Sunday, May 17, 2009
9:00 a.m. – 12:00 Noon | White Plains 4
Short Course 1: Prediction of Interindividual Variability in ADME Using In Vitro Data Coupled with Modeling and Simulations (Part 1: Metabolic Clearance)
9:00 a.m. – 10:00 a.m.
In Vitro - In Vivo Extrapolation to Predict ADME
Amin Rostami-Hodjegan, Royal Hallashire Hospital, Sheffield, England, UK
10:00 a.m. – 10:15 a.m. | White Plains Foyer
Refreshment Break
10:15 a.m. – 12:00 Noon
Hands-On Exercises to Predict CL
Tutors TBD
9:00 a.m. – 12:00 Noon | White Plains 5
Short Course 2: ADME Component of Drug Labeling: Past, Present, and Future Directions and Implications
9:00 a.m. – 9:40 a.m.
Introduction: The ADME Component of Present Drug Labels
Gabrielle M. Hawksworth, University of Aberdeen, Aberdeen, UK
Dennis A. Smith, Pfizer Global R & D, Sandwich, Kent, UK
9:40 a.m. – 10:20 a.m.
How “Personalized Medicine” Is Changing Drug Labeling Today
MHRA Speaker
10:20 a.m. – 10:40 a.m. | White Plains Foyer
Refreshment Break
10:40 a.m. – 11:20 a.m.
Implications for Drug Discovery and Development of Genomic-based Clinical Development and Labeling
Ruth Hyland, Pfizer Global R & D, Sandwich, Kent, UK
11:20 a.m. – 12:00 Noon
Toward a Prescriber- and Patient-Friendly Label
Munir Pirmohamed, University of Liverpool, Liverpool, England, UK
12:00 Noon – 2:00 p.m. | White Plains Foyer Lunch for Short Course Attendees (only)
2:00 p.m. – 5:00 p.m. | White Plains 4
Short Course 3: Prediction of Interindividual Variability in ADME Using In Vitro Data Coupled with Modeling and Simulations (Part 2: Prediction of Pediatric Pharmacokinetics)
2:00 p.m. – 3:00 p.m.
IVIVE Parameters in Pediatrics Contributing to Variation of ADME
Trevor Johnson, Royal Hallamshire Hospital, Sheffield, England, UK
3:00 p.m. – 3:15 p.m. | White Plains Foyer
Refreshment Break
3:15 p.m. – 5:00 p.m.
Hands-On Exercise to Predict Variation with Age
Tutors TBD
2:00 p.m. – 5:00 p.m. | White Plains 5
Short Course 4: Zebrafish for Metabolic and Toxicity Studies
2:00 p.m. – 2:40 p.m.
Overview of the Application and Relevance of Zebrafish for the Safety Evaluation of Drugs and Chemicals
Frank Bonner, Focus Biosciences Ltd, Newcastle-upon-Tyne, England, UK
2:40 p.m. – 3:20 p.m.
Xenobiotic Metabolism and Excrevation in Zebrafish
Haw Jones, University of Birmingham, Birmingham, UK
3:20 p.m. – 3:40 p.m. | White Plains Foyer
Refreshment Break
3:40 p.m. – 4:20 p.m.
Zebrafish: An In Vivo Model for Drug Safety Assessment
Wendy Alderton, Summit plc, Abingdon, England, UK
4:20 p.m. – 5:00 p.m.
Zebrafish in Environmental Safety Assessment
Stewart Owen, Astra Zenecca, Brixham, UK
Monday, May 18, 2009
8:15 a.m. – 8:30 a.m. | White Plains
Welcome Address
8:30 a.m. – 9:15 a.m. | White Plains
Keynote Lecture 1: Stem Cells and Drug Discovery: The Beginning of a New Era?
Lee Rubin, Harvard University Stem Cell Institute, Cambridge, Massachusetts, USA
9:20 a.m. – 12:00 Noon | White Plains
Plenary Session 1: Transporters in Drug Development and Adverse Drug Reactions
Co-Chairs: Bruno Stieger, University Hospital Zurich, Zurich, Switzerland
Hannelore Daniel, Munich Technical University, Munich, Germany
9:20 a.m. – 9:50 a.m.
