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Hepatotoxicity Special Interest Group

This meeting was held April 8-9, 2009

Recent Research Advances in Drug-Induced Liver Injury

A national/international discussion of recent new findings in the field of drug-induced liver injury (DILI), work in progress, and work that needs to be done.

The program was co-sponsored by the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER), the Pharmaceutical Research and Manufacturers of America (PhRMA), and AASLD.

Program with Presenter Slides
(Note: Click on a Speaker's Name to View His/Her Presentation Slides.)

Wednesday, April 8, 2009

Introductions and Opening Statements
Lana Pauls and John Senior (Co-Chairs)
Food and Drug Administration / Center for Drug Evaluation and Research

Janet Woodcock - FDA / CDER
Alan Goldhammer - PhRMA
Neil Kaplowitz - AASLD


Session I -  Moderator: Roger Ulrich - Calistoga Pharmaceuticals

Session IA: Genetic Susceptibility to DILI or Liver Disease

Systems Biology Approach to Ximelagatran Injury
Karin Cederbrant


MHC II Haplotype Marker for Lumiracoxib Injury
Tim Wright


Powerful HLA Marker of Flucloxicillin Injury Susceptibility
Ann Daly
University of Newcastle

Session IB:  Can Animals be Used to Show Idiosyncratic Responses?
10:15am The Mouse as A Model for Susceptibility to DILI
Ivan Rusyn
University of North Carolina

Idiosyncrasy in Ordinary Laboratory Animals
John Senior
Food and Drug Administration / Center for Drug Evaluation and Research

11:15am Mouse Models of Halothane-Induced Liver Injury
Cynthia Ju
University of Colorado
  Session I Discussion
Session II - Moderator: Paul Watkins - University of North Carolina
Session IIA:  Findings from DILI Genetic Networks
1:15pm Findings from the SAEC International Network
Matt Nelson
2:00pm The Spanish DILI Network
Raúl Andrade
University of Malaga
Session IIB:  What Do the Gene Findings Mean for DILI  Mechanisms?
3:45pm Genotype-Phenotype Relationships
Roger Ulrich
Calistoga Pharmaceuticals
4:15pm Implications of Genetic Susceptibility to DILI
David Goldstein
Duke University
4:45pm Mechanisms of Liver Injury in Susceptible People
Neil Kaplowitz
University of South Carolina
  Session II Discussion
Thursday, April 9, 2009 
Session III - Moderator: Leonard Seeff - National Institutes of Health / NIDDK
Session IIIA:  Research in Progress A
8:00am Screening Populations for Transaminase Elevations
Heide Stirnadel
GlaxoSmithKline-United Kingdom
8:20am Metabolic Effects in Subjects Taking Acetaminophen
Tom O'Connell
University of North Carolina

Update on Acetaminophen Hepatotoxicity
Will Lee
University of Texas Southwestern

9:00am Liver Injury in Patients on Anti-Tuberculosis Therapy
Jussi Saukkonen
Boston University
Session IIIB: Research in Progress B
10:30am Cellular Imaging of Hepatocytes to Predict DILI
Michael Aleo

Blood Transcriptomic Findings in Acute Liver Injury
Rick Paules
National Institutes of Environmental Health Sciences

11:10am Human Hepatocyte Cultures for Study of DILI
Sangeeta Bhatia
Massachusetts Institute of Technology
11:30am Update on Liver Transplants for DI-ALF
Arie Regev
  Session III Discussion
Session IV -  Moderator: Lana Pauls - Food and Drug Administration / CDER
Session IV:  Research that Needs to be Done
1:30pm Research Opportunities Under the New FDA Guidance
Mark Avigan
Food and Drug Administration / Center for Drug Evaluation and Research
1:55pm Using eDISH-like methods to track possible hepatotoxicity: Case Studies
Jack Ostroff
2:20pm IOM and DILIN Suggestions and Plans
Paul Watkins
University of North Carolina
2:40pm In Silico Simulation of DILI Using the Entelos Platform
Harvey Clewell
The Hamner
  Session IV Discussion