Program - Society of Toxicology

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44 th Annual Meeting and ToxExpo Program Description Wednesday Afternoon, March 9 1:30 PM to 4:30 PM Room 207 Wednesday Afternoon, March 9 1:30 PM to 4:30 PM Room 220 WEDNESDAY WORKSHOP SESSION: CONFLICT OF INTEREST Chairperson(s): Jacques Maurissen, The Dow Chemical Company, Midland, MI and Steven Gilbert, Institute of Neurotoxicology and Neurological Disorders, Seattle, WA. Endorsed by: Board of Publications Ethical Legal and Social Issues SS* Regulatory Affairs and Legislative Assistance Committee Regulatory and Safety Evaluation SS The conflict of interest issue has recently been the subject of much attention from the points of view of editorial policy and electoral policy to scientific advisory boards. The perception is that some scientists performing or evaluating research may be tempted to overlook an adverse effect in a research project (hoping to please the sponsor and to secure future funding from the same source); likewise, other scientists may be tempted to overemphasize the significance of a positive result in their research (to gain access to additional grant support from private or institutional foundations or to favor donations from the general public). A number of scientific journals (including Toxicological Sciences) have recently addressed or reviewed the issue of conflict of interest. Similarly, a number of institutions have also codified their policy to help in the selection of members for scientific advisory boards. A number of questions can be asked around several themes: What is a financial conflict of interest? What about grant renewal, university tenure? What is the importance of non-financial conflicts of interest in the decision process, e.g., number of publications, academic competition, public/professional visibility, satisfaction of accomplishment, loyalty? When does a conflict start and stop being a conflict, apparent or real? Should a scientist with a real conflict of interest be prevented from publishing an editorial or a review paper on the basis of a conflict of interest? What if the conflict is not real but perceived? Should a perceived conflict of interest be enough to disqualify an otherwise competent scientist from election to a panel? What is the role of full disclosure in a successful conflict of interest policy? A group of five panelists (from diverse backgrounds) will present their views concerning the conflict of interest. #1678 1:30 CONFLICT OF INTEREST. J. P. Maurissen 2 and S. G. Gilbert 1 . 1 INND, Seattle, WA and 2 Neurotoxicology, Dow Chemical Company, Midland, MI. #1679 1:45 WHAT IS A “CONFLICT OF INTEREST”? T. L. Beauchamp. Kennedy Institute of Ethics, Georgetown University, Washington, DC. Sponsor: S. Gilbert. #1680 2:15 CONFLICT OF INTEREST IN THE PUBLICATION PROCESS. L. D. Lehman- McKeeman. Bristol Myers Squibb Co., Princeton, NJ. #1681 2:45 ROLE OF GOVERNMENT OVERSIGHT. B. A. Schwetz. Office for Human Research Protections, Rockville, MD. #1682 3:15 MANAGING CONFLICTS OF INTEREST: DOES DISCLOSURE GO FAR ENOUGH? M. Goozner. Cntr for Sciences. in the Public Intrst, Washington, DC. Sponsor: S. Gilbert. #1683 3:45 CONFLICT OF INTEREST AND BIAS: A VIEWPOINT FROM INDUSTRY. C. Barrow. Dow Chemical Company, Washington, DC. WORKSHOP SESSION: DOSIMETRY AND POTENTIAL IMPACTS ON REPRODUCTIVE/DEVELOPMENTAL STUDY DESIGN AND INTERPRETATION FOR RISK OR SAFETY ASSESSMENT Chairperson(s): Hugh Barton, U.S. EPA, Research Triangle Park, NC and Ed Carney, Dow Chemical Company, Midland, MI. Endorsed by: Biological Modeling SS Regulatory and Safety Evaluation SS Risk Assessment SS Student Advisory Committee Reproductive and developmental toxicity studies in animals are utilized in assessing the potential adverse effects of chemicals and drugs in pregnant women, nursing infants, and children. The results of these studies are extrapolated to humans