Submitted by Jeff Bemis and Krista Dobo, Chairpersons, 2017 CE PM10
Genetic toxicology is a well-established part of safety testing for product development. Recent advances in methods and technologies, as well as the emergence of new challenges, are changing the type of data that are generated and the way that genetic toxicology data are utilized. This Continuing Education (CE) course, Emerging Approaches for Genotoxicity Assessment During Product Development, will highlight the development and application of novel methods and approaches that have the potential to improve well-established safety studies and risk assessments. In addition, the presentations will focus on in vitro/in vivo systems and computational approaches that can be used to support and enhance the data that are required for regulatory submissions and improve human health risk assessments.
The session will include an introduction to the latest developments in mutagenicity assays followed by a discussion on methods to generate mode of action data that allow for better compound characterization and improve decision-making. Other talks will address novel 3D systems and the application of point of departure metrics to enable quantitative analyses of the data obtained from genotoxicity assays. These topics will be of interest to both genetic toxicology experts, as well as other toxicologists who want to learn about emerging developments in genetic toxicology testing, risk assessment approaches, and how these can be utilized to make informed decisions. The course content also emphasizes the importance of in vitro studies in addressing 3Rs initiatives and their increasing role in genetox testing and human risk assessment.
Overall, this CE course will deliver comprehensive information on new technologies along with practical examples, so attendees will come away with an understanding of how state-of-the-art approaches can be applied to benefit their product development activities. For information on the entire CE program, please visit the SOT website.