Computational Toxicologist
US Food and Drug Administration
Silver Spring, Maryland
Dr. Naomi Kruhlak has worked for US FDA’s Center for Drug Evaluation and Research (CDER) as a computational toxicologist for 22 years, developing and applying (quantitative) structure-activity relationship ((Q)SAR) models to support the regulatory review of pharmaceuticals. She is the Scientific Lead for CDER’s Computational Toxicology Consultation Service and is the Principal Investigator on three FDA/CDER Research Collaboration Agreements with commercial (Q)SAR software vendors, as well as an Inter-Agency Agreement with NIH generating in silico-based drug safety predictions. Dr. Kruhlak has published 46 peer-reviewed articles and book chapters describing data standardization, transformation, and classification for modeling purposes, as well as the creation and regulatory application of (Q)SAR models with chemical interpretability. Most recently, she led the development of the Carcinogenic Potency Categorization Approach for predicting the carcinogenic potency of nitrosamine impurities. Dr. Kruhlak holds B.Sc. and Ph.D. degrees in chemistry from the University of Salford, England, and the University of Calgary, Canada, respectively.
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Tuesday, July 23, 2024
10:25 AM – 10:55 AM CST
Nitrosamine Analysis and Control Panel Discussion
Tuesday, July 23, 2024
10:55 AM – 11:25 AM CST