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Drug-Induced Liver Injury
 

Drug-Induced Liver Injury 2013 Program 
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Drug Induced Liver Injury
Note: this meeting was held March 20-21, 2013

Detecting and Evaluating Drug-Induced Liver Injury and Dysfunction
What’s Normal? What’s Not? What Should We Do About It?

DILI remains a major problem for drug development, and a clinical concern after marketing. We need new understanding, better communication, to avoid the problems. This academic-industry-government international conference will discuss new findings and thinking about drug-induced liver injury (DILI) and dysfunction (DILD), with presentations by experts in clinical hepatology and other fields, and active discussion with all registrants. Come and participate in this conference.

Co-sponsored by FDA/CDER, C-Path, and PhRMA
Endorsed by NIH DILIN and AASLD

Organizers:
John R. Senior, MD and Lana Pauls, MPH

Advisors:
Mark Avigan, MD, CM; Michael Merz, MD; Arie Regev, MD; Leonard Seeff, MD and Paul Watkins, MD

Meeting Agenda

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

 Archived Meetings

 March 20-21, 2013
SessionFilterTalk TitleFilter
Introductions and Opening Statements
John Senior, CDER/FDA
Tim Shi, GlobalMD
Martha Brumfield, C-Path
Session I: What are “normal” liver test results?
 
Moderators: Paul Watkins and Leonard Seeff
Session IA: How are normal ranges determined?
John Senior, CDER
D. Robert Dufour, VAMC
Arie Regev, Lilly
Leonard Seeff, Hill Group
Open discussion
Session IB: How should we make decisions in clinical trials?
Chrisitine Hunt, Duke U
Doug Throckmorton, FDA
Lana Pauls, FDA
General discussion - panel of speakers above, audience
Panel; Audience
Session IIA: The Coming Crush: Is There a Cure Out There for Hepatitis C?

 
Moderators: Christine Hunt and John Senior
Debra Birnkrant, FDA
Marc Ghany, NIH
Harvey Alter, NIH
Leonard Seeff, FDA/SGE
General discussion - panel of speakers above, audience
Panel; Audience
Session IIB: How can we manage it?
Jeff Florian, CDER/FDA
A view from the medical regulatory side
Ed Cox, CDER/FDA
Gary Davis, Baylor
T. Jake Liang, NIH
General discussion - speakers and audience
Panel; All
Session IIIC: Does the July 2009 Guidance on Drug-Induced Liver Injury Need Updating, Revision?
 
 
Moderators: Arie Regev, Robert Temple, and Ruyi He
 
Further discussion of needs for revision, clarification of FDA guidance July 2009
Session III: Everybody says we need new biomarkers; are there any good ones?
 
Moderators: Mark Avigan and Michael Merz
Session IIIA: New biomarkers for DILI
 
 
John Senior, FDA
 
Cynthia Moylan. Duke U
 
Shashi Bala, U MA
 
Christopher MacLauchlin, GSK
 
General discussion – speakers and audience
Panel; All
Session IIIB: Interdependence of organ functions
 
 
Will Lee, UTSW
 
Nancy Xu, FDA/DCRP
 
Willis Maddrey, UTSW
 
Gideon Blumenthal, NIH/FDA
 
General discussion - speakers and audience
Panel; All
Session IV: Maximizing what we can learn from clinical development programs
Moderators: Arie Regev and Lana Pauls
Session IVA: Something old; something new; something better
Mark Avigan, CDER/FDA
Ling Chin, GDU Consulting
Vincent Lo Re, U Penn
Michael Merz, Novartis
General discussion – speakers and audience
Panel; All
Session IVB: Putting the data together
The ECG Warehouse/Cardiac Safety Research Consortium 
Norman Stockbridge, FDA
Ted Guo, FDA/OTS
Michael Merz, Novartis
Chuck Cooper, FDA
Paul Watkins, U NC
General discussion – panel of speakers above, audience 
Panel; All