Marcus Andrews

• Provide early safety assessment to projects, coordinating strategy, application of predictive and investigative tools and nonclinical study design to directly support of the development of the Lilly pipeline (current focus on Diabetes) • Project management across the entire preclinical development paradigm (from pre-candidate support / target selection to clinical submission)

• To provide effective and timely communication of key safety issues, scientific information and risk assessments for all Stiefel units to meet the customer needs and expectations. • Participate in project teams to provide timely recommendations for toxicological assessments or testing and advise project team of the impact that recommended actions will have on project timeline. • Prepare expert toxicological documentation to support regulatory submissions (cosmetic dossiers and Safety assessment) for new and existing products on global markets as well as provide expert toxicological assessments/opinions to address internal and external issues raised on marketed products. • Conduct and document safety assessments of formulations/individual ingredients to determine the safety and regulatory compliance of Stiefel products marketed to the public.

• Multi-disciplinary role emphasising group visibility within Pfizer DSRD and Global Discovery by supporting new projects with laboratory-based and team representative-based activities. • Develop pre-clinical safety packages, including pre-clinical toxicology and enabling mechanisms in preparation for FIH studies for Pain, Allergy & Respiratory and Genitourinary therapeutic areas • Establish early safety profile: outline and implement early target de-risking strategy • Define potential safety and efficacy biomarkers through pathway analysis and toxicogenomics tools • Project-manage mechanistic studies examining impact of target expression in non-target tissue, selection of safety biomarkers and model validation, incorporating modern tissue visualisation techniques such as quantitative immunohistochemisty and in situ hybridisation.

• Contribute towards laboratory-based activities to support goals of Drug Safety R&D and Pfizer Global R&D • Expert target expression: manage characterisation or target expression supporting exploratory portfolio targets, in particular, localisation of target distribution in toxicity-prone tissues, both at the genomic and proteomic levels in various species • DSRD project representative: responsible for risk assessment, and early forecasting of potential safety risks associated with pharmacological manipulation of new targets

• Contribute towards laboratory-based activities to support goals of Drug Safety R&D and Pfizer Global R&D • Experimental focus on development of pre-clincial safety packages, including pre-clincial toxicology and enabling mechanisms in preparation for FIH studies

• Characterizing fetal origins of adult disease using in vivo animal models • Highlights: sequencing and detection of guinea pig neuronal tryptophan hydroxylase (TPH) gene; localization of hypothalamic vasopressin gene expression; identifying long-term changes in serotonin levels in an antenatally treated in vivo fetal animal model using HPLC with electrochemical detection. • Published on mapping neuroanatomical expression of serotonin receptor mRNA and protein

PhD title: Glucocorticoid regulation of basal and stress-induced hypothalamo-pituitary-adrenal axis function. Awards/Distinctions: Wellcome Trust PhD Studentship