Program - Society of Toxicology
Program - Society of Toxicology
Program - Society of Toxicology
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44 th Annual Meeting<br />
and ToxExpo<br />
<strong>Program</strong> Description<br />
Thursday Morning, March 10<br />
8:30 AM to 11:30 AM<br />
Room RO6<br />
WORKSHOP SESSION: SAFETY ASSESSMENT OF BIOLOGICAL<br />
THERAPEUTIC PRODUCTS- DEFINING THE SCIENTIFIC AND<br />
REGULATORY ISSUES<br />
Chairperson(s): Andrea Weir, U.S. FDA, Rockville, MD and Barbara Mounho,<br />
Amgen, Inc., Thousand Oaks, CA.<br />
Endorsed by:<br />
Immunotoxicology SS<br />
Regulatory and Safety Evaluation SS*<br />
Risk Assessment SS<br />
Toxicologic and Exploratory Pathology SS<br />
Women in <strong>Toxicology</strong> SS<br />
Biological therapeutic products (BTPs) are proteins derived from living organisms<br />
or produced via biotechnology means that have provided the medical<br />
community with novel, highly targeted therapies for the diagnosis and treatment<br />
diseases in humans. An integral part <strong>of</strong> the safety evaluation <strong>of</strong> these products is<br />
toxicology studies. BTP—induced toxicities are typically limited to their pharmacological<br />
mechanism <strong>of</strong> action; therefore, toxicology studies need to be<br />
conducted in an animal model that expresses the receptor or epitope that is recognized<br />
by the product. Frequently, a non-human primate (NHP) is the relevant<br />
model. In recent years, the quality <strong>of</strong> NHPs and the availability <strong>of</strong> methods for<br />
assessing toxicity in these animals have increased. In spite <strong>of</strong> these advances,<br />
many challenges remain in the safety assessment <strong>of</strong> BTPs. For example, only a<br />
very limited toxicological assessment can be conducted if the only relevant<br />
model is a chimpanzee. In such cases, toxicologists use innovative approaches,<br />
including the development <strong>of</strong> surrogate molecules, to conduct toxicology studies.<br />
Therefore, identification <strong>of</strong> novel methods is an ongoing effort in the BTP arena.<br />
Regardless <strong>of</strong> the animal model used, the potential for animals to mount an<br />
immune response to BTPs (immunogenicity) exists. Because immunogenicity<br />
can confound interpretation <strong>of</strong> toxicology studies, it is another challenge facing<br />
toxicologists that can result in the need for innovative approaches to safety<br />
assessment. Additionally, because immunogenicity can occur in humans<br />
receiving BTPs, the development <strong>of</strong> animal models to predict this effect in<br />
humans is an area <strong>of</strong> ongoing research. The need for innovative, flexible<br />
approaches when assessing the safety <strong>of</strong> BTPs is reflected in U.S. FDA and international<br />
regulatory documents. The topics covered in this workshop will provide<br />
toxicologists with the most current information on the unique scientific properties<br />
<strong>of</strong> BTPs and with state—<strong>of</strong>—the—art approaches to safety assessment <strong>of</strong><br />
BTPs.<br />
#1990 8:30 SAFETY ASSESSMENT OF BIOLOGICAL<br />
THERAPEUTIC PRODUCTS — DEFINING THE<br />
SCIENTIFIC AND REGULATORY ISSUES. A.<br />
Weir 1 and B. J. Mounho 2 . 1 FDA/CDER, Rockville, MD<br />
