Drug-Drug Interactions and Early Toxicity Screening-2010 (DDI & ETS-2010)

Venue: Red Lion Hotel Fifth Avenue

Location: Seattle, Washington, United States

Event Date/Time: Jun 14, 2010 End Date/Time: Jun 18, 2010
Registration Date: Jun 18, 2010
Early Registration Date: May 14, 2010
Abstract Submission Date: Jan 10, 2010
Paper Submission Date: May 01, 2010
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TWO EVENTS – ONE WEEK – ONE LOCATION: Red Lion Hotel on Fifth Avenue; Seattle, WA, USA

DDI-2010: 13th International Conference on Drug-Drug Interactions:
A Critical Review of Current Scientific Concepts and Practices in DDI Evaluation – Enzyme Inhibition, Enzyme Induction, Transporters, and Biologics
June 14-16, 2010

DDI-2010 is a yearly event providing a comprehensive update on the status of the science of drug-drug interactions and its relevance to drug development. Presentations will be given by experts from industry and academia. Topics covered will include literature and NDA reviews, mechanism and in vitro-in vivo extrapolation of DDI via enzyme and transporter inhibition and induction. The conference will also include a review on the current status of DDI potential of biologics.

Monday, June 14, 2010: Pre-conference Workshop-2010: Practical DDI

Session I: Higher Throughput Evaluation of DDI: Chair: Albert P. Li

• Novel Luciferin-based Substrates for Higher Throughput Quantification of P450 Activities (Jim Cali, Promega Inc.; Madison, WI)
• Automated Multiplexed Cell-Based Cytochrome P450 Assays (Brad Larson, BioTek Instruments, Inc.; Highland Park, TX)
• Alternate Technologies for the Determination of ADME Properties using Hepatocytes (Timothy Moeller, Celsis-In Vitro Technologies; Baltimore, MD)
• HTS Assays with Cryopreserved Human Hepatocytes for P450 Induction and Inhibition (Albert P. Li, APSciences Inc. and IVAL LLC; Columbia, MD)

Session II: DDI Data Evaluation: Chair: Wei Tang
This session is devoted to the evaluation of DDI data generated in the laboratory. Sample data with model drugs as well as data from NCE during routine screening will be used to illustrate the data evaluation approaches.

• P450 Inhibition (Wei Tang, Merck & Co.; Rahway, NJ)
• Development of Simulation Software for Quantitative Predictions of Drug-Drug Interaction (Yuichi Sugiyama, University of Tokyo; Tokyo, Japan)
• Uptake Transporter DDI: (Jasminder Sahi, Life Technologies Inc. Durham, NC)
• Data interpretation: Efflux Transporter Based Drug – Drug Interactions. (Ken Brouwer, Qualyst Inc.; Durham, NC)

Tuesday, June 15, 2010: Main Conference: DDI-2010: 13th International Conference on Drug-Drug Interactions

Session I: Preclinical and Clinical Review: Chair: Ken Thummel
• Opening Remarks & Overview: Current Status of DDI (Ken Thummel, University of Washington; Seattle, WA)
• Critical Review of the Literature 2009-2010 (Houda Hachad, University of Washington; Seattle, WA)
• Properties of Recent FDA-Approved Drugs (Carol Collins, University of Washington; Seattle, WA)

Session II: Enzyme Inhibition: Chair: Wei Tang
• Rules for Evaluating Drug Candidates as System-dependent Inhibitors and Metabolism-dependent Inhibitors of Cytochrome P450 (CYP) Enzymes (Andrew Parkinson, XenoTech LLC; Lenexa, KS)
• Time-dependent P450 Inhibition and Extrapolation of In Vitro Findings to In Vivo (Wei Tang, Merck & Co.; Rahway, NJ)
• CYP2C8-based Drug-Drug Interactions (Robert L. Walsky, Pfizer Global Research & Development; Groton, CT)
• CYP-mediated Drug-drug Interaction Predictions in Human Using Hepatocytes – A Case Study of MLN3897 (Chuang Lu, Millennium-The Takeda Oncology Company; Cambridge, MA)
• Prediction of Human ADME Profiles and DDI for FAK Inhibitor, PF-562,271 (Jing Lin, Pfizer, Inc.; Groton, CT)

Wednesday, June 16, 2010: DDI-2010 – DAY 2

Session III: Enzyme Induction: Chair: Albert P. Li
• Optimization of the P450 Induction Assay in Plateable Cryopreserved Human Hepatocytes (Albert P. Li, APSciences and IVAL LLC; Columbia, MD) 9:30 AM – 10:00 AM
• A comparison of mRNA and activity as endpoints for the prediction of clinical outcome with in vitro P450 induction results (Odette Fahmi, Pfizer Inc.; Groton, CT)
• Preclinical Evaluation of Compounds Displaying Complex DDI Properties: Case Studies Involving Enzyme Inhibition, Induction, and Inactivation (Eleanore Seibert, Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT)

