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2008 Continuing Education Courses

The Continuing Education Program offers a wide range of courses that cover stateoftheart knowledge in toxicology, as well as new developments in toxicology and related disciplines. Courses can be applied toward certifying and licensing board requirements and may also be used for recertification with the American Board of Toxicology (ABT). Both basic and advanced course topics are offered. The basic course is intended to provide a broad overview of an area or to assist individuals in learning new techniques or approaches. The advanced course is intended to be of interest to individuals with previous knowledge of the subject or already working in the field.

*The Primary Specialty Section (SS) or Regional Chapter (RC) Endorser


SR01—MiniPigs As an Alternative NonRodent Species in Toxicology and Safety Studies

Chairperson(s): Glenn Washer, LAB Research Inc., Montreal, Quebec, Canada and Andrew Makin, LAB Research Denmark (Scantox), Copenhagen, Denmark

Endorsed by:
Animals in Research Committee*
Comparative and Veterinary Specialty Section
Dermal Toxicology Specialty Section

This course will focus on the regulatory acceptability and utility of minipigs as an alternative to traditional nonrodent species for nonclinical studies of pharmaceuticals. Attention will be given to their use in general toxicology and safety studies, including nonroutine routes and embryofetal development studies.

The choice of nonrodent species for safety assessment of new pharmaceuticals is becoming increasingly important. For many years researchers have adopted the paradigm that we use the dog, and if the dog is no good, then we use the primate. With the ever increasing ethical concerns relating to the use of primates, and other groups concerned with the use of “man’s best friend”, attention has been increasingly focussed on the potential of the pig and minipig. An increasing appreciation of the similarities between man and the pig in structure of skin, gastrointestinal tract, urogenital system and metabolism is the principal reason for the increased popularity. There are 13 species of pig, however, biomedical research has been largely restricted to the domestic pig derived from the Eurasian wild boar (Sus scofa) and the warthog (Phacochoerus africanus). Smaller strains (“minipigs”) have increasingly come to prominence in nonclinical testing and are now widely employed as nonrodent alternatives for regulatorydriven safety programs. For pharmaceutical compounds whose route is dermal in man, there is a growing realisation that the minipig is a valid model. Pig skin has been shown to be anatomically, physiologically, biochemically and immunologically similar to human skin. Although the use of the minipig in the development of dermal products is well accepted by regulators, its suitability for a wide range of other study types has been somewhat overlooked although in many ways it is more representative of man than other species. The minipig is now recognised as a suitable nonrodent species for efficacy and safety studies of many types of pharmaceutical products. Minipigs are suitable experimental models using many of the commonly applied techniques used in other species, and they have also been used as alternative nonrodent species for embryofetal studies.

Introduction,
Glenn Washer, LAB Research Inc., Montreal, Canada

Practical Considerations of the Use of Minipigs in Toxicology and Safety Studies,
Andrew Makin, LAB Research Denmark (Scantox), Copenhagen, Denmark

The Minipig in NonClinical Toxicology—a Regulatory Perspective,
Abigail Jacobs, USFDA, Silver Spring, MD

AM02/PM08—Introduction to Pathology for Toxicologists and Study Directors

Chairperson(s): Laurene M. Fomby, Battelle, Columbus, OH and Pat Haley, Incyte Corp, Wilmington, DE

Endorsed by:
Comparative and Veterinary Specialty Section*
Toxicologic and Exploratory Pathology Specialty Section

Today, even with the promise of ‘omic’ technologies, pathology plays a critical role in the evaluation of chemicals and drugs. Toxicological pathology uses specialized terms and methods and can generates complex interpretative problems. Effective communication between the toxicologist and the study pathologists will allow the toxicologist to better integrate pathology data into their reports and optimize the scientific content of the study. In this basic course, experienced toxicological pathologists will introduce important concepts in pathology to toxicologists as study directors in order to help the study director appreciate the role of pathology in toxicological studies. The course will begin with a discussion of basic concepts and the role of the toxicological pathologist followed by a discussion of global regulations as they relate to pathology endpoints. Later lectures will discuss the lesions and interpretation of pathology data in nononcogenicity studies and oncogenicity studies. By the end of the session, the study director should have a better understanding of pathology and a basic background that will allow for effective communication with a study pathologist.

