51st Annual Meeting & ToxExpo - Society of Toxicology

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Society of Toxicology 2012 Scientific Workshops The Thematic Track information can be found on pages 8–9. • Volatile and Particulate Environmental Air Pollutants Impede VEGF-Mediated EPC Mobilization from Bone Marrow. A Common Mechanism? Petra Haberzettl, University of Louisville, Louisville, KY. • Ah Receptor Activation in Mice Alters Hematopoietic Stem/ Progenitor Cell Functions and Gene Modulation Reflecting Changes in Cellular Trafficking: Implications for Humans and Hematopoietic Diseases. Thomas Gasiewicz, University of Rochester, Rochester, NY. • Adverse Effects of Polycyclic Aromatic Hydrocarbons on Bone Marrow Progenitor Cells and Its Relationship to Reduced Cellularity in the Spleen and Thymus. Charles Czuprynski, University of Wisconsin, Madison, WI. T-Dependent Antibody Responses in Nonhuman Primates: Challenges and Opportunities Wednesday, March 14, 1:30 PM to 4:15 PM Chairperson(s): Jacintha Shenton, MedImmune Ltd., Granta Park, Cambridge, United Kingdom, and Hervé Lebrec, Amgen Inc., Seattle, WA. Sponsor: Immunotoxicology Specialty Section Endorsed by: Biotechnology Specialty Section Regulatory and Safety Evaluation Specialty Section Increasingly, the T-cell dependent antibody response (TDAR) assay is used as a means to evaluate immunomodulation—immunopharmacology or immunotoxicology—in nonhuman primates (NHPs). This is primarily due to the plethora of immunomodulatory biopharmaceuticals in development. Our focus will be on several key topics relevant to the TDAR and other measures of immune responses to T-dependent (TD) antigens. Traditionally, the TDAR has been used as a means to evaluate immunosuppression. It is less clear whether it is possible or appropriate to use the TDAR to evaluate immunostimulation. In addition, although the read-out of the TDAR is by definition the generation of antigen-specific antibodies, T-helper cells, as well as antigen presenting cells, are also involved in the response, while poorly characterized in the context of this assay in NHPs. There is, for instance, little information on T-cell differentiation towards T-helper [Th]1 versus Th2 responses in this context. Cellular immune responses to TD antigens may also be evaluated using the delayed-type hypersensitivity (DTH) response; however, DTH is notoriously difficult to produce in NHPs and correlative data between the systemic and local responses to the TD antigen are lacking. Although immune responses to TD antigens are routinely evaluated nonclinically there is little understanding of translational data across species and to humans. Furthermore, the increased use of the TDAR in NHPs is associated with a disparity of protocols as well as methods for data interpretation; any discussions on standardization/best practices generally result in significant debate. The goal of this session is to share data and progress in our understanding of the measurable endpoints of the immune response to TD antigens and to provide a forum for discussion on the utility of these endpoints within drug development. • Use of the T Cell-Dependent Antibody Response to Evaluate Immunostimulation. Jacques Descotes, Poison Center and Pharmacovigilance Department, Lyon, France. • Beyond Antibodies: Characterization of the Cellular Immune Response to Keyhole Limpet Hemocyanin. Lynne LeSauteur, Charles River, Montréal, Québec, Canada. • Correlations between Systemic and Local Responses to T-Dependent Antigens. Margreet Jonker, Biomedical Primate Research Centre, Rijswijk, Netherlands. • Translation of the Immune Responses to T-Dependent Antigens between Nonhuman Primates and Humans. Jacintha Shenton, MedImmune, Cambridge, United Kingdom. • Good Practices in the Study Design, Data Analysis, and Reporting of T-Dependent Antibody Response Studies. Hervé Lebrec, Amgen, Inc., Seattle, WA. Thursday Regulatory Science: Bridging the Gap between Discovery and Product Availability Challenges and Opportunities in Evaluating Protein Allergenicity across Biotechnology Industries Thursday, March 15, 9:00 AM to 11:45 AM Chairperson(s): Nicola Stagg, Dow AgroSciences LLC, Indianapolis, IN, and Hanan Ghantous, US FDA, Silver Spring, MD. Sponsor: Biotechnology Specialty Section Endorsed by: Food Safety Specialty Section Immunotoxicology Specialty Section Biotechnology is a field at the cutting-edge of science, using living cells and materials produced by cells to prevent and fight disease, improve food production, and benefit other industries as well, but there are increasing concerns over the allergenicity of biotechnology products that continue to receive increasing attention in public and regulatory domains. These concerns range from the transfer of an existing allergen or cross-reactive protein into another crop or increasing endogenous (existing) allergens in crops to accidental Thematic Session 98 SOT’s 51 st Annual Meeting
