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Archived Content

Tackling Drug-Induced and Idiosyncratic Hepatotoxicity


Day 1 | Day 2 
Download World Pharma Congress Final Brochure or Download Hepatotoxicity Brochure 

About This Conference:

Cambridge Healthtech Institute’s fourth annual conference on Tackling Drug-Induced Idiosyncratic Hepatotoxicity will feature a keynote panel highlighting renowned experts in the field of liver injury, will discuss the opportunities presented by pre-competitive collaborations and working in consortia to tackle liver injury, both in the pre-clinical and clinical stages. The conference short courses will elaborate on the mechanisms underlying hepatotoxicity, the use of stem cell-derived hepatocytes, and the use of computational tools and models for early liver injury assessments. These courses will also offer more in-depth education and networking opportunities with experts in the field.

» Recommended Short Courses 

Mechanistic Insights into Hepatotoxicity 

Addressing Safety Concerns for Biological Drugs  

Computational Tools for Predicting Toxicity 

Recent Developments in Ion Channel Assays for Safety Screening  

Use of Stem Cells for Safety Screening 

Strategies for Safety Testing for Biologics  


12:30 pm Registration



1:30 Chairperson’s Opening Remarks

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

1:40 How to Avoid Being Surprised by Hepatotoxicity at the Final Stages of Drug Development and Approval?

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

Despite increasing efforts to understand and predict idiosyncratic drug induced liver injury (IDILI) it remains largely unpredictable. Currently, the best time to try and identify a drug’s potential to cause IDILI, may be during early clinical development. During this phase, the differentiation between hepatic events which can predict IDILI and those that are not predictive of IDILI is of critical importance. This presentation will review current approaches to identification and monitoring of suspected IDILI during clinical phases of drug development.

» 2:10 KEYNOTE PANEL: Safety in Numbers: Exploring the Pre-Competitive Space

Arie Regev 

Importance of Large Patient Cohorts for IDILI-Related Biomarker Studies

Moderator: Arie Regev, M.D., Eli Lilly and Company

- The importance of adhering to very strict criteria and well characterized phenotypes
- Using shared data on isolated biliary hyperplasia in animals during drug development
- Importance of collaboration between drug makers to improve predictive biomarkers research 


Paul WatkinsSharing Information, Asking Questions - Liver Data Warehouse?

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

- Pre-competitive need to share bio-specimens for testing new DILI biomarkers
- Mining liver safety data put into eDISH
- Establishing a liver safety data warehouse and a Liver Safety Research Consortium 

Richard MillerChallenges in Predicting and Managing Translation of Pre-clinical Hepatic Effects in Clinical Trials

Richard Miller, D.V.M., Ph.D., DipACVP, Vice President, Safety Assessment, GlaxoSmithKline, Inc.;

- Our ability to predict, understand and detect preclinical hepatotoxicity and the potential for clinical hepatotoxicity continues to have deficiencies due to a rather old tool box
- Precompetitive sharing of hepatotoxicity knowledge, assays and data in a consortium setting can overcome limited data sets and assays individual organizations possess
- Translational hepatotoxicity (in vitro to in vivo, and preclinical to clinical) continue to be vexing problems but emerging technologies such as 2- and 3D liver, as well as humanized mouse liver models offer hope, as does in situ tissue imaging coupled with transcriptomics

Gerry KennaDe-risking Projects Early - How Can In Silico Tools and In vitro Assays Help?

Gerry Kenna, Ph.D., Principal Scientist, Hepatic Target Organ Strategy Lead, Safety Assessment, Molecular Toxicology, AstraZeneca


- Limitations of current in silico and in vitro approaches for early pre-clinical safety testing
- Possible improvements that can be facilitated by pre-competitive sharing of ideas and data, both amongst pharmas and with the academic community
- Focus of the new consortium, co-funded by EFPIA and the European Innovative Medicines Initiative to develop mechanism based improved systems for the prediction of drug-induced liver injury (MIP-DILI)


Strand_US 3:10 A Novel in vitro - in silico Platform for Predicting Mechanistic HepatotoxicitySonali Das, Ph.D., Director, Life Sciences, Strand Life Sciences Pvt LtdStrand's hepatotoxicity prediction platform combines in vitro enzymatic assays  on rat/human cell-lines or primary cells along with in silico simulations. Case studies will enlighten the audience how this system allows mechanistic understanding of a compound's impact leading to various classical end points of hepatotoxicity.

3:25 Sponsored Presentation (Opportunity Available)

3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

4:10 Can Biologicals Cause Liver Toxicity?

Paul Vancutsem, D.V.M., Ph.D., Director of Toxicology, Biogen Idec

This presentation will focus on biological compounds (monoclonal antibodies, proteins and others). Using the Danger hypothesis (Kaplowitz et al.) as a background, a review of the potential adverse effects of biologics on the liver (direct and indirect) and of the data already available will be provided. A strategy to address liver findings seen with biologics will be proposed.

4:40 Interactive Discussion Groups

Concurrent problem-solving discussions on specific topics, to provide a forum for exchanging ideas, voicing opinions and meeting potential collaborators. Discussions will be led by a moderator/s, limited to 15 participants per table, and open to all attendees and exhibitors.

5:40 End of Day

Day 1 | Day 2 
Download World Pharma Congress Final Brochure or Download Hepatotoxicity Brochure 

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