Responsibilities included the design of human PK/PD studies that established through modeling the risk assessment of specific toxicological agents in the diet in Phase I clinical studies with healthy volunteers as well as Phase II studies in patients with coronary heart disease. Developing and optimizing analytical methods for reporting toxicant levels in biological matrices.

* Pharmacokinetist in the Pharmacokinics, dynamics, and drug metabolism department evaluating new drug candidates in discovery. * Responsibilities included the development of discovery oncology projects. * Supervised several associates, and characterized with comprehensive in vitro and in vivo techniques numerous novel compounds for a variety of chemotherapeutic targets. * In vitro experiments included protocol development and analytical methodology for metabolic stability; P450 enzyme inhibition, induction, and identification; protein binding; blood to plasma partitioning * In vivo pharmacokinetic studies included oral and systemic delivery of novel agents to small and large animals to determine the pharmacokinetics for compound optimization and prediction of human clearance mechanisms and dosing regimens * Pharmacokinetic and Pharmacodynamic modeling with biomarkers in small animals

Formulated and characterized the association of the nitrosourea lomustine (CCNU) with small unilamellar phospholipid liposomes. Demonstrated through pharmacokinetic and toxicological analysis the therapeutic potential of liposomal CCNU, compared to the free drug, by in vitro culture methods and in vivo studies in an adapted animal tumor model. Conducted pharmacokinetic data analysis that compared the distribution and exposure of the liposomal analgesic agents morphine and sufentanil to free drug after epidural administration in a cannulated pig model. Developed a novel HPLC assay to detect the aminoglycoside antibiotic G418 in mouse tissue after systemic administration of the drug in free or liposomal formulations.

Performed urgent and routine clinical analysis in the departments of: Blood banking, hematology, clinical chemistry, coagulation, urinalysis, microbiology, and phlebotomy.

Activities in this role included the coordination and writing of key project documents such as clinical study protocols, safety sections of informed consents, statistical analysis plans, and clinical study reports. Responsibilities included assisting in the preparation of clinical study manuscripts and review of literature to proactively provide feedback on emerging clinical trends. I worked to prepare clinical trial drug manuals, approve central and local lab service agreements, and contribute to the safety sections of Investigator’s brochures, DSUR, and clinical sections of INDs. I was accountable for the conduct of clinical study safety and efficacy reviews as well as ad hoc pharmacodynamic analysis in collaboration with biometrics.

Responsibilities included research and development of proprietary lipid delivery systems through formulation, stability, and non-clinical pharmacokinetic and pharmacodynamic studies Characterized the non-linear pharmacokinetics and consequent pharmacodynamic behavior of several sustained-release formulations of large molecular therapeutic agents Participated in the creation of a pipeline for the selection of new drug candidates for existing delivery systems