Program - Society of Toxicology

50 th Anniversary Annual Meeting and ToxExpo
Continuing Education (Continued)
CE
subject of several other peer-reviewed publications. The course comprises
lectures describing the link between mode of action, dose-response characterization
and risk assessment, and the role of PBPK models in reducing
and characterizing uncertainty and variability. The course will present
principles for the development, characterization, and communication and
criteria for evaluation of PBPK models for risk assessment applications.
A novel inclusion will be a projected demonstration of real-time changes
in model outcome that depend on choice of model parameter values (e.g.,
breathing rate, metabolic activity). The demonstration of user-friendly
model development software will be demonstrated in the final lecture.
This will show the impact of choices for parameter values, and models
will be exercised and the results interpreted to produce quantitative values
to be used in place of uncertainty factors in health risk assessments.
• Toxicokinetics in Risk Assessment, John C. Lipscomb, U.S. EPA,
Cincinnati, OH
• Developing a PBPK Model, Hugh Barton, Pfizer, Inc., Groton, CT
• Characterizing a PBPK Model, Kannan Krishnan, Université de
Montréal, Montréal, Québec, Canada
• Applying PBPK Models in Risk Assessment, George Loizou, Health
and Safety Laboratory, Buxton, United Kingdom
• Case Study 1, Bette Meek, University of Ottawa, Ottawa, Ontario,
Canada
• Case Study 2, Jos Bessems, RIVM, Bilthoven, Netherlands
Sunday Morning, March 6
8:15 AM to 12:00 NOON
First and Second Level (See signage at CE Booths for room
locations)
Cardiovascular Toxicology
Current Nonclinical Strategies and Methods for Evaluating
Drug-Induced Cardiovascular Toxicity
AM03
CE Basic
Chairperson(s): Hong Wang, Genentech Inc., South San Francisco,
CA, and Dennis J. Murphy, GlaxoSmithKline Pharmaceuticals, King of
Prussia, PA.
Sponsor:
Cardiovascular Toxicology Specialty Section
Endorsed by:
Drug Discovery Toxicology Specialty Section
Regulatory and Safety Evaluation Specialty Section
Cardiovascular (CV) toxicity is among the major causes of withdrawal
of drugs or restriction in their labeling and has had an impact on public
health and the rising cost of developing new drugs. Early identification
and characterization of CV liabilities, better understanding of the predictive
values of nonclinical models, and an integrated and iterative approach
during drug development could greatly facilitate the development of safe
and effective medicines for patients. This course will describe the current
in vitro and in vivo methods for evaluation of functional and structural
CV liabilities, and discuss the strategies that can be applied at early
stages of drug development to help reduce attrition and to avoid unanticipated
liabilities at later development stages in either animal studies
or in the clinic. Study design and data interpretation will be discussed,
as well as the advantages, limitations, and future directions of current
methods involving both functional and structural assessments. Specific
topics such as integration of functional CV endpoints into repeat-dose
toxicity studies, methods for identification and characterization of cardiac
arrhythmia, and special considerations for testing oncology and diabetes
drugs and biologics will be covered. In addition, case study examples
will be provided to highlight how these data can be used to inform decisions
at different stages of development. A regulatory perspective on the
challenges and gaps of CV safety evaluations and opportunities available
to improve the overall CV safety assessment paradigm will also be
presented. Overall, this course will provide participants with a broad overview
of the types of drug-induced CV liabilities, the current nonclinical
strategies and methodologies for early detection of CV liabilities, and a
regulatory perspective on the impact of CV toxicity on the drug-development
process.
• Opening Remarks and Overview of Cardiovascular Toxicity,
Dennis J. Murphy, GlaxoSmithKline Pharmaceuticals, King of Prussia,
PA
• Early Identification of Cardiovascular Functional Liabilities:
Role of In Vitro Assays, Derek Leishman, Eli Lilly & Company,
Indianapolis, IN
• Integrated Assessment of Cardiovascular Functional Liabilities: In
Vivo Animal Models, R. Dustan Sarazan, Data Sciences International,
St. Paul, MN
• Assessment of Cardiovascular Injury: Morphological Evaluations
and Biomarkers, Brian Berridge, GlaxoSmithKline Pharmaceuticals,
Research Triangle Park, NC
• A Regulatory Perspective on Drug-Induced Cardiovascular
Liabilities: Challenges, Gaps, and Opportunities, John Koerner,
U.S. FDA, Silver Spring, MD
Sunday Morning, March 6
8:15 AM to 12:00 NOON
First and Second Level (See signage at CE Booths for room
locations)
Systems Biology
Dealing with the Data Deluge: A Live Data Discovery and
Analysis Course
AM04
CE Basic
Chairperson(s): Marc E. Gillespie, St. Johns University, Jamaica, NY,
and Susan M. Bello, Jackson Laboratory, Bar Harbor, ME.
Sponsor:
Molecular Biology Specialty Section
NOTE: Due to the unique “hands on” nature of this course, it is critical
for AM04 course attendees to bring their own laptop computer as well
as their own Internet network connection. The Walter E. Washington
Convention Center offers Internet service for a nominal fee if attendees
prefer to buy connectivity on-site.
Using Web based resources and tools to gain novel scientific insights
and advance your research is a significant step for all researchers. As
the pace of science accelerates, experimental technologies continue
to evolve and the quantity of data increases. With the evolution in
biological research comes an increasing reliance on database resources
and computational analysis tools to parse and integrate this growing
mass of biological data. The field of toxicology is not exempt from these
challenges. In this course, representatives from a diverse group of data
resources have joined their efforts to present a unique series of handson
tutorials. The tutorials follow a hypothetical researcher through the
various stages of experimental design and data analysis, demonstrating
how the different workshop resources can be used to facilitate all steps
of the research process. Participants will identify orthologous biological
information across different species; identify biological trends (pathway,
function, phenotype, xenobiotic interactions) within a submitted data
set; investigate an individual data set with on-line resources, identifying
supplementary information available across multiple data sets; and gain
hands on experience with formatting and submitting data to a diverse set
of on-line data resources.
90 SOT 50th Anniversary Annual Meeting