Dr. Amy Kimzey is a Managing Scientist with ToxStrategies, Inc., and is located in Massachusetts. She is a board-certified toxicologist with nine years of experience in the pharmaceutical industry, with both large pharmaceutical companies and small start-ups. She has experience as a project-team liaison on multidisciplinary discovery and development project teams, with accountability for designing discovery and development toxicology screening and testing paradigms appropriate to the project stage, therapeutic area, and disease setting.
Dr. Kimzey also specializes in writing regulatory submissions (pre-INDs, INDs, IBs, briefing books, carcinogenicity risk assessments, and NDAs), due diligence evaluations, and toxicology monographs for drug impurities and excipients; conducting drug target safety evaluations and early-stage toxicology risk evaluations; interpreting in vitro and in vivo assay results; and designing toxicology programs to maximize value with minimum investment. With a background in biochemistry, Dr. Kimzey understands target pathways, underlying biological mechanisms of disease states, biological mechanisms of toxicity, and bioanalytical approaches used to support pharmaceutical toxicology.
Dr. Kimzey also has toxicology expertise with oncology products, the design and monitoring of non-GLP and GLP toxicology studies, managing infusion reactions on nonclinical studies, and summarizing the chemical contributions (e.g., aromatic amines, chelating groups) and biological contributions (e.g., target, near-neighbor) of small-molecule and large-molecule candidates for toxicology risk profiles.
Prior to joining ToxStrategies, Dr. Kimzey worked as a toxicologist in the pharmaceutical industry, and prior to that, she was a biochemist/cell biologist for a start-up company.