Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career path and continuously increasing responsibility over her 25 years at Merck, she has developed expertise within US Regulatory Affairs, Global Labeling, Global Chemistry Manufacturing & Controls (CMC), Regulatory Operations, and Quality Auditing (Manufacturing). Diane currently leads regulatory affairs at Merck for US product shortages, discontinuations, and import/export activities. She has directly supported supply recovery efforts and developed business continuity plans for large-scale disruptive events. Additionally, she is the chair of the ISPE Drug Shortage Initiative Team.