Dr. Leonowens has 11 years of experience in clinical and pre-clinical pharmacokinetic and pharmacodynamic study design, modeling/simulation, data analysis/interpretation, and drug interaction studies. Her primary focus is on early clinical drug development where data, team discussions and development decisions are dynamic and evolving. Her technical experience is in utilizing pre-clinical and clinical pharmacokinetic and pharmacodynamic modeling and simulation, analysis, and interpretation to drive project, clinical and regulatory results. Her experience includes pre-clinical, First in Human Studies, and Phase 1-3 development of Oncologic, Anti-Infective and Dermatologic therapeutics. She is recognized for leading data-driven team discussions and decisions to support drug development milestones (e.g. Pediatric Oncologic Drugs Advisory Committee meeting, study design, regulatory submissions) using fundamental pharmacology principles. Dr. Leonowens has worked on 2 NDAs, 1 BLA, 2 INDs, 60+ PK analyses and 40+ modeling/Population PK analyses.