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Drug-Induced Liver Injury 2012 Program 
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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

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

Advisors:
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)

 Archived Meetings

 March 14-15, 2012

SessionFilterTalk TitleFilter
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?
 
Organizers: John R. Senior and Lana Pauls, with advice from Mark Avigan, Robert Fontana, Christine Hunt, Michael Merz, Arie Regev, Leonard Seeff, Paul Watkins
Stephen Spielberg, FDA, Carolyn Compton, CPI, and Paul Watkins, AASLD
Session I: How and why do people respond differently to the same drug?
Moderators: Paul Watkins and Leonard Seeff
Session IA: Are there dose-related and idiosyncratic hepatotoxic drugs?
 
L. Pauls, CDER
J. Senior, CDER
The Seven Advisors
All registrants present
Session IB: What may explain the different ways people respond?
 
Matt Nelson, GSK
Igor Koturbash, NCTR/FDA
Gyongyi Szabo, U Mass
Panel; All
Session II: Lessons to learn from
Moderators: Bob Fontana and Christine Hunt
Session IIA: Examples to make us think

 
Robert Fontana, U MI
Lloyd Klickstein, Novartis
Ed LeCluyse, Hamner-U NC
Jack Uetrecht, U Toronto
All
Session IIB: Focus on the patients
 
Keith Lindor, U AZ State
Ross Pierce, CBER
Heide Stirnadel. GSK
Mark Alter, U PA
Panel; All
Session IIC: Revise the guidance on Drug-Induced Liver Injury?
 
Moderators: Michael Merz, Christine Hunt, and John Senior
Session III: What new and useful biomarkers (and predictors) are out there?
Moderators: Mark Avigan and Arie Regev
Session IIIA: New biomarkers for DILI
 
Mark Avigan, CDER/FDA
Robert Roth, U MI
Jonathan Moggs, Novartis
Hari Mehendele, U LA Monroe
All
Session IIIB: What else is new?
 
Arie Regev, Lilly
Michael Gottesman, OD/NIH
Michael Merz, Novartis
Xiwu Lin, GSK
Paul Watkins, Hamner-U NC
All
Session IV: The Real World: Should trial subjects reflect patients to be treated?
Moderators: Bob Temple and John Senior
John Senior, CDER/FDA
Leonard Seeff, FDA/SGE
Eugene Schiff, U Miami
Sif Ormarsdottir, AstraZeneca
Robert Temple, CDER/FDA
All