and 2 Amgen Inc., Thousand Oaks, CA.<br />
#1991 8:35 DIFFERENCES BETWEEN SMALL<br />
MOLECULES AND BIOLOGICAL<br />
THERAPEUTIC DRUG PRODUCTS. B. Mounho.<br />
<strong>Toxicology</strong>, Amgen, Inc., Thousand Oaks, CA.<br />
#1992 9:05 IMMUNOGENICITY- IMPACT ON<br />
TOXICOLOGY STUDIES AND BEYOND. D.<br />
Wierda and H. Smith. Immunotoxicology, Eli Lilly<br />
Research Laboratories, Greenfield, IN.<br />
#1993 9:35 THE NONHUMAN PRIMATE AS AN ANIMAL<br />
MODEL FOR THE SAFETY EVALUATION OF<br />
BIOLOGICAL THERAPEUTIC PRODUCTS. J.<br />
Kapeghian. Discovery and Development Services,<br />
Charles River Laboratories, Sierra Division, Sparks,<br />
NV.<br />
#1994 10:05 ALTERNATIVE METHODS FOR THE SAFETY<br />
EVALUATION OF BIOLOGICAL THERAPEUTIC<br />
PRODUCTS — SURROGATE ANTIBODIES AND<br />
BEYOND. J. Clarke. BiogenIdec, Cambridge, MA.<br />
#1995 10:35 SAFETY ASSESSMENT OF BIOLOGICAL<br />
PRODUCTS — A REGULATORY PERSPECTIVE.<br />
H. Ghantous. FDA/CDER/ODEVI/DTBIMP, Rockville,<br />
MD.<br />
Thursday Morning, March 10<br />
8:30 AM to 11:30 AM<br />
La Louisiane Ballroom B<br />
POSTER SESSION: ALTERNATIVES TO MAMMALIAN MODELS<br />
Chairperson(s): Irvin Schultz, Battelle Pacific Northwest Laboratories,<br />
Sequim, WA and George DeGeorge, MB Research Laboratories, Spinnerstown,<br />
PA.<br />
Displayed: 8:30 AM–11:30 AM<br />
Attended: 8:30 AM–10:00 AM<br />
#1996 NOVEL REPORTER GENE ASSAY FOR<br />
DEVELOPMENTAL TOXICITY TESTING. S.<br />
Schwengberg 1 , A. Ehlich 1 , H. Marquardt 2 , J. Hescheler 3<br />
and H. Bohlen 1 . 1 Axiogenesis AG, Cologne, Germany,<br />
2 <strong>Toxicology</strong>, University Hospital, Hamburg, Germany<br />
and 3 Neurophysiology, University Hospital, Cologne,<br />
Germany.<br />
#1997 VALIDATION STATUS OF THE HENS EGG<br />
TEST-CHORIOALLANTOIC MEMBRANE (HET-<br />
CAM) TEST METHOD. N. Choksi 1,2 , D. Allen 1,2 , C.<br />
Inh<strong>of</strong> 1,2 , J. Truax 1,2 , R. Tice 1,2 and W. Stokes 1 .<br />
1 NICEATM, NIEHS, Research Triangle Park, NC and<br />
2 ILS, Inc., Research Triangle Park, NC.<br />
#1998 GENE EXPRESSION SIGNATURES FOR<br />
CADMIUM, MERCURY, AND ACRYLAMIDE<br />
EXPOSURE IN CAENORHABDITIS ELEGANS. D.<br />
Jackson 1 , M. Szilagyi 2 , E. Gehman 2 and E. Clegg 1 . 1 US<br />
Army Center for Environmental Health Research, Fort<br />
Detrick, MD and 2 Geo-Centers, Inc., Fort Detrick, MD.<br />
#1999 CYTOKINE SECRETION PROFILES OF MOUSE<br />
DENDRITIC CELLS : IMPACT OF CELL<br />
TRAUMA. G. Beckwith 1 , C. J. Betts 1 , C. A. Ryan 2 , F.<br />
Gerberick 2 , R. J. Dearman 1 and I. Kimber 1 . 1 Syngenta<br />
CTL, Macclesfield, United Kingdom and 2 Procter &<br />
Gamble, Cincinnati, OH.<br />
#2000 MATRIX METALLOPROTEINASES AS<br />
BIOMARKERS FOR DIOXIN EXPOSURE IN<br />
DEVELOPING JAPANESE MEDAKA (ORYZIAS<br />
LATIPES). V. L. Prince, V. LaPrete, C. M. Villano and<br />
L. A. White. Biochemistry and Microbiology, Rutgers<br />
University, New Brunswick, NJ.<br />
#2001 EPIOCULAR HUMAN CELL CONSTRUCT:<br />
TISSUE VIABILITY AND HISTOLOGICAL<br />
CHANGES FOLLOWING EXPOSURE TO<br />
SURFACTANTS. M. E. Blazka 1 , M. Diaco 2 , J. W.<br />
Harbell 2 , H. Raabe 2 , A. Sizemore 2 , N. Wilt 2 and D. M.<br />
Bagley 1 . 1 Colgate-Palmolive Co., Piscataway, NJ and<br />
2 Institute for In Vitro Sciences, Inc., Gaithersburg, MD.<br />
THURSDAY<br />
up-to-date information at www.toxicology.org 203