Introduction,
Pat Haley, Incyte Corp, Wilmington, DE

Basic Concepts in Morphologic Pathology and the Roles of the Toxicological Pathologist,
Sarah Hale, EPL, Raleigh, NC

Important Induced Lesions, and Interpretation of Pathology Data in NonOncogenicity Studies,
Paul Howroyd, MDS Pharma, Lyon, France

Pathology Endpoints in Routine Repeated Dose Toxicology Studies: A Review of Global Regulations,
Ken Schafer, Vet Path Services, Mason, OH

An Introduction to Pathology in Carcinogenicity Studies,
Dianne Creasy, Huntingdon Life Sciences, East Millstone, NJ

AM03—Stem Cells and their Multi-Potential Uses and Potential Dangers

Chairperson(s): David Lawrence,Wadsworth Center, Albany, NY and Marc J. Pallardy, University of Paris, Chatenay Malabry, France

Endorsed by:
Immunotoxicology Specialty Section*
Mechanisms Specialty Section
Metals Specialty Section
Neurotoxicology Specialty Section

Stem cells can theoretically divide without limit to replenish cells and each daughter cell has the potential to remain a stem cell or develop into a fully functional differentiated cell. Therefore, stem cells have the potential to develop into many cell types that could benefit the health status of many individuals but the types of cells that could differentiate from stem cells must be considered in that certain growth and differentiation factors could give rise to conditions that could be harmful including development of a cancer stem cell. Additionally, environmental factors can skew the developmental patterns of stem cells leading to harmful deficiencies or expansions of certain types of progenitors. This course is designed as a basic level course to provide an overview of the field of stem cell biology, touch upon the differences of adult versus embryonic stem cells and provide a foundation for understanding the implications of the use of stem cells in toxicological research. Presentations will cover in vitro and in vivo proliferation and differentiation of stem cells and the influences of toxicants on these processes. Quantification of normal and aberrant immunophenotypic changes with development, mechanisms that influence proliferation, differentiation, and functional changes, and in vivo control of progenitors in their developmental niche will be discussed. The effect of environmental toxicants on a single molecular pathway controlling cell signaling and development of the CNS will be presented. Finally, the challenges in pharmacologically regulated cell therapy including the ability to regulate the fate of engineered cells will be deliberated.

Analysis and Use of CD34+ Stem Cells from Human Cord Blood,
David Lawrence, Wadsworth Center, Albany, NY

Human Dendritic Cells Derived from Hematopoietic Progenitors for Detecting Sensitizing Molecules,
Marc J. Pallardy, Univerisity of Paris, Chatenay Malabry, France

Pharmacologically Regulated Cell Therapy,
Anthony C. Blau, University of Washington, Seattle, WA

The Critical Interaction between Hematopoietic Progenitor Cells (HPC) and the Bone Marrow Microenvironment in Normal Hematopoiesis and Hematopoietic Toxicology,
David W. Pyatt, Summit Toxicology, LLP, Colorado and University of Colorado Health Sciences Center, Schools of Pharmacy and Medicine

Redox Modulation of Neural Progenitor Cell Function by Environmental Toxicants,
Mark Noble, University of Rochester, Rochester, NY

AM04—Dose-Response Modeling for Occupational and Environmental Risk Assessment

Chairperson(s): David G. Dolan, Amgen Inc., Thousand Oaks, CA and Andrew Maier, Toxicology Excellence for Risk Assessment, Cincinnati, OH

Endorsed by:
Occupational and Public Health Specialty Section*
Risk Assessment Specialty Section

The development noncancer exposure guidance values—whether for environmental or occupational sources of exposure—is rooted in the ‘critical adverse effect’ concept. Thus, derivation of such guidance values requires understanding the methods and approaches for estimating thresholds for the onset of adverse effects. This course will describe the history of the development of methods to develop ‘safe’ exposure limits using adverse effect level estimation. The lecture will focus on current methods and issues for using doseresponse modeling for developing potency and point of departure estimates for limitsetting. Each lecture will include presentations followed by handson application of key elements from the lecture as applied to model toxicological datasets. The participants are expected to obtain sufficient knowledge to estimate critical effect levels for risk assessment using a variety of modeling techniques and addressing key considerations of current interest.

