Alcoholic Hepatitis Workshop FDA, NIAAA, AASLD Clinical Trial Endpoints for AH

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

 
Link for watching the workshop remotely: https://collaboration.fda.gov/greatv/
 
 
Purpose: The purpose of this workshop is to address challenges related to clinical trial designs and drug development in Alcoholic Associated Liver Disease (AALD) and Alcoholic Hepatitis (AH) including populations to study, endpoints, and diagnostic criteria.
 
The workshop will bring together health agencies, clinical researchers, industry and patient advocacy groups to develop approaches for enhancing the scientific basis of regulatory decision making, so that standards and approaches can be fully integrated into the entire product development process for AH therapies. In addition, the workshop will include presentations on alcohol addiction and treatment, which is a new emerging topic for the hepatology field. The discussion will inform future trial designs and improve outcomes for AH patients.

 

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:

  • 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.

  • Review clinical research progress to determine best practices in designing drug development trials using the knowledge and tools available.

  • Discuss biomarkers that have potential for use in clinical trials.

  • Identify the key challenges, needs and gaps, and new opportunities for the field.

 

Expected Outcomes from the Workshop:

  • 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.

  • 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:

  1. Vijay Shah, Mayo Clinic, Rochester, Minn
  2. Patrick Kamath, Mayo Clinic, Rochester, Minn
  3. Arun Sanyal, Virginia Commonwealth University, Richmond, Virginia
  4. Naga Chalasani, Indiana University, Indianapolis, IN
  5. Suthat Liangpunsakul, Indiana University, Indianapolis, IN
  6. Gyongyi Szabo, MD, University of Massachusetts Medical School, Worcester, MA
  7. Craig McClain, University of Louisville, Louisville, KY
  8. Srinivasan Dasarathy, Cleveland Clinic, Cleveland, OH
  9. Mack Mitchell, University of Texas Southwestern Medical Center, Dallas, Texas
  10. Tim Morgan, Southern California Institute for Research and Education, Orange, CA
  11. Juan Gonzalez Abraldes, University of Alberta, Alberta, Canada
  12. Philippe Mathurin, MD, INSERM, Lille, France
  13. Rajiv Jalan, UCL Medical School, London, UK
  14. Nitzan Roth, Icahn School of Medicine at Mount Sinai
  15. Michael Lucey, UW Health Clinics, Wisconsin, WI
  16. Andrea DiMartini, University of Pittsburgh Medical Center, Pittsburgh, PA
  17. Alexnadre Louvet, INSERM, Lille, France
  18. Rob Myers, Gilead
  19. Bruce Barton, UMMS, MA
  20. Samer Gawrieh, Indiana University, Indianapolis, IN
  21. Veronica Miller, Forum for Collaborative Research, UC Berkeley School of Public Health, Washington, DC
  22. Anna Mae Diehl, Duke University School of Medicine, Durham, NC 
  23.  Brian Borgult , patient advocacy
  24.  Norah Terrault, UCSF, San Francisco, CA 
  25. George Koob (NIAAA)
  26. Dragos Roman, FDA
  27. Kathy Jung, NIAAA
  28. Raye Litten, NIAAA
  29. Veronica Pei, FDA
  30. Daniel Falk, NIAAA
  31. Lori Ducharme, NIAAA
  32. Mark Avigan, FDA
  33. Ewan Forrest, NHS Greater Glasgow and Clyde, Glasgow, UK
  34. Ashwani Singal, University of Alabama, Birmingham, AL
  35. Lorenzo Leggio, NIAAA
  36. Mary Lee, NIAAA
 
 
 
 
 
Link for watching the workshop remotely: https://collaboration.fda.gov/greatv/
 
 
 

Logistics Contact: Bridgette Green --  greenbd@mail.nih.gov