SOT and the CE Committee are proud to offer a diverse online continuing education program: CEd-Tox. With the changing economy, we recognize it is more important than ever to keep your skills sharp, learn new techniques, and stay competitive in your field. This program is dedicated to providing such opportunities and resources to the scientific community in order to facilitate professional development beyond the Annual Meeting, as well as provide a low-cost alternative to those who are unable to attend.
Most courses run approximately three and a half hours and are divided into a brief introduction followed by approximately four, 45-minute segments that are viewed individually. Registrants will have 30-day unlimited access to the course(s) beginning on the date of purchase. The course segments are viewed via online streaming audio and slide presentation, and are not downloadable.
Chairperson(s): Katie Sprugel, Amgen, Seattle, WA, and Nancy Everds, Amgen, Seattle, WA
Sponsor: Toxicologic and Exploratory Pathology Specialty Section
Endorsed by: Immunotoxicology Specialty Section
Regulatory and Safety Evaluation Specialty Section
Women in Toxicology Special Interest Group
Stress can confound the interpretation of toxicity studies. The biology of stress includes complex interrelationships between neurologic and endocrine pathways. Stressors can have effects on in-life, clinical pathology, endocrine, and immune system parameters. Effects on any of these systems may be observed during a toxicity study. The challenge in toxicology is to differentiate between primary test article-related changes and secondary changes related to stress. This differentiation is fundamental to the assessment of stress in the regulatory environment. Understanding the pathophysiology of major systems impacted by stress and the potential range of responses is key to assessing the contribution of stress to study findings. Effects of stress in animals and humans, including potential biomarkers, will be discussed. Key references for the understanding of stress-related findings will be provided.
Introduction, Katie Sprugel, Amgen Inc., Seattle, WA
Neurohormonal Aspects of Stress, David Dorman, North Carolina State University, Raleigh, NC
Stress and Clinical Pathology, Nancy Everds, Amgen Inc., Seattle, WA
Stress and Endocrine Organs, George Foley, Schering-Plough, Summit, NJ
Stress and the Immune System, Paul Snyder, Purdue University, West Lafayette, IN
AM07—Translation of Safety Biomarkers in Drug Discovery and Development (Advanced)
Chairperson(s): Kay Criswell, Pfizer Global Research and Development, Groton, CT, and Jennifer Colangelo, Pfizer, Inc., Groton, CT
Sponsor: Regulatory and Safety Evaluation Specialty Section
Endorsed by:
Comparative and Veterinary Specialty Section
Drug Discovery Toxicology Specialty Section
Several major areas prove problematic in translating animal data/biomarkers to humans. This course focuses on translational issues in hematology, clinical chemistry, protein and peptide assays. It concludes with a risk assessment presentation summarizing the realities of implementing the overall process in defining human relevance of safety and efficacy from preclinical data. Preclinical data gathered in laboratory animals is required by regulatory agencies to determine safety in humans prior to marketing of new products. Species-specific differences in routine and esoteric serum biomarkers make the relevance of findings in animals difficult to interpret. Knowledge in this area is beneficial to the safe conduct of clinical trials and the inclusion of relevant biomarkers as effective safety and efficacy endpoints during new product development. Research scientists, industry scientists, laboratory personnel, and pathologists interested in biomarker development, translation, execution and applications from preclinical through clinical trials may be interested. The difference between data obtained in preclinical and clinical circumstances will be covered in this course. Therefore, it may be of interest to anyone in a preclinical research setting through those engaged in clinical trials, as well as those evaluating the safety of industrial chemicals. Course objectives include identification of potential relevance or non-relevance of animal-based hematologic and clinical chemistry biomarkers to humans, identification of methods of overcoming species-specific problems in protein and peptides biomarkers, and understanding human relevance of animal data and the impact of biomarker utilization on speed and decision-making.
Translation of Safety Biomarkers: Introduction, Kay Criswell, Pfizer Global Research and Development, Groton, CT
Does Preclinical Hematology Predict Human Safety? Nancy Everds, Amgen Inc., Seattle, WA
Translation of Clinical Chemistry Biomarkers: Pitfalls and Solutions, Denise Bounous, Bristol-Myers Squibb, Princeton, NJ
Overcoming the Problem of Species-Specific Proteins and Peptides in Assay Development, Jennifer Colangelo, Pfizer Global Research and Development, Groton, CT
Connecting the Dots to Define Human Relevance to Preclinical Data: Implementing Techniques to Enhance Speed of Delivery and Decision Making, Michael R. Bleavins, Michigan Technology and Research Institute, Ann Arbor, MI
Salt Lake City, 2010 Annual Meeting
PM08—Assessment of Ocular Toxicity in Toxicology Studies Conducted for Regulatory Purposes (Basic)
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Chairperson(s): Margaret Collins, Charles River Laboratories, Reno, NV, and Andrea Weir, Charles River Laboratories, Reno, NV
Sponsor: Toxicologic and Exploratory Pathology Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
Comparative and Veterinary Specialty Section
Ocular toxicity is known to occur following intended or unintended exposure of ocular tissues to xenobiotics. It can occur following local exposure of the eye to an agent or after exposure via oral or other routes of administration. In order to define the risks that pharmaceuticals, pesticides, and other toxic substances pose to the eye, an assessment of ocular toxicity is routinely included in general toxicology studies conducted for regulatory purposes. Because anatomical and physiological differences between species can impact the nature of the ocular effects observed, understanding species differences is important. Although it is possible to detect some ocular effects, such as conjunctivitis, with the naked eye, more sensitive techniques are routinely used to assess ocular toxicity. Slit lamp biomicroscopy and indirect ophthalmoscopy are routinely utilized to more closely evaluate the anterior and posterior chambers of the eye, respectively, during the course of toxicology studies. At the time of necropsy, ocular tissues are collected and processed for histopathological evaluation. More specialized endpoints, such as electroretinography, can be incorporated, as needed. Ocular anatomy and physiology and the assessment of ocular toxicity can be challenging to scientists involved in the safety assessment of pharmaceuticals, pesticides and other agents. This basic course will cover ocular anatomy and physiology in laboratory animals, established methods used to assess ocular toxicity, as well as more novel techniques for toxicity assessment. Examples of ocular toxicity that can occur following different routes of exposure will be discussed.
