Kathryn Costelloe

Associate consultant specialising in nonclinical regulatory affairs providing advice and documentation to meet client requirements including tabulated and written summaries, gap analyses, investment due diligence and PIP documentation. Also supported the Clinical Trail Group with submission of multiple amendments, radiation assurance, regulatory submissions and responses.

Translational scientist working within the Pharmacology and Screening group. Responsible for developing and executing HTS, primary and secondary assays to support validation of neuroscience targets and progression of compounds: - Supported multiple targets across both Astrocyte and Microglia platforms - Subject matter expert for Multi-Electrode Array (MEA) technology, provided expertise to MEA users within both the DDI, DRI and wider UCL community by chairing a working group initiative. - Implemented and conducted four HTS campaigns, including the first 1536 HTS within UCL. - Subject matter expert for imaging and flow cytometric assays within the unit. - Coordinated and managed outsourcing of assays to ensure business continuity during COVID-19 ensuring assay validation and comparability of data.

Senior scientist within the Integrated Biology group responsible for the implementation and delivery of assays as per client requests. This included being solely responsible for the delivery of med-chem data to support a Huntington's disease target and the development of an ex vivo biomarker quantification assay.

Responsible for the development and implementation of innovative assays to support both Regenerative Medicine and Pain therapeutic areas: - Singlehandedly delivered a cohort of immunoassays to assess the immunogenicity potential of a cell based therapy within Regenerative Medicine. Successfully transferred and supervised conduct of two of these assays at a CRO to support clinical progression. - Designed and implemented assays to assess phenotypic and functional characteristics of sensory neurons derived from iPSCs on various platforms including MEA, ELISA, calcium release and electro-chemiluminescence in support of Pain therapeutics. Rapidly became an SME for MEA technology having established a first in class screening platform for which I was recognised by a performance award.

Primarily responsible for the development of in vitro cell based assays to de-risk portfolio wide safety liabilities identified during nonclinical exploratory toxicology studies. In addition, I established a GLP laboratory for the in vitro support of cell-based therapy products and cell preparation for nonclinical in vivo regulatory studies. Researched early target knowledge and collaborated with relevant partners to implement appropriate de-risking strategies. Supervised MSc Applied Toxicology student placement, providing both experimental design and technical training.

Study Director for in vitro Genetic Toxicology assays conducted at the Sandwich site and sole point of contact for site wide compound submissions. Responsible for training new colleagues, lab management and study documentation.