Introduction to Identifying Critical Effects for Quantitative Risk Assessment,
Andrew Maier, Toxicology Excellence for Risk Assessment, Cincinnati, OH

DoseResponse Modeling Techniques,
Qiyu (Jay) Zhoa, U.S EPA, Risk Assessment, Cincinnati, OH

DoseResponse Estimation and Critical Effect Selection: Application for Occupational and Environmental Health Settings,
David G. Dolan, Amgen Inc., Thousand Oaks, CA

DoseResponse Estimation and Critical Effect Selection—Special Issues,
Robert Sussman, SafeBridge Inc., New York, NY

AM05—The Use of Transgenic Animal Technology in Toxicological Research

Chairperson(s): Daniel K. Ness, Elan Pharmaceuticals, Inc., South San Francisco, CA and Roy Forster, CIT, Evreux, France

Endorsed by:
Comparative and Veterinary Specialty Section*
Drug Discovery Toxicology Specialty Section
Mechanisms Specialty Section

The ability to direct genetic changes at the molecular level in vivo has resulted in a revolution in biology. Nowhere has this been more apparent than in the production of transgenic animals. A host of techniques has been used to effect change in gene expression and develop new toxicological testing paradigms. Genetically modified animals are commonly produced and often yield important information relevant to safety/toxicological assessment. This session will help guide the toxicologist in the use and interpretation of data derived from transgenic models. The first speaker will introduce this topic and set the stage for subsequent speakers. The second speaker will review the history of genetic engineering technologies leading to the development of lossoffunction, gainoffunction modeling technologies across mammalian platforms. Transgenic animals have provided us with powerful tools to explore cellular and physiological processes in vivo. Current technologies allow us to modify cell, tissueor organspecific gene expression in controlled temporal and spatial fashion. Accordingly, experimental considerations including strainspecific variability impacting experimental outcomes will be explored. The third speaker will cover current practice and previous experience gained in the regulatory use of transgenic animals in testing new products. In the area of safety evaluation, transgenic models have been used in the testing of biotechnology products (homologous models), in carcinogenicity testing, and in early toxicology screening. The presentation will cover the use of transgenics from the point of view of theory, the concrete practical aspects of putting such studies in place and new developments in this area. From genetargeting, genetrapping, and conditional expression modeling, gene knockout technology in mice is employed as an integrated platform to study physiological and behavioral functions and pharmaceutical utility of targeted genes. The fourth speaker will present recent data comparing pharmacological inhibition of selected targets, with a focus on differentiating between mechanism and nonmechanismbased toxicity and in determining ontarget versus offtarget toxicity for drug candidates. The final speaker will discuss how the lack of practical methods for the study of mutagenesis using endogenous genes stimulated the development of alternative mutation assays. These mutation analytical systems, developed first in rodents, and subsequently in fish share a similar general approach. Transgenic mutation models provide opportunities for comparative studies of complex processes of mutagenesis simply not possible otherwise. The introduction of a mutation model based on a transgenic fish, here the transgenic medaka, builds upon the knowledge and experience gained from the rodent models, and expands opportunities for increasing the understanding of fundamental mechanisms of mutagenesis.

Introduction,
Daniel K. Ness, Elan Pharmaceuticals, Inc., South San Francisco, CA

Overview of Transgenic Animal Technology,
Carl A. Pinkert, Auburn University Auburn, AL

Current Use of Transgenics in Screening and Regulatory Toxicology,
Roy Forster, CIT, Evreux, France

Using Mouse Knockouts to Predict MechanismBased Toxicity,
Brian P. Zambrowicz, Lexicon Pharmaceuticals, The Woodlands, TX

From Transgenic Rodent to Fish Modeling: Enhancing Insights into Shared Mechanisms of Mutagenesis,
Richard N. Winn, University of Georgia, Athens, GA

AM06—Process Based Approaches to Modulating Gene and Protein Expression In Vivo and In Vitro

Chairperson(s): Richard S. Pollenz, University of South Florida, Tampa, FL and Robert Tanguay, Oregon State University, Corvallis, OR

