Materials
Session I: Welcome and Introductory Remarks
Welcome & Forum Overview
Edyth Dwyer & Sehyr Khan, Forum
Introductory Remarks
Michelle Long, Novo Nordisk
Veronica Miller, Forum
Arun Sanyal, VCU
Session II: PEDDLE Working Group Update & Toolkit Proposal
PEDDLE Forward: Driving Patient-Centered Innovation in MASH Drug Development
Michael Betel, Fatty Liver Alliance
From Ideas to Impact: Our Patient Engagement Journey So Far
Rosemarie Sellati, Regeneron Pharmaceuticals
Moving Forward: Building the Toolkit for Engagement
Henry Chang, Fatty Liver Foundation
Session III: Forum NITs for RLSE Proposal- Focus on Fibrogenesis
Discussion Framework of Liver Forum Proposal for a New NIT-based RLSE in MASLD
Quentin Anstee, Newcastle University
Session IV: Data & Analysis Review
FCR NIT Literature Review
Richard Haubrich, Forum
Unicorn Biomarkers
Morten Karsdal, Nordic Bioscience*
Moving ELF closer to a Reasonably Likely Surrogate Endpoint
Matthew Gee, Siemens Healthineers
LSM by VCTE as a Reasonably Likely Surrogate Endpoint: Review of the Latest Clinical Evidence
Céline Fournier, Echosens
Insights into NIT CV from the Pfizer MIRNA Trial
Quentin Anstee, Newcastle University
Exploratory analysis: ELF components in 4296 and 4492
Michelle Long, Novo Nordisk
Non-Invasive Tests for Reasonably- Likely Surrogate Endpoints: MRE
Kay Pepin, Resoundant*
Session V: Consideration of Non-Fibrogenic Biomarkers
cT1 as a Reasonably Likely Surrogate Endpoint in MASH Clinical Trials
Rajarshi Banerjee & Andrea Dennis, Perspectum
Session VI: Coming to Consensus on NITs for an RLSE
What is Meaningful to the Patients?
Henry Chang, Fatty Liver Foundation
Session VII: Future of NITs & Day Wrap Up
Day Wrap Up
Michelle Long, Novo Nordisk
Veronica Miller, Forum
Arun Sanyal, VCU
Session VIII: Stretch Exercise in Statistics
Beyond Binary Outcomes
Michael Harhay, University of Pennsylvania*
Session IX: Defining Progression to Cirrhosis
Progression to Cirrhosis– Considerations in Operationalizing the Endpoint
Arun Sanyal, VCU
MAESTRO-NASH Outcomes: Identification of F4 without Biopsy
Becky Taub, Madrigal Pharmaceuticals
Session X: Closing Remarks
Closing Remarks
Michelle Long, Novo Nordisk
Veronica Miller, Forum
Arun Sanyal, VCU
*Remote participation
