
Patrice Gilooly
Title: Leaps of Faith - My Biotech Journey
Bio
Patrice Gilooly is a senior quality executive with over 30 years of experience in biopharmaceutical manufacturing, spanning early clinical through commercial launch and post-marketing phases. Patrice was most recently Senior Vice President of Quality Assurance and Operations for Regeneron Pharmaceuticals, Inc., a multi-national, fully integrated biotechnology company that develops highly specialized parenteral therapies for serious unmet medical needs such as age-related macular degeneration, atopic dermatitis, asthma, cancers and chronic obstructive pulmonary disease. During Patrice’s 27-year career with Regeneron, she contributed to the company growth from a $100 million market capitalization to over $100 billion and was primarily responsible for the company’s GMP Quality Assurance program and personnel globally. This responsibility spanned multiple functions and geographies, including a global team that grew from approximately 20 US-based to over 1000 QA professionals across North America, Europe and Asia as well as oversight of dozens of contract manufacturing organizations (CMO). She was instrumental in growing the quality culture and strong compliance mindset for a clinical phase and small-scale manufacturing organization to a global leader in large scale commercial biologics manufacturing. She was also involved in the approval of over 10 biologic license approvals (BLA) for fusion proteins and monoclonal antibody therapies as well as an emergency use authorization for a COVID-19 therapy.
Abstract
This presentation will reflect on a transformative 30-year career in the biotechnology industry, highlighting pivotal moments, technological advancements, and evolving trends. From early-stage clinical development to the commercialization of groundbreaking therapies, the journey spans critical innovations in drug discovery, facility design, quality system maturity, operational excellence and organizational development. Key lessons learned in navigating regulatory landscapes, fostering cross-disciplinary collaborations, and driving innovation will be shared, along with insights into the future trajectory of biotech. The presentation aims to provide a comprehensive view of the industry’s progress and the personal and professional growth that has accompanied a dynamic and rewarding career.