12 Application of Computational Methods for the Safety Assessment …
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Patra Volarath is Lead Cheminformatics Scientist in the Office of Food Additive Safety (OFAS)
at the Center for Food Safety and Applied Nutrition (CFSAN) at the United States Food and Drug
Administration. She received her Ph.D. in Biophysical Chemistry (2008) and M.S. in Molecular
Genetics and Biochemistry (2002) from Georgia State University. She joined the National Center
for Computational Toxicology at the U.S. Environmental Protection Agency as a Postdoctoral Fellow in 2010, before joining OFAS in 2013 to work on the FDA’s Chemical Evaluation and Risk
Estimation System (CERES) project.
Yu (Janet) Zang is Board-Certified Toxicologist at United States Food and Drug Administration
(FDA) Center for Food Safety and Applied Nutrition (CFSAN). As a toxicology reviewer, she
conducts pre-market safety review of FDA-regulated food substances, including direct and indirect
food additives, color additives, and other food ingredients. She received her B.S and M.S. degrees
in Environmental Biology from Nanjing University, China. She obtained her Ph.D. in Pharmacology and Toxicology from University of Louisville School of Medicine. Before she joined FDA in
2009, she completed her toxicology postdoctoral training at Johns Hopkins Bloomberg School of
Public Health. She has served as the toxicological and risk assessment resource person on many
national and international food safety working groups convened by NIH, NTP, OECD, FAO, and
WHO. She is selected to the current (2016–2020) Joint FAO/WHO Expert Committee on Food
Additives (JECFA) Roster of Toxicological and Epidemiological Experts and has authored a number of JECFA monographs. She has also served in several leadership committees within the Society of Toxicology (SOT), including the Carcinogenesis Specialty Section and Food Safety Specialty Section.
Shruti V. Kabadi is Pharmacologist at the United States Food and Drug Administration (US
FDA). She works as a toxicology reviewer in the Office of Food Additive Safety (OFAS) at the
Center for Food Safety and Applied Nutrition (CFSAN) where she performs primary toxicological reviews of food contact notifications (FCN) and prenotification consultations (PNC). She
received her Ph.D. in Pharmacology from Massachusetts College of Pharmacy and Health Sciences (MCPHS) in Boston in 2009. She completed her postdoctoral training in neuropharmacology (traumatic brain injury) at Georgetown University (Washington, DC) and University of Maryland (Baltimore, MD). She worked as a research faculty member at the School of Medicine of
the University of Maryland prior to joining the FDA in 2014. Over the past four years, she has
specialized in the use of mechanistically informed modeling approaches for safety assessments
of food ingredients. She has utilized classic as well as physiologic pharmacokinetic modeling for
predicting toxicity or evaluating the safety of food substances. Her work has been published as
peer-reviewed original research articles, review articles, and chapters. She has received awards for
her work as a reviewer at FDA and has participated in and chaired sessions at international conferences. She teaches pharmacokinetics classes to undergraduate and graduate students in some
universities outside of her work responsibilities at the US FDA.
257
Patra Volarath is Lead Cheminformatics Scientist in the Office of Food Additive Safety (OFAS)
at the Center for Food Safety and Applied Nutrition (CFSAN) at the United States Food and Drug
Administration. She received her Ph.D. in Biophysical Chemistry (2008) and M.S. in Molecular
Genetics and Biochemistry (2002) from Georgia State University. She joined the National Center
for Computational Toxicology at the U.S. Environmental Protection Agency as a Postdoctoral Fellow in 2010, before joining OFAS in 2013 to work on the FDA’s Chemical Evaluation and Risk
Estimation System (CERES) project.
Yu (Janet) Zang is Board-Certified Toxicologist at United States Food and Drug Administration
(FDA) Center for Food Safety and Applied Nutrition (CFSAN). As a toxicology reviewer, she
conducts pre-market safety review of FDA-regulated food substances, including direct and indirect
food additives, color additives, and other food ingredients. She received her B.S and M.S. degrees
in Environmental Biology from Nanjing University, China. She obtained her Ph.D. in Pharmacology and Toxicology from University of Louisville School of Medicine. Before she joined FDA in
2009, she completed her toxicology postdoctoral training at Johns Hopkins Bloomberg School of
Public Health. She has served as the toxicological and risk assessment resource person on many
national and international food safety working groups convened by NIH, NTP, OECD, FAO, and
WHO. She is selected to the current (2016–2020) Joint FAO/WHO Expert Committee on Food
Additives (JECFA) Roster of Toxicological and Epidemiological Experts and has authored a number of JECFA monographs. She has also served in several leadership committees within the Society of Toxicology (SOT), including the Carcinogenesis Specialty Section and Food Safety Specialty Section.
Shruti V. Kabadi is Pharmacologist at the United States Food and Drug Administration (US
FDA). She works as a toxicology reviewer in the Office of Food Additive Safety (OFAS) at the
Center for Food Safety and Applied Nutrition (CFSAN) where she performs primary toxicological reviews of food contact notifications (FCN) and prenotification consultations (PNC). She
received her Ph.D. in Pharmacology from Massachusetts College of Pharmacy and Health Sciences (MCPHS) in Boston in 2009. She completed her postdoctoral training in neuropharmacology (traumatic brain injury) at Georgetown University (Washington, DC) and University of Maryland (Baltimore, MD). She worked as a research faculty member at the School of Medicine of
the University of Maryland prior to joining the FDA in 2014. Over the past four years, she has
specialized in the use of mechanistically informed modeling approaches for safety assessments
of food ingredients. She has utilized classic as well as physiologic pharmacokinetic modeling for
predicting toxicity or evaluating the safety of food substances. Her work has been published as
peer-reviewed original research articles, review articles, and chapters. She has received awards for
her work as a reviewer at FDA and has participated in and chaired sessions at international conferences. She teaches pharmacokinetics classes to undergraduate and graduate students in some
universities outside of her work responsibilities at the US FDA.
