51st Annual Meeting & ToxExpo - Society of Toxicology

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Society of Toxicology 2012 Continuing Education activity assessments, which will be described within the context of various target organs, animal models, and toxicology programs. In addition, investigating innate immune function on a molecular level through evaluating cell signaling molecules and regulated expression of antimicrobial peptides, chemokines, and cytokines will be discussed. In closing, the application of innate immunity testing in the clinic and translatability of nonclinical findings to the clinic will be examined. This course should be of broad interest to toxicologists with the desire to learn about the innate immune system and how innate immune evaluations can be applied to toxicology testing. In addition, the course will appeal to scientists who are interested in learning methodologies of innate immune function testing and applicability thereof. • Innate Immunity and Its Relevance to Toxicology: An Introduction. Jacintha M. Shenton, MedImmune, Inc., Cambridge, United Kingdom. • Not Just a Physical Barrier: Cellular and Molecular Innate Immune Defense Mechanisms of the Epidermis. Jamie J. Bernard, Rutgers University, Piscataway, NJ. • The Why, When, What and How of Macrophage and Neutrophil Function Testing in Drug Development. Wendy J. Freebern, Bristol-Myers Squibb, North Brunswick, NJ. • Accessing Natural Killer Cell Activity in Nonclinical Toxicity Studies. Christina Satterwhite, Charles River Laboratories, Reno, NV. • Innate Immunity in Drug-Induced Liver Injury. Cynthia Ju, University of Colorado, Aurora, CO. • Translating Nonclinical Innate Immune Testing into the Clinic. Wendy J. Komocsar, Eli Lilly and Company, Indianapolis, IN. Aberrant Gene Expression in Toxicity and Disease—Epigenetics and microRNAs Noncoding RNAs and Their Role in Biology and Toxicology MicroRNAs in Biology and Toxicology length, that regulate gene expression by binding to 3'untranslated regions (UTR), coding sequences or 5'UTR of target messenger RNAs (mRNAs), and leading to inhibition of translation or mRNA degradation. It is estimated that miRNAs regulate approximately 30% of the human protein-coding genome. miRNAs control the expression of genes involved in several biological processes, including apoptosis, proliferation, differentiation, and metastasis. Given the prominent role miRNAs play in organismal function, it is not surprising that the aberrant expression of miRNAs can lead to a wide range of human diseases and disorders, including cancer, neurodegenerative diseases, diabetes, and a variety of cardiovascular and hepatic disorders. In addition to contributing to the underlying cause of a particular disease, miRNAs can also represent potential therapeutic targets and diagnostic biomarkers. The recent discovery of circulating miRNAs are promising biomarker candidates since they can be detected from readily attainable blood samples. On account of the critical role that miRNAs play in biological function and the diverse range of applications in which miRNA analysis is of value, significant effort has been invested over the past decade to develop new detection methods. We will provide an overview of existing and emerging tools for miRNA analysis, with particular emphasis placed on the current state of the art and important developments in this emerging field. • Overview of microRNA Quantification Methods. Neelakanteswar Aluru, Woods Hole Oceanographic Institution, Woods Hole, MA, and Carmen J. Marsit, Dartmouth Medical School, Hanover, NH. • MicroRNA Functions in Stress Responses. Anthony Leung, John Hopkins University, Bloomberg School of Public Health, Baltimore, MD. • Evaluating the Toxicological Role of microRNAs during Development. Robert L. Tanguay, Oregon State University, Corvallis, OR. • MicroRNAs in Cancer. Stephen H. Safe, Texas A&M University, College Station, TX. • MicroRNA Profiling in Population-Based Studies of Exposure- Related Health Outcomes. Carmen J. Marsit, Dartmouth Medical School, Hanover, NH. CE PM10 CE Basic Chairperson(s): Neelakanteswar Aluru, Woods Hole Oceanographic Institution, Woods Hole, MA, and Carmen J. Marsit, Dartmouth Medical School, Hanover, NH. Sponsor: Molecular Biology Specialty Section MicroRNAs (miRNAs) constitute a critically important class of noncoding, small RNAs, which post-transcriptionally regulate gene expression. miRNAs are approximately 18–24 nucleotides (nt) in Thematic Session 58 SOT’s 51 st Annual Meeting
