Program - Society of Toxicology

50 th Anniversary Annual Meeting and ToxExpo
Continuing Education (Continued)
CE
documents issued by the International Committee on Harmonization
(ICH), the U.S. Food and Drug Administration and the European Medicines
Agency. The course will highlight legal and customary definitions
of “acceptable risk,” as well as risk assessment methods for evaluating
data to estimate risk levels under these programs. The regulations and/
or guidances will be detailed and approaches used to comply with them
will be described. This course will begin with a description methods
underlying U.S. EPA actions to protect the general public, i.e., establishment
of NAAQS and MCLs. The course will then detail requirements,
guidance, and processes to protect specific populations, i.e., workers and
patients. In each case representative examples will be used to illustrate the
processes. The application of toxicological and epidemiological data in
these programs will be described.
• Introduction, Eileen P. Hayes, EP Hayes Toxicology Services LLC,
Longmont, CO
• Clean Air Regulation: Science and the Process, Daniel L. Costa,
U.S. EPA, Research Triangle Park, NC
• Drinking Water Regulation: Science and the Process, Rita Schoeny,
U.S. EPA, Washington, D.C.
• Setting Occupational Exposure Limits, Bruce D. Naumann, Merck
& Co., Inc., Whitehouse Station, NJ
• Qualification of Impurities in Drug Products, Timothy J.
McGovern, SciLucent, LLC, Herndon, VA
Sunday Morning, March 6
8:15 AM to 12:00 NOON
First and Second Level (See signage at CE Booths for room
locations)
Drug Hypersensitivity Reactions: Risk Assessment and
Management
AM07
CE Basic
Chairperson(s): Marija Popovic, Eli Lilly & Company, Indianapolis,
IN, and Jessica Whritenour, Pfizer Global Research and Development,
Groton, CT.
Sponsor:
Immunotoxicology Specialty Section
Drug hypersensitivity reactions are not a common problem in drug development;
however, when they do occur they can have a significant impact
on the drug candidate’s developmental success. Drug hypersensitivity
reactions are usually discovered in Phase II or III clinical trials, or in the
post-marketing phase. Once allergic reactions are observed in patients,
one needs to determine if the reaction is mediated by an immune response
to the drug, or another mechanism. There are a few ex vivo diagnostic
methods that can be used to identify immune-mediated reactions, but one
needs to be aware of the limitations and advantages of each approach.
In vitro methods, or animal models presently being developed to predict
drug’s potential to trigger hypersensitivity reaction in the patient population
are being developed, but at present, they have significant limitations.
Risk management strategies may include selection of patient populations
based on the HLA haplotype. This course is intended as an introduction
for those with limited background in the area of hypersensitivity, or
allergic reaction to drugs. The focus of the course will be on systemic
hypersensitivity reactions (drug administered orally or parenterally)
and will include discussions both on drugs that are small molecules and
biologics.
• Impact and Issues Associated with Drug Hypersensitivity
Reactions on Drug Development and Commercialization, Thomas
T. Kawabata, Pfizer Global Research and Development, Groton, CT
• Clinical Overview: Description of the Types of Drug
Hypersensitivity Reactions, Franklin Adkinson, Johns Hopkins
University, Baltimore, MD
• Mechanisms of Drug Hypersensitivity Reactions: Types I-IV
Mechanisms, Hapten, PI, and Danger Hypotheses, Cynthia Ju,
University of Colorado, Denver, Aurora, CO
• Pseudoallergic and Anaphylactoid Drug Hypersensitivity
Reactions, Jessica Whritenour, Pfizer Global Research and
Development, Groton, CT
• Risk Management of Drug Hypersensitivity Reactions: Application
of Diagnostic Testing and Pharmacogenomic Approaches, Thomas
T. Kawabata, Pfizer Global Research and Development, Groton, CT
• Predictive Testing: Different Animal Models and Future
Possibilities, Marija Popovic, Eli Lilly & Company, Indianapolis, IN
Sunday Morning, March 6
8:15 AM to 12:00 NOON
First and Second Level (See signage at CE Booths for room
locations)
Toxicology and Risk Assessment of Chemical Mixtures
AM08
CE Basic
Chairperson(s): Jane Ellen Simmons, U.S. EPA, Research Triangle Park,
NC, and Christopher J. Borgert, Applied Pharmacology Toxicology, Inc.,
Gainesville, FL.
Sponsor:
Mixtures Specialty Section
Endorsed by:
Biological Modeling Specialty Section
Occupational Health and Public Health Specialty Section
Assessment of the safety and risk of environmental chemicals, pharmaceuticals,
consumer and personal care products, pesticides, and food
additives increasingly requires consideration of the potential pharmacological
and toxicological interactions that might occur as these agents
are encountered as mixtures by patients, consumers, and through environmental
exposures (e.g., mixtures present in air, water, soil). Both
toxicological evaluations and risk assessments of mixtures of chemicals
are complex due to the potential pharmacokinetic and pharmacodynamic
mechanisms that might result in nonadditive interactions. While greater
than expected toxicity is of most concern for environmental exposures,
both less than and greater than additive toxicity are of pharmacological
concern. Toxicological evaluation of chemical mixtures necessitates study
designs, methods of analysis, and limits on interpretation not required
for single chemicals. This course will cover the fundamentals of study
design and data analysis for mixtures that apply to all classes and categories
of chemicals encountered by humans and animals, regardless of
market application. The objectives of this course are to 1) describe the
basic principles that underlie modern concepts of the toxicology and risk
assessment of chemical mixtures; 2) survey the basic tools and techniques
needed to design, conduct, analyze and interpret experimental data with
defined or complex mixtures of chemicals; and 3) review the guidance,
underlying assumptions, and techniques used in risk assessment of chemical
mixtures. This course will be of interest to experimentalists who wish
to conduct studies on mixtures that are meaningful for evaluation of risk
as well as safety and risk assessors who must evaluate and apply data on
mixtures and interactions in assessments.
• Basic Principles of Additivity Underyling Methods, Designs, and
Techniques for Evaluation of Mixtures, Jane Ellen Simmons, U.S.
EPA, Research Triangle Park, NC
92 SOT 50th Anniversary Annual Meeting