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Hepatotoxicity Special Interest Group
This meeting was held March 23-24, 2011

Drug-Induced Liver Injury: Are We Ready to Look?
Co-sponsored by: AASLD, FDA/CDER and PhRMA

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

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

A national/international discussion of recent findings and thinking in the field of drug-induced liver injury (DILI), with presentations by experts in clinical hepatology, toxicology, and other disciplines.

Meeting Agenda
Presentations (Note: Click on the Presentation Title to view slides) 

March 23-24, 2011    
Drug-Induced Liver Injury: Are We Ready to Look?    
Welcome Lana Pauls, MPH
Introductions and Brief Opening Statements Robert Temple, MD, Alice Till, PhD and Paul Watkins, MD
Session I: Liver Injury and Dysfunction in Patients Session Transcript Moderators: Lana Pauls, MPH and Robert Fontana, MD
Session IA: What Should We Be Looking For?    
What is Meant by Looking? Lana Pauls, MPH
Why is the Probable Cause so Important? John Senior, MD
Comments by Advisors The Six Advisors
Open Discussion All registrants present
Session IB: How Have We Been Looking?    
“Liver Tox” – A New Resource from the NLM Jay Hoofnagle, MD
Retrospective and Prospective DILIN Cases Robert Fontana, MD
Characteristics of the ALF Population William Lee, MD
General Discussion  
Session II: Liver Reaction to Injury Session Transcript Moderators: Leonard Seeff, MD and Paul Watkins, MD
Session IIA: Adaptation without Morphologic Change    
Development of Tolerance to Acetaminophen Martin Black, MD
Animal Studies of Adaptation to Acetaminophen Robert Roth, PhD
Studies in Healthy Subjects Exposed to Drugs Paul Watkins, MD
How Often Does it Happen in Patients? Leonard Seeff, MD
General Discussion Panel; All
Session IIB: Liver Repair and Regeneration Defense and Repair Mechanisms in Drug-induced Liver Injury Hari Mehendale, PhD
Regeneration of the Liver After Severe Drug Injury George Michalopoulos, MD, PhD
One Way the Liver Changes Itself – Demethylation Epigenetics Jonathan Moggs, PhD
General Discussion  
Informal Evening Session Open Discussion of Proposals for Guidance Revision Innovative Medicine Initiative, et. al.
Session III: Biomarkers and Predictors of Liver Injury and Dysfunction Session Transcript Moderators: Mark Avigan, MD, CM and Arie Regev, MD
Session IIIA     
Lessons from the Kidney Frank Sistare, PhD
Qualification of Biomarkers Marc Walton, MD
 New Liver Injury Biomarkers Jeff Lawrence, MD
Hepatotoxic Drugs: Wolves and Sheep? Donna Mendrick, PhD
ROC Traps, Research Toxicology Model John Senior, MD
General Discussion  
Session IIIB    
Is Serious Liver Injury Predictable? Mark Avigan, MD, CM
Moving from Preclinical to Clinical Studies Arie Regev, MD
Are New and Better Biomarkers “Out There”? Stephen Furlong, PhD
The IMI Safe – T Initiative in Europe Michael Merz, MD
New Predictive Biomarker Profiles for Human APAP Toxicity Ina Schuppe-Koistinen, MD
General Discussion  
Session IV: The Real World: Post-marketing DILI Session Transcript Moderators: Christine Hunt, MD and John Senior, MD
Finding Cases in the Post-marketing Environment Christine Hunt, MD
Analyses of Large Databases: Kaiser-Permanente Craig Cheetham, PharmD, MS
Epidemiologic Approaches: OMOP Judy Racoosin, MD, MPH
Modulation by Concomitant Medications Ayako Suzuki, MD, PhD
Should we Propose a Standard of Care for DILI Cases? Leonard Seeff, MD
General Discussion  

 

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