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AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting, 2007 Agenda

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AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting
Brookside Gardens Conference Center, Wheaton MD
January 24 - 25, 2007

Issues and Controversies in DILI
(DILI = drug-induced liver injury)

Presentations from the 2007 meeting



Wednesday, January 24, 2007 


8:15 amWelcomeJohn Senior (FDA)
8:20 amIntroductions; meeting plansLana 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 amDrafting of concept paper: Premarketing Evaluation of DILIRuyi He, M.D. (FDA)
8:40 amRationale for concept paper and proposed guidanceJohn Senior, M.D. (FDA)
8:50 amIndustry commentary on concept paperJerry Stern, M.D. (Boerh-Ing)
9:10 amIndustry commentary on concept paperDeborah Kirby, M.D. (Pfizer)
9:30 amAASLD commentaryNeil Kaplowitz, M.D. (USC)
9:40 amNIH/DILIN commentaryPaul Watkins, M.D. (NIH)
9:50 amGeneral discussionAll present
10:30 amIs the susceptibility to DILI in the genome?Larry Lesko, Ph.D. (FDA)
10:50 amPotential mechanisms of ximelagatran hepatotoxicityT. Andersson, Ph.D. (AstraZ)
11:10 amGeneral discussion of Lesko, Andersson presentationsAll present
11:30 amLUNCH and winter garden walksAll
12:15 pmCombining research with clinical study without regulatory penaltyJanet Woodcock, M.D. (FDA)
12:30 pmGeneral Discussion of Woodcock proposalAll


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 pmNo.Robert Temple, M.D. (FDA)
1:15 pmYes.Hari Mehendale, Ph.D. (U LA)
1:30 pmNo.James H. Lewis, M.D. (G’tn)
1:45 pmYes.William M. Lee, M.D. (UTSW)
2:00 pmRebuttals: 5’eachPros & Cons
2:20 pmGeneral discussionAll
2:50 pmBREAK 
3:10 pmMechanisms of hepatic repair and regeneration in DILIRebecca Taub, M.D. (Roche)
3:30 pmClinical evidence that it’s the patient, not the drugMark Avigan, M.D. (FDA)
3:45 pmPutting it all togetherRobert Fontana, M.D, (U MI)
4:00 pmDiscussionAll
4:30 pmADJOURN
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?

8:30 amImmune system mechanismsJack Uetrecht, Ph.D. (U Tor)
9:00 amNon-immune mechanisms
Neil Kaplowitz, M.D. (USC)
9:30 amGeneral discussionAll
10:00 amBREAK 
10:20 amAutoimmune hepatitis and drugsJohn Vierling, M.D. (Baylor)
10:50 amDrugs that appeared to cause AIHLeonard Seeff, M.D. (NIH)
11:10 amCan drugs cause or aggravate or uncover AIH?Herb Bonkovsky, M.D. (UCT)
11:30 amGeneral discussion: AIH and DILIAll
12:30 pmADJOURN
Box lunch to go or stay

*AASLD = American Association for the Study of Liver Diseases
  FDA = Food and Drug Administration
  NIH = National Institutes of Health
  PhRMA = Pharmaceutical Research and Manufacturers of America


Presentations from the 2007 meeting 

Thanks to PhRMA, AASLD, and NIH/DILIN for their support of this meeting!