51st Annual Meeting & ToxExpo - Society of Toxicology

Society of Toxicology 2012
Continuing Education
CE
Aberrant Gene Expression in Toxicity
and Disease—Epigenetics and
microRNAs
Applications of Biomarkers in the Assessment of
Health and Disease
AM02
CE Advanced
Chairperson(s): Vishal S. Vaidya, Harvard Medical School, Boston,
MA, and Donna L. Mendrick, US FDA, Jefferson, AR.
Sponsor:
Drug Discovery Toxicology Specialty Section
Endorsed by:
Association of Scientists of Indian Origin Special Interest Group
Disease Prevention Task Force
Risk Assessment Specialty Section
Biomarkers serve as quantitative measures of chemical exposures
and biologically effective doses, early warning signals of biologic
effect, predict outcome in a patient with disease, and identify who
will respond to an intervention and whether the intervention is
working. The current era of scientific discovery has brought seemingly
limitless opportunities for improvements in medical care.
Translational biomarkers that can be measured in blood or urine
in both experimental animals and man are of particular interest.
Given the importance to the clinical, pharmaceutical, and regulatory
communities motivated by more specific and timely diagnoses, early
intervention, and safer therapies, clinically useful biomarkers have
evolved over time, reflecting the scientific and technologic progress
made over the centuries. An increasing number of clinically relevant
tests and procedures are available to estimate organ injury and guide
treatment. The use of molecular signals in the assessment of health and
disease is not new; however, the concept of what constitutes a useful
biomarker has evolved considerably in the past two to three decades
given the advanced enabling technologies, the deeper molecular
understanding of disease, and the advent of a regulatory framework
for biomarker qualification. Our panel experts will highlight the
potential of these molecular signals over a wide variety of applications
spanning preclinical–clinical safety and disease monitoring in therapeutic
and environmental exposures pertaining to cancer, and lung,
heart, and kidney disease. Coordinated efforts at biomarker discovery
and validation as well as technologies for biomarker measurement
will help ensure that the ultimate goal of safer drugs, a cleaner environment,
and improved patient outcomes is realized.
• Introduction. Donna L. Mendrick, US FDA, Jefferson, AR.
• Discovering Cancer Biomarkers: From Diagnosis and Prognosis
through Therapy. Marsha A. Moses, Children’s Hospital-Boston,
Harvard Medical School, Boston, MA.
• Advanced Molecular Biomarkers in Understanding Lung
Exposure Biology. David E. Christiani, Harvard School of Public
Health, Boston, MA.
• Biomarkers of Cardiac Dysfunction—Beyond Troponins.
James R. Turk, Amgen, Inc., Thousand Oaks, CA.
• Kidney Safety Signal: From Identification to Point of Care
Testing. Vishal S. Vaidya, Harvard Medical School, Boston, MA.
Basic Embryology and Developmental
Toxicity Testing
AM03
CE Basic
Chairperson(s): Christopher J. Bowman, Pfizer Worldwide Research
and Development, Groton, CT, and Lori A. Dostal, Exponent, Inc.,
Farmington Hills, MI.
Sponsor:
Reproductive and Developmental Toxicology Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
Embryonic and fetal development in mammalian species is a complex
process that is sensitive to the effects of maternal and environmental
factors. The timing of development of the major organ systems varies
between humans and other animal species, but the basic biology of
development is similar in all species, thus allowing extrapolation
of animal testing results for xenobiotics to humans. The course
will begin by providing an overview that highlights developmental
biology from fertilization of the gametes to normal maturation of a
full-term placenta and fetus, including examples of developmental
toxicants and teratogens with known modes of action. Subsequently,
applied toxicology concepts for evaluation of the potential for bio/
pharmaceuticals and chemicals to affect pregnancy and embryofetal
development will be discussed. Global regulatory strategies and
requirements to minimize health effects on women and unborn children
will also be addressed. Finally, key information will be presented
to provide for a better understanding of the biological and toxicological
basis of prenatal developmental toxicity testing and the impact of
various outcomes on drug development, chemical use, environmental
impact, and human health risk.
• Introduction. Lori A. Dostal, Exponent, Inc., Farmington Hills, MI.
• Implantation, Placentation, and Early Embryonic Development.
John M. DeSesso, Exponent, Inc., Alexandria, VA.
• Demystifying Mammalian Embryogenesis.
Kathleen K. Sulik, University of North Carolina, Chapel Hill, NC.
• The Importance of Developmental Toxicity Testing to
Pharmaceutical Development. Kimberley A. Treinen, Merck,
Summit, NJ.
Thematic Session
54
SOT’s 51 st Annual Meeting