Drugs
AASLD-FDA-NIH-PhRMA- Hepatotoxicity Special Interest Group Meeting
2008 Presentations
Abstracts and Presenter Biosketches are linked through the presenter's name, presentations are linked through the presentation title.
Introductions and Brief Opening Statements:
Welcome Statements [PDF]
Janet Woodcock, FDA/CDER; Alan Goldhammer, PhRMA; John Vierling, AASLD;
Session I: Moderator, Paul Watkins, UNC; Watkins' Opening Remarks [PDF]
Session IA: When should an investigational drug be stopped during a trial?
- Naga Chalasani, INU; Clinical meaning of elevated aminotransferase activity [PDF]
- Robert Tipping, Merck; [PDF]
- John Senior, FDA/CDER; Lessons from isoniazid –would it be approved today? [PDF]
Session IB: Tools to help decide if cases are important or drug-induced
- Kate Gelperin, FDA/CDER; A simple tool for finding important cases in a clinical trial [PDF]
- Ted Guo, FDA/CDER;
- Adrian Reuben, MUSC; Hy’s Law explained [PDF]
- Don Rockey,UTSW; Was it the drug, or a disease? How to determine it [PDF]
- General discussion
- Discussion IA and IB [PDF]
Session II:Moderator, Paul Seligman, FDA/CDER; Seligman's Opening Remarks [PDF]
Session IIA: Should rechallenge be used to prove the drug caused the reaction?
- Jack Uetrecht, U Toronto; Immune-allergic sensitization to a xenobiotic [PDF]
- Discussion of Uetrecht [PDF]
- Leonard Seeff, NIH; Hierarchy of evidence – how much do we need to know? [PDF]
- Discussion of Seeff [PDF]
- Julie Papay, GSK; Positive Rechallenge Following Drug-induced Liver Injury [PDF]
- Discussion of Papay [PDF]
- Discussion of IIA [PDF]
Session IIB: Ethical, management, and regulatory issues
- Sara Goldkind, FDA; Ethical perspectives [PDF]
- Discussion of Goldkind [PDF]
- Jay Barth, Merck; Industry perspectives [PDF]
- Andrew BartholomaeusTherapeutic Goods Adminstration, Australia; International regulatory perspectives [PDF]
- General discussion IIB [PDF]http://wcms.fda.gov/ucm/resources/wcm/sitestudio/
Session III: Moderator, John Pears, AstraZeneca; Pears' Opening Remarks for IIIA [PDF]
Session IIIA: Should patients with stable underlying liver disease be included?
- Robert Temple, FDA/CDER; Study the patients who will be treated [PDF]
- William Lee, UT SW; Would this increase the risk of DILI? [PDF]
- Discussion of Lee [PDF]
- Arie Regev, Lilly; Case for continuing to exclude them [PDF]
- General Discussion IIIA [PDF]
Session IIIB: Can we find a truly predictive biomarker to prevent serious adverse reactions?
- Pears' Opening Remarks for IIIB [PDF]
- Mark Avigan, FDA/CDER; What kind of a biomarker do we need? [PDF]
- Jack Bloom, Lilly; How might we find one? [PDF]
- Arthur Holden, SAEC** ; Role of clinical trials in cracking the nut [PDF]
**Serious Adverse Event Consortium - General Discussion IIIB [PDF]
Public statements on the draft guidance: Lana Pauls, FDA/CDER (coordinator);
- Brief 5 minute statements (arguments, questions, comments) from interested persons, groups
- Audience Asking the questions, and discussion of each:
- Paul Watkins: What should be the stopping rules for study drug administration? [PDF]
- Discussion of Watkins [PDF]
- Paul Seligman: When should rechallenge be done or not done? [PDF]
- Discussion of Seligman [PDF]
- John Pears: Should patients with preexisting liver disease be studied? [PDF]
- Discussion of Pears [PDF]
- Paul Watkins: What should be the stopping rules for study drug administration? [PDF]
Free copies of some articles cited in the abstracts can be obtained by going through PubMed. More information can be found at the PubMed How to Get the Journal Article page.
