Vince Anicetti is a Fellow in Scientific and Regulatory Affairs with the Parenteral Drug Association. He is also an Adjunct Professor with the Keck Graduate Institute (KGI) of Applied Life Sciences teaching in the area of Biopharmaceutical Quality and Regulatory Affairs. Prior to joining PDA and KGI, Vince enjoyed a highly successful 30-year career with Genentech. During this time Vince held a variety of leadership roles within Genentech. Most recently, he served as Head of Biologics Quality for the Roche/ Genentech Biologics’ manufacturing network comprising 10 large-scale Biotech product sites in North America, Europe and Asia. In this role Vince was responsible for Quality Assurance and Quality Control operations at each site and regulatory compliance to cGMP’s. Prior to this role in Quality, Vince was a key leader in Product Development and Regulatory Affairs Vince has worked closely with regulatory agencies in the development and approval of new biotech products and application of cGMP (current Good Manufacturing Practices) for Biotech operations. Vince Anicetti holds a BS in microbiology and MS in clinical chemistry from San Francisco State University. He is a past chairman and member of the Executive Committee of the Parenteral Drug Association (PDA). Currently, Vince is leader of the PDA Biotech Interest group, an editor of the PDA letter, and served as co-chairman of the 2012 annual meeting.