We are all familiar with the old adage “better‐faster‐cheaper, Pick Two”. However, in today’s world of product development and manufacturing, all three are needed and needed now. Organizations are tasked with moving diverse and complex pipelines forward in record time with undivided attention required for product quality, safety, and reliability of manufacturing. These challenges don’t require incremental change in the operating model but revolutionary change in our model. In this talk, we will discuss activities, specifically process and product innovation geared to customer value and standards‐based thinking for product lifecycle management and partnership models. We will discuss the implications for the processes, plants and people to ensure successful commercial products.
Paul McKenzie is the Senior Vice President for Global Biologics Manufacturing & Technical Operations at Biogen, recently joining in early 2016. As Senior Vice President for Global Biologics Manufacturing & Technical Operations, Paul is responsible for the Manufacturing, Engineering, and Manufacturing Sciences operations in Denmark, Switzerland, Massachusetts and North Carolina. These facilities cover world‐class biopharmaceutical large scale drug substance & finished goods with a focus on Next Generation Automation & Manufacturing. Paul oversees the production of life‐changing medicines to patients around the world with five commercial products available including, Avonex TM , Tysabri TM , Elocatate TM , Alprolix TM , and Peglidry TM . Paul is a member of the Pharmaceutical Operations & Technology Leadership Team where he brings a strong focus to ensuring clinical supply of product and providing patient convenience. Prior to his current role, Paul was the Vice President of Johnson & Johnson Medical Devices, Ethicon Research & Development (R&D). As a member of the Ethicon Global Management Board and the Johnson & Johnson Medical Devices R&D Leadership Team, Paul was a trusted leader, responsible for R&D’s global strategy, portfolio prioritization and execution, resource strategy & development, and advancement of R&D talent. Paul joined Johnson & Johnson in 2008 as the Head of Bio‐Pharmaceutical Development & Manufacturing Support and was later appointed Head of the Global Development Organization of Janssen Pharmaceutical Companies. He also served as Vice President of Manufacturing and Technical Operations directing the Janssen Supply Chain Internal Manufacturing and External Supply Integration functions. Prior to his time at Johnson & Johnson Paul held several executive positions at Bristol‐Myers Squibb and Merck. Paul holds a B.S. in Chemical Engineering from the University of Pennsylvania and a Ph.D. in Chemical Engineering from Carnegie Mellon University. He has served on numerous professional and academic boards and is currently a member of the Board of Trustees on the Illinois Institute of Technology and the Society for Biological Engineering.