Alcoholic Hepatitis Workshop - FDA, NIAAA, AASLD
March 26-27, 2018
Food and Drug Administration
Great Room – White Oak Campus
10903 New Hampshire Ave., Silver Spring, MD
Link for watching the workshop remotely: https://collaboration.fda.gov/greatv/
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General Information
Clinical Trial Design and Endpoints for Alcoholic Hepatitis and other Alcohol-Associated Liver Diseases
Organizers:
Lara Dimick-Santos
Svetlana Radaeva
Gyongyi Szabo
Scientific Advisory Committee:
Arun Sanyal
Mack Mitchell
Ramon Bataller
Craig McClain
Timothy Morgan
Michael Lucey
Donna Griebel
Dragos Roman
Lisa Soule
Stephanie O. Omakaro
Irene Tebbs
Bridget Williams-Simmons
Workshop Goals:
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Develop recommendations for standardized definitions, variable sets, screening and assessment tools and procedures to advance the state of the science in AALD and AH clinical research and the overlap of those entities.
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Review clinical research progress to determine best practices in designing drug development trials using the knowledge and tools available.
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Discuss biomarkers that have potential for use in clinical trials.
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Identify the key challenges, needs and gaps, and new opportunities for the field.
Expected Outcomes from the Workshop:
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Publish a white paper of the final recommendations from the workshop to inform AALD and AH investigators, clinicians, funding and regulatory organizations, families and other stakeholders in the field.
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Build buy-in for Common Data Elements through improved understanding of what they are and when they might be used to increase adoption and value to clinical research.
Invited speakers:
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Vijay Shah, Mayo Clinic, Rochester, Minn
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Patrick Kamath, Mayo Clinic, Rochester, Minn
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Arun Sanyal, Virginia Commonwealth University, Richmond, Virginia
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Naga Chalasani, Indiana University, Indianapolis, IN
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Suthat Liangpunsakul, Indiana University, Indianapolis, IN
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Gyongyi Szabo, MD, University of Massachusetts Medical School, Worcester, MA
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Craig McClain, University of Louisville, Louisville, KY
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Srinivasan Dasarathy, Cleveland Clinic, Cleveland, OH
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Mack Mitchell, University of Texas Southwestern Medical Center, Dallas, Texas
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Tim Morgan, Southern California Institute for Research and Education, Orange, CA
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Juan Gonzalez Abraldes, University of Alberta, Alberta, Canada
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Philippe Mathurin, MD, INSERM, Lille, France
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Rajiv Jalan, UCL Medical School, London, UK
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Nitzan Roth, Icahn School of Medicine at Mount Sinai
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Michael Lucey, UW Health Clinics, Wisconsin, WI
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Andrea DiMartini, University of Pittsburgh Medical Center, Pittsburgh, PA
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Alexnadre Louvet, INSERM, Lille, France
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Rob Myers, Gilead
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Bruce Barton, UMMS, MA
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Samer Gawrieh, Indiana University, Indianapolis, IN
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Veronica Miller, Forum for Collaborative Research, UC Berkeley School of Public Health, Washington, DC
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Anna Mae Diehl, Duke University School of Medicine, Durham, NC
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Brian Borgult , patient advocacy
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Norah Terrault, UCSF, San Francisco, CA
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George Koob (NIAAA)
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Dragos Roman, FDA
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Kathy Jung, NIAAA
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Raye Litten, NIAAA
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Veronica Pei, FDA
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Daniel Falk, NIAAA
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Lori Ducharme, NIAAA
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Mark Avigan, FDA
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Ewan Forrest, NHS Greater Glasgow and Clyde, Glasgow, UK
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Ashwani Singal, University of Alabama, Birmingham, AL
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Lorenzo Leggio, NIAAA
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Mary Lee, NIAAA
Logistics Contact: Bridgette Green -- greenbd@mail.nih.gov