primarily based on the dose or the exposure in the mother due to the complexity of describing the dose, pharmacokinetics, and tissue dosimetry of chemicals during pregnancy, lactation, and postweaning periods. Transporters are increasingly recognized as a key factor in dosimetry during early life along with development of metabolism and other clearance processes. For pharmaceuticals, measurement of maternal blood levels, and sometimes placental and lactational transfer, are addressed for safety assessment. Classical and physiologically-based pharmacokinetic analyses are increasingly being applied across these life stages of reproduction. Identification of the critical window of sensitivity, and how this critical period and its associated pharmacokinetics correlates with humans, is a significant challenge. This workshop will present approaches to characterizing measures of internal dose in reproductive and developmental toxicity studies, and how this impacts study designs and applications for safety and risk assessment. #1684 1:30 DOSIMETRY AND REPRODUCTIVE/DEVELOPMENTAL STUDY DESIGN AND INTERPRETATION FOR RISK OR SAFETY ASSESSMENT. E. Carney 2 and H. A. Barton 1 . 1 U.S. EPA, Research Triangle Park, NC and 2 Toxicology & Environmental Research & Consulting, Dow Chemical Company, Midland, MI. #1685 1:40 LIFE-STAGE DEPENDENT DOSIMETRY AND POTENTIAL IMPACTS ON RISK ASSESSMENT. H. A. Barton. U.S. EPA, Research Triangle Park, NC. #1686 2:10 INCORPORATING DOSIMETRY IN DEVELOPMENTAL TOXICITY ASSESSMENTS: STUDY DESIGN AND DATA INTERPRETATION. E. Mylchreest and S. A. Gannon. DuPont Haskell Laboratory, Newark, DE. #1687 2:40 TRANSPORTERS DURING DEVELOPMENT. C. D. Klaassen. Pharmacology, U Kansas Med. Ctr, Kansas City, KS. #1688 3:10 PHARMACEUTICAL PERSPECTIVE ON DOSIMETRY IN REPRODUCTIVE AND DEVELOPMENTAL STUDIES AND THE IMPACT ON DRUG DEVELOPMENT. G. Pastino. Drug Metabolism and Pharmacokinetics, Schering Plough Research Institute, Lafayette, NJ. #1689 3:40 PBPK MODELING OF EARLY LIFESTAGES AND ESTIMATION OF DOSIMETRY FOR RISK ASSESSMENT. H. Clewell 1 and R. Clewell 2 . 1 2 ENVIRON, Ruston, LA and CIIT Centers for Health Research, Research TrianglePark, NC. 178 SOT’s 44 th Annual Meeting
44 th Annual Meeting and ToxExpo Program Description Wednesday Afternoon, March 9 1:30 PM to 4:30 PM Room RO6 WORKSHOP SESSION: SKIN MODEL SELECTION FOR SAFETY ASSESSMENT OF TOPICAL DRUG PRODUCTS: REGULATORY AND INDUSTRY PERSPECTIVES Chairperson(s): Guilin Gary Qiao, U.S. FDA, Rockville, MD and Abby Jacobs, U.S. FDA, Rockville, MD. Endorsed by: Regulatory and Safety Evaluation SS Risk Assessment SS Student Advisory Committee Improper skin model selection in drug R&D and regulatory approval may under- or over-estimate systemic toxicity risk of a topical drug, resulting in significant resource and public health costs. Comparison and careful selection of in vitro versus in vivo, animal versus human, healthy versus diseased skin models under various exposure conditions during topical drug development and approval are critical. However, our knowledge base in chemical dermal absorption is mainly built on the healthy skin absorption data. For this reason, the regulatory evaluation of drug safety profile has been largely based on healthy skin study data submitted by drug sponsors, especially in the animal drug sector. FDA, per its general guidelines, requires target animal safety profiles to be tested in healthy subjects for veterinary drug products including topical drugs to be applied to diseased skin. Human dermal drug safety testing employs a wider range of animal models for various purposes. The question is weather the healthy skin data can predict what happens in patients with compromised skin and weather our testing methods are reflecting the most recent progresses in this filed. Data have suggested diseased or damaged skin can compromise skin barrier function, and thus enhance systemic