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
Technical Program Manager, NIIMBL at NIST OMA
Kelley Rogers is the Technical Program Manager for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) at the National Institute of Standards and Technology (NIST) Office of Advanced Manufacturing (OAM). In this role, Kelley provides oversight to ensure mission alignment and effectiveness of the technical activities within NIIMBL, a NIST-sponsored Manufacturing USA institute focused on the acceleration of biopharmaceutical manufacturing innovation in the United States. In addition to her responsibilities with NIIMBL, Kelley is the Technical Program Director for Biosciences for NIST's Material Measurement Laboratory. In this role, she works to develop NIST’s technical portfolio to meet current and future measurement sciences needs for the industrial and clinical applications of biotechnology. Kelley received a Ph.D. in Molecular Biophysics and Biochemistry from Yale University and a B.A. in Chemistry from Hendrix College, and was a post-doctoral and staff fellow in the National Institute of Digestive, Diabetes, and Kidney Diseases, at the National Institutes of Health. Her research expertise is in bacterial protein synthesis and cell signaling pathways. After completing her fellowship at NIDDK, and prior to joining NIST, Kelley worked as a Principal Investigator in the biopharmaceutical industry, identifying novel targets for antimicrobial drugs.