AASLD/FDA/PhRMA Drug-Induced Liver Injury: Getting the Medicine and Science Together

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AASLD/FDA/PhRMA Drug-Induced Liver Injury: Getting the Medicine and Science Together
March 24-25, 2010
George Meany Center National Labor College, Silver Spring, Maryland

Final Program, Transcripts, and Presentations

Course Description
A national/international discussion of recent clinical and basic findings in the field of drug-induced liver injury (DILI), with presentations by experts in clinical hepatology and scientific investigation of underlying mechanisms, to include active discussion with interested audience registrants. We invite your comments about the tentative program, and ask you to save the date, plan to register, come, and participate actively in this not-for-profit conference.

The program is being 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 the American Association for the Study of Liver Disease (AASLD).

Wednesday March 24,2010	Session	Presentation	Presenter
7:30 AM	Continental Breakfast
8:00 AM		Introductions and Brief Opening Statements	Doug Throckmorton, FDA/CDER Alan Goldhammer, PhRMA Paul Watkins, AASLD, DILI SIG
8:15 AM	Session I: CLINICAL FINDINGS AND CONCEPTS OF THE DILIN		Moderators: Robert Fontana, University of Michigan Naga Chalasani, University of Indiana
8:15 AM - 9:15 AM	Session IA	New Findings from Prospective Reports of DILI	Robert Fontana, University of Michigan
		Pediatric DILI in the United States	Naga Chalasani, Univeristy of Indiana
		Role of Liver Histopathology in DILI	David Kleiner, National Cancer Institute
9:45 AM	Break
10:15 AM - 11:15 AM	Session IB	Herbal and Dietary Supplement Hepatotoxicity	Victor Navarro, Thomas Jefferson University
		Surreptitious HCV and HEV Infections mimicking DILI	Timothy Davern, University of California, San Francisco
		Treatments for DILI – Steroids,NAC and Nrf-2 Activators?	Willian Lee, University of Texas
		General Discussion	All
12:15 PM	Lunch
1:15 PM	Session II: GENETICS, GENOMICS, AND IDIOSYNCRASY		Moderators: Munir Pirmohamed, University of Liverpool Arthur Holden, International SAE Consortium
1:15 PM - 2:45 PM	Session IIA: FINDINGS FROM SAEC NETWORKS	New Directions for the International SAEC	Arthur Holden, International SAE Consortium
		SAEC DILI Genetics Overview	Matt Nelson, GlaxoSmithKline
		HLA Associations with Tykerb Hepatotoxicity	Colin Spraggs, GlaxoSmithKline
		General discussion	Speakers and audience
3:15 PM	Break
3:45 PM - 5:15 PM	Session IIB: FINDINGS FROM DILIN GENETIC DATA, MORE SAEC	Analyses from DILIN Studies	Thomas Urban, Duke University
		Systems Biology of Human Liver	Andrew Kasarskis, Sage
		HLA Genotypes and Phenotypes in Liver Disease	Munir Pirmohamed, University of Liverpool
		General discussion	All
6:00 PM - 7:00 PM	Reception

Thursday March 25,2010	Session	Presentation	Presenter
7:30 AM	Continental Breakfast
8:00AM - 9:20AM	Session IIIA: AT THE HAMNER	Plans and Progress of the Hamner Programs	Paul Watkins, Hamner Institute
		Circulating Liver-mRNA as a DILI Biomarker	Rusty Thomas, Hamner Institute
		DILI and Immunity - A New Mouse Model	Lishan Su, University of North Carolina
		Collaborative Cross - New DILI Resourse	David Threadgill, North Carolina State University
		The Acetaminophen - DILI Physiolab Platform	Harvey Clewell, Hamner Institute
		General Discussion	All
10:00 AM	Break
10:30 AM - 11:50 AM	Session IIIB: CONCURRENT COLLABORATIVE WORK	The inflammasome in DILI	Wajahat Mehal, Yale University
		Novel Protein Biomarkers Platform	Zhijuan Hu, Systems Biology
		Mining AERS: Tool for Theoretical Framework Generation	Ayako Suzuki, Duke University
		Modeling of Clincial Data to Predict DILI Potential	Harry Southworth, Astrazeneca
		General Discussion	All
12:30 PM	Lunch
1:30 PM - 3:00 PM	Session IV: DEBATABLE ISSUES IN THE FDA GUIDANCE OF 2009		Moderator: Mark Avigan, FDA
		Elements of Current Guidance	Mark Avigan, FDA
		Does Elevated Alkaline Phosphatase Exclude Hy’s Law?	Robert Temple, FDA Neil Kaplowitz, University of Southern California
		Are the ALT stopping Rules too Conservative?	John Senior, FDA Arie Regev, Lilly
		Should Rechallenge be Considered More Often?	Leonard Seeff,NIH Christine Hunt, GlaxoSmithKline
3:10 PM	Adjourn

Tentative Program (Note: Topics and speakers are subject to change.)

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AASLD/FDA/PhRMA Drug-Induced Liver Injury: Getting the Medicine and Science Together

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