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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

Evening Session

Does the July 2009 Guidance on Drug-Induced Liver Injury Need Updating, Revision?

Presentations (Note: Click on the Presentation Title to view slides)
March 20-21, 2013    
Introductions and Opening Statements Welcome  
  Genesis of the DILI Conferences 1999-2013 John Senior, CDER/FDA
  Introduction of the Chinese Delegation Tim Shi, GlobalMD
  Developing Consensus-Driven Standards for Understanding DILI Martha Brumfield, C-Path
Session I: What are “normal” liver test results? Session Transcript Moderators: Paul Watkins and Leonard Seeff
Session IA: How are normal ranges determined? How much and what testing assures normality?  John Senior, CDER
  What is a “normal”value for serum ALT activity?  D. Robert Dufour, VAMC
  Cut-off values for interrupting or permanently stopping new drugs Arie Regev, Lilly
  Use xB versus xULN for assessing drug effects? Leonard Seeff, Hill Group
  Open discussion  
Session IB: How should we make decisions in clinical trials? Balancing the risks of harms and chances of benefits  Chrisitine Hunt, Duke U
  Understanding each other across disciplines, organizations Doug Throckmorton, FDA
  Misunderstandings, Misnomers, Miscommunications 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
  A coming flood of new drug applications for treating hepatitis C  Debra Birnkrant, FDA
  Predicting trial outcomes using baseline and on-study data  Marc Ghany, NIH
  Hepatitis C: End of the beginning or beginning of the end?  Harvey Alter, NIH
  How to rule out DILI in subjects with active liver disease Leonard Seeff, FDA/SGE
  General discussion - panel of speakers above, audience Panel; Audience
Session IIB: How can we manage it? Antiviral management information system Jeff Florian, CDER/FDA
  A view from the medical regulatory side  Ed Cox, CDER/FDA
  A view from the industry side  Gary Davis, Baylor
  A view from academia (AASLD)  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? Session Transcript 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? Session Transcript Moderators: Mark Avigan and Michael Merz
Session IIIA: New biomarkers for DILI Should be better than {ALT & BILI} together John Senior, FDA
  Pre-marketing ALT predicts post-marketing liver safety  Cynthia Moylan. Duke U
  Serum miRNA markers for human DILI  Shashi Bala, U MA
  Possible mechanisms of lapatinib hepatotoxicity Christopher MacLauchlin, GSK
  General discussion – speakers and audience Panel; All
Session IIIB: Interdependence of organ functions Drug-induced hepatic encephalopathy  Will Lee, UTSW
  Kidney-liver dependency – lessons from the hepatorenal syndrome Nancy Xu, FDA/DCRP
  Cardiac hepatopathy  Willis Maddrey, UTSW
  Should oncology patients be evaluated differently for DILI?  Gideon Blumenthal, NIH/FDA
  General discussion - speakers and audience Panel; All
Session IV: Maximizing what we can learn from clinical development programs Session Transcript Moderators: Arie Regev and Lana Pauls
Session IVA: Something old; something new; something better Can we harmonize across clinical trials to find predictive biomarkers?  Mark Avigan, CDER/FDA
  Getting the right information to assess DILI causality likelihood Ling Chin, GDU Consulting
  Clarifying classification of liver injury in administrative data  Vincent Lo Re, U Penn
  Proposed Best Practices – from the 9 November conference  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
  Proposals for eDISH2 development  Ted Guo, FDA/OTS
  Alternative analytical systemsfor assessing liver safety: interactive graphics Michael Merz, Novartis
  JReview/JANUS Chuck Cooper, FDA
  Proposal for a Liver Safety Research Consortium Paul Watkins, U NC
  General discussion – panel of speakers above, audience  Panel; All

 

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