Introduction and Overview, Margaret Collins, Charles River Laboratories, Reno, NV
Comparative Ocular Anatomy and Physiology in Laboratory Animals, Mark Vezina, Charles River Laboratories, Montreal, Quebec, Canada
Diagnostics in Ocular Toxicology, Robert Munger, Animal Ophthalmology Clinic, Dallas, TX
Diagnostics and Ocular Imaging in the 21st Century, Christopher Murphy, University of California, Davis, CA
Ocular Pathology: Looking at the Eye, Ken Schafer, Vet Path Services, Inc., Greenfield, IN
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Chairperson(s): Richard Parent, Consultox Ltd., Damariscotta, ME, and Daniel Costa, U.S. EPA, Research Triangle Park, NC
Sponsor: Inhalation and Respiratory Specialty Section
Endorsed by:
Immunotoxicology Specialty Section
Drug Discovery Toxicology Specialty Section
Regulatory and Safety Evaluation Specialty Section
All mammals have evolved respiratory structures to ensure that the principal function of the lung, gas exchange, is met under varying physiological conditions. However, this essential function is achieved despite significant differences in the structural organization, cellular composition, and related functions mediated through the respiratory system and across mammalian species. Translational toxicology requires that one understand these innate differences in fundamental respiratory biology if one is to appropriately interpret and extrapolate findings in animal models. On a gross level, the nasal passages, pleural thickness, vascularity, and connective tissue structure vary between species. Quantitative evaluation of the tracheobronchial airway tree demonstrates few consistent features between species. The epithelial cell populations lining the lung differ in cell type, location, and abundance. The metabolic enzymes, cytokines, chemokines, protease, and anti-oxidant potential, although showing some similarities, also demonstrate vast differences. Similarly, basic immunological functions in laboratory animals must be understood and related to those in humans to enable appropriate species translation. We will illustrate many of these fundamental differences, describe methods for making measurements in different species, and most importantly, focus on the fundamentals of appropriate interpretation of study data derived in animals for human use. Attendees will gain a basic understanding of the value and pitfalls extending from these species differences, which will enable improved study design and extrapolation of research data for efficacy, safety pharmacology, and toxicology studies. This course is intended to provide attendees with a basic understanding of lung structure-function relationships and associated immunological and metabolic functions in laboratory animals that will aid in the extrapolation of inhalation or respiratory data to humans.
Introduction, Richard Parent, Consultox Ltd., Damariscotta, ME, and Daniel Costa, U.S. EPA, Research Triangle Park, NC
Comparative Anatomy of Mammalian Respiratory Systems, Kent Pinkerton, University of California, Davis, CA
Interpretation and Limitations in the Assessment of Lung Function in Laboratory Mammals, Jeffrey Tepper, Tepper Nonclinical Consulting, San Carlos, CA
Metabolism and Enzymatic Balance in the Respiratory Tract, Laura Van Winkle, University of California, Davis, CA
Pulmonary Immune Functions Important for Translational Toxicology and Predictive of Risk in Humans, Gary R. Burleson, BRT—Burleson Research Technologies, Inc., Morrisville, NC
PM10—Mitochondrial Toxicity: Animal Models and Screening Methods in Drug Development (Basic)
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Chairperson(s): Yvonne Will, Pfizer Global Research and Development, Groton, CT, and Carlos Palmeira, University of Coimbra, Coimbra, Portugal
Sponsor: Drug Discovery Toxicology Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
Mitochondria produce almost all the energy in cells, but also chronically expose the cell to cytotoxic free radicals. Mitochondrial disease and toxicity is a rapidly advancing field and the consequences of mitochondrial impairment should be appreciated by scientists in all disciplines. It is estimated that more than 75 diseases and metabolic disorders are attributable, at least in part, to mitochondrial dysfunction. Mitochondrial dysfunction can lead to many different pathologies of the liver, heart, muscle, kidney, and CNS through diverse mechanisms. Numerous widely prescribed therapeutics can undermine mitochondrial function by interfering with DNA replication or expression, and more acutely, by uncoupling or inhibiting oxidative phosphorylation, leading to organ dysfunction and damage. In addition, numerous environmental agents can contribute to diseases and toxicity through modifications of mitochondrial function, leading for example to Parkinson’s Disease and Autism. This course will review fundamental concepts of mitochondrial biology and the many different mechanisms by which xenobiotics interfere with mitochondrial function. Both common and novel in vitro screening approaches will be described, as well as in vivo animal models used to study mitochondrial-mediated toxicities and pathologies, with an emphasis on both their utility and limitations. The course will also introduce Structure-Activity Relationship and systems biology approaches to reveal common factors and novel mechanisms of mitochondrial toxicity. Upon completion of this course, participants will have a deeper understanding of how xenobiotics can alter the basic biochemistry and physiology of mitochondria, how minute changes in mitochondrial processes translate into complex toxicities, organ pathologies, and diseases, as well as a basic understanding of how to study mitochondria and mitochondrial dysfunction.
