Drug-Induced Injury: Standardization of Nomenclature and Causality Assessment - >December 1–2, 2008 Drug-Induced Injury: Standardization of Nomenclature and Causality Assessment - >December 1–2, 2008
Drug-Induced Injury: Standardization of Nomenclature and Causality Assessment - >December 1–2, 2008
Drug-Induced Injury: Standardization of Nomenclature and Causality Assessment - >December 1–2, 2008

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Day 1—Monday, December 1, 2008 — Lister Hill Auditorium
 
   
7:00 a.m.

Registration and Continental Breakfast

   
8:00 a.m.

Welcome and Aims
Jay Hoofnagle, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, MD

Donald Lindberg, M.D., National Library of Medicine (NLM), Bethesda, MD

   

Session 1:  Drug-Induced Liver Injury Overview

   

Moderators:  Jay Hoofnagle, M.D., NIDDK, and Robert Fontana, M.D., University of Michigan School of Medicine, Ann Arbor, MI

   
8:10 a.m.

Introduction to Issues of Nomenclature and Causality                                    
Leonard Seeff, M.D., NIDDK, Bethesda, MD

   
8:20 a.m.

Introduction to Drug-Induced Liver Disease
Neil Kaplowitz, M.D., University of Southern California Keck School of Medicine, Los Angeles, CA

   
8:50 a.m.

Categorization of Hepatotoxicity
Mark Avigan, M.D., U.S. Food and Drug Administration, Silver Spring, MD

   
9:10 a.m.

DILIN Network Study in the United States
Jose Serrano, M.D., Ph.D., NIDDK, Bethesda, MD

   
9:30 a.m. Discussion
   
10:00 a.m. Break
   

Session 2:  European Hepatotoxicity Networks

   

Moderators:  John Senior, M.D., Center for Drug Evaluation and Research/U.S. Food and Drug Administration, Rockville, MD, and Maribel Lucena, M.D., Servico de Farmacologia Clinica, Malaga, Spain

   
10:30 a.m.

Spain
Raul Andrade, M.D., Ph.D., University Hospital of Malaga, Malaga, Spain

   
10:50 a.m.

United Kingdom 
Christopher Day, M.D., Ph.D., University of Newcastle Medical School, Newcastle, United Kingdom

   
11:10 a.m.

Sweden 
Einar Björnsson, M.D., Ph.D., Sahlgrenska University Hospital, Gothenburg, Sweden

   
11:30 a.m. France
Dominique Larrey, M.D., Ph.D., Hospital St. Eloi Montpelier School of Medicine, Montpelier, France
   
11:50 a.m. Discussion
   
12:20 p.m.

Lunch Buffet (for those who preordered lunch) and Poster Viewing

   

Session 3:  Asian Hepatotoxicity Networks

   

Moderators:  Christopher Day, M.D., Ph.D., University of Newcastle Medical School, United Kingdom, and Herbert Bonkovsky, M.D., Carolinas Health Care System, Charlotte, NC

   
1:20 p.m.

Japan
Hajime Takikawa, M.D., Ph.D., Teikyo University School of Medicine, Tokyo, Japan

   
1:40 p.m.

Singapore
Seng Gee Lim, M.D., National University of Singapore, Singapore

   
2:00 p.m.

Korea
Byung Min Ahn, M.D., Gumi CHA Hospital, South Korea

   
2:20 p.m. Discussion
   
2:40 p.m. Break
   
Session 4:  Issues Related to Causality Assessment
   

Moderators:  Raul Andrade, M.D., Ph.D., University Hospital of Malaga, Spain, and Paul Watkins, M.D., University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill, NC

   
3:00 p.m.

RUCAM, Strengths and Weaknesses
Maribel Lucena, M.D., Servico de Farmacologia Clinica, Malaga, Spain

   
3:30 p.m.

The R-Ratio for Characterizing Liver Injury in DILI
James Rochon, Ph.D., Duke Clinical Research Institute, Durham, NC

   
3:50 p.m.

