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
Senior Vice President, Pharmaceutical Development & Technology, bluebird bio
Susan Abu-Absi, Ph.D. is Senior Vice President, Pharmaceutical Development & Technology at bluebird bio, a clinical stage gene therapy company located in Cambridge, MA. The integrated product platforms at bluebird bio encompass gene therapy, cancer immunotherapy and gene editing – providing the potential to treat a broad range of serious diseases. She leads the teams that develop the CMC strategy and deliver and support the manufacturing processes and analytical methods required to advance therapies through clinical stages to commercial products and throughout the lifecycle. Susan has over 20 years of experience in biologics process development and manufacturing. Prior to joining bluebird bio, she spent more than ten years in the Manufacturing Sciences & Technology organization at Bristol-Myers Squibb. As a leader at BMS, she contributed to the successful development and commercial supply of several products, including the launches of Opdivo®, Empliciti™, Yervoy®, and Nulojix®. Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota.