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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).

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)

Session Presentation Presentor
March 19-20, 2014
  Welcome Lana Pauls and John Senior
  The DILI Conferences 1999-2014 John Senior, FDA/OPE
  Review of new drug applications for liver safety Mwango Kashoki, FDA/OND
  Surveillance for liver toxicity after marketing Gerald Dal Pan, FDA/OSE
  Application of translational science to drug safety Shashi Amur, FDA/OTS
  Discussion, opening session Speakers, All
Session IA: Can we really predict? Or just detect?   Moderators: Christine Hunt and Robert Fontana
Critical Path’s Predictive Safety Testing Consortiium - 10 years of progress John-Michael Sauer, CPI
How predictive is “Hy’s Law”? Robert Temple, FDA/CDER
Industry initiatives: what's new?  Michael Merz, Novartis
Academic research breakthroughs – will biomarkers do it?  Paul Watkins, U NC
CDER Outstanding Service Award presented to John R. Senior Janet Woodcock, FDA/CDER
Launching the Critical Path Initiative: intents, consequences Janet Woodcock, FDA/CDER
LiverTox - an update Jay Hoofnagle, NIH
Do the hepatologists (AASLD) have any answers?  Gyongi Szabo, AASLD
Session IB: What may explain the different ways people respond?    
It’s the genome - Ann Daly, Newcastle UK
Modeling for susceptibility factors Kyunghee Yang, Hamner Inst.
It’s the immune system -  Jack Uetrecht, U Toronto
General discussion IB – panel of speakers above, audience Panel; All
Session IIA: RUCAM or Expert Opinions --- a Debate   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
Session IIB: Focus on New and Hot Findings    
Sting-IRF# pathway for apoptosis in early alcoholic injury Gyongyi Szabo, U MA
Mitochondrial-autophagy drive hepatocyte polariazation Irwin Arias, NIH
Drug-induced hepatic steat-osis/itis Arie Regev, Lilly
Reckless behavior causes acute liver failure 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
Session IIIA: New biomarkers for DILI DILI biomarkers – what is really needed? Mark Avigan, CDER/FDA
Translational mechanistic biomarkers Dan Antoine, Liverpool UK
Mitochondrial dysfunction biomarkers Mitch McGill, U KS
In silico insights Brett Howell, Hamner Inst
Lessons from healthy volunteers Paul Watkins, U NC
General discussion IIIA – speakers and audience All
Session IIIB: What else is new?  
DILIN experience with biomarkers Herb Bonkovsky, Carolinas
European IMI SAFE-T consortium: progress and challenges Michael Merz, Novartis
Predictive Safety Testing Consortium Initiatives Jeff Lawrence, Amgen
General discussion IIIB – speakers and audience All
Presentation of eDISH Plaque to John R. Senior Paul Watkins, U NC
Session IV: The Real World: Should trial subjects reflect patients to be treated? Moderators: Bob Temple and Lana Pauls
Results of RUCAM vs Expert Opinion Poll and discussion Lana Pauls, all
How can we reconcile inherent conflicts? John Senior, CDER/FDA
Subjects with active liver disease need special observation Leonard Seeff, consultant
A view from an academic consultant to industry Willis Maddrey, UTSW
A view from the pharmaceutical industry Sif Ormarsdottir, AstraZeneca
A view from the medical regulatory side Robert Temple, CDER/FDA
General discussion IV – speakers and audience All




Archived Meetings

2008-1999 (FDA website)