Vince AnicettiAdjunct Professor | Senior Vice President, Global Quality at Coherus Biosciences
Regulatory Affairs, Project Management
In addition to being an adjunct professor at KGI, Mr. Anicetti is the senior vice president of global quality at Coherus Biosciences. A leading biologics platform company, Coherus focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-changing medications. Prior to joining Coherus, he was the executive director of quality for Boehringer-Ingelheim's California facility, responsible for quality and on-site regulatory chemistry, manufacturing, and control. Previously, he spent 30 years with Genentech and held senior leadership roles in quality, regulatory affairs and project portfolio management, including vice president of biologics quality for Genentech and Roche Biologics manufacturing sites around the world. At KGI, he teaches classes in biopharmaceutical quality and CMC regulatory affairs. Mr. Anicetti has been very active in the Parenteral Drug Association (PDA), serving as past chair and member of the executive committee. He was also the leader of the PDA Biotech Interest group, editor of the PDA newsletter and served as co-chairman of the 2012 annual meeting. He holds B.A. and M.S. degrees in biological sciences from San Francisco State University and serves on the San Francisco State University Foundation Board.
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.