novo Nordisk
Veronica Miller, Forum
Arun Sanyal, VCU

Session II: Division of Hepatology and Nutrition & Biomarker Qualification Program Perspective on NITs for a RLSE

Discussion
Frank Anania, U.S. Food and Drug Administration
Jeff Siegel, U.S. Food and Drug Administration
Vanitha Sekar, U.S. Food and Drug Administration
Tram Tran, U.S. Food and Drug Administration

Session III: Forum Proposal for NITs as a RLSE

Review of Histology as a RLSE
Michelle Long & Sune Boris Nygård, Novo Nordisk
Overview of Forum Proposal
Quentin Anstee, Newcastle University
Overview of Data Sources
Richard Haubrich, Forum

Session IVa: Baseline and Change from Baseline Correlation: ELF and VCTE

Overview of Studies
Richard Haubrich, Forum
ELF
Matthew Gee, Siemens Healthineers*
VCTE
Céline Fournier, Echosens
Discussion: Summary of Strengths, Weaknesses, & Gaps in Data
All Participants

Session IVb: Baseline and Change from Baseline Correlation: MRE and MRI-PDFF

MRI-PDFF & MRE
Richard Haubrich, Forum
Comments
Mustafa Bashir, Duke University*
Kay Pepin, Resoundant
Claude Sirlin, UCSD*
Discussion: Summary of Strengths, Weaknesses, & Gaps in Data
All Participants

Session V: Progress and Challenges in Determining Thresholds & Cut-Offs: ELF, VCTE, MRE & MRIPDFF

Open Discussion
All Participants

Session VI: Opportunities and Challenges in Non-Invasive Definition of Progression to Cirrhosis as a Clinical Endpoint

Progression to Cirrhosis – Considerations in Operationalizing the Endpoint
Arun Sanyal, VCU
Distinguishing F3 from F4 MASH
Becky Taub, Madrigal Pharmaceuticals

 

*Remote participation