Drug-Induced Liver Injury 2011 Program

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Hepatotoxicity Special Interest Group
Note: 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)

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March 23-24, 2011

Session	Presentation	Presenter
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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Archived Meetings

March 23-24, 2011

Drug-Induced Liver Injury 2011 Program

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