DILIN Causality Assessment
Don Rockey, M.D., University of Texas Southwestern Medical Center, Dallas, TX

   
4:20 p.m.

Assessment of Causality in Suspected DILI:  Clinical Risk Factors
Naga Chalasani, M.D., Indiana University School of Medicine, Indianapolis, IN

   
4:40 p.m.

Drug-Induced Liver Injury and Pre-existing Liver Disease                    
Robert Fontana, M.D., University of Michigan School of Medicine, Ann Arbor, MI

   
5:00 p.m. Discussion
   
5:30 p.m. Adjourn for the Day
   
 
Day 2—Tuesday, December 2, 2008 — Lister Hill Auditorium
 
   
7:00 a.m. Registration and Continental Breakfast
   
8:00 a.m.

Welcome and Comments
Robert Fontana, M.D., University of Michigan School of Medicine, Ann Arbor, MI

   

Session 5:  Challenges in Causality Assessment

   

Moderators: Don Rockey, M.D., University of Texas Southwestern Medical Center, and James Lewis, M.D., Georgetown University, Washington, DC

   
8:10 a.m.

HIV and Drug-Induced Liver Injury                          
Timothy Davern, M.D., University of California San Francisco, San Francisco, CA

   
8:30 a.m.

Drug-Induced Liver Injury in Children                      
William Balistreri, M.D., Children’s Hospital Medical Center, Cincinnati, OH

   
8:50 a.m.

DILI:  Histopathologic Associations
David Kleiner, M.D., Ph.D., National Cancer Institute, Bethesda, MD

   
9:10 a.m.

Biomarkers to Aid in the Diagnosis of DILI                             
Paul Watkins, M.D., University of North Carolina School of Medicine, Chapel Hill, NC

   
9:30 a.m. Discussion
   
10:00 a.m. Break
   

Session 6:  Definitions and Grading Severity in Drug-Induced Liver Injury

   
Moderators:  John McHutchison, M.D., Duke University Medical Center, Durham, NC, and Neil Kaplowitz, M.D., University of Southern California Keck School of Medicine, Los Angeles, CA
   
10:30 a.m.

DILIN:  Assessing Severity
Paul Hayashi, M.D., University of North Carolina at Chapel Hill, Chapel Hill, NC

   
10:50 a.m. 

Immunoallergic and Autoimmune Features
Herbert Bonkovsky, M.D., Carolinas Health Care System, Charlotte, NC

   
11:10 a.m.

Chronicity in Drug-Induced Liver Injury
Guruprasad Aithal, M.D., Ph.D., University Hospital, Nottingham, United Kingdom

   
11:30 a.m. Discussion
   
12:00 p.m. Lunch Buffet (in foyer for those who pre-paid) and Poster Viewing
   

Session 7:  Research Collaborations and Future Directions

   

Moderators:  Leonard Seeff, M.D., NIDDK, Bethesda, MD, and Jose Serrano, M.D., Ph.D., NIDDK, Bethesda, MD

   
1:00 p.m.

LiverTox:  An Online Resource for Information on Drug-induced Liver Injury
Jay Hoofnagle, M.D., NIDDK, Bethesda, MD

   
1:20 p.m.

LiverTox Website Demonstration                              
James Knoben, Pharm.D., M.P.H., NLM, Bethesda, MD   

   
1:40 p.m.

Minimal Elements for Diagnosis and Publication
John McHutchison, M.D., Duke University Medical Center, Durham, NC

   
2:00 p.m.

Treatment Strategies for Drug-Induced Liver Injury
William Lee, M.D., University of Texas Southwestern Medical Center, Dallas, TX

   
2:20 p.m. Discussion
   
Session 8:  Summary and Overview
   
2:50 p.m.

Future Collaborations
Jay Hoofnagle, M.D., NIDDK, Bethesda, MD

   
3:20 p.m.  Adjourn the Workshop
   
Drug-Induced Injury: Standardization of Nomenclature and Causality Assessment - >December 1–2, 2008
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