Program - Society of Toxicology

Society of Toxicology 2011
Program Description (Continued)
Abstract #
Tuesday Morning, March 8
6:30 AM to 7:50 AM
Room 144
Tuesday Morning
Roundtable Session: Current Uses and Understanding of the
Tissue Cross Reactivity Assay
Chairperson(s): Jeanine Bussiere, Amgen, Inc., Thousand Oaks, CA, and
Michael Leach, Pfizer, Andover, MA.
Sponsor:
Biotechnology Specialty Section
Endorsed by:
Toxicologic and Exploratory Pathology Specialty Section
Tissue cross-reactivity (TCR) studies are screening assays conducted
with monoclonal antibodies and related antibody-like biopharmaceuticals
primarily to identify off-target binding, and secondarily to identify sites of
on-target binding that were not previously identified. As presently utilized
by the biopharmaceutical industry and regulatory agencies, TCR studies
usually involve the ex vivo immunohistochemical (IHC) staining of a
panel of frozen tissues from humans and animals. However, other methods
of conducting TCR studies are possible. While ex vivo TCR studies have
become routine in the development of antibody therapeutics, their value
for the purpose of making safety assessment decisions by both industry and
regulatory agencies has been questioned as experience with the assay has
increased. Recently, an industry white paper was published to review the
use of tissue cross-reactivity studies in the development of antibody-based
biopharmaceuticals: history, experience, methodology, and future directions.
In addition, a multinational pharmaceutical and biotechnology company
survey was conducted to gain a better understanding of the use and value of
the TCR assay in the development of biotherapeutic molecules. The information
from this survey can be used to help understand the appropriate use
and interpretation of this assay in a nonclinical drug development program.
Our panel of experts will address the following issues of importance
including how we got to where we are today; the technical aspects of the
TCR assay and issues with interpretation; case studies and summary from
white paper on use of TCR; industry survey results on use of the TCR assay;
and, the new technologies for identifying off-target binding of monoclonal
antibodies.
#881 6:30 CURRENT USES AND UNDERSTANDING
OF THE TISSUE CROSS REACTIVITY
ASSAY. ​J. L. Bussiere 1 , J. Cavagnaro 5 , E.
Galbreath 3 , T. Machlachlan 6 , N. Dybdal 4 and M.
Leach 2 . 1 Toxicology, Amgen, Inc., Thousand Oaks,
CA, 2 Drug Safety Research and Development,
Pfizer, Andover, MA, 3 Toxicology, Lilly Research
Laboratories, Indianapolis, IN, 4 Safety Assessment,
Genentech, Inc., South San Francisco, CA,
5
AccessBio, Boyce, VA and 6 Pharmacology and
Toxicology, Genzyme, Framingham, MA.
6:30 TCR: HOW WE GOT TO WHERE WE ARE
TODAY. ​Joy Cavagnaro
6:45 TECHNICAL ASPECTS OF THE TCR ASSAY
AND ISSUES WITH INTERPRETATION. ​
Elizabeth Galbreath
7:00 CASE STUDIES AND SUMMARY FROM
THE WHITE PAPER ON USE OF TCR. ​Tim
MacLachlan
7:15 INDUSTRY SURVEY RESULTS ON USE OF
THE TCR ASSAY. ​Jeanine L. Bussiere
7:30 PANEL DISCUSSION/Q&A.
Abstract #
Tuesday Morning, March 8
6:30 AM to 7:50 AM
Room 143
Emerging Global Public Health Issues
Roundtable Session: Risk and Risk Management of
Potentially Toxic Compounds Formed by Cooking Food
Chairperson(s): Steven Hermansky, ConAgra Foods, Inc., Omaha, NE,
and Wu Li, Frito-Lay, Inc., Plano, TX.
Sponsor:
Food Safety Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
Risk Assessment Specialty Section
The discovery of acrylamide in food in 2002 by Swedish researchers initiated
an international effort to assess exposure and manage risk to the public.
Millions of dollars and countless hours of resources have been dedicated to
this effort around the world. The concept that cooking changes the chemistry
of food is not new but the presence of acrylamide across a wide variety of
foods brought a new perspective to food safety for the international regulatory
community. This issue continues to develop as different research groups
focus on multiple heat-formed chemicals and various aspects of toxicology
of these naturally occurring compounds. From the recent completion of the
European Union HEATOX (Heat-Generated Food Toxicants: Identification,
Characterization, and Risk Minimization) project to the development of
increasingly sensitive and refined analytical methods that are able to detect
ever lower concentrations of compounds in foods, it is becoming increasingly
clear that acrylamide only represents one compound of many. This
revelation presents challenges to both the scientific and regulatory communities.
Just as importantly, resources are more frequently stretched thin
as scientific debates are played out in the mass media and the credibility
of the scientific and regulatory process is challenged. We will discuss the
challenges and opportunities presented by risk management of compounds
formed in food during cooking.
#882 6:30 RISK AND RISK MANAGEMENT OF
POTENTIALLY TOXIC COMPOUNDS
FORMED BY COOKING FOOD. ​S. J.
Hermansky 1 , W. Li 8 , R. Lane 2 , N. Rachman 4 , S.
Olin 5 , T. Troxell 3 , M. Bolger 6 and A. Tritscher 7 .
1
ConAgra Foods, Omaha, NE, 2 Pepsico, Valhalla,
NY, 3 Exponent, Washington, D.C., 4 Grocery
Manufacturer’s Association, Washington, D.C., 5 ILSI
Research Foundation, Washington, D.C., 6 U.S. FDA
Center for Food Safety and Nutrition, Washington,
D.C., 7 World Health Organization, Geneva,
Switzerland and 8 Frito Lay, Plano, TX.
6:30 INTRODUCTORY REMARKS AND
SUMMARY OF NEW DATA. ​Steven J.
Hermansky
6:35 THE POLITICS OF CHEMICAL FOOD
SAFETY. ​Richard Lane
6:47 THE NEW FOOD LANDSCAPE:
BALANCING THE BENEFITS WITH THE
CHEMICAL RISKS OF COOKING. ​Nancy J.
Rachman
6:59 EVALUATING THE TOXICOLOGY OF
CHEMICALS IN FOOD: DO WE NEED A
NEW PARADIGM? ​Steve S. Olin
7:11 ESTABLISHING A FUTURE RISK
MANAGEMENT VISION FOR COOKING
TOXINS. ​Terry Troxell
7:23 PANEL DISCUSSION. ​Mike Bolger and
Angelika Tritscher
Tuesday
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