Mitochondrial Function and Dysfunction in Disease and Drug-Induced Toxicity, James Dykens, Pfizer Global Research and Development, Sandwich, United Kingdom
Animal Models of Mitochondria-Mediated Drug Toxicity, Urs A. Boelsterli, University of Connecticut School of Pharmacy, Storrs, CT
In Vitro Approaches to Assess Mitochondria-Mediated Drug Toxicity and Possible Biomarker Development: Advantages and Limitations, Yvonne Will, Pfizer Global Research and Development, Groton, CT
Integrated Mitochondrial and Nuclear Genomic Regulation of Oxidative Phosphorylation in the Study of Mitochondrial Toxicity and Function, Toshimori Kitami, Broad Institute of MIT and Harvard University, Cambridge, MA
PM12—Segment-Specific Renal Pathology for the Non-Pathologist (Basic)
Chairperson(s): Debie Hoivik, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, and Susan G. Emeigh Hart, Auxilium Pharmaceuticals, Inc., Malvern, PA
Sponsor: Toxicologic and Exploratory Pathology Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
The structural and functional complexity of the kidney uniquely predisposes it to be a sensitive target organ for a number of toxicants. By taking a segment-specific approach to the kidney, participants will gain a broad understanding of structure and function, spontaneous changes, the utility of biomarkers for injury, and morphological changes associated with injury. The different segments of the nephron will be reviewed. Species and gender-related differences in renal structure and function will be emphasized, especially where these contribute to differences in nephrotoxic responses. These differences need to be considered when determining the relevance of findings seen in animal studies to humans. We will review some of the more commonly noted spontaneous lesions and their overall incidences, variance by strain (rodents) and age, all of which can impact study outcome. Lesions such as renal amyloidosis in the mouse and chronic progressive nephropathy in the rat are just two examples of spontaneous lesions which may adversely impact the outcome of a study or may be enhanced by chemical administration, often complicating findings and interpretation. Representative examples of segment-specific morphological changes that occur as a direct response to toxicant exposure will be provided, focusing on those changes evident in laboratory animals used for regulatory testing of new chemical entities. For each morphological change, a corresponding control will be provided to clearly depict the nature of the change. Finally, when choosing a biomarker to monitor for kidney effects, it is critical to understand the utility and limitations of traditional and novel serum and urinary markers of renal injury. Participants will gain a broader perspective on selection and implementation of biomarkers, particularly of the newer urinary markers which provide insight into segment specificity or mechanisms of nephrotoxic injury. Moreover, the participants will understand the specificity of each biomarker as a predictor of injury for specific parts of the nephron.
The Kidney: Anatomic and Physiologic Features of Mechanistic Relevance, Susan G. Emeigh Hart, Auxilium Pharmaceuticals, Inc., Malvern, PA
Spontaneous and Background Changes in Laboratory Animals, John Seely, Experimental Pathology Laboratories, Inc., Research Triangle Park, NC
Renal Toxicant Induced Lesions by Nephron Segment, Jim Stoltz, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Biomarkers of Renal Injury, Daniela Ennulat, GlaxoSmithKline, King of Prussia, PA
Washington, D.C., 2011 Annual Meeting
Applications of Computational Systems Biology for Toxicology (Basic)
Chairpersons: Melvin E. Andersen, The Hamner Institutes for Health Sciences, Research Triangle Park, NC, and Rory B. Conolly, U.S. EPA, Research Triangle Park, NC
The field of toxicity testing and risk assessment is undergoing a shift from reliance on high-dose animal studies towards increased use of human in vitro systems that promise to provide mechanistic understanding of toxicity for environmentally relevant low-dose exposure. For this fundamental change, toxicologists will need to adopt more integrated experimental and computational approaches to resolve the structures of key signaling pathways, which are composed of functional network motifs, and to understand the consequences of chemical perturbation on the dynamic and steady-state behaviors of these pathways. This course introduces state-of-the-art computational systems biology tools that are being used for organizing and understanding molecular circuits under both physiological and perturbed conditions. A broad overview will first provide a historical context of dose-response studies based on understanding mode of action through cellular pathway perturbation. The course will describe signaling properties of a suite of recurring network motifs, including ultrasensitivity, feedback, and feedforward loops, to appreciate the basic building blocks of complex biochemical pathways and networks. Secondly, focusing on the DNA damage response and cell cycle progression pathways, we will illustrate how these network motifs are organized into molecular circuits to give rise to higher-level cellular functions and if perturbed, how functional aberrations result. Signal transduction networks activated by growth factors are then examined to show how pathway cross-talk and feedback loops define the activation logic of the downstream MAPK, which is a key determinant of cell growth and survival. Finally, we will shows how stochastic gene expression and the resulting non-genetic cell-to-cell variability plays a role in influencing dose response curves using examples such as B cell differentiation and its disruption by dioxin. The course concludes with a short summary and suggestions for applying these computational systems biology tools to future toxicity testing.
Introduction, Melvin E. Andersen, The Hamner Institutes for Health Sciences, Research Triangle Park, NC
Network Signaling Motifs, Qiang Zhang, The Hamner Institutes for Health Sciences, Research Triangle Park, NC
From Dynamics to Decisions: Quantitative Modeling of the Mammalian DNA Damage Response, Jared E. Toettcher, University of California San Francisco, San Francisco, CA
Dynamic Regulation of Growth Factor Signaling Networks, Jason M. Haugh, North Carolina State University, Raleigh, NC
Stochastic Gene Expression and Heterogeneous Cellular Response, Sudin Bhattacharya, The Hamner Institutes for Health Sciences, Research Triangle Park, NC
Biodegradable Materials for Tissue Engineering: Applications and Safety Assessment (Basic)
Chairpersons: Ronald P. Brown, Center for Devices and Radiological Health (CDRH), U.S. FDA, Silver Spring, MD, and Richard W. Hutchinson, Ethicon Inc., Johnson & Johnson, The Woodlands, TX
Sponsor: Medical Device Specialty Section
Endorsed by: In Vitro and Alternative Methods Specialty Section
The incorporation of biodegradable materials as a fundamental component in tissue regeneration strategies began in the early 1980’s and continues today. The function of a biodegradable material is to act as a temporary support matrix for transplanted or host cells so as to restore, maintain, or improve tissue. In order for this function to be achieved, biodegradable materials must undergo a number of critical examinations to define their properties. For example, degradation rate, degradation products, and the tissue response to these products must all be characterized. In this presentation we will introduce a number of natural and synthetic biodegradable materials that are commonly considered in regenerative medicine, as well as some recently developed novel materials. The techniques utilized to describe their physical properties and the relationship between physical properties and tissue response will be examined, and advanced techniques for material characterization and toxicological effects will be considered. Finally, the application of these biodegradable materials in tissue engineering strategies will be described.
