Resolving the Unexpected: Strategies for Understanding Genetox Data

This seminar will provide a high-level overview of standard genetic toxicology assays followed by secondary and mechanistic assays that could be used in the case of a positive result in the standard battery of tests. Additionally, the seminar will cover testing requirements for impurities.

Seminar Topics include:

• High-level overview of genetox and why it's required by regulators

• FISH/CREST in vitro assays for elucidating mode of action
• CREST in vivo
• Comet assay
• Pig-a assay

• Bonus! Impurities testing including Enhanced Ames Test for Nitrosamines

Speaker Bios:

Shambhu Roy, MSc, PhD, DABT, ERT Principal Scientist/Study Director Genetic Toxicology

Dr. Roy is a Board Certified (DABT and ERT) Toxicologist with over 20 years of experience in the field of genetic toxicology including three years of post-doctoral research with hands-on practical work knowledge. Shambhu Roy is currently Principal Scientist, oversees the in vivo and in vitro genetic toxicology assays at Inotiv, Rockville MD. Dr. Roy received M.S. and PhD degrees from Gujarat University, India in 1992 and 2000, respectively; studied life sciences with special emphasis on cell biology, role of tobacco in mutagenesis and cancer genetics. Dr. Roy joined a postdoctoral program at University of California, Riverside, in the department of Environmental Toxicology and Neurosciences from 2000-2003. During postdoctoral research he worked extensively on fluorescence in situ hybridization and CREST techniques to screen aneugenic compounds. Since then, he has held various scientific and supervisory positions in contract research organizations. Dr. Roy has conducted thousands of Toxicological assays in multiple in vivo and in vitro test systems, has participated in developing and validating new assay system to meet the emerging challenges in Toxicology. Dr. Roy has published his research works in multiple peer reviewed journals and presented in scientific meetings. Dr. Roy’s current focus is on the development and validation of animal alternative assays (i.e., 3D skin model based micronucleus assay for the safety assessment of dermatological product, particularly for cosmetic industries and spheroid model using organ specific cells). Prior to Inotiv, Dr. Roy served as a Senior Scientist and Study Director in the Genetic Toxicology Divisions of both BioReliance and Covance Labs.

Shannon Wilson Bruce, MFS Senior Scientist/Study Director Genetic Toxicology

Shannon Wilson Bruce is a Senior Scientist and Study Director for various genetic toxicology assays at Inotiv. She received her master’s degree from The George Washington University, Washington DC. She has more than 16 years of laboratory experience in performing various screening assays, mutation assays, cell transformation assays, and DNA damaging assays. She has participated in several international validation studies including both Japanese Center for Validation of Alternative Methods (JaCVAM) – In-Vitro Comet assay and In Vivo Comet assay validations, European Centre for Validation of Alternative Methods (ECVAM) – SHE Cell Transformation assay at neutral and low pH, and New Energy and Industrial Technology Development Organization, Japan (NEDO) project – Bhas-42 Cell Transformation Assay. She is co-author of more than 12 publications including peer-reviewed articles. Prior to Inotiv, Shannon was a Senior Scientist in the Genetic Toxicology Division at BioReliance.