Tom Kern Email & Phone Number

Wilmington, Massachusetts, Us

Study Director and Scientist for ADME preclinical study designs using radiolabeled test articles to determine Pharmacokinetics Properties, Mass Balance, Tissue Distribution and Metabolite Profiling. Key elements – Protocol Development, Data analysis, Formulations, Chromatography, Radiodetection, Radiopurity, Knowledge of Preclincal models, ADME Data Interpretation, Report Preparation and Customer Interactions. Principal Investigator for Dosimetry analysis. Member of the IACUC. GLP experienced.

Staff Scientist, Study Direction o Study Director in Global Drug Metabolism group responsible for design, conduct and reporting of Pharmacokinetic (PK) studies to meet scientific, regulatory and client requirements o Responsible for client interaction and management of client relationshipso Offer direction and guidance to study staff and to make scientific contributions where appropriateo Responsible for protocol design, managing resources, solving study issues, and communicating all related study information to the appropriate individuals, including clients

Manager of Preclinical Studies, Toxicology Formulations and Specimen Processing o Managed team of approximately 20 technical staff which was involved in the conduct of preclinical, primarily pharmacokinetic studies (PK)o Managed the Dose Formulations team which was responsible for preparation of test articles for dosing live phase animal studies o Managed the Specimen Processing team which performed the processing of samples derived from live phase studieso Key initiatives of the above roles: o Responsible for hiring, staffing, performance reviews, productivity metrics, SOP approvals, training and process innovations o Established Specimen Processing resource and staffed group using first site contractor serviceso Consolidated study staff and equipment to one site for greater efficiencyo Served on Six Sigma Blackbelt project to decrease the ADME PK study’s scheduling time from 13 days to 4 or 7 days o Assumed the role of Radiation Study Principal Investigator increasing the efficiency and safety of using C14, H3 and I125 in animal studies

Wilmington, Massachusetts, Us

Manager of Lead Optimization Toxicologyo Hired to bring Lead Optimization (LO) Toxicology service line to the Charles River siteo Completely responsible for establishing a new service area and serving as the only study director for LO studieso Made site visits with sale representative to promote service to pharmaceutical customers needing lead optimization toxicology to further their drug discovery processes

o Supervisor for Lead Optimization Toxicology and Drug Discovery studies conducted to evaluate the early toxicity and pharmacokinetic profiles of new chemical entitieso Oversight of multiple procedures in rodents, canines, primates, and rodent surgical modelso Responsible for presentations to management, customers and associates regarding changes in processes, resources, and resultso Responsible for startup and promotion of a Drug Disposition support team within the traditional toxicology site

o Study director and area manager for acute and short-term toxicology studies conducted in compliance with federal and international guidelines and Good Laboratory Practices (GLP)

Degree Of Master Of Science - Pharmacology And Toxicology, Pharmacology And Toxicology

Degree Of Bachelor, Biology