Biography

Dr. David Gortler is a clinical research scientist in the areas of atherosclerosis, atheroprogression, cholesterol metabolism (including: statin pharmacology and lipid/ LDL/ HDL modulation) and obesity. He is proficient in the drug development process, the drug approval process, clinical trial design, the FDA efficacy/safety review process and drug labeling. Among other reviews, he was the lead FDA clinical reviewer for the SEARCH Trial which compared simvastatin 20 mg to 80 mg. Prior to being a Senior Medical Analyst and Medical Officer at the FDA in the Office of New Drugs, he was an Assistant Professor of Pharmacology at Yale University, and prior to that he was an early-phase Investigational Medicine Scientist at Pfizer Inc. in the area of lipid metabolism and, atherosclerosis.