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Recommended Short Courses*
Monday, June 14
9:00 am – 12:00 pm
(SC3) Translating Safety Biomarkers from the Lab to the Clinic
(SC4) Use of Stem Cells for Safety Screening
2:00 pm – 5:00 pm
(SC6) Addressing Safety Concerns for Biological Drugs
(SC8) Mechanistic Insights into Cardiotoxicity
Wednesday, June 16
6:00 pm – 9:00 pm (Dinner will be served)
(SC9) Mechanistic Insights into Hepatotoxicity
*Separate Registration Required.
WEDNESDAY, JUNE 16
12:30 pm Registration
1:55 Chairperson's Opening Remarks
Arie Regev, M.D., Hepatology Consultant and Chair, Liver Safety Committee, Global Patient Safety, Eli Lilly & Co.
2:00 Early Prediction of Drug-Induced Hepatotoxicity: Where are We Now and Where are We Going?
Arie Regev, M.D., Hepatology Consultant and Chair, Liver Safety Committee, Global Patient Safety, Eli Lilly & Co.
Drug induced liver injury (DILI) is the most common drug-safety issue leading to regulatory action including withdrawal of drugs from the market, restrictions in indications, and warnings to health care providers and patients. In the vast majority of these cases the hepatotoxicity is of the idiosyncratic type and is typically missed in the preclinical stages of drug development. This presentation will review the current knowledge on early prediction of idiosyncratic DILI, and will focus on future endeavors to address unmet needs in this field.
2:30 Better Prediction of Idiosyncratic Hepatotoxicity in Pre-Clinical Species Using a Multiple -Omics Approach
William Salminen Ph.D., DABT, Director of the Center for Hepatotoxicity, U.S. FDA National Center for Toxicological Research
Idiosyncratic hepatoxicity can not be predicted using traditional preclinical animal models and is a major cause of post-marketing drug removal. This presentation will provide an overview of a multiple -omics (genomics, proteomics, and metabolomics) approach being applied at the US FDA NCTR to better predict idiosyncratic hepatotoxicity in preclinical animal models. A unique aspect of this study is the use of mutliple genomics samples(blood and liver mRNA and blood microRNA) combined with proteomics and metabolomics analyses. The results from this study will be published in the public domain to facilitate the identification of biomarkers that will allow better predicition of idiosyncratic hepatotoxicity.
3:00 Sponsored PresentationSponsored by
3:15 Sponsored Presentation (Opportunity Available)
3:30 Networking Refreshment Break, Poster and Exhibit Viewing
4:30 KEYNOTE ADDRESS
New Approaches to Understand and Predict Idiosyncratic Hepatotoxicity
Paul 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
Our institute is collaborating with the FDA and Entelos to develop computer models that will explain idiosyncratic hepatotoxicity (IH). The knowledge required to complete these models is being obtained though multiple avenues, including analyses of DNA banks obtained from patients who have experienced IH and, in partnership with industry, studies of many proprietary compounds that have failed in clinical trials due to hepatoxicity. These studies involve a new panel of inbred mice, the Collaborative Cross, that mimics the genetic heterogeneity observed in man.
5:00 PANEL DISCUSSION
Early Prediction of Idiosyncratic DILI: What is the Forecast for This Decade and What Should Drug Makers Do Today?
Moderator: Arie Regev, M.D., Hepatology Consultant and Chair, Liver Safety Committee, Global Patient Safety, Eli Lilly & Co.
5:30 End of Day
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