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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
Meeting was held Tuesday-Wednesday 6-7 June 2017
College Park Marriott Hotel and Conference Center

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

OPENING REMARKS Sweet and Sour DILI Keynotes John Senior
SESSION I: Best Practices in Clinical Drug Development
Moderators: Arie Regev and Naga Chalasani
Special recognition of Neil Kaplowitz' book Yimin Mao
Alcoholic hepatitis as a drug-induced disorder Gyongyi Szabo
Detection and management of DILI in NASH/NAFLD subjects in drug development Naga Chalasani
Reactivation of hepatitis B in clinical trials with immune suppressive drugs Rajender Reddy
General discussion of issues all present
Chronic liver disease after acute hepatocellular DILI Bob Fontana
Is chronic liver disease after acute hepatocellular DILI over-estmated? Einar Bjornsson
Detection and evaluation of DILI in Patients with active or advanced liver diseases Jim Lewis
General discussion of issues all present
SESSION II: Evaluating DILI Signals in Clinical Trials to Inform Benefits, Risks
Moderators: Michael Aleo and Mark Avigan
How clinical signature of DILI impacts benefits and risks Mark Avigan
Do pharmacokinetic and hepatocellular steps inform risk assessment? Raj Madabushi
Current industry perspectives on hepatotoxicity in drug discovery Will Proctor
Do histologic features inform DILI mechanisms? Dave Kleiner
Agents that alter immune tolerance; what can we predict? Amy Rosenberg
General discussion of issues all present
Quantitative benefit-risk assessment of DILI Rebecca Noel
Agents that inhibit the BSEP and mitochondrial function - what do we know? Michael Aleo
Improved survival-what tradeoffs make sense? Dan Suzman
Need for consideration of issues for guidance revision Bob Temple
General dIscussion of Issues all present

Wednesday, 7 June 2017

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

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