INTERNATIONAL WORKSHOP ON

NASH BIOMARKERSWASHINGTON DC, USA • 5-6 MAY 2017

ORGANIZING COMMITTEE

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

Pierre Bedossa, MD, PhDUniversity of Paris-Diderot, Paris, France

Charles Boucher, MD, PhDErasmus Medical Center, Rotterdam, the Netherlands

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

Greg Everson, MD, FACP University of Colorado Denver, Denver, CO, United States

Christopher Leptak, MD, PhDFDA Office of New Drugs, Silver Spring, MD, USA

Veronica Miller, PhDThe Liver Forum, Washington, DC, USA

Arun Sanyal, MD, MBBSVirginia Commonwealth University, Richmond, VA, USA

Elmer Schabel, MDEuropean Medicines Agency, London, UK & BfArM, Bonn, Germany

Claude Sirlin, MDUC San Diego, San Diego, CA, USA

WHO SHOULD ATTEND?

Clinical, basic and translational researchers from academia and industry, physicians, pharmacologists, drug development experts, government representatives, young investigators and other experts involved in biomarker- and drug development for NASH

VENUE

Washington Marriott Georgetown 1221 22nd Street NW Washington, District Of Columbia 20037, USA

WHY SHOULD YOU ATTEND?

This independent workshop will provide a high quality platform for presentation of the latest research results in the field of biomarkers for NASH

It provides an interactive forum to experts for in-depth discussion and debate in order to reach consensus and develop strategies

The program gathers experts from all relevant disciplines in order to integrate efforts and advance this important field of research

Registration and information: www.expertmedicalevents.com

MEETING PARTNERSWORKSHOP ORGANIZERS

Elucidating Pathways of SteatohepatitisEPoS

Discounted registration fees apply to government employees

(FDA, NIH)

Registration and information: www.expertmedicalevents.com

SUBMIT YOUR DATA FOR THIS WORKSHOP

We invite you to submit abstracts for a poster or oral presentation on the following topics:

• Innovations in Design and Analysis

• Markers of Disease Activity

• Markers of Disease Stage

• Novel technologies in NASH biomarker development

MEETING OBJECTIVES

• Review the current regulatory landscape and gaps in regulatory science related to biomarker development for NAFLD

• Review the gaps in evidence needed to qualify specific biomarkers for NAFLD

• Stimulate collaborative science to accelerate biomarker development for NAFLD

• Promote innovation in design and analytic approaches to biomarker development for NAFLD

FRIDAY DAY 5 MAY 2017 - DAY 1

8:00 AM Registration & walk-in Coffee

Session 1: Piorities in Biomarker Development for NASH

9:00 AM Workshop Opening

9:10 AM Opening Plenary Lecture: A pathologist, a radiologist and a hepatologist walked into a bar

9:40 AM Innovation in histological assessment of NASH

10:00 AM Panel Discussion: Many perspectives, one goal

11:00 AM Coffee break

Session 2: Pathways to Biomarker Qualification and Acceptance

11:30 AM Plenary Lecture: View from the Top/ Potential impact of 21st Century Cures Act?

12:00 PM EU Perspective

12:15 PM Linking drug development to biomarker development- challenges and opportunities

12:30 PM Collaboration in action 1: BEST

12:40 PM Collaboration in action 2: FNIH

12:50 PM Collaboration in action 3: IMI

1:00 PM Panel Discussion: Building synergy accross the atlantic

1:30 PM Lunch break

2:15 PM Poster Tour 1

Session 3: Circulating Biomarkers

3:00 PM Lipidomics and Proteomics

3:20 PM Role of Genetic assessments

3:40 PM Nucleic Acids and Combination Panels

4:00 PM Discussion

4:30 PM Coffee break

Session 4: Imaging Biomarkers

5:00 PM MRI; what can it deliver

5:20 PM VCTE

5:40 PM Oral abstract presentations

6:00 PM Panel Discussion

6:30 PM Open Poster Session/Welcome Reception

7:00 PM Workshop Dinner

SATURDAY 6 MAY 2017 - DAY 2

Session 5: Quantiative Assessment of Hepatic Health

8:00 AM Breath tests

8:15 AM Cholate clearance

8:30 AM Kinetic markers

8:45 AM Oral abstract presentations

9:35 AM Panel/discussion: Learning from functional, imaging and circulating biomarkers: Challenges of qualification in absence of highly effective therapy

10:15 AM Coffee break

Session 6: Challenges Opportunities in integrating 'OMICS

10:45 AM Invited talk: Big Data vs. the individual liver from a regulatory perspective

11:00 AM Invited talk: Big Data vs. the individual liver from a developer's perspective

11:15 AM Invited talk: Future scenarios of algorithm building

11:30 AM Oral abstract presentations

12:00 PM Panel Discussion

12:00 PM Lunch break

Session 7: The Liver in Context

1:00 PM Special Lecture: Integrated Assessment of diabetes, cardiovascular and liver risks and its potential application in the clinical management of NAFLD

1:30 PM Special Lecture: Biomarkers from FDA perspective - an overview

2:00 PM Round Table discussion: The way forward

2:45 PM Closure and abstract award ceremony

3:00 PM Closure of the workshop

PRELIMINARY PROGRAM