AASLD-FDA-NIH-PhRMA- Hepatotoxicity Special Interest Group Meeting, 2007 Presentations
Issues and Controversies in DILI
(DILI = drug-induced liver injury)
Session I: FDA Concept Paper: Premarketing Evaluation of DILI (Moderator – Paul Watkins, M.D., UNC, DILIN)
How can we best find and study DILI in clinical trials?
- Ruyi He, M.D., FDA, Drafting of concept paper: Premarketing Evaluation of DILI
- John Senior, M.D., FDA, Rationale for concept paper and proposed guidance
- Jerry Stern, M.D., Boehringer Ingelheim, Commentary on concept paper
- Deborah Kirby, M.D., Pfizer, Commentary on concept paper
- Neil Kaplowitz, M.D., USC, AASLD commentary
- Paul Watkins, M.D., NIH, NIH/DILIN commentary
- Larry Lesko, Ph.D., FDA, Is the susceptibility to DILI in the genome?
- T. Andersson, Ph.D., AstraZeneca, Potential mechanisms of ximelagatran hepatotoxicity
- Janet Woodcock, M.D., FDA, Combining research with clinical study without regulatory penalty
- Session I: Summary of discussion, questions and answers [PDF 210KB]
Session II: Does Preexisting Liver Disease Make DILI More Likely? (Moderator – Neil Kaplowitz, M.D., USC)
Does liver disease increase chances of getting DILI?
- Robert Temple, M.D., FDA, No.
- Hari Mehendale, Ph.D., U LA, Yes.
- James H. Lewis, M.D., Georgetown, No.
- William M. Lee, M.D., UTSW, Yes.
- Rebecca Taub, M.D., Roche, Mechanisms of hepatic repair and regeneration in DILI
- Mark Avigan, M.D., FDA, Clinical evidence that it’s the patient, not the drug
- Robert Fontana, M.D, U MI, Putting it all together
- Session II: Summary of discussion, questions and answers [PDF 105KB]
Session III: Role of the Immune System in DILI, (Moderator – Holly A. Read, M.D., Abbott)
Why the variable latent period between exposure and onset of DILI?
- Jack Uetrecht, Ph.D., University of Toronto, Immune system mechanisms
- Neil Kaplowitz, M.D., USC, Non-immune mechanisms
- John Vierling, M.D., Baylor, Autoimmune hepatitis and drugs
- Leonard Seeff, M.D., NIH, Drugs that appeared to cause AIH
- Herb Bonkovsky, M.D., UCT, Can drugs cause or aggravate or uncover AIH?
- Session III: Summary of discussion, questions and answers [PDF 216KB]
Contact list for Authors.