Biodegradable Materials for Tissue Engineering: Applications and Safety Assessment, John P. Fisher, University of Maryland, College Park, MD
Best Practices for Developing, Characterizing, and Applying Physiologically Based Pharmacokinetic Models in Risk Assessment (Advanced)
This course is aimed at increasing confidence in the evaluation and application of PBPK models in quantitative health risk assessments, through systematic consideration of relevant criteria for their development and documentation, based on guidance. These principles (Best Practices for PBPK Modeling Applied to Health Risk Assessment) have been recently collected and expanded upon in guidance published by the WHO International Programme on Chemical Safety (2010), and have been the subject of several other peer-reviewed publications. The course comprises lectures describing the link between mode of action, dose-response characterization and risk assessment, and the role of PBPK models in reducing and characterizing uncertainty and variability. The course will present principles for the development, characterization, and communication and criteria for evaluation of PBPK models for risk assessment applications. A novel inclusion will be a projected demonstration of real-time changes in model outcome that depend on choice of model parameter values (e.g., breathing rate, metabolic activity). The demonstration of user-friendly model development software will be demonstrated in the final lecture. This will show the impact of choices for parameter values, and models will be exercised and the results interpreted to produce quantitative values to be used in place of uncertainty factors in health risk assessments.
Toxicokinetics in Risk Assessment, John C. Lipscomb, U.S. EPA, ORD/NCEA, Cincinnati, OH
Developing a PBPK Model, Hugh Barton, Pfizer, Inc., Groton, CT
Characterizing a PBPK Model, Kannan Krishnan, University of Montreal, Montreal, Québec, Canada
Applying PBPK Models in Risk Assessment, George Loizou, Health and Safety Laboratory, Buxton, United Kingdom
Case Study 1, Bette Meek, University of Ottawa, Ottawa, Ontario, Canada
Case Study 2, Jos Bessems, RIVM, Bilthoven, Netherlands
Current Non Clinical Strategies and Methods for Evaluating Drug-Induced Cardiovascular Toxicity(Basic)
Endorsed by: Drug Discovery Toxicology Specialty Section Regulatory and Safety Evaluation Specialty Section
Cardiovascular (CV) toxicity is among the major causes of withdrawal of drugs or restriction in their labeling and has had an impact on public health and the rising cost of developing new drugs. Early identification and characterization of CV liabilities, better understanding of the predictive values of nonclinical models, and an integrated and iterative approach during drug development could greatly facilitate the development of safe and effective medicines for patients. This course will describe the current in vitro and in vivo methods for evaluation of functional and structural CV liabilities, and discuss the strategies that can be applied at early stages of drug development to help reduce attrition and to avoid unanticipated liabilities at later development stages in either animal studies or in the clinic. Study design and data interpretation will be discussed, as well as the advantages, limitations, and future directions of current methods involving both functional and structural assessments. Specific topics such as integration of functional CV endpoints into repeat-dose toxicity studies, methods for identification and characterization of cardiac arrhythmia, and special considerations for testing oncology and diabetes drugs and biologics will be covered. In addition, case study examples will be provided to highlight how these data can be used to inform decisions at different stages of development. A regulatory perspective on the challenges and gaps of CV safety evaluations and opportunities available to improve the overall CV safety assessment paradigm will also be presented. Overall, this course will provide participants with a broad overview of the types of drug-induced CV liabilities, the current nonclinical strategies and methodologies for early detection of CV liabilities, and a regulatory perspective on the impact of CV toxicity on the drug-development process.
Opening Remarks and Overview of Cardiovascular Toxicity, Dennis J. Murphy, GlaxoSmithKline Pharmaceuticals, King of Prussia, PA
Early Identification of Cardiovascular Functional Liabilities: Role of In Vitro Assays, Derek Leishman, Eli Lilly & Company, Indianapolis, IN
Integrated Assessment of Cardiovascular Functional Liabilities: In Vivo Animal Models, R. Dustan Sarazan, Data Sciences International, St. Paul, MN
Assessment of Cardiovascular Injury: Morphological Evaluations and Biomarkers, Brian Berridge, GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC
A Regulatory Perspective on Drug-Induced Cardiovascular Liabilities: Challenges, Gaps, and Opportunities, John Koerner, U.S. FDA, Silver Spring, MD
Dealing with the Data Deluge: A Live Data Discovery and Analysis Course (Basic)
Chairpersons: Marc E. Gillespie, Saint Johns University, Jamaica, NY, and Susan M. Bello, Jackson Laboratory, Bar Harbor, ME
Sponsor: Molecular Biology Specialty Section
Endorsed by: N/A
Using Web based resources and tools to gain novel scientific insights and advance your research is a significant step for all researchers. As the pace of science accelerates, experimental technologies continue to evolve and the quantity of data increases. With the evolution in biological research comes an increasing reliance on database resources and computational analysis tools to parse and integrate this growing mass of biological data. The field of toxicology is not exempt from these challenges. In this course, representatives from a diverse group of data resources have joined their efforts to present a unique series of hands-on tutorials. The tutorials follow a hypothetical researcher through the various stages of experimental design and data analysis, demonstrating how the different workshop resources can be used to facilitate all steps of the research process. Participants will identify orthologous biological information across different species; identify biological trends (pathway, function, phenotype, xenobiotic interactions) within a submitted data set; investigate an individual data set with online resources, identifying supplementary information available across multiple data sets; and gain hands on experience with formatting and submitting data to a diverse set of online data resources.
Today toxicologists must select appropriate model organisms, manage abundant high-throughput data, understand legacy data, and develop pathway-based understanding of environmental factors influencing biological systems. Mastery of these concepts improves toxicity prediction while providing insights into environmentally influenced diseases and phenotypes. A clear understanding of the diverse online data resource aims and limitations equips the researcher with the best combination of resources to effectively address their questions.
