Stacy Holdsworth is the Senior Advisor for U.S. Regulatory Policy & Strategy at Eli Lilly and Company. Her primary responsibilities are to lead a team of regulatory professionals in the development and implementation of an external regulatory policy agenda that encourages innovation and delivers a pipeline of new medicines for patients. Stacy has been in her current role for more than ten years and has supported regulatory policy initiatives ranging from influencing the use of benefit/risk assessment in regulatory decision making, to shaping pediatric study requirements, to encouraging the use of real world evidence in pre and post approval regulatory decisions. During her career, Stacy has been involved in multiple PDUFA negotiations and other discussions about FDA-related legislation.
In her prior role at Lilly, Stacy led the regulatory advertising and promotion group for seven years, during which she was responsible for oversight of efforts to ensure compliance with relevant laws and regulations while also enabling successful commercialization of marketed products. Prior to that, Stacy completed a fellowship program in regulatory affairs focused on late stage endocrine assets. She received her Doctor of Pharmacy degree from Butler University.