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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, Maryland
March 26-27, 2008
Presentations from the 2008 meeting
Program
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A national/international discussion and debate on issues raised by the draft guidance of 25 October 2007 (Docket No. 2007D-0396) toward building consensus among interested parties of the pharmaceutical industry, regulatory bodies, academic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, Silver Spring MD, 26-27 March, 2008
10000 New Hampshire Avenue
at Powder Mill Road,
Silver Spring MD 20903
Wednesday, 26 March |
7:30 |
Continental Breakfast |
8:00 |
Introductions 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? |
8:15 |
Clinical meaning of elevatedaminotransferase activity? |
Naga Chalasani,IN U |
8:45 |
Liver test elevations seen inpatients on placebo. |
Robert Tipping, Merck |
9:15 |
Lessons from isoniazid –would it be approved today? |
John Senior, FDA/CDER |
9:45 |
Break |
Session IB: Tools to helpdecide if cases are important or drug-induced |
10:15 |
A simple tool for findingimportant cases in a clinical trial |
Kate Gelperin, FDA/CDER Ted Guo, FDA/CDER |
10:45 |
Hy’s Law explained |
Adrian Reuben, MU SC |
11:15 |
Was it the drug, or adisease? How to determine it. |
DonRockey,UT SW |
11:45 |
General discussion |
All |
12:15 |
Lunch |
1:30 Session II:Moderator, Paul Seligman, FDA/CDER Session IIA: Shouldrechallenge be used to prove the drug caused the reaction? |
1:30 |
Immune-allergic sensitizationto a xenobiotic |
Jack Uetrecht, U Toronto |
2:00 |
Hierarchy of evidence – howmuch do we need to know? |
Leonard Seeff, NIH |
2:30 |
Balancing the risks and benefits of rechallenge |
Christine Hunt, GSK Julie Papay, GSK |
3:00 |
General discussion –speakersand audience |
All |
3:30 |
Break |
Session IIB: Ethical,management, and regulatory issues |
4:00 |
Ethical perspectives |
Sara Goldkind, FDA |
4:20 |
Industry perspectives | Jay Barth, Merck |
4:40 |
International regulatoryperspectives |
Andrew Bartholomaeus* *Therapeutic Goods Adminstration, Australia |
5:00 |
General discussion –speakersand audience |
All |
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 treated |
Robert Temple, FDA/CDER |
8:30 |
Would this increase the risk of DILI? |
William Lee, UT SW |
9:00 |
Case for continuing to exclude them |
Arie Regev, Lilly |
9:30 |
General discussion, panelists and audience |
|
10:00 |
Break |
|
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 nut |
Arthur Holden, SAEC**
**Serious Adverse Event Consortium |
12:00 |
General discussion –speakers and audience |
All |
12:30 |
Lunch |
|
1:30 |
Public statements on the draft guidance:
Brief 5’ statements (arguments, questions, comments) from interested persons, groups |
Lana Pauls, FDA/CDER
(coordinator)
Audience |
2:30
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Asking the questions, and discussion of each: Moderators, audience
- What should be the stopping rules for study drug administration?
- When should rechallenge be done or not done?
- Should patients with preexisting liver disease be studied?
- Other questions, issues?
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3:30 |
Adjourn |
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For details and changes follow information posted at website: www.fda.gov/cder/livertox
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 |
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Date created: April 29, 2008 |
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