NOTE: This was a unique “hands on” interactive course presented at the 2011 Annual Meeting. AM04 course attendees brought their own laptop computers as well as their own Internet network connection. The interactive nature of this course may be lost for those viewing the course online
Reactome Knowledgebase, Marc E. Gillespie, Saint Johns University, Jamaica, NY
Comparative Toxicogenomics Database (CTD), Carolyn J. Mattingly, Mount Desert Island Biological Laboratory, Salisbury Cove, ME
PharmGKB, Teri E. Klein and Li Gong, Stanford University Medical Center, Stanford, CA
Mouse Genome Informatics Database, Susan M. Bello, Jackson Laboratory, Bar Harbor, ME
Drug Hypersensitivity Reactions: Risk Assessment and Management (Basic)
Chairpersons: Marija Popovic, Eli Lilly & Company, Indianapolis, IN, and Jessica Whritenour, Pfizer Global Research and Development, Groton, CT
Sponsor: Immunotoxicology Specialty Section
Endorsed by: N/A
Drug hypersensitivity reactions are not a common problem in drug development; however, when they do occur they can have a significant impact on the drug candidate’s developmental success. Drug hypersensitivity reactions are usually discovered in Phase II or III clinical trials, or in the post-marketing phase. Once allergic reactions are observed in patients, one needs to determine if the reaction is mediated by an immune response to the drug, or another mechanism. There are a few ex vivo diagnostic methods that can be used to identify immune-mediated reactions, but one needs to be aware of the limitations and advantages of each approach. In vitro methods, or animal models presently being developed to predict drug’s potential to trigger hypersensitivity reaction in the patient population are being developed, but at present, they have significant limitations. Risk management strategies may include selection of patient populations based on the HLA haplotype. This course is intended as an introduction for those with limited background in the area of hypersensitivity, or allergic reaction to drugs. The focus of the course will be on systemic hypersensitivity reactions (drug administered orally or parenterally) and will include discussions both on drugs that are small molecules and biologics.
Clinical Overview: Description of the Types of Drug Hypersensitivity Reactions, Franklin Adkinson, Johns Hopkins University, Baltimore, MD
Mechanisms of Drug Hypersensitivity Reactions: Types I-IV Mechanisms, Hapten, PI, and Danger Hypotheses, Cynthia Ju, University of Colorado Denver, Aurora, CO
Pseudoallergic and Anaphylactoid Drug Hypersensitivity Reactions, Jessica Whritenour, Pfizer Global Research and Development, Groton, CT
Predictive Testing: Different Animal Models and Future Possibilities, Marija Popovic, Eli Lilly & Company, Indianapolis, IN
Epigenetics in Toxicology: Introduction, Mechanistic Understanding, and Applications in Safety Assessment (Basic)
Chairpersons: Mayurranjan S. Mitra, Washington University School of Medicine, St. Louis, MO, and Thomas Sussan, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD
Epigenetics refers to molecular mechanisms that cause heritable changes in gene expression without altering the DNA sequence. The most widely studied epigenetic mechanisms encompass DNA methylation, histone modifications, and gene regulation by non-coding RNAs, such as microRNAs. Typically, these mechanisms are required for normal cellular development and differentiation; however, perturbations in them can lead to diseases, notably cancer. Increasing evidence suggest that environmental factors such as diet, stress, and exposure to radiation and xenobiotics can induce heritable changes in the epigenetic status, potentially affecting the health of the present and future generations. Importantly, the long-term and life-threatening consequences of environment/chemical-induced changes in epigenetics, makes this field a critical area for future exploration by toxicologists. The course will begin by introducing the fundamental concepts of epigenetics and reviewing the various underlying mechanisms. Methods to assess epigenetic changes will be discussed, followed by a discussion of the role of DNA cytosine methylation in the regulation of carcinogen-inducible CYP450 genes. Mechanistic understanding of the role of microRNAs in the regulation of cellular toxicity and the influence of environment on epigenetics that cause developmental effects will also be presented. Finally, the future of epigenetics in toxicology and its potential applications for safety assessment will be discussed. Students as well as toxicologists working in academia, federal and pharmaceutical industries, and researchers interested in mechanistic toxicology will benefit from taking this course.
Introduction, Mayurranjan S. Mitra, Washington University School of Medicine, St. Louis, MO
Introduction and Overview of Epigenetics, James G. Herman, The Johns Hopkins School of Medicine, Baltimore, MD
Role of Epigenetics in the Regulation of Carcinogen-Metabolizing Enzymes, Oliver Hankinson, University of California Los Angeles, Los Angeles, CA
Retroelements and MicroRNAs in the Epigenetic Regulation of Cellular Differentiation, Proliferation, and Toxicity, Kenneth S. Ramos, University of Louisville, Louisville, KY
Epigenetic Gene Regulation: Linking Early Developmental Environment to Adult Disease, Dana Dolinoy, University of Michigan, Ann Arbor, MI
What We Need to Know Prior to Incorporating an Epigenetic Evaluation into Safety Assessments, Jay I. Goodman, Michigan State University, East Lansing, MI
Evaluating Toxicity of Engineered Nanomaterials: Issues with Conventional Toxicology Approaches (Basic)
Chairpersons: Srikanth S. Nadadur, NIEHS-DERT, Research Triangle Park, NC, and Frank A. Witzmann, Indiana University School of Medicine, Indianapolis, IN
Sponsor: Nanotoxicology Specialty Section
Endorsed by: Cardiovascular Toxicology Specialty Section In Vitro and Alternative Methods Specialty Section Inhalation and Respiratory Specialty Section
Engineered nanomaterials (ENMs) have become an integral part of numerous consumer products, cosmetics, building materials, medical devices, therapeutic agents, and environmental remediation. Global demand for nanomaterials and nano-enabled devices has been projected to surpass $3.1 trillion by 2015. The widespread use of nanotechnology-derived products presents opportunities for intentional and unintentional exposure to ENMs. The size and size-dependent novel physical and chemical properties that make ENMs unique compared to micro-scale products of similar chemical composition makes it difficult to determine their interaction with biological matrices. The recent flood of toxicology literature without proper physical and chemical characterization of ENMs proposes adverse to no health effects for certain common ENMs such as carbon nanotubes and metal oxide nanoparticles. The course will provide an overview of the issues facing nanotechnology that the scientific community must grapple with in regard to predicting toxicity and biological outcomes associated with nanoscale properties and the need to identify and integrate novel approaches for safety of ENMs. To begin, focus will be placed on the importance of incorporating physical and chemical characteristics of ENMs in interpreting biological data; high throughput in vitro approaches using multiple parameters to classify ENMs toxicity profile will then be covered. Altered proteomic profiles in a model in vitro system to understand molecular alterations will be explored. Finally, the interpretation of data from in vivo studies using inhalational routes of exposure will be discussed. The goal of this course is to encourage both the novice and the toxicologist trained in conventional toxicity assessment to think outside the box to design rational toxicology studies in evaluating the safety of ENMs that are currently in use, and to develop models to predict potential toxicity of second and third generation ENMs.