Endorsed by:
Mechanisms Specialty Section
Molecular Biology Specialty Section*

The mechanistic analysis of cellular responses to xenobiotics requires the ability to modulate important genes involved in specific pathways. Such genes include those that encode receptors that associate with xenobiotics as well as the enzymes involved in xenobiotic metabolism. The ability to modulate these genes and proteins in vitro and in vivo has become accessible to more laboratories with the refinement of techniques such RNA interference (RNAi), viral gene delivery, morpholinomediated gene knock down and targeted gene disruption. However, the ability to utilize these techniques and generate reproducible results requires a detailed understanding of the advantages and applications of each procedure. Thus, the goal of this course is to provide the investigator with an overview of experimental design and the use of proper controls for four cutting edge techniques. The first talk will focus on experimental design and analysis of RNAi to reduce endogenous target proteins in culture cells with emphasis on controls and endpoint analysis. The second presentation will move to the zebrafish model system and discuss the use of morpholinomediated gene knock down to reduce the expression of specific proteins in embryos. The third presentation will discuss gene delivery utilizing the adenovirus system for reduction of gene expression in mice. The forth presentation will detail the use or transgenic approaches in mouse models to modulate the expression of specific target genes or knockin genes from other species. This course should be of broad interest to laboratories considering a mechanistic approach to understanding signal transduction pathways, gene expression and proteinprotein interactions as well as those currently investigating these endpoints.

Use of siRNA Technology to Modulate Gene Expression in Culture Cells,
Richard S. Pollenz, University of South Florida, Tampa, FL

Use of Morpholinos to Modulate Gene Expression in Zebrafish,
Robert Tanguay, Oregon State University, Corvallis, OR

AdenovirusMediated Gene Delivery to Modulate Protein Expression In Vivo
Cornelius Elferink, UTMB, Galveston, TX

Transgenic Approaches to Modulate Gene Expression in Mouse Models,
Frank Gonzalez, NCI, Bethesda, MD

AM07–Basic Embryology and Developmental Toxicology

Chairperson(s): Lori A. Dostal, Ann Arbor, MI and John M. Rogers U.S. EPA, Research Triangle Park, NC

Endorsed by:
Reproductive and Developmental Toxicology Specialty Section*

Embryonic and fetal prenatal development in mammalian species is a complex process which is sensitive to the effects of maternal and environmental factors. The timing of development of major organ systems varies between humans and various test species used in assessment of developmental toxicity of xenobiotics. This basic course will cover normal development from fertilization through early stages of implantation and embryogenesis, through development of the major organ systems (cardiovascular, central nervous system, craniofacial, skeletal, urogenital). The effects of known human and animal teratogens on fetal development will be presented as examples, including etiologies of abnormal development. Current requirements and study designs for developmental toxicology studies required for new chemicals and new drugs will be covered in the context of the biological concepts of organ systems described in the initial lectures.

Introduction and Overview,
Lori A. Dostal, Ann Arbor, MI

Cleavage, Implantation, Gastrulation, Neurulation Gastrulation,
E. Sidney Hunter, U.S. EPA, Research Triangle Park, NC

Cardiovascular and Craniofacial/Pharyngeal Development,
Kathleen K. Sulik, University of North Carolina, Chapel Hill, NC

Development of the Skeletal System Including Limbs, and the Urogenital System,
John M. Rogers, U.S. EPA, Research Triangle Park, NC

Developmental Toxicology Testing and Interpretation,
Rochelle W.Tyl, RTI International Research Triangle Park, NC

PM08–Introduction to Pathology for Toxicologists and Study Directors

Chairperson(s): Laurene M. Fomby, Battelle, Columbus, OH and Pat Haley, Incyte Corp, Wilmington, DE

Endorsed by:
Comparative and Veterinary Specialty Section*
Toxicologic and Exploratory Pathology Specialty Section

Today, even with the promise of ‘omic’ technologies, pathology plays a critical role in the evaluation of chemicals and drugs. Toxicological pathology uses specialized terms and methods and can generates complex interpretative problems. Effective communication between the toxicologist and the study pathologists will allow the toxicologist to better integrate pathology data into their reports and optimize the scientific content of the study. In this basic course, experienced toxicological pathologists will introduce important concepts in pathology to toxicologists as study directors in order to help the study director appreciate the role of pathology in toxicological studies. The course will begin with a discussion of basic concepts and the role of the toxicological pathologist followed by a discussion of global regulations as they relate to pathology endpoints. Later lectures will discuss the lesions and interpretation of pathology data in nononcogenicity studies and oncogenicity studies. By the end of the session, the study director should have a better understanding of pathology and a basic background that will allow for effective communication with a study pathologist.

