Saturday, September 3, 2005

Saturday, September 3, 2005
7:00 AM–7:00 PM
Market Street Foyer

REGISTRATION OPEN

Saturday, September 3, 2005
8:00 AM–12:30 PM
Bayview

SHORT COURSE

APPLIED AND REGULATORY GENETIC TOXICOLOGY

Chair: Paul A. White, Health Canada, Ottawa, ON, Canada

Sponsored by Health Canada

This course will provide an overview of genetic toxicology test batteries, genetic toxicology tests approved for regulatory purposes, and regulatory guidelines for interpreting genetic toxicology test data. Detailed information will be provided on all of the major genetic toxicology tests, including how they are conducted and how the results are interpreted. The use of genetic toxicology data in industry and governmental regulatory agencies will be discussed.

Welcome and Introduction

Paul A. White, Health Canada, Ottawa, ON, Canada

Overview of Test Batteries, Approved Regulatory Tests, and Regulatory Guidelines

Paul A. White, Health Canada, Ottawa, ON, Canada

Use of Genetic Toxicology Testing in the Assessment of Existing Chemical Substances under the Canadian Environmental Protection Act

Kathy Hughes, Health Canada, Ottawa, ON, Canada

Framework for the Use of Genetic Toxicity Test Results for the Regulation of Chemical Products

Kerry L. Dearfield, USDA, Washington, DC, United States

Genetic Toxicology Testing in the Agrochemical Industry and Its Role in Product Safety Assessment and Mechanistic Research

Bhaskar Gollapudi, The Dow Chemical Company, Midland, MI, United States

Genetic Toxicology Testing and Product Safety Assessment in the Pharmaceutical Industry

Robert J. Mauthe, Pfizer Global R&D, Ann Arbor, MI, United States

Saturday, September 3, 2005
8:00 AM–12:30 PM
Seacliff A/B

SHORT COURSE

EMERGING ISSUES IN MOLECULAR EPIDEMIOLOGY

Chairs: Stefano Bonassi, INRC, Genoa, Italy and
Marianne Berwick, University New Mexico, Albuquerque, NM, United States

The recent availability of high-throughput techniques for population studies has provided the potential for discovering genetic risks of disease in individuals and modeling gene-environment interactions. This course addresses issues regarding various genetic biomarkers, such as the use of SNPs and gene-expression profiles in the study of human populations, as well as the potential of banking biological sampling. Statistical methods for analyzing data from new molecular endpoints will be presented, along with new perspectives on the classic disciplines of biodosimetry and exposure assessment.

How Molecular Epidemiology Is Changing with New Techniques

John S. Witte, University California, San Francisco, CA, United States

Association Studies in Molecular Epidemiology

Marianne Berwick, University New Mexico, Albuquerque, NM, United States

SNPs and Microarrays in Population Studies

Martyn T. Smith, University California, Berkeley, CA, United States

Statistical Methods in Molecular Epidemiology

Sandrine Dudoit, University California, Berkeley, CA, United States

Biodosimetry: From Chromosomes to Gene Expression Profiling

James D. Tucker, Wayne State University, Detroit, MI, United States

Tissue Repositories: Issues and Challenges, A View from the Trenches

Vann E. Schaffner, University New Mexico, Albuquerque, NM, United States

Exposure Biomarkers: A Role for DNA Adducts

Peter B. Farmer, University Leicester, Leicester, United Kingdom

Saturday, September 3, 2005
8:00 AM–12:30 PM
Seacliff C

SHORT COURSE

NEW DEVELOPMENTS AND APPLICATIONS OF THE COMET ASSAY

Chairs: N.P. Singh, University Washington, Seattle, WA, United States and
Peggy Olive, BC Cancer Research Centre, Vancouver, BC, Canada

Sponsored by Integrated Laboratory Systems, Inc.

This course will cover the various primary applications of the Comet (or single cell gel electrophoresis) assay. For each major area of interest, instructors will review innovative applications, proper study design, the types of mechanistic data that can be obtained by modifying the assay, data analysis, and study interpretation.