Intestinal Membrane Transport of Drugs and Nutrients
Hannelore Daniel, Munich Technical University, Munich, Germany
9:50 a.m. – 10:20 a.m.
Hepatic Drug Transport: From the Sinusoid to the Canaliculus and Back
Bruno Stieger, Institute of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland
10:20 a.m. – 10:50 a.m. | New Orleans Ballroom Refreshment Break
10:50 a.m. – 11:20 a.m.
Understanding the Role of Blood-Brain Barrier Permeability for Drug Disposition
Pierre-Olivier Couraud, Institut Cochin, Université Paris Descartes, Paris, France
11:20 a.m. – 11:50 a.m.
Integration of Transporters as Important DMPK Determinants in Drug Development
Christoph Funk, F. Hoffmann-La Roche, Basel Switzerland
12:00 Noon – 2:00 p.m. | New Orleans Ballroom
Lunch Break/Poster Viewing
12:30 p.m. – 1:30 p.m. | White Plains 3
Industry-Supported Symposium
2:00 p.m. – 5:00 p.m. | White Plains 4
Symposium 1: Biomarkers of Drug Safety and Efficacy
Co-Chairs: Ina Schuppe Koistinen, AstraZeneca, Sodertalje, Sweden
Frank Dieterle, Novartis, Basel, Switzerland
2:00 p.m. – 2:30 p.m.
Biomarker Opportunities and Challenges within Drug R&D
Ina Schuppe Koistinen, AstraZeneca R&D, Sodertalje, Sweden
2:30 p.m. – 3:00 p.m.
Biomarkers of Kidney Damage
Frank Dieterle, Novartis AG, Basel, Switzerland
3:00 p.m. – 3:30 p.m.
Novel Approaches to Generate Biomarkers of Idiosyncratic Hepatotoxicity
Paul Watkins, University of North Carolina, Chapel Hill, North Carolina, USA
3:30 p.m. – 4:00 p.m. | New Orleans Ballroom
Refreshment Break
4:00 p.m. – 4:30 p.m.
Biomarkers of Drug-induced Vascular Injury (DIVI)
David Brott, AstraZeneca R&D, Wilmington, Delaware, USA
4:30 p.m. – 5:00 p.m.
Biomarkers for Hepatotoxicity
B. Kevin Park, University of Liverpool, Liverpool, UK
2:00 p.m. – 5:00 p.m. | White Plains 5
Symposium 2: Humanized Animal Models in Drug Metabolism
Co-Chairs: Colin Henderson, University of Dundee, Scotland, UK
Nico Scheer, Taconic-Artemis, Cologne, Germany
2:00 p.m. – 2:30 p.m.
Humanized Mouse Models for PK and Safety Profiling of Compounds
Nico Scheer, Taconic-Artemis, Cologne, Germany
2:30 p.m. – 3:00 p.m.
Use of Gene Knockout and Reporter Mice as Humanized Models of Drug Metabolism
Colin Henderson, University of Dundee, Scotland, UK
3:00 p.m. – 3:30 p.m.
Insights from CYP3A Knockout and Transgenic Mice
Alfred Schinkel, Netherlands Cancer Institute, Amsterdam, The Netherlands
3:30 p.m. – 4:00 p.m. | New Orleans Ballroom
Refreshment Break
4:00 p.m. – 4:30 p.m.
Knockout and Humanized Animal Models in the Pharmaceutical Industry: The Humanized PXR Mouse Model
Michael Sinz, Bristol Myers Squibb, Wallingford, CT, USA
4:30 p.m. – 5:00 p.m.
Knockout and Humanized Mouse Models for Sulfotransferases: Usage in Biotransformation and DNA Adducts Studies with Various Carcinogens
Hansruedi Glatt, German Institute for Human Nutrition, Potsdam, Germany
5:00 p.m. – 7:00 p.m. | New Orleans Ballroom
Welcome Reception
Tuesday, May 19, 2009
7:15 a.m. – 8:15 a.m. | White Plains 3
Industry-Supported Symposium
8:30 a.m. – 9:15 a.m. | White Plains
Keynote Lecture 2: Adverse Drug Reactions: Who Cares?