Session IV: Transporters: Chair: Yuichi Sugiyama
• Clinically Significant DDI: Identification, Mechanism, and Prevention (Jash Unadkat, University of Washington; Seattle, WA)
• Drug Metabolizing Enzymes and Transporters in Drug-Drug Interactions: A Pharmacokinetic Treatment (Yuichi Sugiyama, University of Tokyo; Tokyo, Japan)
• Uptake Transporters (Jasminder Sahi, Life Technologies, Inc.; Durham, NC
• Importance of Hepatocellular Concentration in Predicting Transporter Based Drug – Drug Interactions (Ken Brouwer, Qualyst Inc.; Durham, NC)

Session V: DDI Evaluation of Biologics: Chair: Albert P. Li
• PK Based Interactions of Protein Therapeutics: Science and Strategies in Drug Development (Frank-Peter Theil, Genentech Inc.; South San Francisco, CA)

ETS-2010: 8th International Conference on Early Toxicity Screening: Early Elimination of NCE with Hepatotoxicity and Idiosyncratic Toxicity: Scientific Concepts, Challenges and Novel Technologies
June 17-18, 2010

Early Elimination of NCE with Hepatotoxicity and Idiosyncratic Toxicity: Scientific Concepts, Challenges and Promising Approaches. ETS-2010 is a bi-yearly event with emphasis on promising approaches and challenges in the accurate prediction of adverse drug effects during drug development. This year’s theme will be mechanism-based evaluation of adverse drug effects, with academic and industrial experts presenting data from in vitro, animal, and clinical studies. Topics covered will include risk factors observed in the clinic and preclinical animal species, mechanisms and mechanism-based evaluation of hepatotoxicity and cardiotoxicity, as well as the recent advancements in the prediction of idiosyncratic drug toxicity.

Thursday, June 17, 2010 - ETS-2010 – DAY 1

Keynote Lecture: Assessment of Stable and Chemically-Reactive Metabolites in Early Clinical Trials (Thomas A. Baillie, University of Washington; Seattle, WA)
Session I: Mechanism of Drug-induced Hepatotoxicity and Idiosyncratic Drug Toxicity: Chair: Mohammed Bourdi
• Mechanism of Drug-Induced Liver Injury: Lessons from Laboratory Mice Strains (Mohammed Bourdi,
LMI, NHLBI, NIH; Bethesda, MD)
• Inflammatory Stress and Idiosyncratic Hepatotoxicity: Hints from Animal Models (Xiaomin Deng, Mississippi State University; Mississippi State, MS)
• Mechanism of Valproic Acid-induced Hepatotoxicity (Thomas Chang, University of British Columbia; Vancouver, BC Canada)

Session II: Current Approaches for the Evaluation of Hepatotoxicity and Idiosyncratic Drug Toxicity: Chair: Roger Ulrich
• Mechanism-based Evaluation of Hepatotoxicity and Idiosyncratic Drug Toxicity During Drug Development (Roger Ulrich, Calistoga Pharmaceuticals, Inc.; Seattle, WA
• Evaluation of Mitochondrial Toxicity in Hepatocytes in Drug Development (James Dykens, Pfizer Inc.; Groton, CT)
• Toxicogenomic Approaches to Evaluate the Mechanism of Drug-induced Hepatotoxicity (Weida Tong, U. S. FDA, National Center for Toxicological Research; Jefferson, AR)

Session III: Novel approaches: In Vitro and In Silico: Chair: Albert P. Li, Ph. D.
• Mechanism-based Evaluation of Xenobiotic Toxicity: Translation of National Academy of Sciences Recommendations to Practice (Abby A. Li and Joyce S. Tsuji, Exponent Inc. San Francisco, CA and Seattle, WA)
• Human Hepatocytes and IdMOC as In Vitro Experimental Systems for the Evaluation of Human-specific adverse Drug Effects (Albert P. Li, APSciences Inc. and In Vitro ADMET Laboratories LLC; Columbia, MD)
• 3-D Cell Culture Microarray System for Early Toxicity Screening (David Rozzell, Solidus Biosciences, Inc.; San Francisco, CA)
• Engineering Microscale Models of the Liver for Drug Development and Toxicity Screening (Salman R. Khetani, Hepregen Corporation; Medford, MA)

Friday, June 18, 2010- ETS-2010 – DAY 2

Capture Compound Mass Spectrometry for the Evaluation of the Molecular Mechanisms of Liver Toxicity (Friedrich Kroll, Caprotec Bioanalytics GmbH; Berlin, Germany)

Session IV: Novel Approaches: In Vivo: Chair: Frank Gonzalez
• P450-Null Mice for the Evaluation of Metabolism-dependent Hepatotoxicity and Carcinogenicity (Frank J. Gonzalez, National Cancer Institute, Bethesda, MD)
• Humanized Transgenic Mice for the Evaluation of Drug Toxicity (Cliff Elcomb, CRX Biosciences Inc.; Dundee, Scotland)
• Xenogenic Mice with Human Hepatocytes for Pharmacological and Toxicology Studies (Katsutoshi Yoshizato, PhoenixBio; Higashi-Hiroshima City, Japan)


1415 Fifth Avenue
United States

Additional Information

Please visit http://www.isciencex.com/register for fee schedule and travel information or contact Nola Mahaney at nola@isciencex.com or 410-869-9166