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Drug-Induced Liver Injury 2010 Program 
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Hepatotoxicity Special Interest Group
This meeting was held March 24-25, 2010

Drug Induced Liver Injury:  Getting the Medicine and Science Together

Description
A national/international discussion of recent clinical and basic findings in the field of drug-induced liver injury (DILI), with presentations by experts in clinical hepatology and scientific investigation of underlying mechanisms.

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.

 Archived Meetings

 

Meeting Agenda
Presentations
(Note: Click on the Presentation Title to view slides)

Wednesday, March 24
Session Presentation Presenter
Introductions and Brief Opening Statements Doug Throckmorton, FDA/CDER
Alan Goldhammer, PhRMA
Paul Watkins, AASLD, DILI SIG
Session I:  Clinical Findings and Concepts of the DILIN
Moderators:  Robert J. Fontana, University of Michigan; Naga Chalasani, Indiana University
Session IA
New findings from prospective reports of DILI Robert J. Fontana, University of Michigan
Pediatric DILI in the United States Naga Chalasani, Indiana University
Role of liver histopathology in DILI David E. Kleiner, National Cancer Institute
Session IB
Herbal and dietary supplement hepatotoxity Victor Navarro, Thomas Jefferson University
Liver injury with low drag causality scores:  HCV, HEV Timothy J. Davern, California Pacific Medical Center
Treatments for DILI - steroids, NAC, Nrf-2 activators? William M. Lee, UT Southwestern Medical Center
General Discussion - speakers and audience All
Session II:  Genetics, Genomics, and Idiosyncrasy
Moderator:  Arthur L. Holden, International SAE Consortium
Session IIA:  Findings for SAEC Networks
New directions for the international SAEC Arthur L. Holden, International SAE Consortium
SAEC DILI genetics overview Matthew R. Nelson, GlaxoSmithKline
HLA associations with Tykerb hepatotoxicity Colin Spraggs, GlaxoSmithKline
General Discussion - speakers and audience All
Session IIB:  Findings from DILIN genetic data, more SAEC
Analyses for DILIN studies Thomas J. Urban, Duke University
Systems biology of human liver Andrew Kasarskis, Sage Bionetworks
General Discussion - speakers and audience All
Thursday, March 25
Session III:  The Hamner-UNC Institues for Drug Safety Sciences
Moderator:  Paul B. Watkins, University of North Carolina
Session IIIA:  At the Hamner
Plans and progress of the Hamner programs Paul B. Watkins, University of North Carolina
Circulating Liver-mRNA as a DILI Biomarker Russell S. Thomas, The Hamner Institutes
Collaborative Cross - New DILI Resource David Threadgill, North Carolina State University
The Acetaminophen - DILI Physiolab Platform Harvey Clewell, The Hamner Institutes
Session IIIB:  Concurrent Collaborative Work
The inflammasome in DILI Wajahat Mehal, Yale University
Novel Protein Biomarkers Platform Zhiyuan Hu, Institute for Systems Biology
Mining AERS: Tool for Theoretical Framework Generation Ayako Suzuki, Duke University
Modeling of Clincial Data to Predict DILI Potential  Harry Southworth, AstraZeneca
General Discussion - speakers and audience All
Session IV:  Debatable Issues in the FDA Guidance of 2009
Moderator:  Mark Avigan, FDA; Timekeeper:  Lana Pauls, FDA
Elements of Current Guidance Mark Avigan, FDA
Does Elevated Alkaline Phosphatase Exclude Hy’s Law?
Yes Robert J. Temple, FDA
No  Neil Kaplowitz, University of Southern California
Rebuttal  Robert J. Temple, FDA
Rebuttal Neil Kaplowitz, University of Southern California
Are the ALT stopping Rules too Conservative?
Yes John R. Senior, FDA
No  Arie Regev, Eli Lilly
Rebuttal John R. Senior, FDA
Rebuttal Arie Regev, Eli Lilly
Should Rechallenge be Considered More Often?
Yes Leonard B. Seeff, NIH
No  Christine M. Hunt, GlaxoSmithKline
General Discussion - speakers and audience All