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Symposium

Drug-Induced Liver Injury (DILI): Risk Assessment of Drug Candidates and Metabolites in Drug Discovery and Clinical Development


Speakers: William Treem (J&J), Michael Rothenberg (Genentech), Weida Tong (NCTR/FDA), Yazen Alnouti (UNMC), Donna Dambach (Genentech), Cyrus Khojasteh (Genentech), Kenneth Brouwer (Qualyst), Gary Peltz (Stanford University Medical School)
Organizers: Cyrus Khojasteh and Will Proctor (Genentech)
Date: 2017-06-02
Time: 8:45-17:00 Pacific Time
Registration fee (USD): Regular: $195; Academic: $125; Students or Unemployed: $35
Location: Crowne Plaza, Foster City, CA
Major Sponsor:
Vendor show vendors registered to date: (12)BioDuro; BioreclamationIVT; Cellular Dynamics Intl; Cyprotex; Cytovier LLC; Hurel Corporation; Lonza; Optivia Biotechnology; Organovo; Qualyst Transporter Solutions, LLC; SOLVO Biotechnology; XenoTech
Registration: http://www.PBSS.org
Registration deadline:2017-05-30  (it will close sooner if the seating cap is reached)

About the Topic

Drug-induced liver injury (DILI) continues to be a leading cause of attrition during small molecule drug development, withdrawal post-marketing, and cautionary / restrictive labeling. Hepatotoxicity risk is difficult to predict based on the various etiologies that encompass DILI, with unknown factors driving patient susceptibility towards hepatic stress and injury, coupled with the poor concordance of preclinical species to identify human hepatotoxicants in vivo. However, retrospective analysis over the past 50 years has identified several factors associated with DILI that include but are not limited to physicochemical properties of the drug, dose, metabolism and disposition, and signals in a battery of in vitro assays.  As such, the pharmaceutical industry and regulatory agencies alike are focused on more comprehensive risk assessment to reduce and/or mitigate DILI risk in drug discovery and early development.  

This full-day mini-symposium is centered on contemporary perspectives on DILI from an academic, industry, and regulatory perspective, with focused talks addressing mechanisms of DILI, clinical presentation and management, hepatotoxicity risk assessment in drug discovery, and novel tools (including biomarkers) emerging in the field.

 

Agenda 

8:45am - 8:50am     PBSS Welcome Organizer

8:50am – 9:00am

  • General Introduction to the DILI Workshop (Will Proctor, PhD, Genentech)

9:00am - 9:40am

  • Filling in the Guidance Gaps and Defining Best Practices in monitoring for and diagnosing DILI in clinical trials: The IQ-DILI Consortium (William Treem, MD, J&J) 

9:40am – 10:20am

  • The challenges of potential DILI in early clinical development (Michael Rothenberg, MD, PhD, Genentech)
10:20am - 10:45am     Break   

 10:45am – 11:25am

  • Liver Toxicity Knowledge Base – A knowledge base approach for drug-induced liver injury (Weida Tong, PhD, NCTR/FDA)

 11:25am – 12:00pm

  • The role of bile acids in DILI and liver diseases (Yazen Alnouti, PhD, University of Nebraska Medical Center (UNMC))

 12:00pm - 1:00pm     Lunch   

 1:00pm – 1:40pm

  • Multi-parametric assessment of hepatotoxicity risk in drug discovery (Donna Dambach, VMD, PhD, Genentech)

 1:40pm – 2:20pm

  • Reactive metabolites: from assessment to removal in drug discovery (Cyrus Khojasteh, PhD, Genentech)

 2:20pm - 2:45pm     Break   

 2:45pm – 3:25pm

  • Risk Assessment for Cholestatic Hepatotoxicity: Integrating Transporter Inhibition and FXR Mediated Regulation into a Predictive In Vitro Assay (Kenneth R. Brouwer, PhD, RPh, Qualyst Transporter Solutions)

 3:25pm – 4:05pm

  • Human Liver Engineering: From Safer Drugs to Liver Regeneration      (Gary Peltz, MD, PhD, Stanford University Medical School)

 4:05pm – 4:45pm

  • Panel Discussion (All Speakers)


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