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
Past Director of Strategic Development and Innovation at Novartis Pharmaceuticals
Dr. Rod Rietze is the past Director of Strategic Development and Innovation at Novartis Pharmaceuticals (Cambridge, MA), where he supported the development of novel bioprocesses, analytics and other enabling technologies for next generation cell and gene therapies, as well as the global manufacture of Kymriah™, the first FDA-approved personalized CAR-T cell therapy. This role was a continuation of his work at Novartis’s Cell and Gene Therapy Unit, where he led the Automation Network that was responsible for transforming a portfolio of small-scale manufacturing processes into scalable platforms sufficient for late stage clinical and commercial scale production. Prior to joining Novartis, Rod led research teams in the discovery and early clinical development of both small molecule and cell-based therapeutics for neural, cardiovascular and auto-immune indications at Pfizer Regenerative Medicine (Cambridge, UK). Preceding his transition to Industry, Rod was a co-founder and faculty member of the Queensland Brain Institute (Brisbane, Australia), where his lab focused on understanding the biology and harnessing the regenerative capacity of resident neural stem cells to slow age-related cognitive decline. His seminal discoveries were featured on the covers of Nature and Science, and received numerous awards including Science Magazine’s “Breakthrough of the Year”. Dr. Rietze has nearly two decades of technical, operational and strategic leadership experience in the development of novel therapeutics and is passionate about delivering innovative technologies and medicines to transform the treatment of disease. He holds a BSc and MSc from the University of Calgary, and a PhD from The Walter and Eliza Hall Institute (University of Melbourne, Australia).