Tom MacDonald, University of Dundee, Dundee, Scotland, UK
9:20 a.m. – 12:00 Noon | White Plains
Plenary Session 2: Epigenetics and Micro RNAs
Chair: Patrick Maurel, INSERM U632, Montpellier, France
9:20 a.m. – 9:50 a.m.
Epigenomic Regulation of Drug Metabolism Genes
Alvaro Puga, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
9:50 a.m. – 10:20 a.m.
Role of miRNA in Epigenetics
Minoo Rassoulzadegan, INSERM, U636, Nice, France
10:20 a.m. – 10:50 a.m. | New Orleans Ballroom
Refreshment Break
10:50 a.m. – 11:20 a.m.
Epigenomic Profiling in Response to Xenobiotics
Richard Meehan, MRC Human Genetics Unit, Edinburgh, Scotland, UK
11:20 a.m. – 11:50 a.m.
MicroRNAome Dysregulation during Chemical Carcinogenesis
Igor Pogribny, National Center for Toxicological Research, Jefferson, Pennsylvania, USA
12:00 Noon – 2:00 p.m. | New Orleans Ballroom
Lunch Break/Poster Viewing
12:30 p.m. – 1:30 p.m. | White Plains 3
Industry-Supported Symposium
2:00 p.m. – 3:00 p.m. | White Plains 4
Poster Awards Lectures and Awards Presentation
3:00 p.m. – 6:00 p.m. | White Plains 4
Symposium 3: Biological Agents as Drugs: New Challenges
Co-Chairs: B. Kevin Park, University of Liverpool, Liverpool, UK
3:00 p.m. – 3:30 p.m.
The Safe Introduction and Use of Biologicals
Munir Pirmohamed, University of Liverpool, Liverpool, England, UK
3:30 p.m. – 4:00 p.m.
Aligning Protein Production, Bioprocessing and Therapeutic Efficacy: The Challenge for Biopharmaceuticals
Alan Dickson, University of Manchester, Manchester, England, UK
4:00 p.m. – 4:30 p.m.
How to Predict and Prevent the Immunogenicity of Therapeutic Proteins
Huub Schellekens, Utrecht University, The Netherlands
4:30 p.m. – 5:00 p.m. | New Orleans Ballroom
Refreshment Break
5:00 p.m. – 5:30 p.m.
PK/PD Modeling of Therapeutic Antibodies
Lene Alifrangis, Novo Nordisk, Copenhagen, Denmark
5:30 p.m. – 6:00 p.m.
Safety Assessment of Biopharmaceuticals
Stephen Poole, National Institute for Biological Standards and Control, Potters Bar, England, UK
3:00 p.m. – 6:00 p.m. | White Plains 5
Symposium 4: Interspecies Differences in Drug Metabolism
Co-Chairs: Mike Coughtrie, University of Dundee, Scotland, UK
Vera Ribeiro, University of Algarve, Faro, Portugal
3:00 p.m. – 3:30 p.m.
Interspecies Differences in Drug Metabolism: Implications for Drug Development
W. Griffith Humphreys, Bristol Myers Squibb, Princeton, New Jersey, USA
3:30 p.m. – 4:00 p.m.
Regulation of Environmental Contaminants Based on Interspecies Differences in Distribution and Response
John Lipscomb, Environmental Protection Agency, Cincinnati, Ohio, USA
4:00 p.m. – 4:30 p.m.
Molecular Basis for Interspecies Differences in Glucuronidation
Michael Court, Tufts University School of Medicine, Boston, Massachusetts, USA
4:30 p.m. – 5:00 p.m. | New Orleans Ballroom
Refreshment Break
5:00 p.m. – 5:30 p.m.
Implications of Interspecies Differences in Sulfation for Chemical Safety Assessment
Mike Coughtrie, University of Dundee, Scotland, UK
5:30 p.m. – 6:00 p.m.
In Silico and Systems Biology Approaches to Understanding Interspecies Differences in Drug Metabolism
Sean Ekins, Collaborations in Chemistry, Jenkintown, Pennsylvania, USA
7:00 p.m. – 10:00 p.m.
