Add to Calendar 4/25/2019 8:00:00 AM 4/25/2019 10:00:00 AM Crossing the Chasm: Clinical to Commercial Scale-up of Gene Therapies
“Growing pains”, “bottle neck”, “capacity crunch”, “viral backlog” and are just a few descriptions of the quantum leap required to achieve global commercial scale-up of gene therapies. Gene therapies in the R&D pipeline are poised to take on diseases with much larger patient populations than those currently on the market for rare diseases. What’s more, gene therapies are often given fast track designations increasing the manufacturing and supply chain pressures and are very costly to produce. With over 700 INDs filed with FDA and hundreds more expected in subsequent years, the need for timely gene therapy manufacturing solutions is increasing in intensity. This forum will explore how biopharmas, CMOs and regulators are tackling this challenge, who the movers and shakers are, and what’s on the near-term horizon to make gene therapies a mainstay in treating many of our devastating and intractable diseases. MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139
COO, uniQure
Dr. Scott McMillan joined uniQure as Chief Operating Officer in August 2017. Dr. McMillan served most recently as Senior Vice President of Quality and Technical Operations at AMAG Pharmaceuticals where he also was a member of its Executive Management Team. Before joining AMAG Pharmaceuticals, Dr. McMillan held similar positions at AVANT Immunotherapeutics, Inc., and with Johnson Matthey Pharmaceutical Materials, Inc. Dr. McMillan has over 25 years of biotechnology experience in quality, process development, scale-up, technology transfer from bench to commercial scale as well as manufacturing operations. Dr. McMillan holds a Ph.D. in Chemical Engineering from Georgia Institute of Technology, a Master’s degree in Economics and Bachelor’s degree in Chemical Engineering from the University of Delaware.