Dr. Ali Chesney is a Scientist III in ToxStrategies’ Biopharmaceutical and Pharmaceutical Practice. She oversees the study design, protocol development, study conduct, data interpretation, and reporting of pharmacokinetic, pilot, and general toxicology studies (non-GLP and GLP) and reproductive and developmental toxicity studies in various animal species. Dr. Chesney designs and oversees nonclinical study programs to support clinical development plans and regulatory filings. She has expertise in translational science, with a thorough understanding of GLP requirements and broad knowledge of Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) requirements.
Dr. Chesney has experience with a variety of drug and chemical modalities, including small molecules and biologics for a variety of indications (oncology, immunology, and infectious diseases). She has a close working relationship with multiple high-quality Contract Research Organizations (CROs) in the United States and internationally, and helps clients identify the most appropriate lab based on cost analysis, scientist experience, regulatory compliance, assay validation, and available schedule. She is proactive in avoiding GLP deviations and has a record of working with CROs to minimize impact statements of necessary exceptions.
Dr. Chesney also creates regulatory submissions (pre-INDs, INDs, investigational brochures [IBs], briefing books, carcinogenicity risk assessments, and NDAs), due-diligence evaluations, target liability assessments, and toxicology monographs for drug impurities and excipients. She has experience reviewing and analyzing digital data sets from nonclinical toxicology studies (i.e., Standard for Exchange of Nonclinical Data [SEND]).
She has served as a Study Director in a Contract Research Organization (CRO) in the US and China, where she directed nonclinical acute, short-term, sub-chronic, chronic, and carcinogenicity studies to assess the general toxicology of a variety of pharmaceutical, biological, and food product compounds in support of regulatory agency submissions. She was responsible for the technical conduct of nonclinical toxicology studies, as well as the study design, interpretation, analysis, documentation, and reporting of results. Dr. Chesney has experience developing protocols in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
Dr. Chesney earned her Ph.D. in Molecular and Environmental Toxicology from the University of Wisconsin in Madison; her research focused on amplification and characterization of neuropathogenic proteins, the environmental and in vivo transmission of spongiform encephalopathies (prion diseases), and the inactivation of the prion disease agent. She has experience with a number of animal models including rodents (mice, rats, and hamsters), rabbits, minipigs, canines, nonhuman primates, and cervids. Dr. Chesney is a co-author of numerous meeting abstracts and peer-reviewed publications.