Speakers

Sarah is currently an Associate Director, Regulatory Affairs Strategy and Science, Biosimilars at Sandoz. In this role, she coordinates US biosimilar submissions and develops regulatory and policy strategies.  Sarah came to Sandoz after 12 years in FDA’s Center for Drug Evaluation and Research (CDER), serving in various Regulatory Project Manager capacities. Starting within the Office of Surveillance and Epidemiology (OSE), Sarah successfully led OSE’s project management efforts for the Agency’s first 3 biosimilar approvals, and thereafter served in a team leader role. Following OSE, she transitioned to the Office of Therapeutic Biologics and Biosimilars (OTBB), where she made major outstanding contributions to the biosimilars program, standing up a project management team and implementing BsUFA III processes. Before beginning her career in Regulatory Affairs, Sarah worked as a retail pharmacist and as a healthcare consultant.

Sarah earned her PharmD from the University of Pittsburgh School of Pharmacy and a graduate certificate in Project Management from the George Washington University.  She lives in Frederick, MD with her husband and 2 young children.