Company: Gilead Sciences
Liaison(s): Todd Pascarella
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, Gilead seeks to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, hematology and oncology, inflammatory and respiratory diseases, and cardiovascular conditions. In 2011, Gilead purchased Genentech’s clinical biologics manufacturing facility located in Oceanside, CA, which enabled Gilead to accelerate internal biologics research and development programs. The Oceanside facility is capable of process development and Phase I/II clinical production activities. The purpose of the Gilead Team Master’s Project is to provide global regulatory strategies for biologics manufacturing ( CMC ) change implementation ( upstream and downstream ) and identify the risks associated with each proposed change. The team conducted primary and secondary research to assess the current regulatory landscape on biologic CMC changes, pre-and post-approval for U.S., European, and Japanese regions. Following extensive regulatory guidance literature reviews, the team developed a detailed questionnaire, aiming to benchmark industry’s best practices for the implementation of manufacturing changes through subject matter expert interviews. The results were used to produce a risk analysis matrix that assessed the criticality of each change scenario and the impact it would have on the company’s timeline, business needs and costs to implement the change.