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Asymmetry of Drug Safety and Efficacy in Clinical Trials with DILI- Toward Quantitative Estimate of Net Benefit to Patients

Drug-Induced Liver Injury (DILI) Conference XVII
Tuesday-Wednesday 6-7 June 2017
College Park Marriott Hotel and Conference Center
Register Now: Stephanie Codd Anderson, Critical Path Institute, Tucson AZ

Drug-induced liver injury (DILI) is a major problem for drug development and clinical care. Several unresolved problems require new understanding and consensus. Especially difficult is much greater costs of adequate safety studies than for the proof of efficacy. This international academic-industry-government conference will discuss current findings and thinking on DILI and drug safety by expert hepatology, toxicology and special presentations. We encourage you to register, come, participate, and debate the issues for development of new agreements and guidance.

Meeting Organizers: Paul Watkins, Mark Avigan, John-Michael Sauer, Arie Regev, Gyongyi Szabo, John Senior


Tuesday, 6 June 2017

7:30 am continental breakfast outside the conference room; register  
8 am OPENING REMARKS Sweet and Sour DILI Keynotes John Senior
  SESSION I: Best Practices in Clinical Drug Development
Moderators: Arie Regev and Naga Chalasani
8:05 am Special recognition of Neil Kaplowitz' book Yimin Mao
8:10 am Alcoholic hepatitis as a drug-induced disorder Gyongyi Szabo
8:30 am Detection and management of DILI in NASH/NAFLD subjects in drug development Naga Chalasani
9:50 am Reactivation of hepatitis B in clinical trials with immune suppressive drugs Rajender Reddy
9:10 am General discussion of issues all present
9:40 am mid-morning coffee break  
10:00 am Chronic liver disease after acute hepatocellular DILI Bob Fontana
10:20 am Is chronic liver disease after acute hepatocellular DILI over-estmated? Einar Bjornsson
10:40 am Detection and evaluation of DILI in Patients with active or advanced liver diseases Jim Lewis
11:00 am General discussion of issues all present
11:30 am lunch break  
12:30 pm SESSION II: Evaluating DILI Signals in Clinical Trials to Inform Benefits, Risks
Moderators: Michael Aleo and Mark Avigan
12:30 pm How clinical signature of DILI impacts benefits and risks Mark Avigan
12:50 pm Do pharmacokinetic and hepatocellular steps inform risk assessment? Raj Madabushi
1:10 pm Current industry perspectives on hepatotoxicity in drug discovery Will Proctor
1:30 pm Do histologic features inform DILI mechanisms? Dave Kleiner
1:50 pm Agents that alter immune tolerance; what can we predict? amy Rosenberg
2:10 pm General discussion of issues all present
2:40 pm refreshment break  
3:10 pm Quantitative benefit-risk assessment of DILI Rebecca Noel
3:30 pm Agents that inhibit the BSEP and mitochondrial function - what do we know? Michael Aleo
3:50 pm Improved survival-what tradeoffs make sense? Dan Suzman
4:10 pm Need for consideration of issues for guidance revision Bob Temple
4:30 pm General dIscussion of Issues all present
5 pm reception: wine and hors d'oeurves; mingle, chat, and relax --- dinner on your own  

Wednesday, 7 June 2017

7:30 am continental breakfast outside the conference room  
8 SESSION III: New Tools for Detection and Assessment of DILI
Moderators: John-Michael Sauer and Neil Kaplowitz
8:00 am Serum microRNAs as DILI biomarkers and predictors in clinical trials Herb Bonkovsky
8:20 am New Methods to Predict DILI Risk Jack Uetrecht
8:40 am NCTR rule-of-2 + RM as predictor - can they help predict DILI? Minjun Chen
8:55 am Predicting DILI - n Inside-the-box analysis Tom Jones
9:10 am General Discussion of Issues all present
9:40 am coffee break  
10:10 am DILI-sym initiative Paul Watkins
10:30 am European Quantitative Toxicology (EQT) - liver, kidney, heart-lung Jim Stevens
10:50 am MIP-DILI (mechanism-based integrated prediction of DILI) Chris Goldring
11:10 am Drug-induced liver injury leading to acute liver failure 2017 Will Lee
11:30 am General Discussion of Issues all present
noon lunch break  
1 pm SESSION IV: Consortia for Best Practices to Reduce DILI
Moderators: Paul Watkins and Gyongyi Szab
1 pm The IQ DILI Initiative Arie Regev
1:20 pm The IQ DILI working group on post-marketing risk assessment Frank Czerwiec
1:40 pm SAFE-T Consortium Gerd Kullak-Ublick
2 pm LiverTox update and prospects Jay Hoofnagle
2:20 pm Expert judgment for causality assessment Skip Hayashi
2:40 pm Chinese DILIN experience Yimin Mao
2:55 pm General Discussion of Issues all present
3:25 pm refreshment break  
3:40 pm Is there a general mechanism for DILI? Do we need to know it? Neil Kaplowitz
4 pm Who speaks for the prescribing physicians? John Senior
4:20 pm General Discussion of Issues all present
5 pm Adjourn  

Proceedings Archive

2008-1999 (FDA website)


Contact: Stephanie Codd Anderson, Critical Path Institute, Tucson AZ

Drug-Induced Liver Injury Annual Conference XVII
Jun 6-7, 2017
College Park Marriott
University of Maryland Conference Center