Introduction,
Pat Haley, Incyte Corp, Wilmington, DE

Basic Concepts in Morphologic Pathology and the Roles of the Toxicological Pathologist,
Sarah Hale, EPL, Raleigh, NC

Important Induced Lesions, and Interpretation of Pathology Data in NonOncogenicity Studies,
Paul Howroyd, MDS Pharma, Lyon, France

Pathology Endpoints in Routine Repeated Dose Toxicology Studies: A Review of Global Regulations,
Ken Schafer, Vet Path Services, Mason, OH

An Introduction to Pathology in Carcinogenicity Studies,
Dianne Creasy, Huntingdon Life Sciences, East Millstone, NJ

PM09–Nanotoxicology: The Science of Developing a Safe Technology

Chairperson(s): Justin G. Teeguarden, Pacific Northwest National Laboratory, Richland, WA and Christie M. Sayes, DuPont Haskell Labs, Newark, DE

Endorsed by:
Inhalation and Respiratory Specialty Section
Nanotoxicology Specialty Section*
Occupational and Public Health Specialty Section
Risk Assessment Specialty Section

The objective of this course is to prepare toxicologists and risk assessors to meet the rapidly growing need to understand and evaluate the risks that engineered nanomaterials may pose to human health. Toxicological and risk assessment of nanomaterials requires an understanding of the unique differences between these 'new' materials and their chemical and largeparticle predecessors. Few currently have the multidisciplinary understanding (toxicology, nanoscience, applied physics, dosimetry) to effectively approach the problem of risk and safety assessment of these materials. This basic course will provide an overview of the state of the science of the field of nanotoxicology and develop the scientific basis for evaluating and characterizing exposure, toxicity and the risks associated with engineered nanomaterials. Nanoscience and nanomaterials will be described with a focus on how they may be different than chemicals and previous studied particulates. A summary of current evidence regarding important routes of exposure and materials humans are exposed to will be presented. Current methods for, and challenges to toxicological testing of nanomaterials will be covered with specific examples relating the toxicity of nanoscale TiO2 to more well characterized particulates (e.g. crystalline silica). Guidelines for testing have been proposed by several groups and will be summarized. Finally, the dosimetric basis for extrapolating the results of toxicology studies to humans will then be developed and presented. This course promotes the application of best scientific practices in the toxicological evaluation and risk assessment of this rapidly growing family of new materials.

Introduction and Course Overview,
Justin G. Teeguarden, Pacific Northwest National Laboratory, Richland, WA

Nanomaterials and Nanomaterial Properties,
Christie M. Sayes, DuPont Haskell Labs, Newark, DE

Consumer and Occupational Exposure to Nanomaterials,
Annette Santamaria, ENVIRON, Houston, TX

Nanomaterial Toxicology and Hazard Testing,
David B., Warheit, DuPont Haskell Labs, Newark, DE

Nanomaterial Dosimetry and Risk Assessment,
Justin G. Teeguarden, Pacific Northwest National Laboratory, Richland, WA

PM10–Clinical Dose Setting for Biotherapeutics

Chairperson(s): James D. Green, Biogen Idec, Inc., Cambridge, MA and Shawn M. Heidel, Eli Lilly and Company, Indianapolis, IN

Endorsed by:
Regulatory and Safety Evaluation Specialty Section*
Women in Toxicology Special Interest Group

Preclinical development programs that are designed to support the safe clinical use of biopharmaceuticals have considerations that are very different from programs designed to support the development of small molecule drugs. The International Conference of Harmonization (ICH) S6 document provides guidance regarding scientific and regulatory consensus for key preclinical study design elements. Since the adoption of ICH S6 considerable experience has been developed across a wide variety of biological drug and antibody constructs. This experience has indicated that if ICH S6 guidance is followed and expert assessment of data sets is provided, the safety considerations for first in human and later stage clinical trials has been assured. However, the recent experience involving the humanized monoclonal antibody TGN1412 has raised questions regarding the adequacy of current nonclinical approaches. This session will review the following: 1. current and proposed regulatory guidance documents that determine safe starting doses, 2. basic and advanced concepts in PK and PD that support preclinical and clinical dosimetry, 3. basic and advanced concepts of toxicology that are involved in the assessment of safety of biotherapeutics and 4. the current approaches will be illustrated by several case studies across a wide range of product classes. The course attendee will learn key concepts and design considerations for successful preclinical programs that support the initiation of safe human clinical trials.

