Program - Society of Toxicology

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44 th Annual Meeting and ToxExpo Continuing Education DEVELOPMENTAL TOXICOLOGY STUDIES: DESIGN, INTERPRETATION, AND RISK ASSESSMENT AM 03 BASIC Chairperson(s): Joseph F. Holson, WIL Research Laboratories, Inc, Ashland, OH and Ronald D. Hood, RD Hood & Associates, Toxicology Consultants, Tuscaloosa, AL. Endorsed by: Reproductive and Developmental Toxicology SS* Risk Assessment SS Developmental toxicity studies are among the most complex and challenging in the field of toxicology. They entail multiple and interrelated endpoints and systems that are rapidly changing in characteristics and in their responses to toxic insults over time. These studies inherently generate large data sets. However, because of the decline in relevant training programs, data from developmental toxicity studies are often managed or interpreted by individuals with limited backgrounds in these fields. Although published regulatory agency guidance is available, this course will extend such guidance by presenting in detail current study designs, procedures for study evaluation, and case studies. Lectures will cover fetal endpoints including mortality, growth, visceral exams and skeletal exams, as well as endpoints of maternal toxicity and their relationship to developmental toxicity. Developmental toxicity will be viewed in a broad context, including aspects of postnatal development and multigenerational effects. Proper analysis of developmental toxicity data requires specific statistical considerations, and these will be presented. Finally, putting together all the data from such studies for human risk assessment will be discussed. Considerations of design flexibility, endpoint sensitivities, and use of mode of action analysis and confirmatory studies will be included. Thus, the course will present key information required for understanding the biological and toxicological bases of findings from developmental toxicity studies and will provide guidance for analysis and interpretation. • Evaluation of Fetal Weight, External and Visceral Anomalies in Developmental Toxicity Studies, Donald G. Stump, WIL Research Laboratories, Inc, Ashland, OH. • Overview of Developmental Toxicity Study Designs, Endpoint Sensitivities, Statistical Power, Variability, and Use of Historical Control Data, Joseph F. Holson, WIL Research Laboratories, Inc, Ashland, OH. • Evaluation of Skeletal Endpoints in Developmental Toxicity Studies, John M. Rogers, U.S. EPA, Research Triangle Park, NC. • Use of Developmental Toxicity Data in Risk Assessment, Susan L. Makris, U.S. EPA, Washington, DC. CLINICAL PATHOLOGY—THE GRANDDADDY OF BIOMARKERS AM 04 BASIC Chairperson(s): Thomas Monticello, Sanofi-Aventis, Bridgewater, NJ and Gail Walter, Gail Walter Consultants, Kalamazoo, MI. Endorsed by: Comparative and Veterinary SS Regulatory and Safety Evaluation SS Risk Assessment SS Student Advisory Committee Toxicologic & Exploratory Pathology SS* Research for novel biomarkers of toxicity continues to grow at a rapid pace. While biomarkers of tissue injury have a long history in the discipline of clinical pathology, the full value of these preclinical datasets are oftentimes under and/or over interpreted by scientists not extensively trained in this discipline. This basic course will emphasize current practices in clinical pathology utilized in drug discovery and preclinical safety studies and will also highlight advances in more novel biomarkers of toxicity. Basic interpretation of clinical pathology parameters will be presented in addition to factors to consider with respect to animal model, study design and the assays themselves. Examples of hepatic biomarkers and more recently identified biomarkers of toxicity will be highlighted. The applicability and pitfalls of utilizing reference ranges will be discussed, as will the approach in determining biological relevance of results versus statistical significance. Finally, regulatory perspectives on complete datasets and data interpretation will be addressed. This course is intended for the general toxicology community to improve their understanding of clinical pathology data and the role of clinical pathology in biomarker development. • Clinical Pathology Techniques in Discovery, Safety Assessment and Biomarker Development, Laurie O’Rourke, Novartis, East Hanover, NJ. • Coping with Multiple Masters: The Fine Art of Balancing Clinical Pathology and Toxicology in Preclinical Drug Development, Gail Walter, Gail Walter Consultants, Kalamazoo, MI. • Avoiding Pitfalls in the Interpretation of the Hemogram and other Clinical Pathology Assays Conducted for Toxicology Testing, Nancy Everds, Dupont Haskell Laboratory, Newark, DE. • Regulatory Perspectives on Clinical Pathology Data Analysis, Kenneth Hastings, CDER, U.S. FDA, Rockville, MD. CE 40 SOT’s 44 th Annual Meeting
