Ms. Mease is a Senior Managing Scientist with ToxStrategies, based in Research Triangle Park, NC. She has more than 20 years of experience in the pharmaceutical industry, focusing on nonclinical biopharmaceutical and 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 and pharmaceutical products. This broad experience allows her to provide unique and innovative solutions to drug development challenges. Ms. Mease has extensive experience in the design, conduct, data interpretation, and reporting of in vivo pharmacokinetic and toxicology studies (GLP and non-GLP). She works closely with high-quality Contract Research Organizations (CROs) across multiple countries 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.
Ms. Mease has worked on the development of multiple therapeutic areas, including monoclonal antibodies, enzyme replacement therapies, and small molecules for various indications (e.g., hematology, immunology, neurology, oncology, ophthalmology, pain, and rare diseases), using various routes of administration (intravenous, subcutaneous, intravitreal, epidural, intrathecal, and oral), across nonclinical species (rodents, rabbits, dogs, and non-human primates). In addition, she has written the nonclinical sections of various regulatory documents, including pre-IND (investigational new drug) packages, INDs/CTAs, Investigator Brochures, pediatric study plans, and DSUR annual reports. She also develops nonclinical strategy and regulatory briefing packages for Type B, Type C, and European Scientific Advice interactions, as well as providing representation at regulatory authority meetings in the US and EU.
Ms. Mease’s small-molecule experience also includes drug transporter study design and data interpretation in the assessment of drug candidates.
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. Ms. Mease also 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.