Offsite Event/Banquet
(Ticketed Event)
Wednesday, May 20, 2009
7:30 a.m. – 8:30 a.m. | White Plains 3
Industry-Supported Symposium
9:00 a.m. – 11:30 Noon | White Plains
Plenary Session 3: Pharmacogenomics
Co-Chairs: Magnus Ingelman-Sundberg, Karolinska Institutet, Stockholm, Sweden
Christian Strassburg, Hannover Medical School, Hannover, Germany
9:00 a.m. – 9:30 a.m.
Pharmacoepigenetic Control of Drug Metabolism
Magnus Ingelman-Sundberg, Karolinska Institutet, Stockholm, Sweden
9:30 a.m. – 10:00 a.m.
Role of OATP Transporters in the Disposition of Drugs
Mikko Niemi, University of Helsinki, Helsinki, Finland
10:00 a.m. – 10:30 a.m. | New Orleans Ballroom
Refreshment Break
10:30 a.m. – 11:00 a.m.
Pharmacogenomic Biomarkers for Drug-induced Hepatotoxicity
Ann Daly, University of Newcastle, Newcastle- upon-Tyne, UK
11:00 a.m. – 11:30 a.m.
Drug Transporters Genetics and Liver Disease
Christian Strassburg, Hannover Medical School, Hannover, Germany
11:30 a.m. – 12:00 noon/White Plains
Announcement of Future Meetings
12:00 Noon – 2:00 p.m. | New Orleans Ballroom
Lunch Break/Poster Viewing
12:30 p.m. – 1:30 p.m. | White Plains 3
Industry-Supported Symposium
2:00 p.m. – 3:00 p.m. | White Plains 4
Announcement of the 2009 ISSX European New Investigator Award and Delivery of the ESBP Founders’ Lecture in Honor of Karl Netter by Awardee
3:00 p.m. – 6:00 p.m. | White Plains 4
Symposium 5: Drug Safety in Vulnerable Populations
Co-Chairs: Abby Collier, University of Hawaii–Manoa, Honolulu, Hawaii, USA
Steve Leeder, Children’s Mercy Hospital, Kansas City, Missouri, USA
3:00 p.m. – 3:30 p.m.
Ontogeny of Conjugating Enzymes in Human Liver
Abby Collier, University of Hawaii–Manoa, Honolulu, Hawaii, USA
3:30 p.m. – 4:00 p.m.
Chemicals in the Fetal-Placental Unit and Effects on Placental Function and Steroid Metabolism
Markku Pasane, University of Kuopio, Finland
4:00 p.m. – 4:30 p.m.
Pharmacogenomics of Drug Response in Children
Steve Leeder, Children’s Mercy Hospital, Kansas City, Missouri, USA
4:30 p.m. – 5:00 p.m. | New Orleans Ballroom
Refreshment Break
5:00 p.m. – 5:30 p.m.
Drug Safety in the Elderly
Ulrich Klotz, Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany
3:00 p.m. – 6:00 p.m. | White Plains 5
Symposium 6: Oxidative Stress and Redox Regulation
Co-Chairs: John Hayes, University of Dundee, Scotland, UK
Peter Moldeus, AstraZeneca, Sodertalje, Sweden
3:00 p.m. – 3:30 p.m.
y-Glutamylcycotransferase and Glutathione Homeostasis
Philip Board, John Curtin School of Medical Research, Canberra, Australia
3:30 p.m. – 4:00 p.m.
Glutathione Transferases, Glutathionylation, and Signaling
Ken Tew, Medical University of South Carolina, Charleston, South Carolina, USA
4:00 p.m. – 4:30 p.m.
Role of Thioredoxin and Sulfiredoxin in Combating Oxidative Stress
Michel Toledano, CEA-Saclay, Gif-sur-Yvette, France
4:30 p.m. – 5:00 p.m. | New Orleans Ballroom
Refreshment Break
5:00 p.m. – 5:30 p.m.
Glutathione Peroxidases
Regina Brigelius-Flohe, German Institute of Human Nutrition, Potsdam-Rehbruecke, Germany
5:30 p.m. – 6:00 p.m.
Regulation of Cellular Redox through the Nrf2-Keap1 Pathway
John Hayes, University of Dundee, Scotland, UK
6:00 p.m. – 6:30 p.m. / White Plains 4
Close of Meeting