Gladys V. Erives, Ph.D. (Primary)
Luis Jr., Valerio, Ph.D. (Co-preceptor)
Division of Nonclinical Science (DNCS)
Office of Science/Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD
Gladys V. Erives
Ph.D.- Pharmacology and Toxicology
Minor in Neuroscience
University of Arizona- Tucson
3 years with the US FDA Center for Tobacco Products
Luis G. Valerio, Jr.
Background: Dr. Valerio is a Toxicology Branch Chief in DNCS. He leads a branch of toxicologists and pharmacologists in regulatory review of tobacco product applications and applied regulatory science research. He has over 13 years’ experience at FDA and has a Ph.D. in Pharmaceutical Science from the University of Colorado.
DNCS supports the Center for Tobacco Products Office of Science by providing sound scientific evidence for implementation of the Family Smoking Prevention and Tobacco Control Act. One way DNCS does this is through reviewing applications for substantial equivalent tobacco products, premarket tobacco products, or modified risk tobacco products. In addition, DNCS plans, evaluates and supports a number of research projects aimed at informing our regulatory decision making. Lastly, DNCS provides scientific support for the development of guidance and regulations aimed at protecting the American public from the burden of tobacco related disease.
Proposed Research Project for FDA Fellow
Our goal in DNCS is to use the most current and reliable scientific data to inform our regulatory decision making. In order to do so, it is imperative that we remain abreast of cutting edge research in the fields of toxicology, pharmacology, and risk assessment. Thus, based on the need within the Center, projects may include:
• Interpreting toxicological data from multiple data streams to better elucidate the mechanism of tobacco related disease and specifically towards Electronic Nicotine Delivery Systems (ENDS)
• Evaluating a battery of in vivo ENDs studies and ENDs aerosolization studies to help DNCS understand and assess risks to public health from tobacco products
•Help to develop and evaluate a computational toxicological model for flavors to help understand the tobacco-related risk of toxicity from exposure to flavor ingredients in tobacco products.
• Using scientific research techniques to evaluate the toxicity of certain tobacco products and how changes in such products affect their potential for harm.
Ph.D., DrPH, ScD, or Pharm. D, and research training in pharmacology and/or toxicology is required.
Selected Recent Publications
1. Abdel-Rahman A, Anyangwe N, Carlacci L, Casper S, Danam RP, Enongene E, Erives G, Fabricant D, Gudi R, Hilmas CJ, Hines F, Howard P, Levy D, Lin Y, Moore RJ, Pfeiler E, Thurmond TS, Turujman S, Walker NJ (2011). The safety and regulation of natural products used as foods and food ingredients. Toxicol Sci. 123: 333-348.
2. Erives GV, Lau SS, and Monks TJ (2008). Accumulation of Neurotoxic Metabolites of 3,4(±)-Methylenedioxymethamphetamine in Rat Brain. J Pharmacol Exp Ther 324: 284 -292.
3. Valencia A, Prous J, Mora O, Sadrieh N, Valerio LG Jr. (2013). A novel QSAR model of Salmonella mutagenicity and its application in the safety assessment of drug impurities. Toxicol Appl Pharmacol 273(3):427-34.
4. Valerio LG Jr, Choudhuri S. (2012) Cheminformatics and chemical genomics: potential utility of in silico methods. J. Appl Toxicol 32(11)880-889.
5. Valerio LG Jr, (2011) In silico toxicology models and databases as FDA Critical Path Initiative toolkits. Hum Genomics 5(3):200-7.
6. Valerio LG Jr, (2011) In silico toxicology for the pharmaceutical sciences. Toxicol Appl Pharmacol 241(3):356-70.