OpenTox Virtual Conference 2021 Session 11

QSAR Approaches for Potential Mutagenic Impurities Assessment

Application of (quantitative) structure-activity relationship (QSAR) models for the hazard assessment and classification of potentially mutagenic impurities and the role of expert reviews to determine a final decision on conflicting or inconclusive predictions and supporting the relevance of any positive or negative predictions.

CV: Alejandra Trejo-Martin is a Senior Associate Scientist in the Environmental and Occupational Toxicology group at Gilead Sciences, where she authors QSAR assessments of impurities for ICH M7 compliance, documentation for occupational health categorizations / occupational exposure limits, permitted acceptable daily exposures for cleaning validation, environmental risk assessments, and pharmaceutical impurity assessments. She also monitors and reviews toxicology tests including ecotoxicology, mutagenicity testing for impurities, and worker safety testing. Her background includes extensive experience in medicinal chemistry, in Gilead she worked in HIV and HCV NS5A programs, and in prior companies in a variety of targets in the areas of inflammation, cardiovascular and virology diseases. She has a Master of Business Administration MBA from Golden Gate University and a BS in Chemical Pharmaceutical Biologist from the Universidad Nacional de Mexico.