Drug-Induced Injury: Standardization of Nomenclature and Causality Assessment

AGENDA

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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