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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

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. 

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

Agenda [PDF]

Tuesday, June 6, 2017

Day 1 Transcript [PDF]

OPENING REMARKS

Sweet and Sour DILI Keynotes [PDF]
PowerPoint notes version [PDF]
John Senior (photo, biosketch, abstract) [PDF]

Special recognition of Neil Kaplowitz' book
Yimin Mao

SESSION I: Best Practices in Clinical Drug Development
Moderators: Arie Regev and Naga Chalasani

Alcoholic hepatitis as a drug-induced disorder [PDF]
PowerPoint notes version [PDF]
Gyongyi Szabo (photo, biosketch, abstract) [PDF]

Detection and management of DILI in NASH/NAFLD subjects in drug development [PDF]
PowerPoint notes version [PDF]
Naga Chalasani (photo, biosketch, abstract) [PDF]

Reactivation of hepatitis B in clinical trials with immune suppressive drugs [PDF]
PowerPoint notes version [PDF]
Rajender Reddy (photo, biosketch, abstract) [PDF]

General discussion of issues [PDF]

Chronic liver disease after acute hepatocellular DILI [PDF]
PowerPoint notes version [PDF]
Bob Fontana (photo, biosketch, abstract) [PDF]

Is chronic liver disease after acute hepatocellular DILI over-estmated? [PDF]
PowerPoint notes version [PDF]
Einar Bjornsson (photo, biosketch, abstract) [PDF]

Detection and evaluation of DILI in Patients with active or advanced liver diseases [PDF]
PowerPoint notes version [PDF]
Jim Lewis (photo, biosketch, abstract) [PDF]

General discussion of issues [PDF]

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 [PDF]
PowerPoint notes version [PDF]
Mark Avigan (photo, biosketch, abstract) [PDF]

Do pharmacokinetic and hepatocellular steps inform risk assessment? [PDF]
PowerPoint notes version [PDF]
Raj Madabushi (photo, biosketch, abstract) [PDF]

Current industry perspectives on hepatotoxicity in drug discovery
PowerPoint notes version [PDF]
Will Proctor (photo, biosketch, abstract) [PDF]

Do histologic features inform DILI mechanisms? [PDF]
PowerPoint notes version [PDF]
Dave Kleiner (photo, biosketch, abstract) [PDF]

Agents that alter immune tolerance; what can we predict? [PDF]
PowerPoint notes version [PDF]
Amy Rosenberg (photo, biosketch, abstract) [PDF]

General discussion of issues [PDF]

Quantitative benefit-risk assessment of DILI [PDF]
PowerPoint notes version [PDF]
Rebecca Noel (photo, biosketch, abstract) [PDF]

Agents that inhibit the BSEP and mitochondrial function - what do we know? [PDF]
PowerPoint notes version [PDF]
Michael Aleo (photo, biosketch, abstract pdf)

Improved survival-what tradeoffs make sense? [PDF]
PowerPoint notes version [PDF]
Dan Suzman (photo, biosketch, abstract) [PDF]

Need for consideration of issues for guidance revision [PDF]
PowerPoint notes version [PDF]
Bob Temple (photo, biosketch, abstract) [PDF]

General discussion of Issues [PDF]

Wednesday, June 7, 2017

Day two transcript [PDF]

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 [PDF]
PowerPoint notes version [PDF]
Herb Bonkovsky (photo, biosketch, abstract) [PDF]

New Methods to Predict DILI Risk [PDF]
PowerPoint notes version [PDF]
Jack Uetrecht (photo, biosketch, abstract) [PDF]

NCTR rule-of-2 + RM as predictor - can they help predict DILI? [PDF]
PowerPoint notes version [PDF]
Minjun Chen (photo, biosketch, abstract) [PDF]

Predicting DILI - n Inside-the-box analysis [PDF]
PowerPoint notes version [PDF]
Tom Jones (photo, biosketch, abstract) [PDF]

General Discussion of Issues [PDF]

DILI-sym initiative [PDF]
PowerPoint notes version [PDF]
Paul Watkins (photo, biosketch, abstract) [PDF]

European Quantitative Toxicology (EQT) - liver, kidney, heart-lung [PDF]
PowerPoint notes version [PDF]
Jim Stevens (photo, biosketch, abstract) [PDF]

MIP-DILI (mechanism-based integrated prediction of DILI) [PDF]
PowerPoint notes version [PDF]
Chris Goldring (photo, biosketch, abstract) [PDF]

Drug-induced liver injury leading to acute liver failure 2017 [PDF]
PowerPoint notes version [PDF]
Will Lee (photo, biosketch, abstract) [PDF]

General Discussion of Issues [PDF]

SESSION IV: Consortia for Best Practices to Reduce DILI
Moderators: Paul Watkins and Gyongyi Szab

The IQ DILI Initiative [PDF]
PowerPoint notes version [PDF]
Arie Regev (photo, biosketch, abstract) [PDF]

The IQ DILI working group on post-marketing risk assessment [PDF]
PowerPoint notes version [PDF]
Frank Czerwiec (photo, biosketch, abstract) [PDF]

SAFE-T Consortium [PDF]
PowerPoint notes version [PDF]
Gerd Kullak-Ublick (photo, biosketch, abstract) [PDF]

LiverTox update and prospects [PDF]
PowerPoint notes version [PDF]
Jay Hoofnagle (photo, biosketch, abstract) [PDF]

Expert judgment for causality assessment [PDF]
PowerPoint notes version [PDF]
Skip Hayashi (photo, biosketch, abstract) [PDF]

Is there a general mechanism for DILI? Do we need to know it? [PDF]
PowerPoint notes version [PDF]
Neil Kaplowitz (photo, biosketch, abstract) [PDF]

General Discussion of Issues [PDF]

Chinese DILIN experience [PDF]
PowerPoint notes version [PDF]
Yimin Mao (photo, biosketch, abstract) [PDF]

Who speaks for the prescribing physicians?
PowerPoint notes version [PDF]
John Senior (photo, biosketch, abstract) [PDF]

General Discussion of Issues [PDF]