Introduction,
James D. Green, Biogen Idec, Inc., Cambridge, MA

Review of Current Regulatory Guidances that Determine First Dose in Human,
Mark C. Rogge, Biogen Idec, Inc., Cambridge, MA

PK and PD Principles Supporting the Determination of First in Human Dosing,
Jenn Visich, Zymogenetics, Seattle, WA

Toxicology Considerations Supporting Safe Clinical Development,
Shawn M. Heidel, Eli Lilly and Company, Indianapolis, IN

Application of PK/PD and Toxicology Principles to Support the Determination of Safe Clinical Dosing: Case Studies,
Laura Andrews, Genzyme, Framingham, MA

PM11–Use of Data for Development of Uncertainty Factors in Non-Cancer Risk Assessment

Chairperson(s): John C. Lipscomb, U.S. EPA, Cincinnati, OH and Lynne T. Haber, Toxicology Excellence for Risk Assessment, Cincinnati, OH

Endorsed by:
Biological Modeling Specialty Section
Occupational and Public Health Specialty Section
Risk Assessment Specialty Section*

Promoting clarity and objectivity is a primary concern when advancing the technical basis for human health risk assessment. Default values for uncertainty factors are intended to serve as placeholders, to be replaced when relevant data become available. The default values for the uncertainty factors for inter and intraspecies extrapolation were established before many toxicologists were born, and methods for incorporation of chemicalspecific or categorical data continue to evolve. To understand the rationale for these uncertainty factors and methods for their replacement, this course will present a continuum of approaches to develop nondefault values for uncertainty factors, culminating in the application of advanced toxicokinetic methods to quantify differences in internal dosimetry. The course will describe the history of the development of default values for uncertainty factors, including their recent subdivision into toxicokinetic and toxicodynamic components; methods that make use of generallyapplicable species differences in anatomy and physiology and allometric scaling; specific instruction in the Chemical Specific Adjustment Factor (CSAF) methodology developed by the International Programme on Chemical Safety (IPCS); and the application of physiologically based pharmacokinetic (PBPK) modeling to develop quantitative data for use in replacing default assumptions for inter and intraspecies differences in tissue dosimetry. The concluding lecture will present a series of examples to illustrate how the various approaches introduced in the course can be applied to derive nondefault uncertainty factors for environmental contaminants and pharmaceutical compounds.

Introduction,
John C. Lipscomb, U.S. EPA, Cincinnati, OH

Overview and History of Default Values for Uncertainty Factors,
Lynne T. Haber, Toxicology Excellence for Risk Assessment, Cincinnati, OH

Categorical Default Approaches to Uncertainty Factor Development,
John C. Lipscomb, U.S. EPA, Cincinnati, OH

Development of Chemical Specific Adjustment Factors (CSAF): Guidance from the International Programme on Chemical Safety,
Bette Meek, Health Canada, Ottawa, Ontario, Canada

PBPK Models for Developing ChemicalSpecific Adjustment Factors,
Kannan Krishnan, University of Montreal, Montreal, Quebec, Canada

Examples Illustrating the Use of Data to Replace Default Uncertainty Factors,
Bruce D. Naumann, Merck & Company, Inc., Whitehouse Station, NJ

PM12–Essential Informatics for Toxicologists: Knowledge Management End-to-End

Chairperson(s): William B. Mattes, The Critical Path Institute, Rockville, MD and Lyle D. Burgoon, Toxicogenomic Informatics and Solutions, LLC, Lansing, MI

Endorsed by:
Drug Discovery Toxicology Specialty Section
Molecular Biology Specialty Section*

