DDI and ETS-2012: 15th international Drug-Drug Interaction and 10th Early Toxicity Screening conferences

DDI-2012 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 and industrial perspectives.

ETS-2012 is a 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 transporters and drug toxicity, with academic and industrial experts presenting data. Topics covered will be under the categories of Scientific Concepts of Transporters and Drug Interactions; Clinical Evidence of Transporter-related Drug Toxicity; and Experimental Approaches for Transporter-related Drug toxicity.

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DDI-2012: 15th International Conference on Drug-Drug Interactions:
Literature and NDA Review; Enzyme Inhibition and Induction; Transporters, Biotherapeutics DDI and Industrial Perspective and Practices
June 11-13, 2012
June 11, 2012

Pre-conference Workshop-2012: Novel Approaches and Concepts in Drug-Drug Interactions Session 1: Evaluation of Complex Drug-Drug Interactions – Chair: Albert P. Li • Opening Remarks- Albert P. Li • Mechanism-Based Inhibition: Clinical Significance (Robert Foti, Amgen; Seattle, WA) • Predicting Complex DDI Involving Inactivation, Inhibition, and Induction: Opening the Pandora’s Box (Brian J. Kirby, Gilead Sciences; Foster City, CA) • Assessment of Time-Dependent Inactivation of CYP3A4 in Human Hepatocytes (Yuan Chen, Genentech; South San Francisco, CA) • Long-term Human Hepatocyte Cultures for the Evaluation of Complex Drug-Drug Interactions (Albert P. Li, In Vitro ADMET Laboratories, LLC; Columbia, MD) Session II: Novel Approaches to Improve Prediction of In Vivo Drug-Drug Interactions – Chair: Yuichi Sugiyama • Mechanistic Static versus Mechanistic Dynamic Models for DDI Prediction: Complementary Approaches during Drug Development (Xavier Boulenc, Sanofi; Montpellier, France) • Microdose Clinical Study for Assessment of DDI and Dose-dependency in Oral Drug Absorption (Shinji Yamashita, Setsunan University; Osaka, Japan) • Targeted Quantitative Proteomics as a Novel Approach for In Vitro Induction and Drug Metabolism (Olaf Schaefer, Nippon Boehringer Ingelheim, Kobe, Japan) • Drug-endogenous Compounds Interaction (DECI) in Urinary Excretion (Yuichiro Imamura, Daiichi Sankyo Co., LTD, Tokyo, Japan) • Drug-drug interaction in the GI absorption process: Contribution of influx and efflux transporters and metabolizing enzymes (Yuichi Sugiyama, RIKEN Research Cluster for Innovation; Yokohama, Japan) Main Conference: DDI-2012: 15th International Conference on Drug-Drug Interactions • Opening Remarks & Overview: Current Status of DDI (Ken Thummel, University of Washington; Seattle, WA) • Key Note Presentation: CAR and PXR at the Cross-roads of Drug-cell Signal Interactions (Masahiko Negishi, NIEHS; Research Triangle Park, NC) Session I: Literature and NDA Review – Chair: Carol Collins • Critical Review of the Literature 2011-2012 (Sophie Chung, University of Washington; Seattle, WA) • Clinical DDI Update: New Molecular Entities Approved by FDA in 2011 (Carol Collins, University of Washington; Seattle, WA) Session II: Mechanism-based Enzyme Inhibition – Chair: Robert Foti • Mechanism-based Inactivation of Human Cytochrome P450s: Potential Role in Drug-Drug Interactions (Paul Hollenberg, University of Michigan; Ann Arbor, MI) • Use of Accurate-Mass Spectrometry in the Identification of Novel Cytochrome P450 Protein Adducts (Dan Rock, Amgen; Thousand Oaks, CA) • Insights Gained from Mechanism-Based Inactivation Studies with Cytochromes P450 2B (James R. Halpert, University of California, La Jolla, CA) • Mechanisms of Cytochrome P450 Inactivation by Heme Modification (Robert S. Foti, Amgen; Seattle, WA) • Risk Assessment of Mechanism-based Inactivation in Clinical Drug-Drug Interactions (Nina Isoherranen, University of Washington; Seattle, WA) Session III: Enzyme Induction – Chair: Stephen Ferguson • Nuclear Receptor Regulation of CYP2C8 Gene Expression (Stephen Ferguson, Life Technologies, Durham, NC) • Evaluation of CYP2C8, 2C9, and 2C19 Induction in Human Hepatocytes (David Stresser, BD Biosciences; Woburn, MA) • Current Knowledge in Predicting Clinical DDI for Drugs that are Inducers of CYP2B6, CYP2C8, CYP2C9 or CYP2C19? (Odette Fahmi, Pfizer; Groton, CT) Session IV: Transporters – Chair: Jash Unadkat • Drug-drug Interactions at the Human Blood-brain Barrier (Jash Unadkat, University