Organizers and/or Instructors:

• Brian Burlinson, GlaxoSmithKlein, Herts, United Kingdom
• Andrew R. Collins, University Oslo, Oslo, Norway
• Maria Dusinska, Institution Preventive and Clinical Medicine, Bratislava, Slovakia
• Andreas Hartmann, Novartis, Basel, Switzerland
• Makoto Hayashi, NIHS, Tokyo, Japan
• Günter Speit, University Ulm, Ulm, Germany
• Raymond R. Tice, NIEHS, Research Triangle Park, NC,
  United States

Lecture Topics:

• Assessment of DNA Repair Competency in Mammalian Cells (e.g., Lesion-specific Pathways, use of FISH)
• Human Biomonitoring (e.g., Classes of DNA Damage, Occupational, Environmental Exposures)
• Genetic Ecotoxicology (Aquatic, Terrestrial)
• Genetic Toxicology (Screening/Regulatory Applications, In Vitro/In Vivo Test Methods, Cytotoxicity, Validation)
• Question-and-Answer Panel
• Optional Lecture—Practical Aspects of the Comet Assay

Saturday, September 3, 2005
8:00 AM–12:30 PM
Seacliff D

SHORT COURSE

QUALITY ASSURANCE (QA) IN GOVERNMENT AND INDUSTRY LABORATORIES

Chair: Thomas J. Hughes, US EPA, Research Triangle Park, NC, United States

Sponsored by Celanese

This course will provide an overview of QA and Quality Control (QC) relevant to U.S. government, industrial, and pharmaceutical laboratories. Regulations on the use of rodents in toxicology, including Institutional Animal Care and Use Committee (IACUC) functions, will be given. Good Laboratory Practice (GLP) Regulations will be reviewed, including management of GLP studies at Contract Research Organizations (CROs). QA practices for paper and electronic records in government and the pharmaceutical industry will be described, including techniques to validate computer software and programs for record keeping.

Relationships Among QC, Peer-Review, and QA Procedures at the US EPA

Thomas J. Hughes, US EPA, Research Triangle Park, NC, United States

Regulations and Guidelines for Use of Animals in Toxicological Research

James W. Allen, US EPA, Research Triangle Park, NC, United States

Overview of GLP Regulations and QA

Patricia O’Brien Pomerleau, CIIT Centers for Health Research, Research Triangle Park, NC, United States

Management of GLP Studies at Contract Research Organizations (CROs)

Thomas R. Barfknecht, Celanese Ltd., Dallas, TX, United States

QA and Data Management Techniques at the US EPA

Ron Rogers, US EPA, Research Triangle Park, NC, United States

Computer Systems and Quality Assurance

John Haw, Cary, NC, United States

Final Questions and Answers

Saturday, September 3, 2005
1:30 PM–4:00 PM
Bayview

STUDENT/FACULTY PROGRAMS

GRANT WRITING FOR YOUNG INVESTIGATORS

Chair: Joann B. Sweasy, Yale University, New Haven, CT, United States

1:30 PM TIPS ON WRITING A FUNDABLE GRANT APPLICATION

Lawrence A. Loeb, University of Washington, Seattle, WA, United States

1:50 PM #1 NAVIGATING THE NIH

Syed Quadri, Oncological Sciences Integrated Review Group, Center of Scientific Review, National Institutes of Health, Bethesda, MD, United States

2:10 PM #2 COMMON MISTAKES IN GRANT WRITING

Joann Sweasy, Yale University School of Medicine, New Haven, CT, United States

2:30 PM YOUNG INVESTIGATOR MIXER/SOCIAL

Saturday, September 3, 2005
1:30 PM–4:30 PM
Garden A/B Room
Attendance is free of charge.

THE HUMN WORKSHOP

Chairs: Errol Zeiger, Errol Zeiger Consulting, Chapel Hill, NC, United States and
Michael Fenech, CSIRO Health Science and Nutrition, Adelaide, SA, Australia

The HUMN project is an international collaboration involving 35 labs from 22 countries aimed at studying the frequency of micronuclei and the relevance of this endpoint in human populations. This project was originally launched at the 7th ICEM in Toulouse. We have since had a workshop at each ICEM and ICEMHP aimed at updating knowledge about the use of the micronucleus assay in human populations, reviewing progress of our research program, and launching new initiatives. All registered 9th ICEM attendees are encouraged to attend.

