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Drug-Induced Liver Injury 2014 Program 
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Drug Induced Liver Injury Conference XIV
This meeting was held March 19-20, 2014

Predicting Serious Drug-Induced Liver Injury in Patients
Who Gets It? Who Doesn't?  Why?

Serious drug-induced liver injury is a major problem for both drug development and clinical care. Liver injury defined as serious includes that causing disability from work, need for hospitalization, secondarily impaired renal or brain function, acute liver failure, death, or liver transplantation. Much time, effort, and cost is expended on clinical trials to avoid possibly dangerous new drugs. We seek new understanding to identify especially susceptible rare patients before their liver injury becomes irreversible. We need to solve hepatotoxicity problems that affect pharmaceutical industry protocols, government regulatory bodies, academic consultants to both, and all physicians using drugs to treat patients  in the US and worldwide.

The program is co-sponsored by the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER), the Critical Path Institute (C-Path), and the Pharmaceutical Research and Manufacturers of America (PhRMA).  The program is endorsed by the National Institutes of Health (NIH) drug-induced liver injury network (DILIN), and the American Association for the Study of Liver Diseases (AASLD).

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

Meeting Agenda

Speakers: (Note: Click on the Talk Title to view slides)
Bios and Presentation Links (pdf)

 Archived Meetings

 March 19-20, 2014

SessionFilterTalk TitleFilter
 
Lana Pauls and John Senior
John Senior, FDA/OPE
Mwango Kashoki, FDA/OND
Gerald Dal Pan, FDA/OSE
Shashi Amur, FDA/OTS
Discussion, opening session
Speakers, All
 
Moderators: Christine Hunt and Robert Fontana
John-Michael Sauer, CPI
Robert Temple, FDA/CDER
Michael Merz, Novartis
Paul Watkins, U NC
Janet Woodcock, FDA/CDER
Janet Woodcock, FDA/CDER
Jay Hoofnagle, NIH
Gyongi Szabo, AASLD
 
Ann Daly, Newcastle UK
Kyunghee Yang, Hamner Inst.
Jack Uetrecht, U Toronto
General discussion IB – panel of speakers above, audience
Panel; All
 
Moderators: Arie Regev and Leonard Seeff
RUCAM or Expert Opinions?
Leonard Seeff, Consultant
Robert Fontana and Guru Aithal, 10’ each
Robert Fontana, NIH DILIN and Guru Aithal, UK
Rebuttals, 5’ each; Fontana and Aithal
Michael Merz and Don Rockey, 10’ each
Michael Merz, Novartis and Don Rockey, NIH DILIN
Rebuttals, 5’ each; Merz and Rockey
General discussion IIA – all present
Speakers and audience
 
Gyongyi Szabo, U MA
Irwin Arias, NIH
Arie Regev, Lilly
William M. Lee, UTSW
General discussion IIB - panel of speakers above, audience
Panel; All
Session III: What new and useful biomarkers (and predictors) are out there?
 
Moderators: Mark Avigan and Paul Watkins
 
 
Mark Avigan, CDER/FDA
Dan Antoine, Liverpool UK
 
Mitch McGill, U KS
Brett Howell, Hamner Inst
 
Paul Watkins, U NC
General discussion IIIA – speakers and audience
All
 
Herb Bonkovsky, Carolinas
Michael Merz, Novartis
Jeff Lawrence, Amgen
General discussion IIIB – speakers and audience
All
Paul Watkins, U NC
 
Moderators: Bob Temple and Lana Pauls
Lana Pauls, all
John Senior, CDER/FDA
Leonard Seeff, consultant
Willis Maddrey, UTSW
Sif Ormarsdottir, AstraZeneca
Robert Temple, CDER/FDA
General discussion IV – speakers and audience
All