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Program - Society of Toxicology

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44 th Annual Meeting<br />

and ToxExpo<br />

<strong>Program</strong> Description<br />

WEDNESDAY<br />

#1347 9:10 IMMUNOGENICITY AND SAFETY TESTING OF<br />

VACCINES: A REGULATORY PERSPECTIVE<br />

ON GENERAL REQUIREMENTS AND SPECIAL<br />

ISSUES OF THE RESPIRATORY TRACT. K. L.<br />

Hastings. Office <strong>of</strong> New Drugs, CDER, U.S. FDA,<br />

Rockville, MD.<br />

#1348 9:35 UNIQUE ISSUES ASSOCIATED WITH<br />

TOXICOLOGY ASSESSMENT OF VACCINES<br />

FOR BIOWARFARE AGENTS. R. House. Dynport<br />

Vaccine Company, Frederick, MD.<br />

#1349 10:00 WHO SPONSORED PRECLINICAL TOXICITY<br />

TESTS FOR INHALED MEASLES VACCINE. M.<br />

Papania. Centers for Disease Control and Prevention,<br />

Atlanta, GA. Sponsor: M. Reed.<br />

#1350 10:25 NONCLINICAL SAFETY EVALUATION OF TLR4<br />

AGONISTS ADMINISTERED BY NASAL SPRAY.<br />

C. M. Lynch. Nonclinical Development, Corixa<br />

Corporation, Seattle, WA. Sponsor: M. Reed.<br />

Wednesday Morning, March 9<br />

8:30 AM to 11:30 AM<br />

Room RO3<br />

WORKSHOP SESSION: TOXICOLOGICAL RESEARCH AND<br />

TESTING: BEST PRACTICES AND OPPORTUNITIES FOR<br />

LABORATORY ANIMAL REFINEMENT, REDUCTION, AND<br />

REPLACEMENT<br />

Chairperson(s): Stephen Lasley, University <strong>of</strong> Illinois College <strong>of</strong> Medicine,<br />

Peoria, IL and William Stokes, National Institute <strong>of</strong> Environmental Health<br />

Sciences, Research Triangle Park, NC.<br />

Endorsed by:<br />

Animals in Research*<br />

Risk Assessment SS<br />

In the performance <strong>of</strong> toxicology studies, whether for purposes <strong>of</strong> product safety<br />

testing or identifying mechanisms <strong>of</strong> toxicant action, it is becoming increasingly<br />

important to adopt practices and approaches that refine, reduce, and replace the<br />

numbers <strong>of</strong> laboratory animals utilized. Incorporation <strong>of</strong> best practices into<br />

studies will help ensure that animals are used in the most humane and judicious<br />

manner consistent with successful attainment <strong>of</strong> the research or testing objectives.<br />

Adoption <strong>of</strong> these practices is <strong>of</strong> timely importance because <strong>of</strong> continually<br />

increasing regulatory oversight <strong>of</strong> animal care and use, and thus consideration<br />

<strong>of</strong> these issues from different viewpoints is <strong>of</strong> broad interest to toxicologists.<br />

Best practices for regulatory testing involves careful consideration and appropriate<br />

incorporation <strong>of</strong> in vitro methods, humane endpoints, and tiered testing<br />

strategies (Stokes). Current best practices for housing and providing environmental<br />

enrichment for study animals should be consistently utilized, and factors<br />

considered that might potentially influence study outcomes (Brown). GLP<br />

requirements for pre-clinical safety studies are important factors to address, and<br />

optimal animal welfare practices consistent with compliance must be ensured<br />

(McCormack). Application <strong>of</strong> toxicogenomics to pre-clinical safety studies<br />

involving animals is an emerging concern, and potential opportunities for these<br />

methodologies to refine, reduce, and replace animal use are being developed<br />