51 st Annual Meeting and ToxExpo Continuing Education Regulatory Science: Bridging the Gap between Discovery and Product Availability Regulatory Sciences: Preclinical Drug Development from Small Molecules to Biologics PM11 CE Basic Chairperson(s): Tao Wang, Novartis Pharmaceuticals, Emeryville, CA, and W. David McGuinn, US FDA, Silver Spring, MD. Sponsor: Biotechnology Specialty Section Endorsed by: Immunotoxicology Specialty Section Regulatory and Safety Evaluation Specialty Section Women in Toxicology Special Interest Group Drug development is a highly regulated but science-driven process from early discovery to marketing. Once the drug candidate has been discovered, preclinical safety evaluations are required to ensure the safety of the drug during clinical trials, ultimately bridging the gap between drug discovery and marketing. The preclinical development of four types of drugs, small molecular-weight drugs, biologics, oligonucleotide-based therapeutic drugs, and antibody drug conjugates (ADCs), will be illustrated to emphasize the cross-functional nature of regulatory sciences. In exploration of this important topic, we will begin with a focus on small molecular-weight drug candidates, which require a sliding scale for the degree of development from relatively minimal regulatory requirements for oncology drug development to the much more stringent requirements for the development of drugs for nonlife, threatening conditions and chronic treatment. Next the focus will shift to large molecule biologics and will provide illustrations of the unique challenges the regulatory safety assessment and clinical development that biologic drug candidates present. Our panel of experts will then focus on oligonucleotide-based therapeutics since many of the overarching oligonucleotide class-based properties have been well established, but there unique considerations remain for each subclass of oligonucleotide. This talk will discuss the preclinical development of oligonucleotide-based therapeutic drugs, including antisense, siRNA, and immunostimulatory and aptamer applications. This course will also cover ADCs, which are composed of monoclonal antibodies (biologics) conjugated with drugs or cytotoxins (small molecules). Standard approaches for preclinical safety evaluation of each of the individual components of these conjugates may not always be necessary. The regulatory expectations for this class of therapeutics are continuing to be defined. We will illustrate the safety assessment challenges and development strategies associated with certain ADCs. • Regulatory Sciences: Preclinical Drug Development from Small Molecules to Biologics. Tao Wang, Novartis Pharmaceuticals, Emeryville, CA. • The Preclinical Development of Low Molecular Weight Drugs— Comparison of Oncology and Nononcology Indications. W. David McGuinn, US FDA, Silver Spring, MD. • Safety Assessment and Clinical Development of Biopharmaceuticals. James D. Green, Boehringer Ingelheim Pharmaceuticals, Inc., Sudbury, MA. • Development of Oligonucleotide Therapeutics and Its Toxicological Considerations. Page Bouchard, Novartis Institutes for BioMedical Research, Cambridge, MA. • Development Strategies and Safety Assessment of Antibody Drug Conjugates. Kimberly A. Stickland, Biogen Idec., Inc., San Diego, CA. Specialized Techniques for Dose-Response Assessment and Risk Assessment of Chemical Mixtures PM12 CE Advanced Chairperson(s): Jane Ellen Simmons, US EPA, Research Triangle Park, NC, and Michael J. DeVito, NIEHS, Research Triangle Park, NC. Sponsor: Mixtures Specialty Section Endorsed by: Food Safety Specialty Section Regulatory and Safety Evaluation Specialty Section Risk Assessment Specialty Section A variety of methods are available for chemical mixtures risk assessment. A key step is careful consideration of data quantity and quality to guide the type of assessment done. Whole mixture methods will be summarized that, after considering data quality and quantity, do not differ from single chemical methods. The principal uncertainty for “sufficiently similarity” is ascertaining that two mixtures are sufficiently similar so that one may be used as a surrogate of another. Two approaches for a group of similar mixtures will be reviewed, comparative potency and geographic site-specific assessment. The course will focus on component-based methods (toxic equivalency factors, relative potency factors, binary weight of evidence, hazard index, target-organ toxicity hazard index, interaction-based hazard index) as they are the most frequently performed mixtures assessments. They use single-chemical toxicity and exposure data, with possibly some toxicity information on defined mixtures of the chemicals of interest. For each method (whole mixture and component-based), the presenter will describe data requirements, assumptions, and limitations and illustrate the application by example. Upon conclusion, students will be able to navigate the risk assessment flow chart, have an understanding of the assumptions, limitations, and uncertainties underlying the presented approaches, and be able to either apply the presented methods to their own data, or consult more knowledgeably with risk assessors. The methods and approaches are applicable to the CE up-to-date information at www.toxicology.org 59 CE Target Area
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Appreciates the Generous 51st Annua
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