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Luis Valerio

Luis Valerio

Gathering evidence for the public good

Luis G. Valerio, Jr., PhD ’98, a toxicologist with the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, didn’t envision himself an advocate for the public at the onset of his career. While Valerio’s early research career centered on basic science, his desire to more directly impact people’s lives with the science of toxicology eventually led him to focus his work in public policy. As a pharmacology/toxicology reviewer for the FDA, he assesses the safety and efficacy of new therapeutic drugs for gastroenterology, specifically ulcerative colitis, autoimmune hepatitis and Crohn’s disease.

Valerio shares his knowledge with School of Pharmacy students as an adjunct professor for special projects in the Department of Pharmaceutical Sciences. “I like where I work now and want to stay there, but I also want to stay connected with the school,” he said. “I want to give back to the school which had such an impact on my career, so this arrangement is perfect.”

Valerio received his doctorate in pharmaceutical sciences from the School of Pharmacy in 1998. While at the SOP, he received two predoctoral fellowships to work with Dennis Petersen, PhD, professor of pharmacogenetics and pharmacology,
and John Thompson, PhD, professor of medicinal chemistry. In 2000, he completed his postdoctoral research as a gastroenterology fellow with the School of Medicine. He earned a postdoctoral research fellowship from the National Science Foundation to work in Barcelona, Spain, where he focused on the enzymology and role of oxidative and reductive enzymes in metabolism.

Upon returning to the United States, Valerio wanted a change from basic research and try applied science. He had developed an interest in consumer product safety and took a position as senior scientist in product safety at Mary Kay Inc., a skin care and cosmetics company based in Dallas, Texas.

After three years of safety testing dermatological products in a business driven environment, Valerio was ready to return to a more science-based environment, which led him to the FDA.

“I wanted to get closer to the science that goes directly to the public,” he said. “I wanted to work at the FDA because it’s a place where science and policy come together. There, I could use scientific rationale with regulatory laws to approve or permit products that consumers are exposed to. I felt that was closer to the real world.”

In 2003 he joined the FDA’s Center for Food Safety and Applied Nutrition in College Park, Md, as a toxicology reviewer for the premarket safety assessment of food additives, such as flavoring agents, GRAS ingredients (“generally recognized as safe" by the Food and Drug Administration) and super sweeteners. He then moved to the FDA’s Center for Drug Evaluation and Research (CDER) Office of New Drugs as a pharmacology/toxicology reviewer assessing the safety and efficacy of new medical drugs.

He recently accepted a position as toxicologist with the CDER Office of Pharmaceutical Science, Infomatics and Computational Safety Analysis Staff (ICSAS). ICSAS is an applied regulatory research unit that performs predictive toxicity screening of drugs for human adverse health effects and critical endpoints in the safety evaluation and regulatory approval of drugs such as carcinogenicity, mutagenicity and reproductive toxicity -- endpoints that cannot be tested in humans.

Valerio develops the predictions in silico using advanced computer software and complex quantitative structure-activity relationship modeling of drugs.

Valerio has served as an expert for the United Nations World Health Organization/Food and Agriculture Organization Joint Expert Committee on Food Additives. He has served as an FDA expert toxicology witness in federal government criminal cases involving unapproved food additives and drugs supporting the agency’s enforcement efforts to protect the public’s health.

He was awarded a life-time visiting professor appointment at a private medical university in Lima, Peru; has authored more than 30 publications and has served on the editorial board of Toxicological Reviews. He is associate editor of Toxicology Mechanisms and Methods and was chosen to appear on a national multinetwork television broadcast for the Department of Health and Human Services as a role model encouraging Hispanics to work in U.S. government positions.

His professional interests include xenobiotic metabolism, and predictive modeling of the carcinogenicity, hepatotoxicity, and reproductive toxicity of drugs. In his free time, Valerio enjoys traveling with his family, learning about other languages and cultures, and outdoor activities such as fresh water fishing. Valerio, who grew up in Rye, Colo., lives with his wife, Carmen, and their two children in Maryland, just outside of Washington, D.C.