Naomi Kruhlak, PhD

Scientific Lead, Division of Applied Regulatory Science, OCP, OTS, CDER

Dr. Naomi Kruhlak has worked for US FDA’s Center for Drug Evaluation and Research (CDER) as a computational toxicologist for over 20 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 45 peer-reviewed articles and a book chapter describing data standardization, transformation, and classification for modeling purposes, as well as the creation and regulatory application of (Q)SAR models with chemical interpretability. Dr. Kruhlak holds B.Sc. and Ph.D. degrees in chemistry from the University of Salford, England, and the University of Calgary, Canada, respectively.

Early bird tickets
available now