The combination of the Internet, automated data acquisition, and genomic information has transformed the role of the computer in the modern scientist's life. A familiarity with word processing and simple spreadsheets is simply not adequate preparation for dealing with large datasets such as those generated by large toxicology studies, toxicogenomics or highthroughput screens. Increasingly, the software tools used to deal with such data require an understanding of basic concepts in computer science, database design, bioinformatics and statistics. This 'basic' level course hopes to provide the beginnings of such an understanding. Thus the first lecture will cover some of the essential concepts of operating systems, file and data concepts and programming concepts. This will be followed by a talk discussing the essentials of database design and use, contrasting flatfile and relational databases. A third lecture will provide an overview of the information necessary so that data may be integrated, e.g. pathology with genomics. The final lecture will cover concepts of visual analysis of large data sets, and contrast some of the various approaches used. Hopefully after this course the student will be conversant in informatics to the level of effectively interacting with computer scientists, as well as collecting and manipulating datasets with reasonable skill.

Basics of Operating Systems, Data, and Data Handling,
William B. Mattes, The Critical Path Institute, Rockville, MD

Database Essentials for Toxicologists,
Lyle D. Burgoon, Toxicogenomic Informatics and Solutions, LLC, Lansing, MI

Annotating Data With Study and Subject Details—How, Why, What to Include,
Jennifer Fostel, NIEHS, Research Triangle Park, NC

What Do I Do with All This Data?,
Joseph F. Sina, Merck & Co Inc, West Point, PA

PM13–Epidemiology for Toxicologists: Introduction

Chairperson(s): Richard A. Parent, Consultox Ltd, Damariscotta, ME and Geary Olsen, 3M Corporation, St Paul, MN

Endorsed by:
Carcinogenesis Specialty Section
Regulatory and Safety Evaluation Specialty Section
Risk Assessment Specialty Section

This course is intended to provide participants with insight into epidemiology, a critical component of the discipline of toxicology This course will be presented by accomplished epidemiologists from government and industry.

Over the course of the last 50 years, epidemiology has gained respect as an established scientific discipline. Whereas epidemiologic results were once greeted with scorn and skepticism they are now accorded some degree of respect and in some instances perhaps too much respect. This course will begin by providing an overview of the terminology used to describe the techniques used to measure and quantify disease in populations. Toxicologist will become familiar the with the various study designs used in epidemiologic research to generate and evaluate hypotheses regarding disease occurrence. Next, the distinction between experiments and observational studies will be made with an overview on epidemiologic study designs, and bias in epidemiologic data. We will cover the types of observational study designs characterized according to whether the unit of observation is a group, the individual, or some hybrid of the two. A summary will provide the audience with some general guidelines regarding the tendency of the different types of epidemiologic studies to provide unbiased results.

Both toxicologists and epidemiologists contribute to the answers, and confusion, by providing information for use in hazard identification and dose response which is then cited in the risk characterization process. Toxicologists provide data through experimental descriptive and mechanistic studies with relevancy sometimes becoming an issue (e.g., PPAR mediated liver tumors in rats). Epidemiologists identify opportunistic areas to address the study question but have historically provided answers with exposure disappointingly defined. Many questions arise from toxicologists when trying to understand epidemiology including confusion about study bias, statistical inference, representativeness, and generalization. In this era of biomonitoring, can both disciplines be more effectively understood by each other, let alone others? Our objective is to compare and contrast methodologic strengths and weaknesses of the two disciplines as they attempt to address the public’s question, 'is it safe?' At the conclusion of this course, the presenters will reference presentations and discuss examples of a number of areas where epidemiology is misused, misinterpreted, and overinterpreted. The panelists will include examples of the misapplication of biomarkers in assessing risk ratios, the use of a minimum risk ratio of two to establish causation in the Texas court system, and the misuse of statistical analyses by both epidemiologists and toxicologists, among others.

Setting the Stage,
Richard A. Parent, Consultox Ltd, Damariscotta, ME

Overview and Terminology,
J. Michael Sprafka, Proctor & Gamble Company, Cincinatti, OH

Epidemiolgy Study Designs and Bias in Epidemiologic Data,
Matthew P. Longnecker, NIEHS, Research Triangle Park, NC

Toxicology and Epidemiology—Improving our Mutual Understanding,
Geary W. Olsen, 3M Corporation, St. Paul, MN

Uses and Misuses of Epidemiology,
All panel members will participate