Salma Lemtouni, MD, MPH
Dr. Lemtouni, in her 14 years at the Food and Drug Administration (FDA), acquired deep insight into FDA’s structured approach to Benefit-Risk assessment in drug regulatory decision-making, FDA’s approach to post-marketing safety evaluation and the impetus behind FDA’s policies and regulations.
At FDA’s Division of Cardiovascular and Renal Products, as a Senior reviewer, Dr. Lemtouni guided pharmaceutical industry sponsors into developing sound regulatory plans that furthered drug development programs and achieved approval and marketing of much needed new therapies. At FDA’s Safe Use Initiative, she identified and investigated multiple post-marketing safety signals that led to regulatory action. Dr. Lemtouni was given multiple awards for excellence in review and communication, for her contribution to redesigning New Drug Application review tools and for initiating internal and external collaborations that focused on the safety of FDA approved products.
Previous to her FDA tenure, as a medical officer at Medtronic, Dr. Lemtouni initiated and established the clinical program for the premarket approval of SYNCRATM CRT-P (Cardiac Resynchronization Therapy in heart failure); and as a co-primary investigator, she managed 64 clinical trial centers in one of NIH’s largest studies, ALLHAT (Anti-hypertensive and Lipid Lowering to prevent Heart Attack Trial), the findings of which shaped the guidelines and changed the practice of medicine in the management of hypertension.