Thu, Jun 17 at 12:00 am EDT
Session I: Current Management of NASH

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Overview

This initial session is intended to set the foundation for the meeting by providing an overview of our current understanding of NAFLD/NASH as it pertains to epidemiology, natural history, pathogenesis, liver biopsy diagnosis and current treatment. This session will help frame the current challenges we are facing with NASH and drug development in this field.

SPEAKERS

Program Chairs:

Rohit Loomba, MD
Stephen A. Harrison, MD, FAASLD

Moderators:
Raymond T. Chung, MD, FAASLD
Suzanne R. Sharpton, MD, MAS

Presenters:
Zobair M. Younossi, MD, MPH, FAASLD - Epidemiology and Natural History of NASH
Brent A. Tetri, MD, FAASLD - Pathogenesis of NASH
David Kleiner, MD, PhD - Liver Histologic Assessment and Differential Diagnosis in NAFLD
Kathleen E. Corey, MD, MPH, MMSc - Lifestyle, Current Pharamacologic Treatment of NASH and Bariatric Surgery

Thu, Jun 17 at 12:00 am EDT
Session II: NASH Progression and Co-morbidities

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Overview

This is an exciting session that will cover topics related to childhood NAFLD/NASH. In addition, there will be updates on NASH related HCC and liver transplantation. The utilization of NITs to risk stratify patients and predict response to therapy will also be discussed. 

SPEAKERS 

Moderators:
Rohit Loomba, MD
Naim Alkhouri, MD

Presenters:
Marialena Mouzaki, MD - Diagnosis and Management of Pediatric NASH
Naim Alkhouri, MD - How to Use NIT in Risk Stratification in Clinical Care?
Veeral H. Ajmera, MD - NASH Related HCC and Liver Transplantation
Nobuharu Tamaki, MD - Clinical Utility of 30% Relative Decline in MRI-PDFF in Predicting Fibrosis Regression in Nonalcoholic Fatty Liver Disease
Marialena Mouzaki, MD - Characteristics of Children with NAFLD and Advanced Hepatic Fibrosis
Elizabeth C. Verna, MD, MS - Impact of COVID-19 on Clinical Trial Design and Participation

Thu, Jun 17 at 12:00 am EDT
Session III: NASH Trials- All things Considered

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Overview

What is the ideal NASH drug? What are the challenges and opportunities in clinical trial design relative to enrollment, clinical trial end points, and stabilization of placebo response rates? This session will also cover utilization of MRE to predict fibrotic response in NASH. 

SPEAKERS

Moderators:
Naim Alkhouri, MD  
Summer Collier, MSN, FNP-BC

Presenters:

Brent A. Tetri, MD, FAASLD - Ideal NASH Drug
Arun J. Sanyal, MD, FAASLD - NASH Related Fibrosis and Cirrhosis: Phase 2/3/4 Endpoints
Stephen A. Harrison, MD, FAASLD - Patient Selection and Screen Fail Rate Mitigation (NASH and Cirrhosis)
Charles Wang, MD - Histological Assessment of Mitochondrial Pyruvate Carrier (MPC) as a Lipid Metabolic Regulator and Determination of Disease Severity in Human Non-alcoholic Hepatosteatosis
Rebecca Taub, MD - Prediction of Fibrotic Nash and Treatment with Resmetirom in Phase 3 Maestro Studies: MRI-PDFF and Magnetic Resonance Elastography
Mary E. McCarthy Rinella, MD, FAASLD - Stabilization of Placebo Response Rates in NASH and Cirrhosis Trials

Fri, Jun 18 at 12:00 am EDT
Session IV: Endpoint Analysis

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Overview

Much has been learned from clinical trials in NASH that have already been performed. This session dives into those lessons learned relative to study design, histopathologic assessment and the utilization of AI digital pathology. Combination therapy for NASH will also be discussed. 

SPEAKERS

Moderators:
Veeral H. Ajmera, MD 
Michelle Long, MD, MSc

Presenters:
Cynthia A. Behling, MD, PhD - Refining Histopathologic Data Collection and Analysis
Mazen Noureddin, MD - Utilization of AI in Pathology in Clinical Trials in NASH and Cirrhosis
Michael R. Charlton, MD, FRCP - Combination Therapy and What Does the Future Look Like

Fri, Jun 18 at 12:00 am EDT
Session V: Assessment of Response and Competing Risks

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Overview

This session takes a closer look at NASH cirrhosis and the complications surrounding trials in this space. More specifically, competing risks of DILI, gallbladder disease and decompensation will be discussed. The utilization of NITs to monitor treatment response will be presented. 

SPEAKERS

Moderators:
Anna Mae Diehl, MD, FAASLD 
Stephen A. Harrison, MD, FAASLD

Presenters:
Manal F. Abdelmalek, MD, MPH, FAASLD - Emerging Therapies for NASH Cirrhosis
Vincent Wong, MD - Liver Histology, Functional and HVPG in NASH Cirrhosis
Rohit Loomba, MD - Non-invasive Biomarkers for Treatment Response
Naga P. Chalasani, MD, FAASLD - Competing Risks of DILI, Gall Bladder Disease, and Decompensation in Cirrhosis Trials and Their Impact on Trial Design

Fri, Jun 18 at 12:00 am EDT
Session VI: Deep-dive Innovations in Design

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Overview

The final session will focus on clinical trial endpoints in NASH cirrhosis trials as well as genetic targets for both non-cirrhotic and cirrhotic NASH trials. The meeting will wrap up with an update from the FDA on regulatory guidance for therapeutic development in NASH with fibrosis. 

SPEAKERS

Moderators:
Rohit Loomba, MD 
Mary E. McCarthy Rinella, MD, FAASLD

Presenters:
Juan G. Abraldes, MD - Clinical Endpoints, Sample-size for Phase 2b and Phase 3 Trials in NASH Cirrhosis
Quentin M. Anstee, MBBS, PhD, FRCP - Genetic (PNPLA3, TM6SF2 and HSD17B13) Targetting of Therapies of NASH and Cirrhosis
Frank A. Anania, MD, FAASLD, FACP, AGAF - FDA Regulatory Guidance for Developing Therapy for Non-cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Liver Fibrosis: What’s New?

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