Program

Developed by an international Organizing Committee of leading experts in the field of NASH, the workshop program will offer interactive sessions with state of the art presentations and abstracts.

Below is a preliminary overview of what you can expect during the workshop in May. A PDF of this program can be downloaded hereSign up for our email list to be notified.

Please note that the program presented here is subject to change.

Friday 18 May 2018

Session 1: Regulatory and third party payer perspectives on NASH biomarkers
8:30Workshop opening
8:40Pathways and priorities for biomarker assessment
Peter Stein, MD
U.S. Food and Drug Administration, Silver Spring, MD, USA
9:00Integrating 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
9:20Panel discussion
10:00Coffee break
Session 2: Milestones and road map for biomarker development
10:30Linking “intended use” to evidence needed for bringing a biomarker to market
John Sninsky, PhD
CareDx Brisbane, CA, USA
11:00Repeatability, reproducibility and analytic standards for biomarker development
Abbas Bandukwala
U.S. Food and Drug Administration, Silver Spring, MD, USA
11:20What is needed to link device approval to clinical application approval
David Litwack, PhD 
U.S. Food and Drug Administration, Silver Spring, MD, USA
11:40Reporting standards: STARD & TRIPOD
Patrick Bossuyt, PhD
AMC-UvA, Amsterdam, the Netherlands
12:00Quality standards for imaging studies
Claude Sirlin, MD 
UC San Diego, San Diego, CA, USA
12:20Panel discussion
13:05Lunch & Poster viewing
Session 3: Context of use - Diagnosis of “at risk” pre-cirrhotic NASH
14:05Case definitions for use as reference standards
Mohammed Siddiqui, MD
VCU Medical Center Richmond, VA, USA
14:25Contexts of use and implications for study design
Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP 
Newcastle University, Newcastle, United Kingdom
14:45Machine Learning Analysis Framework in Diagnosis of Advanced Fibrosis and Prediction of Fibrosis Improvement in Patients with Advanced Fibrosis due to NASH
Lulu Wang, PhD
Gilead Sciences, Foster City, CA, USA
15:05Oral 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.
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.
 Mark Gorrell

15:35Discussion
16:15Coffee break
Session 4: Context of use - Diagnosis of cirrhosis
16:45Defining the reference standard for biomarker development - Histology versus clinical outcomes
Kathleen Donohue, MD
U.S. Food and Drug Administration 
17:05

Oral abstract presentations:
A Context of Use Framework for Bioanalytical Validation of the CK18 Apoptosis Biomarker for NASH Drug Development
Sumit Kar

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

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

17:50Round Table Discussion: Redefining cirrhosis for the 21st century
18:30Welcome Reception & Poster viewing
19:30Workshop Dinner

Saturday 19 May 2018 - Day 2

Session 5: Context of use - Assessment of therapeutic response
8:30Defining therapeutic response in precirrhotic and cirrhotic NASH
Manal Abdelmalek , MD
Duke University, Durham, NC, USA
8:50Study design to validate biomarkers of therapeutic response for pre-cirrhotic NASH
Brent Tetri, MD
Saint Louis University, St. Louis, MO, USA
9:10Study design to validate biomarkers of therapeutic response in cirrhosis due to NASH
Detlef Schuppan, MD, PhD
University of Mainz, Mainz, Germany
9:30Oral 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

 

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.
Stephen Rossi

10:00Panel discussion
10:20Coffee break
Session 6: Integrated uses of biomarkers - From Bench to Bedside
10:50The clinical need for integrated assessment of NASH diabetes and heart disease
Arun Sanyal MD, MBBS
Virginia Commonwealth University Richmond, VA, USA
11:10Neoepitope fragments of extracellular matrix as markers of fibrosis in chronic liver disease: Insights into clinical and preclinical utilization for unfolding disease pathogenesis 
Diana Leeming, PhD
Nordic Biosciences A/S, Herlev, Denmark
11:30Oral abstract presentations:
Repeatability and Reproducibility of Multiparametric Magnetic Resonance Imaging of the Liver 
Andrea Dennis

 

Feasibility of Using Deep-learning-based Techniques for Liver Couinaud Segmentation and Proton Density Fat Fraction (PDFF) Estimation
Hashem Almahmoud

12:00Special Lecture: Generating evidence to meet regulatory and third party payer needs for approval - Lessons learned from cologuard
Berry Berger, MD
Exact Sciences, Madison, WI, USA
12:20FDA perspective on parallel review
Rochelle Fink, MD, JD
U.S. Food and Drug Administration, Silver Spring, MD, USA
12:40Discussion
13:00Closure of the workshop
13:05Workshop end