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Drug Induced Liver Injury
This meeting was held March 14-15, 2012

Why DILI Idiosyncrasy? The Immune System and Beyond ...
Why Do Only A Few People Show Serious Liver Dysfunction 
From Drugs That Nearly Everybody Else Can Tolerate or Adapt To?

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

John R. Senior, MD and Lana Pauls, MPH

Mark Avigan, MD, CM; Robert Fontana, MD; Christine Hunt, MD; Michael Merz, MD; Arie Regev, MD; Leonard Seeff, MD and Paul Watkins, MD

DILI is still a major problem for drug development, and a clinical concern after marketing. We need new biomarkers, new understanding, and a path forward to solve the problems. This academic-industry-government international conference will discuss new findings and thinking about drug-induced liver injury (DILI), including presentations by experts in clinical hepatology, toxicology, and other fields, and discussion with all registrants. Come and participate in this conference.

Meeting Agenda
Evening Session
     Open Discussion of FDA 2009 Guidance Revision 

Presentations (Note: Click on the Presentation Title to view slides) 
March 14-15, 2012
Why DILI Idiosyncrasy? The Immune System and Beyond ...   Organizers: John R. Senior and Lana Pauls, with advice from Mark Avigan, Robert Fontana, Christine Hunt, Michael Merz, Arie Regev, Leonard Seeff, Paul Watkins
Why Do Only A Few People Show Serious Liver Dysfunction 
From Drugs That Nearly Everybody Else Can Tolerate or Adapt To?
Introductions and Brief Opening Statements Stephen Spielberg, FDA, Carolyn Compton, CPI, and Paul Watkins, AASLD
Session I: How and why do people respond differently to the same drug? Session Transcript Moderators: Paul Watkins and Leonard Seeff
Session IA: Are there dose-related and idiosyncratic hepatotoxic drugs? What are differences between pre- and post-marketing data?  L. Pauls, CDER
What is idiosyncrasy anyway? Is it dose-related?  J. Senior, CDER
Comments by Advisors  The Seven Advisors
Open discussion   All registrants present
Session IB: What may explain the different ways people respond?  It's the genome -  Matt Nelson, GSK
Not the inherited genome but epigenetic variations -  Igor Koturbash, NCTR/FDA
It's the immune system - Gyongyi Szabo, U Mass
General discussion - panel of speakers above, audience  Panel; All
Session II: Lessons to learn from Session Transcript Moderators: Bob Fontana and Christine Hunt
Session IIA: Examples to make us think  GWAS in DILI: promises and pitfalls  Robert Fontana, U MI
Lumiracoxib -can it be reborn by HLA typing?  Lloyd Klickstein, Novartis
iPS cells and patient-specific hepatocyte cultures  Ed LeCluyse, Hamner-U NC
A fresh look at isoniazid hepatotoxicity  Jack Uetrecht, U Toronto
General discussion Speakers and audience All
Session IIB: Focus on the patients Is it autoimmune hepatitis or DILI?  Keith Lindor, U AZ State
Why and how are biologics different than drugs? Ross Pierce, CBER
Are children not just little adults in how they respond?  Heide Stirnadel. GSK
Plasticity of the transcriptome in autism  Mark Alter, U PA
General discussion - panel of speakers above, audience Panel; All
Session IIC: Revise the guidance on Drug-Induced Liver Injury?   Moderators: Michael Merz, Christine Hunt, and John Senior
   Open discussion of proposals for revision of FDA guidance July 2009  
Session III: What new and useful biomarkers (and predictors) are out there? Session Transcript Moderators: Mark Avigan and Arie Regev
Session IIIA: New biomarkers for DILI  Key features for biomarkers we need  Mark Avigan, CDER/FDA
Animal models of idiosyncratic DILI  Robert Roth, U MI
Serum miRNA markers for human DILI  Jonathan Moggs, Novartis
Another death protein - secretory phospholipase A2  Hari Mehendele, U LA Monroe
General discussion - speakers and audience All
Session IIIB: What else is new? How can we break the logjam for predictive biomarkers?  Arie Regev, Lilly
Other side of the coin - cancer chemotherapy resistance Michael Gottesman, OD/NIH
New liver biomarkers under study in Europe Michael Merz, Novartis
Liver test variations in healthy people  Xiwu Lin, GSK
Sharing information, asking questions - liver data warehouse?  Paul Watkins, Hamner-U NC
General discussion - speakers and audience All
Session IV: The Real World: Should trial subjects reflect patients to be treated?  Session Transcript Moderators: Bob Temple and John Senior
How can we reconcile inherent conflicts?  John Senior, CDER/FDA
Subjects with active liver disease need special observation Leonard Seeff, FDA/SGE
A view from an academic consultant to industry Eugene Schiff, U Miami
A view from the pharmaceutical industry  Sif Ormarsdottir, AstraZeneca
A view from the medical regulatory side Robert Temple, CDER/FDA
General discussion - speakers and audience  All


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