Virginia (ginny) Schmith, Ph.d. Fcp
Clinical Pharmacology and Pharmacometrics
Dr. Schmith has 28 years of leadership and experience in Clinical Pharmacology and Pharmacometrics. Dr. Schmith provides expert consulting in clinical development and pharmacometric strategies for compounds from candidate selection through registration and beyond; development, implementation, and interpretation of strategies (e.g. protocols, analyses, reports, briefing documents, IND, NDA/MAAs) for pharmacokinetics/ pharmacodynamics and modeling and simulation, participating in regulatory meetings (including Advisory Committees), and evaluating the probability of successful differentiation from competitors. Her therapeutic area experience includes Anesthesia, Dermatology, CNS, Antiviral, Gastrointestinal, Cardiovascular, Hematology, Duchenne Muscular Dystrophy, Respiratory, and Inflammation. Dr. Schmith has worked on approximately 10+ NDAs/MAAs, 10+ INDs, 50+ PK/PD or Population PK/PD analyses.
Anesthesia, Dermatology, CNS, Antiviral, Gastrointestinal, Cardiovascular, Hematology