Dr. Anna Bottomley is a Senior Scientist I in ToxStrategies’ Biopharmaceutical/Pharmaceutical practice, with 16 years of experience in both the pharmaceutical and contract research industries. She has nonclinical experience with biologic and small molecule products in all species and multiple routes of administration.
Dr. Bottomley has served as a Study Director for a leading Contract Research Organization (CRO) in the UK, where she directed nonclinical acute, subchronic, chronic, and carcinogenicity studies to assess the general toxicology of a variety of pharmaceutical, biological, and chemical compounds in support of regulatory agency submissions. She was responsible for the technical conduct of nonclinical studies, as well as the study design, interpretation, analysis, and reporting of results. Dr. Bottomley developed particular expertise in conducting non-human primate (NHP) studies with monoclonal and bispecific antibodies and designing novel studies to support specific regulatory requests.
Dr. Bottomley recently served as an Alliance Manager for a global pharmaceutical developer. She was responsible for the key alliance with the main international CRO that delivered the majority of nonclinical studies, representing the firm at governance meetings, measuring key performance indicators, and improving/simplifying processes while maintaining delivery schedules. She held regular meetings with internal and external stakeholders from the toxicology, reproductive toxicology, and safety pharmacology teams focused on objectives for the relationship, implementation of any new techniques/processes, study prioritization, and resolving study issues. She had a close working relationship with multiple international CROs to help the pharmaceutical developer identify the most appropriate CRO to place studies based on a balance of cost, schedule, and scientific expertise. She also served as a Study Monitor for a small-molecule project, delivering the studies required to support the Investigational New Drug (IND) submission.
Dr. Bottomley earned her Ph.D. in Child Health from University College in London; her research focused on using proteomics to find evidence of protein nitration in the cerebral spinal fluid of children diagnosed with acute lymphoblastic leukemia. Her undergraduate work included a year-long study of the effects of radiofrequency radiation on the rat heart and diaphragm function. In 2015, she served as a program manager (1-year sabbatical) for the National Centre for Replacement, Reduction, and Refinement (NC3Rs), a UK-based scientific organization dedicated to replacing, refining, and reducing the use of animals in research and testing. In 2015, Dr. Bottomley chaired a workshop at the Safety Pharmacology Society meeting on the housing of non-rodents during telemetry studies.