Company: Gilead Oceanside
Liaison(s): YenRu Pan
Gilead Sciences is a pharmaceutical company founded in 1987 with headquarters in Foster City, California. Gilead’s Oceanside site primarily supports the development and manufacturing of therapeutic biologics. This established company thrives on creating improved outcomes through cutting edge innovation, always keeping the patient as its main focus. Their mission, to discover and deliver innovative therapies for people with life-threatening diseases, was proudly embraced by its KGI TMP team.
Gilead Oceanside plans to build a statistical platform that links their data storage system to statistical tools to support the setting up of specifications for drug products, determining shelf life, and establishing a workflow from data sources to data analysis tools. To address this business need, the KGI team conducted literature searches to understand industry practices and regulatory expectations for refining control strategy and performed a feasibility assessment for a model data analysis workflow. In the end, the team provided a comprehensive package describing best practices that Gilead can leverage for future initiatives in building a streamlined data management system. This was a one semester project in Fall, 2020.