The purpose of the HUMN project would be to:

1. Review new knowledge on the mechanisms of micronucleus formation and related biomarkers (nucleoplasmic bridges, nuclear buds) which has emerged over the past 4 years.
2. Review new data relating to the CBMN assay (e.g. effect of diet, genotypes, related biomarkers measured in the same assay etc.)
3. Report results of the HUMN project prospective study linking micronucleus frequency in lymphocytes with cancer risk, which will be completed at the end of this year.
4. Report outcome of buccal cell micronucleus assay review (currently underway).

1:30 PM BRIEF INTRODUCTION TO THE HUMN PROJECT, HISTORY, MISSION AND OBJECTIVES

Errol Zeiger, Errol Zeiger Consulting, Chapel Hill, NC, Untied States

1:45 PM REVIEW OF NEW KNOWLEDGE ON THE MECHANISMS OF MICRONUCLEUS FORMATION AND RELATED BIOMARKERS (NUCLEOPLASMIC BRIDGES, NUCLEAR BUDS) AND EFFECTS OF MICRONUTRIENTS

Michael Fenech, CSIRO Health Science and Nutrition, Adelaide, SA, Australia.

2:10 PM #3 REVIEW OF THE EFFECT OF OCCUPATIONAL EXPOSURE TO GENOTOXINS AND GENOTYPE ON MICRONUCLEUS FREQUENCIES IN HUMAN POPULATIONS

Micheline Kirsch-Volders,Vrije Universiteit Brussels, Brussels, Belgium

2:35 PM RESULTS OF THE HUMN PROJECT PROSPECTIVE STUDY LINKING MICRONUCLEUS FREQUENCY IN LYMPHOCYTES WITH CANCER RISK WHICH WAS COMPLETED IN 2005

Stefano Bonassi, National Cancer Research Institute, Genova, Italy

3:05 PM DISCUSS CURRENT STATUS AND PROSPECTS FOR AUTOMATION OF MICRONUCLEUS ASSAYS BY FLOW CYTOMETRY

Steve Dertinger, Litron Laboratories, Rochester, NY, United States

3:30 PM REPORT OUTCOME OF BUCCAL CELL MICRONUCLEUS ASSAY REVIEW AND DISCUSSION OF FEASIBILITY AND SCOPE OF A HUMN BUCCAL CELL PROJECT
(ESTABLISHMENT OF SCORING CRITERIA, INTER-LABORATORY SLIDE SCORING, AND INTERNATIONAL DATA BASE COLLATION/COMPARISON/ANALYSIS TO IDENTIFY KEY METHODOLOGICAL, DEMOGRAPHIC AND GENETIC VARIABLES)

Claudia Bolognesi, National Cancer Research Institute, Genoa, Italy

4:00 PM OPEN DISCUSSION ON FUTURE OF HUMN PROJECT

Saturday, September 3, 2005
5:00 PM–6:30 PM
Grand Ballroom

OPENING SESSION

All registrants are encouraged to attend. Guests must be registered as an Accompanying Person to attend. Badges should be worn.

Sponsored by The Dow Chemical Company

Welcome to the 9th ICEM

Philip C. Hanawalt, Stanford University, Stanford, CA, United States

Welcome from the President of the IAEMS

James M. Gentile, Research Corporation, Tucson, AZ, United States

Welcome from the President of the EMS

Leona D. Samson, MIT, Cambridge, MA, United States

Welcome from the Program Chair of the 9th ICEM

David M. DeMarini, US EPA, Research Triangle Park, NC, United States

Keynote Lecture: “Poor Diets: The Main Environmental Mutagen”

Bruce N. Ames, Children’s Hospital Oakland Research Institute, Oakland CA, United States

Keynote Lecture: “DNA Repair and Mutagenesis: Challenges for the Future”

Philip C. Hanawalt, Stanford University, Stanford, CA, United States

Saturday, September 3, 2005
6:30 PM–8:30 PM
Atrium

OPENING RECEPTION

All registrants are encouraged to attend. Guests must be registered as an Accompanying Person. Badges required.

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