Engineered Nanomaterials (ENMs) Toxicity Evaluation: Issues with Conventional Approaches, Srikanth S. Nadadur, NIEHS-DERT, Research Triangle Park, NC
Importance of Integrating Physicochemical Characterization Information in Toxicity Assessment of Engineered Nanomaterials, Scott McNeil, National Cancer Institute, Bethesda, MD
Emergence of High Content Screening for Assessment of Nanotoxicity,Chris Vulpe, University of California Berkeley, Berkeley, CA
Proteomic Profiling of the Biological Effects of Engineered Nanomaterial Exposure Using In Vitro Models, Frank A. Witzmann, Indiana University School of Medicine, Indianapolis, IN
Correlating In Vitro and In Vivo Nanotoxicity: Limitations and Challenges, Günter Oberdörster, University of Rochester Medical Center, Rochester, NY
New Technologies and Approaches in Genetic Toxicology and Their Expanding Role in General Toxicology and Safety Assessment (Basic)
Chairpersons: Jeffrey C. Bemis, Litron Laboratories, Rochester, NY, and Jennifer C. Sasaki, Johnson & Johnson, Raritan, NJ
Sponsor: Regulatory and Safety Evaluation Specialty Section
Endorsed by: In Vitro and Alternative Methods Specialty Section
For decades, genetic toxicology and the “genetox battery” have been a well-established part of safety testing for pharmaceuticals and other chemical agents. Recent advances in experimental methodologies are contributing to a change in the way that genetic toxicology data are generated and incorporated in the disciplines of toxicology and safety testing. The intention of this course is to illustrate the broader impact that new genetic toxicology approaches are having on drug/chemicals safety assessment and human risk analysis. The structure of the course will provide examples of (1) Early discovery/high-throughput genotoxicity screening of chemical entities; (2) Integration of genetic toxicology assays with repeat-dose in vivo toxicology studies; and (3) New approaches for genotoxicity risk assessment, and conclude with an update on genotoxic impurity management strategies for pharmaceuticals. Speaker presentations will illustrate how genotoxicity testing is evolving from a hazard identification based-discipline to an integrated approach that may ultimately yield quantitative information that can be used for human risk assessment.
This course should be of interest to experienced genetic toxicologists as well as those involved in general toxicology who want to learn about how incorporation of new genotoxicity methods can improve test predictivity, lower costs, reduce animal use, and may ultimately be applied to human risk assessment
Introduction, Jeffrey C Bemis, Litron Laboratories, Rochester, NY
High-Throughput Genetic Toxicity Screening Assays in Discovery Research & Development, Richard Walmsley, Gentronix, Ltd., and The University of Manchester, United Kingdom
The In Vitro Micronucleus Assay in Mammalian Cells: A High Content Assay, Anthony M. Lynch, GlaxoSmithKline, Hertfordshire, United Kingdom
Genetic Toxicity and Thresholds: State of the Science, B. Bhaskar Gollapudi, The Dow Chemical Company, Midland, MI
Integration of Genetic Toxicology Endpoints into Repeat-Dose Toxicity Studies, Maik Schuler, Pfizer PGRD, Groton, CT
Risk Assessment of Genotoxic Impurities in Pharmaceuticals, Lutz Mueller, Hoffmann La Roche, Inc., Basel, Switzerland
Practical How-To and Pitfalls Associated with Current Epigenetic Studies (Advanced)
Chairpersons: Reza John Rasoulpour, The Dow Chemical Company, Midland, MI, and Chunhua Qin, Merck & Co., Inc., West Point, PA
Sponsor: Molecular Biology Specialty Section
Endorsed by:
The study of toxicant-induced epigenetic modifications is greatly expanding in complexity and scope as new tools of measuring these changes become available. Fundamental questions (e.g., how best to quantify changes) become enigmatic with DNA methylation, histone modifications, and microRNA epigenetic modifications that can affect imprinted, coding, non-coding, and global regions of the genome. Understanding these questions is important in interpreting species/strain-specific responses. This advanced course is a practical guide to techniques used in epigenetic research with respect to toxicology for in vivo/ex vivo screening of rodent models, post-fertilization, embryos, developmental biology, and human disease states. Topics range from advancements in techniques to screening strategies and tools, and include techniques to correlate epigenetic changes to gene expression and apical end points, use of imprinted genes as biomarkers, and profiling DNA methylation in human population-based research. For screening tools to determine species-specific responses, a variety of novel technologies will be analyzed such as epigenomic profiling of DNA methylation in mouse tumors, pyrosequencing to examine the activity of endogenous retroviruses (e.g., IAP), and assays to explore miRNA and histone modification changes. In addition, cutting edge techniques such as deep sequencing technologies of bisulfite-converted DNA will be discussed as these have enabled the characterization of methylation changes at the genome level; however, the significant challenge in using this technology is dealing with the massive amount of information obtained and making sense of the observed methylation changes. Scientists in academia, industry, and government will leave this course with an understanding of the strengths and weaknesses of available epigenetic tools, how these tools can be best used in screening and mode-of-action experiments, as well as insight into future potential of mechanistic epigenetic toxicology.
