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12:30 pm Registration


1:55 Chairperson’s Opening Remarks

Arie Regev, M.D., Hepatology Consultant and Chair, Liver and GI Safety Committee, Global Patient Safety, Eli Lilly and Company

2:00 How Good are Currently Available Biomarkers for Idiosyncratic DILI, and Which New Biomarkers Should We Look for? 

Arie Regev, M.D., Chair, Liver and GI Safety Advisory Committee, Global Patient Safety, Eli Lilly and Company; Adjunct Associate Professor of Medicine, Indiana University School of Medicine   

Efforts to develop new biomarkers for IDILI have been largely unsuccessful due to limitations such as, incomplete understanding of the mechanisms, lack of effective in-vitro models, absence of universally accepted animal models, and often, lacking scientific exchange between clinicians and basic science researchers. One important prerequisite for the facilitation of new IDILI biomarkers is enhanced understanding on the types of questions that can and should be addressed. This presentation will outline pertinent clinical issues that could theoretically be addressed by specific diagnostic or predictive biomarkers.

2:30 FEATURED PRESENTATION: Genetic Basis of Susceptibility to DILI

Paul WatkinsPaul B. Watkins, M.D., Director, Hamner-UNC Institute for Drug Safety Sciences, Verne S. Caviness Distinguished Professor of Medicine, University of North Carolina at Chapel Hill    

Over the last several years, some pharmaceutical companies have successfully used genome wide assocation (GWA) to find genetic susceptibility loci for hepatoxicity observed in clinical trials. In one case, this approach has lead to a proposal to reintroduce with routine genetic testing a drug that has been withdrawn from worldwide markets due to DILI. Genotyping data from the largest DILI genebanks (the International Severe Adverse Events Consortium and the U.S. based Drug Induced Liver Injury Network) have been recently pooled. GWA analysis of this dataset, which reflects DILI due to over 200 different drugs, is providing fresh insight into mechanisms underlying DILI and should inform the hunt for epigenetic and environmental factors underlying DILI. 

3:00 Development of a New High Content Methodology for Predicting Hepatotoxicity
Sponsored by
 Marion Zanese, Ph.D., Group Leader, Predictive Toxicology, Fluofarma
Drug-induced liver injury is a major issue during drug development process. Howvere, there remains a shortage of early models to predict in vivo hepatotoxicity satisfactorily. We present here an optimized predictive methodology which relies on high-throughput flow cytometry applied to different cellular models (cell lines, primary rat hepatocytes and cryopreserved human hepatocytes).

3:30 Networking Refreshment Break in the Exhibit Hall

4:30 Pediatric Drug Induced Liver Injury- Children Are Not Just Small Adults     

William Salminen, Ph.D., DABT, Director, Center for Hepatotoxicity, U.S. FDA, National Center for Toxicological Research 

Children are not simply small adults and it follows that children may exhibit differential sensitivity to drug-induced adverse events. This also applies to drug-induced liver injury (DILI). As an embryo develops, leading to the birth of a child, and eventually maturation into an adult, the human body goes through many different development phases. Various factors involved with the developmental phases may make the developing human more or less susceptible to DILI when compared to adults. This presentation will review the major developmental phases of the maturing liver with an emphasis on phases that may pose unique sensitivities to DILI.    

5:00 PANEL DISCUSSION: Early Prediction of Idiosyncratic DILI: Recent Progress and Interesting Trends     

Moderator: Arie Regev, M.D., Hepatology Consultant and Chair, Liver and GI Safety Committee, Global Patient Safety, Eli Lilly and Company

5:30 End of Day


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