NASH 2018

Friday 18 May 2018

Session 1: Regulatory and third party payer perspectives on NASH biomarkers
Stein, Peter 120Pathways 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
Session 2: Milestones and road map for biomarker development
Sninsky, John 2017 120Linking “intended use” to evidence needed for bringing a biomarker to market
John Sninsky, PhD
CareDx Brisbane, CA, USA
Bandukwala, Abbas 2018Repeatability, reproducibility and analytic standards for biomarker development
Abbas Bandukwala
U.S. Food and Drug Administration, Silver Spring, MD, USA
What is needed to link device approval to clinical application approval
David Litwack, PhD 
U.S. Food and Drug Administration, Silver Spring, MD, USA
Bossuyt, Patrick web 120Reporting standards: STARD & TRIPOD
Patrick Bossuyt, PhD
AMC-UvA, Amsterdam, the Netherlands
Sirlin, Claude 120x160Quality standards for imaging studies
Claude Sirlin, MD 
UC San Diego, San Diego, CA, USA
Session 3: Context of use - Diagnosis of “at risk” pre-cirrhotic NASH
Siddiqui, Mohammed web 120Case definitions for use as reference standards
Mohammed Siddiqui, MD
VCU Medical Center Richmond, VA, USA
Anstee, Quentin 2016 120Contexts of use and implications for study design
(Not available)

Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP 
Newcastle University, Newcastle, United Kingdom
10 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
11 12Oral 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
13 Donohue, Kathleen 2018 120x160Defining the reference standard for biomarker development - Histology versus clinical outcomes
Kathleen Donohue, MD
U.S. Food and Drug Administration 
14 15 16 

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

Saturday 19 May 2018 - Day 2

Session 5: Context of use - Assessment of therapeutic response
17 Abdelmalek, Manal 2018 120x160Defining therapeutic response in precirrhotic and cirrhotic NASH
Manal Abdelmalek , MD
Duke University, Durham, NC, USA
18 Tetri, Brent 2017 120Study design to validate biomarkers of therapeutic response for pre-cirrhotic NASH
Brent Tetri, MD
Saint Louis University, St. Louis, MO, USA
19 Study design to validate biomarkers of therapeutic response in cirrhosis due to NASH
Detlef Schuppan, MD, PhD
University of Mainz, Mainz, Germany
 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


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
 Sanyal, Arun 2015_defThe clinical need for integrated assessment of NASH diabetes and heart disease
Arun Sanyal MD, MBBS
Virginia Commonwealth University Richmond, VA, USA
 Leeming, Diana 2018 120x180Neoepitope 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
 Oral 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

 Special Lecture: Generating evidence to meet regulatory and third party payer needs for approval - Lessons learned from cologuard
(Not available)

Berry Berger, MD
Exact Sciences, Madison, WI, USA
 FDA perspective on parallel review
(Not available)
Rochelle Fink, MD, JD
U.S. Food and Drug Administration, Silver Spring, MD, USA