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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.

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 

 
Session IV 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


 

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