BACKGROUND
FOCUS AREAS
AWARDS & HONORS
17 years of FDA regulatory experience in drug development in several therapeutic areas.
Regulatory strategy for drug development.
Novel clinical trial designs.
Biomarkers and surrogate endpoints in clinical trials.
American Society for Clinical Pharmacology and Therapeutics (ASCPT) Presidential Trainee Award.
Merck Foundation International Fellowship Award in Clinical Pharmacology.
CSIC Fellowship in Drug Safety and Pharmacoepidemiology.
As Senior Vice President at ELIQUENT Life Sciences, Silvana Borges utilizes her broad regulatory experience to provide scientific advice and strategic direction on significant aspects of drug development programs.
Silvana is a physician trained in psychiatry, clinical pharmacology, and pharmacogenomics with 17 years of experience at the U.S. Food and Drug Administration (FDA). Her tenure at the FDA included 15 years in the CDER’s Office of New Drugs, where she served in positions of increasing responsibility as clinical reviewer and team leader in the Division of Psychiatry, Associate Director for Regulatory Science in the Office of Drug Evaluation II and the Office of Neuroscience, and Deputy Division Director in the Division of Anesthesiology, Addiction Medicine, and Pain Medicine.
Her expertise spans a wide range of regulatory and policy issues related to the evaluation of investigational new drugs and new drug applications, and the use of novel designs, biomarkers and surrogate endpoints in clinical trials. She can also offer insights into the standards for generic drug development, having served as the Deputy Division Director in the Division of Therapeutic Performance II of the FDA Office of Generic Drugs.
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EDUCATION:
M.D., University of the Republic School of Medicine, Uruguay, ECFMG Certified.
Residency in Child and Adolescent Psychiatry, University of the Republic, Childrens’ Hospital, Uruguay.
Fellowship in Drug Safety and Pharmacoepidemiology, Catalan Institute of Pharmacology, Barcelona, Spain.
Fellowship in Clinical Pharmacology and Pharmacogenomics, Division of Clinical Pharmacology, Indiana University, USA. -
• Deputy Division Director, Division of Anesthesiology, Addiction Medicine, and Pain Medicine, Office of New Drugs, CDER, FDA.
• Deputy Division Director, Division of Therapeutic Performance II, Office of Generic Drugs, CDER, FDA.
• Associate Director for Regulatory Science, Office of Drug Evaluation II and Office of Neuroscience, Office of New Drugs, CDER, FDA
• Senior Clinical Advisor, Guidance and Policy Team, Office of New Drugs, Immediate Office, CDER, FDA
• Clinical Team Leader, Division of Psychiatry Products, Office of New Drugs, CDER, FDA.
• Clinical Reviewer, Division of Psychiatry Products, Office of New Drugs, CDER, FDA.
• Clinical and Genomics Reviewer, Office of Clinical Pharmacology, CDER, FDA.
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