51st Annual Meeting & ToxExpo - Society of Toxicology

51 st Annual Meeting and ToxExpo
The Thematic Track information can be found on pages 8–9.
Workshops
Scientific
modification of therapeutic proteins resulting in autoimmune reactions
to endogenous molecules. This session will provide important
information on allergenicity testing requirements and research in
the agricultural chemical/biotech sector, pharmaceutical/biopharma
sector, and vaccine sector and includes speakers from industry and
regulatory. An anticipated outcome is discussion over why allergenicity
is a concern, what tools are available to evaluate allergenicity in
the different areas of biotechnology, and any challenges we face with
this testing.
• Existing and Emerging Methods and Techniques for Assessing
Allergenicity of Genetically Modified Crops. Greg Ladics, DuPont,
Wilmington, DE.
• Evaluating the Potential Allergenicity of Vaccines. Robert House,
DynPort Vaccine Company, LLC, Frederick, MD.
• Food Regulatory Perspective on Evaluation of Allergenicity.
Steven Gendel, US FDA, College Park, MD.
• Allergenicity Research in the Pharmaceutical/Biopharma Sector.
Kenneth Hastings, sanofi-aventis, Bethesda, MD.
Chemical Standardization of Botanical Medicines
for Safe and Effective Use As Therapeutic Agents
Thursday, March 15, 9:00 AM–11:45 AM
Chairperson(s): Madhu Soni, Soni & Associates Inc., Vero Beach, FL,
and Brinda Mahadevan, Abbott Laboratories, Abbott Park, IL.
Sponsor:
Association of Scientists of Indian Origin Special Interest Group
substances, including heavy metals and interfere with the actions of
commonly prescribed medications, which has resulted in a number
of adverse patient effects. Thus, use of botanical medicines is further
confounded with considerable variations in chemical composition,
inclusion of known toxic components during the processing, uncertain
therapeutic potency, and potential safety issues when used alone or in
combination with pharmaceutical agents. In an effort to broaden the
understanding of the aforementioned issues pertaining to botanical
medicines, the following key aspects will be addressed: the toxicity
of botanical medicines; if it’s natural, is it necessarily safe; successful
scientific strategies that are needed to ensure safe and effective use of
botanical medicines; quality and safety issues of botanical medicines;
chemical standardization of botanical medicines; and current state
and federal regulations affecting this line of therapeutic agents.
• Characterization and Use of Herbal Preparations As Test Articles
in Safety Assessments—Analytical Challenges and Reasonable
Solutions. Cynthia Smith, NIEHS, Research Triangle Park, NC.
• Pharmacopeial Approaches to Setting Specifications for Articles
of Botanical Origin. Nandakumara Sarma, US Pharmacopeia,
Rockville, MD.
• Integrity of a Product: Use of Validated Methods in Assessing
the Quality and Safety of Botanicals. Ikhlas Khan, University of
Mississippi School of Pharmacy, Oxford, MS.
• Standardizing Snowflakes: Using Technology to Normalize
Nature. Craig Hopp, NIH, Bethesda, MD.
• Chemical Standardization of an Herbal Formulation As a Safe
and Effective Therapeutic Agent for Parkinson’s Disease—A Case
Study. Bala Manyam, Penn State University, Hershey, PA.
Endorsed by:
American Association of Chinese in Toxicology
Special Interest Group
Food Safety Specialty Section
Mixtures Specialty Section
Regulatory and Safety Evaluation Specialty Section
Risk Assessment Specialty Section
Botanical medicines have been used for millennia to cure ailments
in traditional societies around the world. According to the World
Health Organization (WHO), in Asian and African countries, over
three fourths of the population rely on botanical medicines for their
primary health care needs. The use of botanical medicines in the
developed world is increasingly on the rise with individuals seeking
alternate and/or complementary medicine options. The popular belief
is that because botanical medicines are derived from natural sources,
they are safe and pose no harm when used. However, within the scientific
community, botanical medicines are under increased scrutiny
due in part to concerns regarding their safety and clinical efficacy.
Safety issues often arise from lack of controlled manufacturing
conditions, unproven formulations, improper storage, and poor or
ineffective quality control measures. In addition, a number of plant
materials have been found to be contaminated with toxicological
up-to-date information at www.toxicology.org 99
Thematic Session