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Friday, June 29, 2018 - 8:00 am to Saturday, June 30, 2018 - 12:00 pm
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Course Description/Needs Statement

The purpose of this workshop is to bring together the academic, regulatory and pharmaceutical communities to discuss therapeutic endpoints, trial designs and appropriate patient populations and safety concerns with regards to novel therapeutic approaches for treatment of NAFLD. This meeting will be unique in that it will bring all the important and relevant parties to the table to discuss these critical issues that need resolution before substantial progress can be made in delivering the next generation of therapeutic agents to affected individuals with NAFLD. AASLD and EASL possess the expertise in NAFLD to bridge the current knowledge gaps that regulatory and pharmaceutical industry have identified as important issues hampering development of novel therapeutic agents for NAFLD.

Program Chairs

  • Arun J. Sanyal, MD, FAASLD
  • Mary E. Rinella, MD, FAASLD
  • Quentin M. Anstee, MBBS, PhD, FRCP
  • Frank Tacke, MD, PhD

Location

  • Metro, DC Area
    Hotel TBD

Learning Objectives

Upon completion of this activity, learners will be able to:

  • Understand how lessons learned from completed NASH trials may influence future clinical trial design and endpoints.
  • Identify potential approaches to phenotyping adult and pediatric patients with NASH.
  • Discuss available methods to study clinical outcomes and their limitations in the context of NASH clinical trials.
  • Understand the strengths and limitations of currently available biomarkers to stage disease and assess dynamic change.

Continuing Education

  • AMA PRA Category Credits™ CME credits will not be provided.

Session I: Current Landscape and Lessons Learned from Recently Completed Trials

Friday, June 29, 2018
Moderators: Arun J. Sanyal, MD, FAASLD and Frank Tacke, MD, PhD

  • 8-8:10 am
    Welcome, Introduction, Goals of Conference
  • 8:10-8:30 am 
    FDA Perspective on NASH and Trial Endpoints
    Lara L. Dimick-Santos, MD
  • 8:30-8:50 am
    EMA Perspective on NASH and Trial Endpoints
    Elmer Schabel, MD
  • 8:50-9:10 am
    Lessons Learned from Studies in Non-Cirrhosis NASH Trials
    Mary E. Rinella, MD, FAASLD
  • 9:10-9:30 am 
    Lessons Learned from Studies in NASH Cirrhosis Trials 
    Arun J. Sanyal, MD, FAASLD
  • 9:30-9:50 am
    Lessons Learned from Studies in Pediatric NASH Trials
    Joel E. Lavine, PhD, FAASLD
  • 9:50-10:10 am
    Panel Discussion 
    Chair: Frank Tacke, MD, PhD
  • 10:10-10:30 am
    Break

Session II: Placebo Arm and Lifestyle Management in Clinical Trials

Friday, June 29, 2018
Moderators: Mary E. Rinella, MD, FAASLD and Joel E. Lavine, PhD, FAASLD

  • 10:30-10:50 am
    Variations in Disease Natural History: Implications for Placebo arm Performance in Clinical Trials 
    Manal F. Abdelmalek, MD, MPH, FAASLD
  • 10:50-11:10 am
    Practical Application of Lifestyle Management in Clinical Trials: Achieving Parity Across Sites 
    Shira Zelber-Sagi, PhD
  • 11:10-11:30 am 
    Geographic and Ethnic Variations in Disease Phenotype: Separate Trials or Stratified Analysis? 
    Vincent Wong, MD, MBChB
  • 11:30-11:50 am 
    Natural Course of the Disease in Pediatric Populations
    Jeffrey Schwimmer, MD 
  • 11:50 am-12:15 pm
    Panel Discussion 
    Chair: Mary E. Rinella, MD, FAASLD
  • 12:15-1:30 pm
    Lunch

Session III: Segmenting the Population – Phenotyping for Clinical Trials

Friday, June 29, 2018
Moderators: Quentin M. Anstee, MBBS, PhD, FRCP and Stavra Xanthakos, MD

