Vince AnicettiAdjunct Professor
Biopharmaceutical Quality, Regulatory Affairs, Project Management
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.
The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance and control. Through a series of lectures and case studies this course will teach the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.
Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular, globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices). Most product supply chains are now multinational with increasing trends towards investment in rapidly developing but poorly regulated nations. The development of regulatory strategies for product development and post approval changes requires the understanding of many national regulatory agencies and international harmonization efforts. The advent of Biosimilars will place increased emphasis on CMC product characterization and process comparability and/or interchangeability as the key criteria for introduction of “generic” biologics.
|Location:||Building 517, Room B222|