Address

868 106th Ave North Naples, FL 34108

Salma Lemtouni, MD, MPH

Regulatory Consultant

Biography

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.

Education

  1. 1989

    Masters in Public Health Epidemiology

    University of Minnesota School of Public Health
  2. 1983

    Doctorate in Medicine

    Université Mohammed V Faculté de Medicine

Professional Experience

  1. 2002-2016
    Medical Officer
    FDA
  2. 1999-2001
    ALLHAT Clinical Trial CoPI
    Minneapolis Medical Research Foundation
  3. 1996-1999
    Medical Officer
    Medtronic, Inc. Minneapolis, MN
  4. 1992-1995
    Visiting Fellow
    National Cancer Institute, Tokyo Japan
  5. 1990-1992
    Post-Doctoral Fellow
    Fred Hutchinson Cancer Center

Awards

  • 2015
    CDER Walk of Fame: Excellence in Communication Award
    FDA
  • 2011
    Assistant Secretary's Honor Award
    HHS
  • 2005
    Leverage/Collaboration Award
    Office of Women’s Health, FDA
  • 1993
    Fellowship
    NIH & Japan Science and Technology Agency
  • 1990
    Fellowship
    NIEHS AND NCI Post-Doctoral Fellow