Day 1- Friday, 5 May 2017

Topics
Meeting category
Date(s)
5 May 2017 - 6 May 2017
Location
Washington D.C.,
United States
Organizer

International Workshop on NASH Biomarkers 2017
Enduring Materials
Session 1: Priorities in biomarker development for NASH -
Chairs

Veronica Miller, PhD
Forum for Collaborative HIV Research
Panel discussion: Many perspectives, one goal
Veronica Miller, PhD
Forum for Collaborative Research, UC Berkeley School of Public Health, United States

Brent Neuschwander-Tetri, MD
Saint Louis University Health Sciences Center

Pierre Bedossa, MD, PhD
University of Paris-Diderot

David Kleiner, MD, PhD
Center for Cancer Research, National Cancer Institute

Sophie Megnien, MD
Genfit SA
Session 2: Pathways to biomarker qualification and acceptance -
Chairs
Veronica Miller, PhD
Forum for Collaborative Research, UC Berkeley School of Public Health, United States
View from the Top - Potential impact of 21st century cures act

Peter Stein, MD
FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA
EU perspective
Collaboration in action - Biomarkers Endpoints & other Tools Resource

Chris Leptak, MD, PhD
FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA
Panel discussion: Building synergy across the Atlantic
Veronica Miller, PhD
Forum for Collaborative Research, UC Berkeley School of Public Health, United States

Moderators: Chris Leptak, MD, PhD
FDA Center for Drug Evaluation and Research

Peter Stein, MD
FDA Center for Drug Evaluation and Research

Roberto Calle, MD, FACE, FACP
Foundation for the National Institutes of Health

Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP
Newcastle University
Session 3: Circulating biomarkers -
Chairs

Sudha Shankar
-

Brent Neuschwander-Tetri, MD
Saint Louis University Health Sciences Center
Lipidomics and proteomics

Puneet Puri, MD
Virginia Commonwealth University, Richmond, VA, USA
Session 4: Imaging biomarkers -
Defining the reference standard for biomarker development - Histology versus clinical outcomes

Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP
Newcastle University, Newcastle, United Kingdom

Lara Dimick-Santos, MD
FDA Center for Drug Evaluation and Research
Abstract-driven presentations
Hepatic proton density fat fraction correlates with histologic measures of steatosis and is responsive to change in those measures in a multi-center nonalcoholic steatohepatitis clinical trial
Michael Middleton, USA
A meta-analysis on repeatability of magnetic resonance elastography of liver
Suraj Serai, USA
Panel discussion

Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRC
Newcastle University

Lara Dimick-Santos, MD
FDA Center for Drug Evaluation and Research

Claude Sirlin, MD
UC San Diego

Raj Vuppalanchi, MBBS
Indiana University School of Medicine

Daniel Krainak, PhD
FDA Center for Devices and Radiological Health
Day 2 - Saturday, 6 May 2017
Session 5: Quantative assessment of hepatic health -
Chairs

Roberto Calle, MD, FACE, FACP
Foundation for the National Institutes of Health

Puneet Puri, MD
Virginia Commonwealth University
Abstract-driven presentations
A real-world, observational cohort of patients with nonalcoholic fatty liver disease: The TARGET-NASH study
Miriam Vos, USA
Novel multiparametric magnetic resonance elastography (MRE) protocol accurately predicts NAS score for NASH diagnosis
Alina Allen, USA
The comparisons of non-invasive markers for assessing fibrosis in Asian patients with nonalcoholic fatty liver disease
Jun Yong Park, South Korea
Serum GP73 as a surrogate biomarker of significant liver fibrosis and cirrhosis in NAFLD
Fengmin Lu, China
Plasma collagen type III (Pro-C3) levels associate with severity of histological features of non-alcoholic steatohepatitis and fibrosis within the screening population from the CENTAUR study
Pamela Vig, USA
Panel discussion: Learning from functional, imaging and circulating biomarkers - Challenges of qualification in absence of highly effective therapy

Moderators: Roberto Calle, MD, FACE, FACP
Foundation for the National Institutes of Health

Moderators: Puneet Puri, MD
Virginia Commonwealth University

Shadab Siddiqui, MD
Virginia Commonwealth University

Greg Everson, MD, FACP
University of Colorado Denver

Eric Lefebvre, MD
Allergan

Chris Leptak, MD, PhD
FDA Center for Drug Evaluation and Research

Irene Tebbs, PhD
FDA Center for Devices and Radiological Health
Session 6: Challenges & opportunities in integrating 'OMICS -
Chairs

Pierre Bedossa, MD, PhD
University of Paris-Diderot

Shadab Siddiqui, MD
Virginia Commonwealth University
Big data vs. the individual liver - developer's perspective

José María Mato de la Paz, PhD
OWL Metabolomics, Derio, Spain
Future scenarios of algorithm building

Tom Travison, PhD
Harvard Medical School & Hebrew SeniorLife Institute for Aging Research, Boston, MA, USA
Abstract-driven presentations
Next-Generation Sequencing (NGS) of two independent cohorts identifies eleven circulating miRNAs for diagnosis of NASH and fibrosis
Sven Francque, Belgium
A new non-invasive diagnostic score to monitor change in disease activity and predict fibrosis evolution in patients with NASH
Stephen Harrison, USA
A precision medicine approach to comprehensive NAFLD diagnosis via metabolomics-based liquid biopsy
Pablo Ortiz, Spain
Session 7: The liver in context -
Chairs
Veronica Miller, PhD
Forum for Collaborative Research, UC Berkeley School of Public Health, United States
Integrated assessment of diabetes, cardiovascular and liver risks and its potential application in the clinical management of NAFLD
Round table discussion: The way forward
Veronica Miller, PhD
Forum for Collaborative Research, UC Berkeley School of Public Health, United States
Raffi Werner, MD
Exalenz Bioscience
Claude Cohen-Bacrie, PhD
SuperSonic Imagine
Elizabeth Fagan
Perspectum Diagnostics
Céline Fournier, PhD
Echosens
Rémi Hanf, PhD
Genfit
Pablo Ortiz, MD, PhD
OWL Metabolomics
Steve Williams, MD, PhD
Somalogic
John Sninsky, PhD
CareDx
Overview
Welcome
We are pleased to look back on a very succesful 2nd International Workshop on NASH Biomarkers, held in Washington, DC, USA on 5-6 May 2017.
156 delegates attended the workshop and the Organizing committee and organizers would like to thank the speakers, chairs and all participants for their contribution to this meeting! In particular we would like to thank our workshop sponsors. Without their financial contribution this workshop would not have been made possible.
The Organizing committee
Committees
Organizing Committee

Quentin Anstee, PhD
Newcastle University, Newcastle, United Kingdom

Pierre Bedossa, MD, PhD
University of Paris-Diderot, Paris, France

Roberto Calle, MD
Foundation for the National Institutes of Health (FNIH), Bethesda, MD, USA

Elmer Schabel, MD
European Medicines Agency, London, UK & BfArM, Bonn, Germany

Claude Sirlin, MD
UC San Diego, San Diego, CA, USA

Greg Everson, MD, FACP
University of Colorado Denver, Denver, CO, USA

Chris Leptak, MD, PhD
FDA Office of New Drugs, Silver Spring, MD, USA

Veronica Miller, PhD
Forum for Collaborative Research, UC Berkeley School of Public Health, United States
Support
Gold Level
Supporter
Contributor
Endorsers