Ann Baker Email & Phone Number

Paris, France, Fr

Toxicologist working as a preclinical safety project team representative on multiple teams responsible for the progression of both biotherapeutics and small molecule compounds for regulatory submissions. Activities include designing and coordinating efforts to support projects through the development of the nonclinical safety strategy including the design and interpretation of toxicity studies. Serving on the Developmental and Reproductive Toxicology (DART) advisory group providing scientific expertise and recommendations to project teams for DART specific strategies for compound evaluation and issue resolution as well as protocol development and data evaluation of regulatory required DART studies.

Direct studies at a contract toxicology lab for GLP and non-GLP nonclinical toxicology studies in mice, rats, dogs, and primates required for IND application, as well as non-human primate developmental and reproductive toxicology studies (NHP DART). Responsible for the technical conduct as well as the interpretation, analysis, documentation, and reporting of results of nonclinical drug development studies. • Complete risk assessment per FDA regulations and ICH guidelines.• Ensure compliance with appropriate standard operating procedures, Good Laboratory Practices, and regulatory agency guidelines. • Routinely use leadership and teamwork skills to ensure timely progress and completion of studies, overseeing multi-disciplinary teams at all stages of in-life and post-life data collection and data analysis. • Manage and analyze datasets to author Quality Assurance-audited reports for regulatory submission. • Manage primate breeding colony. • Use written, verbal, and remote (Microsoft Teams, Webex Meetings, and Zoom) communication skills with clients and internal/external contributing scientists establishing good working relationships and collaborations.

Set up and managed the Endocrinology lab. Developed and optimized hormone assays to be marketed commercially and used in house. Provided hormone assay services to clients and other researchers at MOFA. Conducted research on hormone levels in bovine, porcine, equine and canine to further MOFA's knowledge and allow for development of new products. Safety manager for the International Center of Biotechnology, responsible for setting up and managing safety and training programs.

Madison, Wi, Us

Investigated the changes in placental cell growth during implantation in response to macrophages. Responsibilities included: non human primate IVF, immune cell isolation, cell culture, flow cytometry, multiplex assays, analysis of data, demonstrated techniques to students, and maintained and presented research data.

Princeton, New Jersey, Us

Provided administrative and scientific support to study directors and staff of a contract toxicology lab. Responsibilities included: writing protocols, amendment, and reports and ensuring compliance with appropriate SOPs, GLPs, and regulatory agency guidelines, monitored in-life portion of studies, assisted study directors with proposal management, provided technical and scientific guidance and leadership to ensure accurate project completion, and talked with clients to discuss study progress.

Madison, Wi, Us

Investigated the role of estrogen in microglial cell lines and primary cell culture. Responsibilities included: cell culture, wetern analysis, primary cell culture, PCR, assays, maintained and presented research data, demonstrated techniques to students, and other research techniques.

Seattle, Wa, Us

Performed investigative laboratory work in support of research in a toxicology lab. Responsibilities included: small animal surgery, fetal brain dissection from mouse and rat, micromass, cell culture, wetern analysis, prepared laboratory reagents, maintained research data and laboratory records, demonstrated laboratory techniques to staff and students.

Phd, Endocrinology And Reproductive Physiology

Ms, Endocrinology And Reproductive Physiology

Bs, Major: Biology; Minors: Chemistry, Phsycology

Introduction To The Regulatory Process For Drug Development, Short Course.