  • 1:30-1:50 pm 
    Histological Subtyping and Advances in Histologic Assessment- “Is the NAS Sufficient?”
    Valerie Paradis, MD, PhD
  • 1:50-2:10 pm
    Metabolomics, Sub-phenotyping, Microbiota and Other Modalities to Phenotype NASH
    Michael H. Trauner, MD, FAASLD
  • 2:10-2:30 pm
    Phenotyping and Subtyping the Pediatric Population
    Stavra Xanthakos, MD
  • 2:30-2:50 pm
    Elastrography and Imaging for Staging NAFLD
    Richard Ehman, MD 
  • 2:50-3:20 pm
    Panel Discussion 
    Chair: Quentin M. Anstee, MBBS, PhD, FRCP
  • 3:20-3:40 pm
    Break

Session IV: Clinical Events and Patient-Related Outcomes

Friday, June 29, 2018
Moderators: Zobair M. Younossi, MD, MPH, FAASLD and Miriam B. Vos, MD, MSPH

  • 3:40-3:55 pm 
    Liver-related Outcomes
    Quentin M. Anstee, MBBS, PhD, FRCP
  • 3:55-4:10 pm
    Extra-hepatic Outcomes 
    Kathleen E. Corey, MD, MPH, MMSc
  • 4:10-4:25 pm
    Pediatrics Perspective on Outcomes and Clinical Events
    Valerio Nobili, MD
  • 4:25-4:40 pm
    Patient-related Outcomes 
    Jörn M. Schattenberg, MD 
  • 4:40-5 pm
    DILI in NAFLD Trials: How to Detect, Diagnose and Treat
    Naga Chalasani, MD
  • 5-5:30 pm
    Panel Discussion  
    Chair: Zobair M. Younossi, MD, MPH, FAASLD
  • 5:30-5:45 pm
    Break 
  • 5:45-6:15 pm
    Lessons Learned from Other Fields: New Technology to Assess Organ Fibrosis and Remodeling  
    Detlef Schuppan, MD, PhD
  • 6:15-7:15 pm
    Poster Reception 

Session V: Endpoints – Defining Response to Treatment

Saturday, June 30, 2018
Moderators: Stephen A. Harrison, MD, FAASLD and Philip N. Newsome, MD, PhD

  • 8-8:20 am
    Which Emerging Signals from Preclinical Models are Most Likely to have Clinical Relevance?
    Frank Tacke, MD, PhD 
  • 8:20-8:40 am
    Defining the Spectrum of Responses to Treatment 
    Brent A. Tetri, MD, FAASLD
  • 8:40-9 am
    What Defines a Clinically Meaningful Response with Respect to Histological Assessment in Pre-cirrhotic NASH?
    David Kleiner, MD, PhD
  • 9-9:20 am
    Defining a Clinically Meaningful Change in Circulating Biomarker, Imaging and Elastography Based Assessment of Pre-cirrhotic NASH
    Elisabetta Bugianesi, MD, PhD
  • 9:20-9:40 am
    Defining a Clinically Meaningful Change in Circulating Biomarker, Imaging and Elastography Based Assessment of Cirrhosis Due to NASH
    Rohit Loomba, MD
  • 9:40-10 am
    Panel Discussion 
    Chair: Philip N. Newsome, MD, PhD
  • 10-10:20 am
    Break

Session VI: What Will the NAFLD Landscape Look Like In 2025?

Saturday, June 30, 2018
Moderators: Quentin M. Anstee, MBBS, PhD, FRCP and Brent A. Tetri, MD, FAASLD

  • 10:20-10:40 am
    Current Clinical Trial Landscape in Early Development and Prognosis for 2025
    Vlad Ratziu, MD
  • 10:40-11 am
    Current Clinical Trial Landscape in Late Development (phase 3) and Prognosis for 2025
    Stephen A. Harrison, MD, FAASLD
  • 11-11:20 am
    Current Clinical Trial Landscape in Pediatrics and Prognosis for 2025
    Miriam B. Vos, MD, MSPH
  • 11:20 – 11:40 am
    Panel Discussion
    Chair: Brent A. Tetri, MD, FAASLD
  • 11:40 – Noon
    NAFLD Debrief 
    Arun J. Sanyal, MD, FAASLD