Ms. Mease is a Senior Scientist with ToxStrategies, based in Research Triangle Park, NC. She has more than 10 years of experience in the pharmaceutical industry, focusing on nonclinical biopharmaceutical/pharmaceutical development. During her career, she has accrued extensive experience in the overall drug development process, particularly the nonclinical safety assessment studies required for the development of biopharmaceutical/pharmaceutical products. This broad experience allows her to provide unique and innovative solutions to drug development challenges. Ms. Mease has expertise in the design, conduct, data interpretation, and reporting of in vivo pharmacokinetic and toxicology studies. She works closely with various Contract Research Organizations (CROs) to identify the most appropriate one to perform various in vivo and in vitro studies, and oversees all aspects of study conduct, including cost management, protocol development, study monitoring, report finalization, and regulatory submission support. Additionally, she is skilled in evaluating hazards, risks, and mitigation plans associated with exposures to pharmaceutical compounds and excipients.
Ms. Mease began her pharmaceutical career in biopharmaceuticals and has experience engineering and characterizing high-producing, antibody-secreting, mammalian cell lines for therapeutic products, and evaluating and optimizing novel approaches to increase mammalian protein expression. In addition, she has supported regulatory submissions (e.g., investigational new drugs, biologic license applications [INDs, BLAs]) for biopharmaceutical products. As a scientist in drug metabolism and pharmacokinetics (DMPK), Ms. Mease developed expertise in drug transporters for the purpose of predicting potential drug/drug interactions of small molecules. Thereafter, she became a Study Director, overseeing GLP and non-GLP studies in rodents, canines, and non-human primates. More recently, Ms. Mease worked at the National Institute of Environmental Health Sciences (NIEHS), supporting the small business grant program, with a focus on grants that support exposome research, the National Toxicology Program, and the Superfund Research Program. In this role, she mentored small businesses, providing guidance on bringing technologies from bench to bedside and beyond.