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The Importance of Getting It Right: How to Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnosis

This meeting was held March 18-19, 2015

The FDA held a public conference entitled “Serious Drug-Induced Liver Injury (DILI): The Importance of Getting It Right: How to Measure and Interpret DILI Information and Make Correct Diagnoses.” on March 18-19, 2015. This conference was cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. The purpose of the public conference was to discuss, debate, and share views among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.

2015 Program Presentations Presenter(s)
Welcome (pdf) Solomon Iyasu
photo, biosketch (pdf)
Session I
Moderators: Robert Dufour and Naga Chalasani
Measuring ALT and Other Enzymes in Serum (pdf)
or PowerPoint Notes version (pdf)
Arthur Karmen
photo, biosketch, abstract (pdf)

What’s Normal? (pdf)
or PowerPoint Notes version (pdf)

Daniele Prati
photo, biosketch, abstract (pdf)
Down With the Tower of Babel (pdf)
or PowerPoint Notes version (pdf)
Bob Dufour
photo, biosketch, abstract (pdf)
Rapid Fingerstick Estimation of ALT at Point-of-Care (pdf)
or PowerPoint Notes version (pdf)
Nira Pollock
photo, biosketch, abstract (pdf)
Discussion (pdf) All Present

Compare to Groups or Individuals?  ULN or Baseline? (pdf)
or PowerPoint Notes version (pdf)

Leonard Seeff
photo, biosketch, abstract (pdf)
Development of eDISH2 (pdf)
or PowerPoint Notes version (pdf)
Ted Guo
photo, biosketch, abstract (pdf)
ACG Guidelines for Diagnosis and Management of DILI (pdf)
or PowerPoint Notes version (pdf)
Naga Chalasani
photo, biosketch, abstract (pdf)
Normal Ranges for 12 Novel Biomarkers for Liver Safety (pdf)
or PowerPoint Notes version (pdf)
Patrick Kirby
photo, biosketch, abstract (pdf)
General Discussion and Debate of Issues, Pro and Con (pdf) All Present
Session II
Moderators: Robert Temple and John Senior
Drugs-Chemicals-Hepatotoxins; is it the Substance or the Person? (pdf)
or PowerPoint Notes version (pdf)
Lana Pauls
photo, biosketch, abstract (pdf)
Ideas Building Upon Ideas -- but do it correctly, if possible (pdf)
or PowerPoint Notes version (pdf)
John Senior
photo, biosketch, abstract (pdf)
Assessment and Grading of Severity of DILI; CTCAE v.5 (pdf)
or PowerPoint Notes version (pdf)
Alice Chen
photo, biosketch, abstract (pdf)
Mild transaminase Elevations in Treatment of Serious Diseases:
 Congestive heart failure (pdf) or PowerPoint Notes version (pdf)
 Chronic hepatitis C (pdf) or PowerPoint Notes version (pdf)

Karen Hicks
photo, biosketch, abstract (pdf)
Wendy Carter
photo, biosketch, abstract (pdf)
 
General Discussion of Issues (pdf) All Present
Origins of RUCAM (pdf) Willis Maddrey
photo, biosketch (pdf)
Limits of Labeling and Warnings (pdf)
or PowerPoint Notes version (pdf)
Robert Temple
photo, biosketch, abstract (pdf)
General Discussion of Issues Raised (pdf) All Present
Autoimmune Hepatitis or DILI – One or Both?
Session III
Moderators: Mark Avigan and Albert Czaja
Navigating Immunologic Responses to Drugs and Biologics to Predict Clinical Outcomes (pdf)
or PowerPoint Notes version (pdf)
Jack Uetrecht
photo, biosketch, abstract (pdf)
Autoimmune Hepatitis – Transitioning from “Idiopathic” to Explainable (pdf)
or PowerPoint Notes version (pdf)
Albert Czaja
photo, biosketch, abstract (pdf)
Autoimmune DILI – Recognition and Management (pdf)
or PowerPoint Notes version (pdf)
Einar Bjornsson
photo, biosketch, abstract (pdf)
Discussion on how best to diagnose AIH All Present
Why are Drug-Associated Immune Organ Injuries Important? (pdf)
or PowerPoint Notes version (pdf)
Mark Avigan
photo, biosketch, abstract (pdf)
Autoimmune RIsks of Immune-oncologic Therapies – What Are We Learning? (pdf)
or PowerPoint Notes version (pdf)
David Berman
photo, biosketch, abstract (pdf)
Dose-related DILI, Hypersensitivity Type – A Case Series (pdf)
or PowerPoint Notes version (pdf)
Arie Regev
photo, biosketch, abstract (pdf)
Discussion on distinguishing AIH from DILI (pdf) All Present
Review of proposal for a Liver Safety Research Consortium & further discussion (pdf) Paul Watkins
photo, biosketch, abstract (pdf)
Hot New Research and Clinical Breakthroughs in the DILI Field
Session IV
Moderators: Paul Watkins and Gyongyi Szabo

MicroRNA-122 – Uses and Applications (pdf)
or PowerPoint Notes version (pdf)

Discussion (pdf)

Gyongyi Szabo
photo, biosketch, abstract (pdf)

DILIN Experience with Hy’s Law in Patients with Existing Liver Disease (pdf)
or PowerPoint Notes version (pdf)

Discussion (pdf)

Paul Hayashi
photo, biosketch, abstract (pdf)
Update on Genetic Susceptibility to DILI (pdf)
or PowerPoint Notes version (pdf)
Tom (J.) Urban
photo, biosketch, abstract (pdf)
Personalized DILI Risk Management – The Tolvaptan Initiative (pdf)
or PowerPoint Notes version (pdf)
Merrie Mosedale
photo, biosketch, abstract (pdf)
HMGB1 Variants Determine if DILI is Benign or Dangerous (pdf)
or PowerPoint Notes version (pdf)

Discussion (pdf)
Dan Antoine
photo, biosketch, abstract (pdf)
Serum Cytokeratin18 as a Biomarker for Liver Injury (pdf)
or PowerPoint Notes version (pdf)

Discussion (pdf)
Brett Howell
photo, biosketch, abstract (pdf)
The ‘Rule of 2” – Do Drug Properties Predict DILI ? (pdf)
or PowerPoint Notes version (pdf)

Discussion (pdf)
Minjun Chen
photo, biosketch, abstract (pdf)
Transforming Monocytes into Hepatocyte urrogates (pdf)

Discussion (pdf)
Alexander Gerbes, Andreas Benesic
speakers, biosketches, abstracts (pdf)

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