Posters - NCDEU: An Annual Meeting Sponsored by ASCP

Featured Speakers
Silvana Borges, M.D.
Food and Drug Administration
Dr. Borges received her Medical Degree from the State
University School of Medicine in Uruguay. She completed
her medical residency and got board certified in Child
& Adolescent Psychiatry. She joined the Department of
Pharmacology and Therapeutics in the State University
School of Medicine as an Assistant Professor and then
became an Assistant Professor and Founding Member
of the “National Center for Drug Safety” in Uruguay. She
was a Scholar at the Catalan Institute of Pharmacology
(Barcelona, Spain) focusing her training in drug safety and
pharmacoepidemiology. She received the Merck Foundation International Fellowship in
Clinical Pharmacology Award and completed a fellowship in clinical pharmacology and
pharmacogenetics at Indiana University, being mentored by Dr. David Flockhart. She
was the recipient of the American Society for Clinical Pharmacology and Therapeutics
Presidential Trainee Award for her work on the role of CYP2D6 genetic polymorphism
on tamoxifen metabolism and its interaction with antidepressants. She is currently a
Medical Officer with the Division of Psychiatry Products, Office of New Drugs, U.S.
Food and Drug Administration.
Phillip Kronstein, M.D.
Food & Drug Administration
Phillip Kronstein, M.D. is a Senior Medical Officer in the
Division of Psychiatry Products (DPP) at the U.S. Food
and Drug Administration’s Center for Drug Evaluation and
Research (CDER). In this position, Dr. Kronstein manages
clinical reviews of Investigational New Drugs (INDs) and
New Drug Applications (NDAs). Prior to joining the FDA
in January 2008, he was a Clinical Research Fellow in the
Experimental Therapeutics and Pathophysiology Branch
at the National Institute of Mental Health, where he
conducted trials in treatment-resistant depression
and bipolar disorder. He received a Bachelor’s of Science in Chemistry from the
University of Chicago in 1995 and a Doctor of Medicine from Tufts University School
of Medicine in 2001. He completed his residency training in Psychiatry at the Johns
Hopkins Hospital in June 2005. In addition to his review responsibilities at the FDA, Dr.
Kronstein is currently involved in regulatory research looking at sexual dysfunction with
antidepressants. He is also the Division Data Standard Lead for DPP as CDER, as part
of a larger FDA initiative, continues to develop and implement standards to represent
study data submitted in support of regulatory applications.
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