Screening Tools and Approaches for Methylation Analysis of Imprinted Genes, Reza John Rasoulpour, The Dow Chemical Company, Midland, MI
Profiling Epigenetic Changes in Rodent Tumor Models, Chunhua Qin, Merck & Co., Inc., West Point, PA
Evaluating Epigenetic Changes in Germ Cells and Early Embryos, Barbara F. Hales, McGill University, Montreal, Québec
Evaluating Epigenetic Changes Using Bisulfite Deep Sequencing, Russell S. Thomas, The Hamner Institutes for Health Sciences, Research Triangle Park, NC
Population-Based DNA Methylation Profiling in Exposure-Related Disease, Carmen Marsit, Brown University, Providence, RI
Protecting Human Health: Use of Toxicological and Epidemiological Data in Determining Safe Levels for Human Exposure (Basic)
Chairpersons: Eileen P. Hayes, EP Hayes Toxicology Services LLC, Longmont, COand Terry Gordon, New York University School of Medicine, Tuxedo Park, NY
Sponsor: Occupational and Public Health Specialty Section
Endorsed by: N/A
Toxicological and epidemiological data are the basis for risk assessment processes used to determine acceptable levels of exposure. This is the case for the general public who may be exposed to pollutants via ambient air and/or drinking water, for workers who may be exposed to chemicals in the workplace, and for patients who may have exposure to both active pharmaceutical ingredients (API) and impurities that may be present in the product. The goal of this course is to provide students with an understanding of the regulatory background and the practical application of both toxicological and epidemiological information in setting exposure levels considered to be protective of public health. The objectives of this course are 1) to describe the regulatory requirements that underlie development of acceptable levels of exposure for either the general population or select populations (workers, patients) via the media described above; and 2) to describe the evaluation of toxicological and epidemiological data in determining acceptable levels of exposure. Case studies of representative compounds will illustrate the processes. The U.S. Environmental Protection Agency (U.S. EPA) has well-defined processes for establishing both National Ambient Air Quality Standards (NAAQS) under the Clean Air Act and drinking water Maximum Contaminant Levels (MCLs) under the Safe Drinking Water Act. The Occupational Health and Safety Administration (OSHA) promulgates permissible exposure limits (PELs) for the workplace. The American Conference of Government Industrial Hygienists (ACGIH), a non-profit, non-governmental organization publishes Threshold Limit Values (TLVs) that are used globally by many public and private-sector employers to protect the health of their employees. Additionally, many employers have established programs to derive acceptable levels of workplace exposure for compounds not specifically regulated by government agencies. Acceptable identification, reporting, and safety thresholds for impurities in drug products are governed under guidance documents issued by the International Committee on Harmonization (ICH), the U.S. Food and Drug Administration and the European Medicines Agency. The course will highlight legal and customary definitions of “acceptable risk,” as well as risk assessment methods for evaluating data to estimate risk levels under these programs. The regulations and/or guidances will be detailed and approaches used to comply with them will be described. This course will begin with a description methods underlying U.S. EPA actions to protect the general public, i.e., establishment of NAAQS and MCLs. The course will then detail requirements, guidance, and processes to protect specific populations, i.e., workers and patients. In each case representative examples will be used to illustrate the processes. The application of toxicological and epidemiological data in these programs will be described.
Introduction, Eileen P. Hayes, EP Hayes Toxicology Services LLC, Longmont, CO
Clean Air Regulation: Science and the Process, Daniel L. Costa, U.S. EPA-ORD, Research Triangle Park, NC
Drinking Water Regulation: Science and the Process, Rita Schoeny, U.S. EPA, Washington, DC
Setting Occupational Exposure Limits, Bruce D. Naumann, Merck & Co., Inc., Whitehouse Station, NJ
Qualification of Impurities in Drug Products, Timothy J. McGovern, SciLucent, LLC, Herndon, VA
Quantitative In Vitro to In Vivo Extrapolation: The Essential Element of In Vitro Assay Based Risk Assessment (Basic)
Chairpersons: Harvey J. Clewell, III, The Hamner Institutes for Health Sciences, Research Triangle Park, NC, and Bastiaan Johan Blaauboer, Utrecht University, Utrecht, Netherlands
Sponsor: Risk Assessment Specialty Section
Endorsed by: Biological Modeling Specialty Section In Vitro and Alternative Methods Specialty Section Nanotoxicology Specialty Section
There is increasing recognition of the need to use efficient approaches to assess the risk assessment of high numbers of chemicals in a short time. The reliance on approaches consisting of animal experimentation has its drawbacks in terms of ethical, economical, and—not least—scientific limitations in assessing risks in a high-throughput mode. The quantitative interpretation of toxic effects of compounds in in vitro studies, using in silico approaches such as systems biological descriptions of toxicity pathways and physiologically based pharmacokinetic modeling (PBPK), are a necessary component of the National Academy of Sciences vision on toxicity testing in the 21st Century. The limited studies performed with this approach to date have shown that good predictions for the risk of the use of chemicals can be made. However, a number of limitations have also become clear and more standardization of methods is needed before implementation of quantitative in vitro-in vivo extrapolations (QIVIVE) in risk assessments can be achieved.
In this course, the following elements of the approach for assessing risks on the basis of in vitro toxicity data will be discussed:
How can we improve the applicability of in vitro methods by determining the real concentrations that come into contact with the cells in vitro, both for chemical compounds and for particles?
How can we effectively and efficiently integrate the metabolism of compounds, for clearance as well as for bioactivation?
How can we provide a flexible and yet robust scheme for integrating the different elements in a high-throughput environment?
