Dr. Amy Kimzey is a Senior Scientist with ToxStrategies, Inc., and is located in the Massachusetts area. She is a board-certified toxicologist with seven years of experience in the pharmaceutical industry, with both large pharmaceutical companies and small start-ups. As a discovery toxicologist, Dr. Kimzey has worked on dozens of early-stage projects in the cancer and antibiotic therapeutic areas. She has extensive experience as a project-team liaison on multidisciplinary discovery project teams with accountability for designing discovery toxicology screening and testing paradigms appropriate to the project stage, therapeutic area, and disease setting, in order to advance lead discovery candidates through the selection process and into formal GLP development.
Dr. Kimzey also specializes in writing toxicology monographs for drug impurities and excipients, writing regulatory submissions (pre-INDs, INDs, IBs), conducting drug target safety evaluations and early-stage toxicology risk evaluations, assessing toxicities specific to antibiotics, interpreting in vitro assay results, and designing discovery toxicology programs to maximize value with minimum investment. With a background in biochemistry, Dr. Kimzey is uniquely qualified to understand target pathways, underlying biological mechanisms of disease states, toxicology biological mechanisms, and bioanalytical approaches used to support pharmaceutical toxicology.
Dr. Kimzey also has toxicology expertise with oncology products, designing early-stage oral and intravenous (bolus, infusion) in vivo toxicology studies, and summarizing the chemical contributions (e.g., aromatic amines, chelating groups) and biological contributions (e.g., target, near-neighbor) of small-molecule candidates for toxicology risk profiles.
Prior to joining ToxStrategies, Dr. Kimzey worked in the pharmaceutical industry for seven years, and prior to that, she was a biochemist/cell biologist for a start-up company.