51 st Annual Meeting and ToxExpo The Thematic Track information can be found on pages 8–9. Workshops Scientific modification of therapeutic proteins resulting in autoimmune reactions to endogenous molecules. This session will provide important information on allergenicity testing requirements and research in the agricultural chemical/biotech sector, pharmaceutical/biopharma sector, and vaccine sector and includes speakers from industry and regulatory. An anticipated outcome is discussion over why allergenicity is a concern, what tools are available to evaluate allergenicity in the different areas of biotechnology, and any challenges we face with this testing. • Existing and Emerging Methods and Techniques for Assessing Allergenicity of Genetically Modified Crops. Greg Ladics, DuPont, Wilmington, DE. • Evaluating the Potential Allergenicity of Vaccines. Robert House, DynPort Vaccine Company, LLC, Frederick, MD. • Food Regulatory Perspective on Evaluation of Allergenicity. Steven Gendel, US FDA, College Park, MD. • Allergenicity Research in the Pharmaceutical/Biopharma Sector. Kenneth Hastings, sanofi-aventis, Bethesda, MD. Chemical Standardization of Botanical Medicines for Safe and Effective Use As Therapeutic Agents Thursday, March 15, 9:00 AM–11:45 AM Chairperson(s): Madhu Soni, Soni & Associates Inc., Vero Beach, FL, and Brinda Mahadevan, Abbott Laboratories, Abbott Park, IL. Sponsor: Association of Scientists of Indian Origin Special Interest Group substances, including heavy metals and interfere with the actions of commonly prescribed medications, which has resulted in a number of adverse patient effects. Thus, use of botanical medicines is further confounded with considerable variations in chemical composition, inclusion of known toxic components during the processing, uncertain therapeutic potency, and potential safety issues when used alone or in combination with pharmaceutical agents. In an effort to broaden the understanding of the aforementioned issues pertaining to botanical medicines, the following key aspects will be addressed: the toxicity of botanical medicines; if it’s natural, is it necessarily safe; successful scientific strategies that are needed to ensure safe and effective use of botanical medicines; quality and safety issues of botanical medicines; chemical standardization of botanical medicines; and current state and federal regulations affecting this line of therapeutic agents. • Characterization and Use of Herbal Preparations As Test Articles in Safety Assessments—Analytical Challenges and Reasonable Solutions. Cynthia Smith, NIEHS, Research Triangle Park, NC. • Pharmacopeial Approaches to Setting Specifications for Articles of Botanical Origin. Nandakumara Sarma, US Pharmacopeia, Rockville, MD. • Integrity of a Product: Use of Validated Methods in Assessing the Quality and Safety of Botanicals. Ikhlas Khan, University of Mississippi School of Pharmacy, Oxford, MS. • Standardizing Snowflakes: Using Technology to Normalize Nature. Craig Hopp, NIH, Bethesda, MD. • Chemical Standardization of an Herbal Formulation As a Safe and Effective Therapeutic Agent for Parkinson’s Disease—A Case Study. Bala Manyam, Penn State University, Hershey, PA. Endorsed by: American Association of Chinese in Toxicology Special Interest Group Food Safety Specialty Section Mixtures Specialty Section Regulatory and Safety Evaluation Specialty Section Risk Assessment Specialty Section Botanical medicines have been used for millennia to cure ailments in traditional societies around the world. According to the World Health Organization (WHO), in Asian and African countries, over three fourths of the population rely on botanical medicines for their primary health care needs. The use of botanical medicines in the developed world is increasingly on the rise with individuals seeking alternate and/or complementary medicine options. The popular belief is that because botanical medicines are derived from natural sources, they are safe and pose no harm when used. However, within the scientific community, botanical medicines are under increased scrutiny due in part to concerns regarding their safety and clinical efficacy. Safety issues often arise from lack of controlled manufacturing conditions, unproven formulations, improper storage, and poor or ineffective quality control measures. In addition, a number of plant materials have been found to be contaminated with toxicological up-to-date information at www.toxicology.org 99 Thematic Session
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Monday, March 12 8:00 AM-9:00 AM PL
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9:00 AM-12:30 PM Poster Sessions
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Clinical Toxicology from Bedside to
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Registration Form SOT 51 st Annual
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Scientific Posters SNACK BAR 016 11
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Congratulations! Society of Toxicol
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