|
Wednesday, January 24, 2007 |
|
7:45 am |
CHECK-IN and CONTINENTAL BREAKFAST |
|
8:15 am |
Welcome |
John Senior (FDA) |
8:20 am |
Introductions; meeting plans |
Lana Pauls (FDA) |
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? |
8:30 am |
Drafting of concept paper: Premarketing Evaluation of DILI |
Ruyi He, M.D. (FDA) |
8:40 am |
Rationale for concept paper and proposed guidance |
John Senior, M.D. (FDA) |
8:50 am |
Industry commentary on concept paper |
Jerry Stern, M.D. (Boerh-Ing) |
9:10 am |
Industry commentary on concept paper |
Deborah Kirby, M.D. (Pfizer) |
9:30 am |
AASLD commentary |
Neil Kaplowitz, M.D. (USC) |
9:40 am |
NIH/DILIN commentary |
Paul Watkins, M.D. (NIH) |
9:50 am |
General discussion |
All present |
10:10 am |
COFFEE BREAK |
All |
10:30 am |
Is the susceptibility to DILI in the genome? |
Larry Lesko, Ph.D. (FDA) |
10:50 am |
Potential mechanisms of ximelagatran hepatotoxicity |
T. Andersson, Ph.D. (AstraZ) |
11:10 am |
General discussion of Lesko, Andersson presentations |
All present |
11:30 am |
LUNCH and winter garden walks |
All |
12:15 pm |
Combining research with clinical study without regulatory penalty |
Janet Woodcock, M.D. (FDA) |
12:30 pm |
General Discussion of Woodcock proposal |
All |
Session II: Does Preexisting Liver Disease Make DILI More Likely?
(Moderator – Neil Kaplowitz, M.D., USC)
Does liver disease increase chances of getting DILI? |
1:00 pm |
No. |
Robert Temple, M.D. (FDA) |
1:15 pm |
Yes. |
Hari Mehendale, Ph.D. (U LA) |
1:30 pm |
No. |
James H. Lewis, M.D. (G’tn) |
1:45 pm |
Yes. |
William M. Lee, M.D. (UTSW) |
2:00 pm |
Rebuttals: 5’each |
Pros & Cons |
2:20 pm |
General discussion |
All |
2:50 pm |
BREAK |
|
3:10 pm |
Mechanisms of hepatic repair and regeneration in DILI |
Rebecca Taub, M.D. (Roche) |
3:30 pm |
Clinical evidence that it’s the patient, not the drug |
Mark Avigan, M.D. (FDA) |
3:45 pm |
Putting it all together |
Robert Fontana, M.D, (U MI) |
4:00 pm |
Discussion |
All |
4:30 pm |
ADJOURN
Libations and dinner ad lib by personal arrangements |
|
|
Thursday, January 25, 2007
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? |
8:00 am |
CONTINENTAL BREAKFAST |
|
8:30 am |
Immune system mechanisms |
Jack Uetrecht, Ph.D. (U Tor) |
9:00 am |
Non-immune mechanisms
|
Neil Kaplowitz, M.D. (USC) |
9:30 am |
General discussion |
All |
10:00 am |
BREAK |
|
10:20 am |
Autoimmune hepatitis and drugs |
John Vierling, M.D. (Baylor) |
10:50 am |
Drugs that appeared to cause AIH |
Leonard Seeff, M.D. (NIH) |
11:10 am |
Can drugs cause or aggravate or uncover AIH? |
Herb Bonkovsky, M.D. (UCT) |
11:30 am |
General discussion: AIH and DILI |
All |
12:30 pm |
ADJOURN
Box lunch to go or stay |
|