(Schechtman). Finally, updating <strong>of</strong> European Union animal welfare laws<br />

continue to evolve, and their potential impact on harmonization <strong>of</strong> animal care<br />

programs and toxicological research is a relevant concern to multinational<br />

companies (Donovan).<br />

#1351 8:30 TOXICOLOGICAL RESEARCH AND TESTING:<br />

BEST PRACTICES AND OPPORTUNITIES FOR<br />

LABORATORY ANIMAL REFINEMENT,<br />

REDUCTION, AND REPLACEMENT. S. M. Lasley 1<br />

and W. S. Stokes 2 . 1 Department <strong>of</strong> Pharmacology,<br />

University <strong>of</strong> Illinois College <strong>of</strong> Medicine, Peoria, IL<br />

and 2 NICEATM, NIEHS/NIH/DHHS, Research<br />

Triangle Park, NC.<br />

#1352 8:35 BEST PRACTICES FOR USING HUMANE<br />

ENDPOINTS AND TIERED TESTING<br />

STRATEGIES TO REFINE, REDUCE, AND<br />

REPLACE ANIMAL USE IN TOXICOLOGICAL<br />

RESEARCH AND TESTING. W. S. Stokes.<br />

NICEATM, NIEHS/NIH/DHHS, Research Triangle<br />

Park, NC.<br />

#1353 9:05 BEST PRACTICES FOR ENVIRONMENTAL<br />

ENRICHMENT AND HOUSING FOR<br />

LABORATORY ANIMALS USED IN<br />

TOXICOLOGICAL RESEARCH AND TESTING.<br />

M. J. Brown. Charles River Laboratories, East Thetford,<br />

VT. Sponsor: S. Lasley.<br />

#1354 9:35 BALANCING ANIMAL WELFARE AND GLP<br />

COMPLIANCE IN NONCLINICAL<br />

LABORATORY SAFETY STUDIES. J. F.<br />

McCormack. Office <strong>of</strong> Regulatory Affairs, US Food and<br />

Drug Administration, Rockville, MD. Sponsor: W.<br />

stokes.<br />

#1355 10:05 APPLICATION OF TOXICOGENOMICS TO PRE-<br />

CLINICAL SAFETY TESTING: VALIDATION<br />

CONSIDERATIONS FOR POTENTIAL<br />

LABORATORY ANIMAL REFINEMENT,<br />

REDUCTION, AND REPLACEMENT. L. M.<br />

Schechtman. FDA/NCTR, Rockville, MD.<br />

#1356 10:35 REVISIONS TO EUROPEAN ANIMAL WELFARE<br />

LEGISLATION: IMPACT ON ANIMAL CARE<br />

AND TOXICOLOGY STUDIES. J. C. Donovan.<br />

BioResources, Wyeth Research, Collegeville, PA.<br />

Sponsor: S. Lasley.<br />

Wednesday Morning, March 9<br />

8:30 AM to 11:30 AM<br />

Room 220<br />

PLATFORM SESSION: AH RECEPTOR<br />

Chairperson(s): Mark Hahn, Woods Hole Oceanographic Institute, Woods<br />

Hole, MA and Richard Pollenz, University <strong>of</strong> South Florida, Tampa, FL.<br />

#1357 8:30 THE ROLE OF THE COOH-TERMINAL<br />

TRANSACTIVATION DOMAIN OF THE MOUSE<br />

AH RECEPTOR IN LIGAND-DEPENDENT AND<br />

INDEPENDENT DEGRADATION. R. S. Pollenz and<br />

J. Popat. Biology, University <strong>of</strong> South Florida, Tampa,<br />

FL.<br />

#1358 8:50 KINETIC STUDIES OF ARYL HYDROCARBON<br />

RECEPTOR ACTIVATION BY INDOLO[3, 2-<br />

B]CARBAZOLES, INDIGOS AND 2, 3, 7, 8-<br />

TETRACHLORODIBENZO-P-DIOXIN IN<br />

HUMAN HEPG2 CELLS. A. Rannug 1 , S. Pettersson 1 ,<br />

L. Poellinger 2 and M. Backlund 1,2 . 1 Institute <strong>of</strong><br />

Environmental Medicine, Karolinska Institutet,<br />

Stockholm, Sweden and 2 Cell and Molecular Biology,<br />

Karolinska Institutet, Stockholm, Sweden.<br />

154<br />

SOT’s 44 th Annual Meeting

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