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