The Use of In Vitro Metabolism Data and Biokinetic Modeling to Conduct QIVIVE for Chemicals, Bastiaan Johan Blaauboer, Utrecht University, Utrecht, Netherlands
Characterizing Free Test Chemical Concentration During In Vitro Toxicity Assays, Nynke Kramer, Utrecht University, Utrecht, Netherlands
Particokinetic Modeling to Support QIVIVE for Particle Toxicity Assays, Justin G. Teeguarden, Pacific Northwest National Laboratory, Richland, WA
QIVIVE in a High-Throughput Environment, Harvey J. Clewell, III, The Hamner Institutes for Health Sciences, Research Triangle Park, NC
Stem Cells Utility in Toxicology Screening (Basic)
Chairpersons: Manu M. Sebastian, Columbia University, New York, NY, and Zaher A. Radi, Pfizer Global Research and Development, Cambridge, MA
Sponsor: Society for Toxicologic Pathology Toxicologic and Exploratory Pathology Specialty Section
Endorsed by: N/A
The development of toxicological screening tools for evaluating toxicity of new drug candidates has been a major focus in the pharmaceutical industry. Human embryonic stem (hESC) cells and induced pluripotent stem (iPS) cells and their lineage cells can be used as tools to predict developmental and other toxicities of drug candidates since several of the human biochemical pathways are active in these cells. In addition, stem cells can also be used to help in the mechanistic understanding of how a specific class of compounds leads to toxicity. Participation in this course will provide a basic overview of the utility of stem cells in drug discovery and update toxicologists on a variety of stem cells applications as screening tool for evaluating toxicity in multiple organ systems, thereby giving toxicologists a better understanding of the potential practical application of these in vitro methods for safety and risk assessment.
Introduction: Stem Cells As Tools for Toxicology Screening, Manu M. Sebastian, Columbia University, New York, NY
Metabolomics of Human Embryonic Stem Cells and Predictive Biomarkers of Developmental Toxicity, Gabriela Cezar, University of Wisconsin, Madison, WI
Stem Cells and Mice with Humanized Livers: New Tools for Drug Metabolism and Toxicology, Stephen Strom, University of Pittsburgh Medical School, Pittsburgh, PA
Using Embryonic Stem Cell Models to Profile Potential Developmental Toxicants, E. Sidney Hunter III, U.S. EPA, Research Triangle Park, NC
Stem Cells in Preclinical Drug Development, Hirdesh Uppal, Genentech, Inc., South San Francisco, CA
The Biology and Toxicology of the Peri- and Post-Natal Development (Basic)
Chairpersons: Gregg D. Cappon, Pfizer Global Research and Development, Groton, CT, and Gary J. Chellman, Charles River Laboratories, Reno, NV
Sponsor: Reproductive and Developmental Toxicology Specialty Section
Endorsed by: N/A
The susceptibility to toxicity of organ systems during in utero and post-natal development is a concern for both drugs and environmental chemicals. While developmental toxicity can be manifested by death, structural abnormalities, and altered growth, alterations in the functional competence are of special concern during post-natal development. The primary focus in the past has been on functional toxicity to the CNS and reproduction, but the potential for developmental exposure to impact function of other systems such as the cardiovascular, respiratory, immune, endocrine, and digestive systems is now widely recognized. This basic course will begin with a review of post-natal development of major organ systems in humans and how those developmental processes might translate to sensitive periods for toxicity. Focus will be placed on study designs for evaluation of pharmaceuticals during the pre- and post-natal development period and designs for juvenile animal toxicity studies to support pediatric drug development. Next, designs will be presented for assessment of post-natal and juvenile toxicity studies in non-human primates, a rapidly expanding area given the increase in biopharmaceutical research. The course will wrap up with a discussion of multigenerational studies used to assess potential toxicity of environmental chemicals. Attendees will leave this course with an appreciation of the complex biology of pre- and post-natal development periods and an overview of current approaches to evaluating safety during this period.
Post-natal Maturation of Major Organ Systems, Christopher J. Bowman, Pfizer Inc., Groton, CT
Post-natal and Juvenile Toxicity Studies: Basic Study Designs and Practical Approaches, Donald G. Stump, WIL Research Laboratories LLC, Ashland, OH
Post-natal and Juvenile Toxicity Studies in Non-Human Primates, Gary J. Chellman, Charles River Laboratories, Reno, NV
One and Two-Generation Studies for Assessment of Environmental Chemicals, Sue Marty, The Dow Chemical Company, Midland, MI
Toxicology and Risk Assessment of Chemical Mixtures (Basic)
Chairpersons: Jane Ellen Simmons, U.S. EPA, Research Triangle Park, NC, and Christopher J. Borgert, Applied Pharmacology Toxicology, Inc., Gainesville, FL
Sponsor: Mixtures Specialty Section
Endorsed by: Biological Modeling Specialty Section Occupational Health and Public Health Specialty Section
Assessment of the safety and risk of environmental chemicals, pharmaceuticals, consumer and personal care products, pesticides, and food additives increasingly requires consideration of the potential pharmacological and toxicological interactions that might occur as these agents are encountered as mixtures by patients, consumers, and through environmental exposures (e.g., mixtures present in air, water, soil). Both toxicological evaluations and risk assessments of mixtures of chemicals are complex due to the potential pharmacokinetic and pharmacodynamic mechanisms that might result in nonadditive interactions. While greater than expected toxicity is of most concern for environmental exposures, both less than and greater than additive toxicity are of pharmacological concern. Toxicological evaluation of chemical mixtures necessitates study designs, methods of analysis, and limits on interpretation not required for single chemicals. This course will cover the fundamentals of study design and data analysis for mixtures that apply to all classes and categories of chemicals encountered by humans and animals, regardless of market application. The objectives of this course are to 1) describe the basic principlesthatunderlie modern concepts of the toxicology and risk assessment of chemical mixtures; 2) survey the basic tools and techniques needed to design, conduct, analyze and interpret experimental data with defined or complex mixtures of chemicals; and 3) review the guidance, underlying assumptions, and techniques used in risk assessment of chemical mixtures. This course will be of interest to experimentalists who wish to conduct studies on mixtures that are meaningful for evaluation of risk as well as safety and risk assessors who must evaluate and apply data on mixtures and interactions in assessments.
Basic Principles of Additivity Underyling Methods, Designs, and Techniques for Evaluation of Mixtures, Jane Ellen Simmons, U.S. EPA, Research Triangle Park, NC
The Intersection of Design and Interpretation of Mixtures Data, Christopher J. Borgert, Applied Pharmacology Toxicology, Inc., Gainesville, FL
Pharmacokinetic and Pharmacodynamic Mechanisms of Interactions in Mixtures, Sami Haddad, Université de Montreal, Montreal, Québec
Applications of Mixtures Data in Health Risk Assessment, Moiz Mumtaz, CDC-ATSDR, Atlanta, GA
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