AASLD/FDA/PhRMA Hepatotoxicity Steering Group Meeting -- Presentation Slides

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Recent Research Advances in Drug-Induced Liver Injury
Note: This meeting took place April 8-9, 2009 Liver Toxicity
George Meany Center National Labor College
10000 New Hampshire Avenue at Powder Mill Road
Silver Spring, MD 20903

Description
A national/international discussion of recent new findings in the field of drug-induced liver injury (DILI), work in progress, and work that needs to be done.

The program was co-sponsored by the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER), the Pharmaceutical Research and Manufacturers of America (PhRMA), and AASLD.

Program with Presenter Slides
(Note: Click on a Speaker's Name to View His/Her Presentation Slides.)

Wednesday, April 8, 2009
8:00am	Introductions and Opening Statements Welcome Lana Pauls and John Senior (Co-Chairs) Food and Drug Administration / Center for Drug Evaluation and Research Janet Woodcock - FDA / CDER Alan Goldhammer - PhRMA Neil Kaplowitz - AASLD

Session I - Moderator: Roger Ulrich - Calistoga Pharmaceuticals
Session IA:	Genetic Susceptibility to DILI or Liver Disease
8:15am	Systems Biology Approach to Ximelagatran Injury Karin Cederbrant AstraZeneca
8:45am	MHC II Haplotype Marker for Lumiracoxib Injury Tim Wright Novartis
9:15am	Powerful HLA Marker of Flucloxicillin Injury Susceptibility Ann Daly University of Newcastle
Session IB:	Can Animals be Used to Show Idiosyncratic Responses?
10:15am	The Mouse as A Model for Susceptibility to DILI Ivan Rusyn University of North Carolina
10:45am	Idiosyncrasy in Ordinary Laboratory Animals John Senior Food and Drug Administration / Center for Drug Evaluation and Research
11:15am	Mouse Models of Halothane-Induced Liver Injury Cynthia Ju University of Colorado
	Session I Discussion

Session II - Moderator: Paul Watkins - University of North Carolina
Session IIA:	Findings from DILI Genetic Networks
1:15pm	Findings from the SAEC International Network Matt Nelson GlaxoSmithKline
2:00pm	The Spanish DILI Network Raúl Andrade University of Malaga
Session IIB:	What Do the Gene Findings Mean for DILI Mechanisms?
3:45pm	Genotype-Phenotype Relationships Roger Ulrich Calistoga Pharmaceuticals
4:15pm	Implications of Genetic Susceptibility to DILI David Goldstein Duke University
4:45pm	Mechanisms of Liver Injury in Susceptible People Neil Kaplowitz University of South Carolina
	Session II Discussion

Thursday, April 9, 2009
Session III - Moderator: Leonard Seeff - National Institutes of Health / NIDDK
Session IIIA:	Research in Progress A
8:00am	Screening Populations for Transaminase Elevations Heide Stirnadel GlaxoSmithKline-United Kingdom
8:20am	Metabolic Effects in Subjects Taking Acetaminophen Tom O'Connell University of North Carolina
8:40am	Update on Acetaminophen Hepatotoxicity Will Lee University of Texas Southwestern
9:00am	Liver Injury in Patients on Anti-Tuberculosis Therapy Jussi Saukkonen Boston University
Session IIIB:	Research in Progress B
10:30am	Cellular Imaging of Hepatocytes to Predict DILI Michael Aleo Pfizer
10:50am	Blood Transcriptomic Findings in Acute Liver Injury Rick Paules National Institutes of Environmental Health Sciences
11:10am	Human Hepatocyte Cultures for Study of DILI Sangeeta Bhatia Massachusetts Institute of Technology
11:30am	Update on Liver Transplants for DI-ALF Arie Regev Lilly
	Session III Discussion

Session IV - Moderator: Lana Pauls - Food and Drug Administration / CDER
Session IV:	Research that Needs to be Done
1:30pm	Research Opportunities Under the New FDA Guidance Mark Avigan Food and Drug Administration / Center for Drug Evaluation and Research
1:55pm	Using eDISH-like methods to track possible hepatotoxicity: Case Studies Jack Ostroff Pfizer
2:20pm	IOM and DILIN Suggestions and Plans Paul Watkins University of North Carolina
2:40pm	In Silico Simulation of DILI Using the Entelos Platform Harvey Clewell The Hamner
	Session IV Discussion

Previous Meetings

DILI Programs and Presentations 1999-2008 (available on FDA website)

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AASLD/FDA/PhRMA Hepatotoxicity Steering Group Meeting -- Presentation Slides

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