International Workshop on NASH Biomarkers 2018

Day 1- Friday, 18 MAy 2018

Session 1: Regulatory and third party payer perspectives on NASH biomarkers -

Pathways and priorities for biomarker assessment

Peter Stein, MD

U.S. Food and Drug Administration, Silver Spring, MD, USA

Integrating science, logistics and cost in approval of hierarchical testing strategies for NASH - The payer's perspective

Robert LoNigro, MD

Heritage Provider Network, Northridge, CA, USA

Slideset

Session 2: Milestones and road map for biomarker development -

Linking “intended use” to evidence needed for bringing a biomarker to market

John Sninsky, PhD

CareDx Brisbane, CA, USA

Slideset

Repeatability, reproducibility and analytic standards for biomarker development

Abbas Bandukwala

U.S. Food and Drug Administration, Silver Spring, MD, USA

Slideset

What is needed to link device approval to clinical application approval

David Litwack, PhD

U.S. Food and Drug Administration, Silver Spring, MD, USA

Slideset

Reporting standards: STARD & TRIPOD

Patrick Bossuyt, PhD

AMC-UvA, Amsterdam, the Netherlands

Slideset

Quality standards for imaging studies

Claude Sirlin, MD

UC San Diego, San Diego, CA, USA

Slideset

Session 3: Context of use - Diagnosis of “at risk” pre-cirrhotic N -

Case definitions for use as reference standards

Mohammed Siddiqui, MD

VCU Medical Center Richmond, VA, USA

Slideset

Contexts of use and implications for study design (Not available)

Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP

Newcastle University, Newcastle, United Kingdom

Machine Learning Analysis Framework in Diagnosis of Advanced Fibrosis and Prediction of Fibrosis Improvement in Patients with Advanced Fibrosis due to NASH (Not available)

Lulu Wang, PhD

Gilead Sciences, Foster City, CA, USA

Oral abstract presentations:

Validation of NIS4 algorithm for detection of NASH at risk of cirrhosis in 467 NAFLD patients prospectively screened for inclusion in the RESOLVE-IT trial. (Not available)

Rémy Hanf

A sequential circulating Fibroblast Activation Protein (cFAP) based model is superior to Hepascore alone in excluding significant fibrosis in non-alcoholic fatty liver disease. (Not available)

Mark Gorrell

Session 4: Context of use - Diagnosis of cirrhosis -

Defining the reference standard for biomarker development - Histology versus clinical outcomes

Kathleen Donohue, MD

U.S. Food and Drug Administration

Slideset

Oral abstract presentations:

A Context of Use Framework for Bioanalytical Validation of the CK18 Apoptosis Biomarker for NASH Drug Development

Sumit Kar

Slideset

Serum markers of collagen formation are associated with the severity of Liver fibrosis and Non-Alcoholic Steatohepatitis (NASH) histological features and to impaired renal function (IRF) in a NAFLD cohort

Samuel Daniels

Slideset

Algorithm to identify non-alcoholic steatohepatitis (NASH) patients with a NAS≥4 and F≥2: algorithm derived in an American screening cohort and validation in a British non-alcoholic fatty liver disease (NAFLD) cohort

Celine Fournier

Slideset

Day 2 - Saturday, 19 MAY 2018

Session 5: Context of use - Assessment of therapeutic response -

Defining therapeutic response in precirrhotic and cirrhotic NASH

Manal Abdelmalek , MD

Duke University, Durham, NC, USA

Slideset

Study design to validate biomarkers of therapeutic response for pre-cirrhotic NASH

Brent Tetri, MD

Saint Louis University, St. Louis, MO, USA

Slideset

Study design to validate biomarkers of therapeutic response in cirrhosis due to NASH

Detlef Schuppan, MD, PhD

University of Mainz, Mainz, Germany

Slideset

Oral abstract presentations

Use of plasma PRO-C3, PRO-C5, and PRO-C6 for the diagnosis and follow-up of fibrosis stage in patients with nonalcoholic fatty liver disease (NAFLD).

Diana Leeming

Slideset

NGM282 Rapidly Decreases PRO-C3 Levels in Biopsy-Confirmed NASH Patients Correlating with Changes in MRI-PDFF, ALT and Liver Histology: Results from a Phase 2 Dose-Finding Study. (Not available)

Stephen Rossi

Session 6: Integrated uses of biomarkers - From Bench to Bedside -

The clinical need for integrated assessment of NASH diabetes and heart disease

Arun Sanyal, MD, MBBS

Virginia Commonwealth University Richmond, VA, USA

Slideset

Neoepitope fragments of extracellular matrix as markers of fibrosis in chronic liver disease: Insights into clinical and preclinical utilization for unfolding disease pathogenesis