of Washington; Seattle, WA) • Predictions of Transporter-mediated Drug-drug Interactions in the Liver from In Vitro Data (Yuichi Sugiyama, RIKEN Research Cluster for Innovation; Yokohama, Japan) Session V: Biotherapeutics DDI – Chair: Eugenia Kraynov • Indirect DDI Between Anti-cytokine Monoclonal Antibodies and Small Molecule Drugs via Modulation of Circulating Levels of Plasma Proteins (Eugenia Kraynov, Pfizer; San Diego, CA) • Evaluation of DDI potential for Antibody Drug Conjugates (ADCs) (Sandhya Girish, Genentech; South San Francisco, CA) • In Vitro Approaches to Assessing the Enzyme Suppressing Effects of Biologics (Faraz Kazmi, XenoTech; Lenexa, KS) • Current Perspective on the Evaluation of Biotherapeutics DDI in the Clinical Setting: Readout from the Population PK TP-DDI Task Force (Diane Wang, Pfizer; San Diego, CA) • Novel In Vitro Approaches for the Evaluation of Biotherapeutic Drug Interactions (Albert P. Li, In Vitro ADMET Laboratories, LLC.; Columbia, MD) Session VI: Industrial Perspective and Practices of Application of PBPK Modeling in DDI Prediction and Clinical Trial Design – Chair: Chuang Lu • AstraZeneca Experience on Using Physiological Based Pharmacokinetic Tool (SimCYP Simulator) for Prediction of Drug-Drug Interactions (Pawel Baranczewski, AstraZeneca R&D, CNSP iMED DMPK, Södertälje, Sweden) • Helen Jenkins, Takeda UK, Clinical Pharmacology – TBD • PBPK-based predictions of DDIs in Eisai (Edgar Schuck, Eisai Pharmaceuticals, Inc., Andover, MA) • Application of PB-PK Modeling and Simulation in Drug-Drug Interaction Risk Assessment in Oncology Drug Development (Neeraj Gupta, Millennium Pharmaceuticals, Inc.; Cambridge, MA) • Application of Physiologically Based Pharmacokinetic Modeling and Simulation for Waiver of Drug-drug Interaction Trials (Chuang Lu, Millennium Pharmaceuticals, Inc., Cambridge, MA) Early Toxicity Screening-ETS-2012: Thursday, June 14, 2012 Session I: Neurotoxicity – Chair: Tim Schafer • In Vitro Approaches for Developmental Neurotoxicity Testing (Pam Lein, University of California at Davis; Davis, CA) • Bovine Microvessels for the Evaluation of Blood Brain Barrier Toxicity (Joseph Bressler, Kennedy Krieger Institute; Baltimore, MD) • Using Microelectrode Arrays for Neurotoxicity Screening (Timothy Shafer, U.S. Environmental Protection Agency; Research Triangle Park, NC) Session II: Hepatotoxicity and Cardiotoxicity – Chair: Stephen Ferguson • Hepatic Model Systems as Predictive Tools for In Vitro Toxicology Screening (Stephen Ferguson, Life Technologies; Durham, NC) • Accurate Prediction of Human Hepatotoxicity with a Novel Multiple Endpoint Primary Human Hepatocyte Assay (Jie Zhang, FDA National Center for Toxicological Research; Jefferson, AR) • Primary Human Hepatocyte Assays for Steatosis and Cholestasis Evaluation (Kenneth Brouwer, Qualyst, Inc.; Durham, NC) • Functional Cardiotoxicity Profiling and Screening Using the xCELLigence RTCA Cardio System (Yama Abassi, ACEA Biosciences; San Diego, CA) Friday, June 15, 2012 – DAY 2 – ETS-2012 Session III: Stem Cell and Bone Marrow Toxicity – Chair: Ivan Rich • The U.S. EPA's ToxCast Chemical Screening Program and Predictive Modeling of Toxicity (Nicole C. Kleinstreuer, National Center for Computational Toxicology, U.S. Environmental Protection Agency; Research Triangle Park, NC) • Stem Cell In Vitro Screening Models for Toxicity Testing (Ivan Rich, Hemogenix; Colorado Springs, CO) • Utility of Primary Stem Cell Colony Assays in Drug Development (Jackie Damen, StemCell Technologies; Vancouver, BC, Canada) Session IV: High Throughput, 3-D and Co-culture Technologies – Chair: Albert P. Li • Future Toxicity Testing: A Focus on In Vitro Methods Using a qHTS Platform (Menghang Xia, NIH/NHGRI; Bethesda, MD) • Alginate based 3-D Hydrogels as an In Vitro Co-Culture Model Liver Platform (Binil Starly, University of Oklahoma; Norman, OK) • Three-dimensional Model of the Small Intestine (Katja Schenke-Layland, Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB; Stuttgart, Germany) • Biomatrix-based Micro-channel 3-D Culture Systems for Toxicity Evaluation (Hossein Hosseinkhani; Taiwan University; Taipei, Taiwan) • IdMOC Technology for the Evaluation of Metabolism-dependent Toxicity and Organ-selective Toxicity (Albert P. Li, APSciences and In Vitro ADMET Laboratories; Columbia, MD)

11 Jun - 15 Jun 2012
United States of America
meeting website