S16 Is There a Role for “Modern Toxicology” in Regulatory Science?

Sunday, July 26, 2015: 1:30 PM-5:00 PM
B115 - B116 (Oregon Convention Center)
Primary Contact: Marianne Solomotis
Organizers: Marianne Solomotis and Suzanne Fitzpatrick
Convenors: Marianne Solomotis and Suzanne Fitzpatrick
Many frequently used food chemical substances may affect different organs and their potential toxicity needs to be tested for determining their safety; several food chemical substances have not been tested for safety.  Regulatory agencies rely on the best available science to obtain the information necessary to develop guidelines and regulations to ensure the safety of food chemical substances (food additives, colors, contact materials and dietary supplements).  Current toxicological methodologies rely primarily on animal testing which is costly, laborious and time consuming.  Additionally, traditional toxicological tests may not identify new and evolving areas of toxicological concern such as endocrine disruption, cardiotoxicity and neurobehavioral effects.

Advances in regulatory science are critical to effectively translate cutting-edge developments in science and technology.  Agencies such as EPA and FDA are moving towards a systematic approach for developing research to fill data gaps identified by risk assessments and regulatory needs.   More rapid higher throughput methods such as in vitro, ex vivo, and in silico models, are evolving and have been successfully used as screening tools. Their potential role for regulatory purposes, however, has yet to be established. There is also the need to determine how to translate these in vitro results into in vivo practical information and relate these results to the industry and the consumer.  The objectives of this symposium are two-fold: 1) identify the regulatory needs for determining whether a substance is unsafe;  2) describe new and emerging methodologies and discuss how these new methodologies can be used to address our regulatory needs.

Presentations

1:30 PM
FDA Chemical-specific Regulatory Needs
Suzanne Fitzpatrick, U.S. Food and Drug Administration-CFSAN
2:30 PM
The Body Reassembled: In Vitro Models for Safety Assessment
Robert Chapin, Pfizer Pharmaceuticals, Inc.
3:00 PM
Break
3:30 PM
4:00 PM
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