44 th Annual Meeting and ToxExpo Continuing Education IMMUNOLOGY FOR TOXICOLOGISTS AM 05 BASIC Chairperson(s): Ian Kimber, Syngenta Central Toxicology Laboratory, Macclesfield,Cheshire, United Kingdom and Dori R. Germolec, National Institute for Environmental Health Sciences, Research Triangle Park, NC. Endorsed by: Immunotoxicology SS* Risk Assessment SS The adaptive immune system that is found in mammals comprises a dedicated interacting system of tissues, cells and molecules that work in concert to provide specific immune responses and host resistance to pathogenic microorganisms and transformed cells. Specific immunity is supplemented by, and works in harmony with, the phylogenetically more ancient innate immune system. Immunotoxicology describes the study of adverse health effects that may result from the interaction of xenobiotics with one or more components of the immune system. Such health effects may take a variety of forms. These include frank immunotoxicity where there is functional impairment of the immune system. The concern here is that compromised immune function may translate into an increased susceptibility to infectious and/or malignant disease. A second potential consequence of the interaction of chemicals or proteins with the immune system is allergy; defined as the adverse health effects that may arise from the stimulation of a specific immune response. Allergic disease may take a variety of forms, those of greatest significance for toxicologists being skin sensitization and allergic contact dermatitis, allergic sensitization of the respiratory tract, food allergy and idiosynctratic allergic drug reactions. Finally, xenobiotics have been implicated in the induction or exacerbation of autoimmune reactions and autoimmune disease. This course will provide a grounding in fundamental and clinical aspects of immunology, and will describe the basic elements immunotoxicity, allergy and autoimmunity. The objective is deliver an accessible guide to the immune system and immunotoxicology for general toxicologists. • An Introduction to Immunology: Fundamental and Clinical Aspects, Ian Kimber, Syngenta Central Toxicology Laboratory, Macclesfield, Cheshire, United Kingdom. • Elementary Immunotoxicology, Robert House, DynPort Vaccine Company, Frederick, MD. • Allergy and Allergic Disease, MaryJane Selgrade, U.S. EPA, Research Triangle Park, NC. • Autoimmunity and Autoimmune Disease, Dori R. Germolec, National Institute for Environmental Health Sciences, Research Triangle Park, NC. EVALUATION OF CARDIAC DRUG TOXICITY IN PHARMACEUTICAL DISCOVERY AND DEVELOPMENT AM 06 (REPEATS AS PM 12) BASIC Chairperson(s): Brian Short, Allergan, Irvine, CA and Y. J. Kang, University of Louisville, Louisville, KY. Endorsed by: Comparative and Veterinary SS HESI Biomarkers Technical Committee Mechanisms SS Regulatory and Safety Evaluation SS Student Advisory Committee Toxicologic and Exploratory Pathology SS The heart is an important potential target organ to evaluate in nonclinical and clinical studies during drug development as well as a therapeutic site of action for many cardiovascular diseases. There are examples in almost every therapeutic class of drugs that produced unanticipated cardiotoxicity leading to market withdrawal or cessation of development. Toxicologists are an integral part of an interdisciplinary group, including physiologists, pharmacologists, pathologists, clinicians, and regulators, which assess cardiac safety. As such, toxicologists play a critical role in the screening of pharmaceutical agents for cardiotoxicity as well as in establishing an adequate margin of safety and working basis for monitoring therapeutic endpoints and clinical safety of trial participants. The goal of this continuing education course is to illustrate the integration of physiology, pharmacology, toxicology, and pathology of the heart addressing both recent scientific advances and practical knowledge in pharmaceutical company setting. This course will cover in vitro and in vivo models of drug-induced cardiac injury and recent advances in biomarkers of cardiac injury to improve the strategy for detection and nonclinical and clinical monitoring of drug-related cardiotoxicity. This CE course will provide current understanding of the physiology of the heart with a focus on normal and drug-induced disturbances in cardiac electrophysiology and cardiac function, as well as testing strategies for assessing potential cardioactive drug candidates prior to entry into clinical trials. It will also cover basic and advanced knowledge of pathology of the heart, including a review of cardiac pathological evaluation, and provide case examples of the integration of physiological and pathological parameters and risk assessment to humans. Biochemical, cellular and molecular mechanisms of cardiac toxicity, including recent work in experimental animal studies and novel approaches directed toward understanding mechanisms of druginduced cardiac injury, cardiomyopathy and cardiac hypertrophy will be presented. Finally, biomarkers of drug-induced cardiac injury will be discussed. This will include a review of the findings of the Expert Working Group on Biomarkers of Drug-Induced Cardiac Toxicity, an in-depth look at serum troponins, and related work currently in progress under the ILSI-sponsored Subcommittee on the Development and Application of Biomarkers of Toxicity. • Physiological Basis for Cardiac Drug Toxicity and Evaluation, Robyn L. Phelps, Allergan, Irvine, CA. • Integrating Cardiac Pathology into Drug Discovery and Development, Calvert Louden, AstraZeneca Pharmaceuticals, Wilmington, DE. • Mechanisms of Drug-Induced Cardiotoxicity, Y. J. Kang, University of Louisville, Louisville, KY. • Biomarkers of Drug-Induced Cardiac Toxicity, Malcolm J. York, GlaxoSmithKline, Ware, Hertfordshire, United Kingdom. CE up-to-date information at www.toxicology.org 41
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Program - Society of Toxicology

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