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AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting: 2008 Agenda

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AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting
National Labor College, Silver Spring, MD
March 26-27, 2008

Presentations from the 2008 meeting


Detecting and Investigating Drug-Induced Liver Injury During Clinical Trials

What should we be doing about uncommon but potentially serious adverse events (e.g., DILI, Stevens-Johnson syndrome, rhabdomyolysis, prolonged QT interval, etc.) found during controlled clinical trials?

A national/international discussion and debate on issues raised by the draft guidance of 25 October 2007 (Docket No. 2007D-0396) toward building consensus among interested parties of the pharmaceutical industry, regulatory bodies, academic investigators and consultants, and public groups or individuals. 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).

National Labor College
10000 New Hampshire Avenue
at Powder Mill Road,
Silver Spring MD 20903

Wednesday, 26 March
7:30Continental Breakfast
8:00Introductions and Brief (5’)Opening Statements

Janet Woodcock, FDA/CDER

Alan Goldhammer, PhRMA

John Vierling, AASLD

8:15 Session I: Moderator, Paul Watkins, U NC

Session IA: When should aninvestigational drug be stopped during a trial?

8:15Clinical meaning of elevatedaminotransferase activity?Naga Chalasani,IN U
8:45Liver test elevations seen inpatients on placebo.Robert Tipping, Merck
9:15Lessons from isoniazid –would it be approved today?John Senior, FDA/CDER
Session IB: Tools to help decide if cases are important or drug-induced
10:15A simple tool for findingimportant cases in a clinical trial

Kate Gelperin, FDA/CDER


10:45Hy’s Law explainedAdrian Reuben, MU SC
11:15Was it the drug, or adisease? How to determine it.DonRockey,UT SW
11:45General discussionAll

1:30 Session II: Moderator, Paul Seligman, FDA/CDER

Session IIA: Shouldrechallenge be used to prove the drug caused the reaction?

1:30Immune-allergic sensitizationto a xenobioticJack Uetrecht, U Toronto
2:00Hierarchy of evidence – howmuch do we need to know?Leonard Seeff, NIH
2:30Balancing the risks and benefits of rechallenge

Christine Hunt, GSK

Julie Papay, GSK

3:00General discussion –speakersand audienceAll
Session IIB: Ethical,management, and regulatory issues
4:00Ethical perspectivesSara Goldkind, FDA
4:20Industry perspectivesJay Barth, Merck
4:40International regulatoryperspectives

Andrew Bartholomaeus*

*Therapeutic Goods Adminstration, Australia

5:00General discussion –speakersand audienceAll
6:00 – 7:00

Reception: wine and cheese, mingle and relax ---

Dinner on your own


Thursday, 27 March

7:30                                             Continental Breakfast

8:00                             Session III: Moderator, John Pears, AstraZeneca
 Session IIIA:  Should patients with stable underlying liver disease be included?
8:00 Study the patients who will be treatedRobert Temple, FDA/CDER
8:30Would this increase the risk of DILI?William Lee, UT SW
9:00Case for continuing to exclude themArie Regev, Lilly
9:30General discussion, panelists and audience 


Session IIIB: Can we find a truly predictive biomarker to prevent serious adverse reactions?
10:30 What kind of a biomarker do we need?Mark Avigan, FDA/CDER
11:00 How might we find one?Jack Bloom, Lilly
11:30 Role of clinical trials in cracking the nutArthur Holden, SAEC**
**Serious Adverse Event Consortium
12:00General discussion –speakers and audienceAll


1:30Public statements on the draft guidance:
Brief  5’ statements (arguments, questions, comments) from interested persons, groups
Lana Pauls, FDA/CDER

Asking the questions, and discussion of each:                       Moderators, audience

  1. What should be the stopping rules for study drug administration?
  2. When should rechallenge be done or not done?
  3. Should patients with preexisting liver disease be studied?
  4. Other questions, issues?


For details and changes follow information posted on the Liver Toxicity website.
Registration by AASLD: $350 for industry; $175 for government or academia
(go to www.aasld.org, Meetings, Hepatotoxicity Special Interest Group Meeting)
Lodging reservations on your own at NLC or at Silver Spring Hotels