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
11:35Reporting standards: STARD & TRIPOD
Patrick Bossuyt, PhD
AMC-UvA, Amsterdam, the Netherlands
11:50Quality standards for imaging studies
Claude Sirlin, MD 
UC San Diego, San Diego, CA, USA
12:05Oral abstract presentations
12:25Panel discussion
13:05Lunch
13:50Poster Tour 1
Session 3: Context of use - Diagnosis of “at risk” pre-cirrhotic NASH
14:35Case definitions for use as reference standards
Mohammed Siddiqui, MD
VCU Medical Center Richmond, VA, USA
14:50Contexts of use and implications for study design
Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP 
Newcastle University, Newcastle, United Kingdom
15:05Population heterogeneity, sample size and analytic considerations in biomarker development
U.S. Food and Drug Administration (t.b.c.)
15:20Oral abstract presentations
15:40Discussion
16:20Coffee break
Session 4: Context of use - Diagnosis of cirrhosis
16:50Redefining cirrhosis for the 21st century
t.b.c.
17:10Defining the reference standard for biomarker development - Histology versus clinical outcomes
Kathleen Donohue, MD
U.S. Food and Drug Administration 
17:30Integrating risk benefit assessment of testing in biomarker qualification process in nash with cirrhosis
t.b.c.
17:50Oral abstract presentations
17:50Discussion
18:30Open Poster Session/Welcome Reception
19:00Workshop 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
t.b.c.
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
9:40Panel discussion
Session 6: Integrated uses of biomarkers - Reducing the testing burden for the patient as well as physician
10:10The clinical need for integrated assessment of NASH diabetes and heart disease
Arun Sanyal MD, MBBS
Virginia Commonwealth University Richmond, VA, USA
10:30Common mechanisms of fibrogenic remodeling in end organs related to metabolic syndrome
t.b.c.
10:50Oral abstract presentations
11:10Panel Discussion
11:40Coffee break
Session 7: Challenges and oppurtunities in parallel review
12:20Special 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
12:40FDA perspective on parallel review
Rochelle Fink, MD, JD
U.S. Food and Drug Administration, Silver Spring, MD, USA
12:55Oral abstract presentations
13:15Discussion
13:55Closure of the workshop
14:00Workshop end