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Strategic guidance from
proven professionals

Fethi Trabelsi, Ph.D.

Vice President, Clinical Pharmacology

Dr. Fethi Trabelsi has over 23 years of experience in scientific and regulatory clinical development for Phase 1-3 clinical pharmacology studies. Dr. Trabelsi has extensive experience with pharmacokinetics (PK), pharmacodynamics (PD), clinical endpoint studies for innovative drug development, and BA-BE studies for NDAs, ANDAs, and 505(b)(2) applications. Dr. Trabelsi is considered an industry leader in the study design for PK/PD trials for new, generic, and hybrid applications for major regulatory agencies. Dr. Trabelsi has supported many pharmacometric modeling projects such as PK/PD (exposure-response), population PK (popPK), physiologically-based pharmacokinetic (PBPK), and concentration-QT (C-QT) analysis. Dr. Trabelsi has supported many pre-IND meetings with FDA, scientific-advice meetings with european agencies, and has interacted regularly with major agencies for clinical innovative programs. His therapeutic area expertise includes oncology, cardiovascular, CNS, and more.

Education

  • Post-Doctoral Research Fellow, Physiology-Pharmacology
    • University of Montreal, Canada
  • Doctor of Kinesiology, Exercise Physiology
    • University of Montreal, Canada
  • Master of Exercise Physiology
    • University of Montreal, Canada