AASLD: American Association for the Study of Liver Diseases
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Drug-Induced Liver Injury 2014 Program 

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

Wednesday, March 19, 2014
Thursday, March 20, 2014

Marriott Inn & Conference Center
University of Maryland
University College
3501 University Blvd.
East Hyattsville, Maryland 20783


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).

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

Meeting Agenda

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 Wednesday, March 19

Talk TitleFilter
7:30 am
Continental breakfast outside the conference room; register
8:00 am
The DILI Conferences 1999-2014
John Senior, FDA/OPE
8:05 am
Review of new drug applications for liver safety
Mwango Kashoki, FDA/OND
8:20 am
Surveillance for liver toxicity after marketing
Gerald Dal Pan, FDA/OSE
8:35 am
Application of translational science to drug safety
Shashi Amur, FDA/OTS
8:50 am
Speakers, All
Session IA: Can we really predict? Or just detect? What progress has been made?
Moderators: Christine Hunt and Robert Fontana
9:00 am
Critical Path’s Predictive Safety Testing Consortiium - 10 years of progress
John-Michael Sauer, CPI
9:12 am
How predictive is “Hy’s Law”?
Robert Temple, FDA/CDER
9:24 am
Industry initiatives: what's new?
Michael Merz, Novartis
9:36 am
Academic research breakthroughs – will biomarkers do it?
Paul Watkins, U NC
9:48 am
10:00 am
10:15 am
Launching the Critical Path Initiative: intents, consequences
Janet Woodcock, FDA/CDER
10:30 am
LiverTox - an update
Jay Hoofnagle, NIH
10:45 am
Do the hepatologists (AASLD) have any answers?
Gyongi Szabo, AASLD
Session IB: What may explain the different ways people respond?
11:00 am
It’s the genome -
Ann Daly, Newcastle UK
11:15 am
Modeling for susceptibility factors
Kyunghee Yang, Hamner Inst.
11:30 am
It’s the immune system -
Jack Uetrecht, U Toronto
11:45 am
General discussion – panel of speakers above, audience
Panel; All
12:00 pm
Session IIA: RUCAM or Expert Opinions --- a Debate
Moderators: Arie Regev and Leonard Seeff
1:00 pm
RUCAM or Expert Opinions?
Leonard Seeff, Consultant
1:05 pm
Guru Aithal and Robert Fontana,   10’ each
Guru Aithal, UK
1:25 pm
Rebuttals, 5’ each; Aithal and Fontana
Robert Fontana, NIH DILIN
1:35 pm
Michael Merz and  Don Rockey, 10’ each
Michael Merz, Novartis
1:55 pm
Rebuttals, 5’ each; Merz and Rockey
Don Rockey, NIH DILIN
2:05 pm
General discussion – all present
Speakers and audience
2:15 pm
Session IIB: Focus on New and Hot Findings
2:30 pm
Sting-IRF# pathway for apoptosis in early alcoholic injury
Gyongyi Szabo, U MA
2:50 pm
Mitochondrial-autophagy drive hepatocyte polariazation
Irwin Arias, NIH
3:10 pm
Drug-induced hepatic steat-osis/itis
Arie Regev, Lilly
3:50 pm
Reckless behavior causes acute liver failure
William M. Lee, UTSW
4:10 pm
General discussion – panel of speakers above, audience
Panel; All
4:30 pm
Reception: wine and cheese, mingle and relax ---
6:00 pm
Dinner on your own

 Thursday, March 20

Talk TitleFilter
7:30 am
Continental Breakfast outside the conference room
Session III: What new and useful biomarkers (and predictors) are out there?
Moderators: Mark Avigan and Paul Watkins
Session IIIA:  New biomarkers for DILI
8:00 am
DILI biomarkers – what is really needed?
Mark Avigan, CDER/FDA
8:20 am
Translational mechanistic biomarkers
Dan Antoine, Liverpool UK
8:40 am
Mitochondrial dysfunction biomarkers
Mitch McGill, U KS
9:00 am
In silico insights
Brett Howell, Hamner Inst
9:20 am
Lessons from healthy volunteers
Paul Watkins, UNC
9:40 am
General discussion – speakers and audience
10:00 am
Session IIIB:  What else is new?
10:20 am
DILIN experience with biomarkers
Herb Bonkovsky, Carolinas
10:40 am
European IMI SAFE-T consortium: progress and challenges
Michael Merz, Novartis
11:00 am
Predictive Safety Testing Consortium Initiatives
Jeff Lawrence, Amgen
11:20 am
General discussion – speakers and audience
12:00 pm
Session IV:  The Real World: Should trial subjects reflect patients to be treated?
Moderators: Bob Temple and Lana Pauls
1:30 pm
How can we reconcile inherent conflicts?
John Senior, CDER/FDA
1:50 pm
Subjects with active liver disease need special observation
Leonard Seeff, consultant
2:10 pm
A view from an academic consultant to industry
Willis Maddrey, UTSW
2:30 pm
A view from the pharmaceutical industry
Sif Ormarsdottir, AstraZeneca
2:50 pm
A view from the medical regulatory side
Robert Temple, CDER/FDA
3:10 pm
General discussion – speakers and audience
3:30 pm