as well as local toxicity risk. Those issues deserve closer research and regulatory attention. Through this workshop, impact of compromised skin barrier function by skin diseases or by other exposure variables on systemic versus local, short term versus long term risk are addressed from academic research, industrial R&D, and regulatory approval perspectives. Comparative skin histology, skin biology, skin barrier function assessment, dermal absorption, cutaneous drug disposition, and government guidelines for safety testing of human and animal dermal drugs are to be discussed with research data. Inputs from the scientific community on those issues are helpful for future government guideline revisions. #1690 1:30 SKIN MODEL SELECTION FOR SAFETY ASSESSMENT OF TOPICAL DRUG PRODUCTS: REGULATORY AND INDUSTRY PERSPECTIVES. G. G. Qiao. CVM and CDER, U.S. FDA, Rockville, MD. #1691 1:40 COMPARATIVE MODEL SELECTION BETWEEN SPECIES AND ABNORMAL SKIN: MORPHOLOGY, DERMAL DRUG DELIVERY, AND OVERALL BARRIER FUNCTION. N. A. Monteiro-Riviere. Center for Chemical Toxicology Research and Pharmacokinetics, North Carolina State University, Raleigh, NC. #1692 2:20 SKIN MODEL SELECTION IN TOPICAL DRUG R&D AND REGULATORY APPROVAL: CHALLENGES AND SOLUTIONS IN DRUG SAFETY ASSESSMENT. G. G. Qiao 1 and A. C. Jacobs 2 . 1 CVM, U.S. FDA, Rockville, MD and 2 CDER, U.S. FDA, Rockville, MD. #1693 3:00 TEST METHODS AND MODELS USED IN THE DEVELOPMENT OF TOPICALLY-APPLIED PRODUCTS. J. F. Nash. Central Product Safety, Procter & Gamble Company, Cincinnati, OH. #1694 3:40 GUIDANCE AND ANIMAL MODEL SELECTION FOR SAFETY ASSESSMENTS FOR DERMAL DRUG PRODUCT DEVELOPMENT AND APPROVAL. A. Jacobs 1 and G. Qiao 2 . 1 CDER U.S. FDA, Rockville, MD and 2 CVM U.S. FDA, Rockville, MD. Abstracts 1695-1699 moved forward to follow 1642. Wednesday Afternoon, March 9 1:30 PM to 4:30 PM Room RO1 PLATFORM SESSION: BIOINFORMATICS: APPLICATIONS TO TOXICOLOGY Chairperson(s): Kyle Kolaja, Iconix, Mountain View, CA and John Schlager, Wright Patterson, AFB, Wright-Patterson AFB, OH. #1700 1:30 SUPPORT VECTOR MACHINE ALGORITHM FOR THE PREDICTION OF GENE FUNCTION USING A LARGE CHEMOGENOMIC REFERENCE DATABASE. G. Natsoulis, M. Fielden, W. Hu, S. Dunlea, B. Eynon and K. Kolaja. Chemogenomics and Toxicology, Iconix Pharmaceuticals Inc., Mountain View, CA. #1701 1:50 A MULTIVARIATE DATA ANALYSIS TECHNIQUE FROM THE SYNTHESIS OF A PRIORI KNOWLEDGE AND EMBEDDED STATISTICAL STRUCTURE. P. Wilson. Air Force Research Laboratory, Wright-Patterson AFB, OH. Sponsor: J. Schlager. #1702 2:10 PROBING ALTERATIONS OF THE MITOCHONDRIAL MEMBRANE PROTEOME IN A MURINE MODEL OF PARKINSON’S DISEASE USING LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY. D. R. Cawthon 1 , J. A. Gantt 2 , M. B. Goshe 2 , Z. A. Xu 1 , W. Slikker 1 and S. F. Ali 1 . 1 Neurotoxicology, U.S. FDA/NCTR, Jefferson, AR and 2 Molecular and Structural Biochemistry, NC State University, Raleigh, NC. #1703 2:30 NOVEL NETWORK ANALYSIS FOR TOXICOLOGY USING KEYMOLNET. H. Sato, M. Fukuda, M. Shigetaka, N. Iwasaki, Y. Inoue, Y. Kikushima, K. Nakanishi, M. Ogura, Y. Wakamatsu, H. Kuriki, Y. Mizoguchi, R. Taniguchi, T. Nanba, Y. Ozeki, A. Nogi and A. Itai. Bioinformatics, Institute of Medicinal Molecular Design, Inc. (IMMD), Tokyo, Japan. Sponsor: Y. Aoki. #1704 2:50 BIOINFORMATICS METHODS FOR LIVER CANCER ANALYSIS USING CROSS SPECIES MAPPING BASED ON RAT GENE EXPRESSION PROFILING. W. Tong 1 , H. Fang 2 , R. Perkins 2 , L. Shi 1 , S. H. Yim 3 , J. M. Ward 3 and Y. P. Dragan 1 . 1 Systems Toxicology, National Center for Toxicolological Research, Jefferson, AR, 2 Division of Bioinformatics, Z-Tech, NCTR, Jefferson, AR and 3 Center for Cancer Research, National Cancer Institiute, Bethesda, MD. WEDNESDAY up-to-date information at www.toxicology.org 179
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Program - Society of Toxicology

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