Dr. Smith has 29+ years of leadership and experience in clinical development, clinical pharmacology, and pharmacokinetics across multiple therapeutic areas for small and large compounds from candidate selection through registration and beyond. She has developed, implemented, and interpreted strategies (protocols, analysis/interpretations, dose selection, clinical reports, briefing documents, IND/NDA/MAA, labels). Her therapeutic experience includes 19 years in Oncology [cytotoxic, signal transduction, and immunotherapies], plus Hypereosinophilia, CNS (migraines, epilepsy), CV (anti-hypertensives, bile acid transport inhibitors). Dr. Smith has worked on approximately 4 NDAs/CTDs, 1BLA, and 4 sNDA/sCTDs, 11 INDs/CTDs, 50+ PK or PK/PD analyses.
Education