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
MassBio Co-Chair for DRUGMAN & SUPPLY Working Group President and Founder, ThinkQuality, LLC
Kevin is President and Founder of ThinkQuality, LLC – an innovative consulting firm providing clients across the life science ecosystem with practical strategies, solutions and coaching to address a wide array of quality and regulatory compliance-related challenges and opportunities from early stage discovery through critical CMC development milestones to product approval/launch and beyond. He has over 25 years of real world boots-on-the-ground experience/insights into the complex and global rigors of small and large organizations and draws on over 10 regulatory product approvals (from Lipitor® to Linzess®) and many more investigational and commercial products from numerous therapeutic categories and delivery systems. He earned a B.S. in Chemistry at Tufts University and a Ph.D. in Analytical Chemistry from the University of Massachusetts at Amherst – beginning his career as a scientist/analytical chemist in the consumer products industry. Kevin transitioned into a broader Quality role while at Warner-Lambert/Parke Davis (now Pfizer). Since then, he served in senior, global Quality leadership roles at Purdue Pharma (Director, Research Quality Assurance), AstraZeneca (Global Head, R&D GMP Quality Assurance), Nektar Therapeutics (Vice President and Head, Quality) and Ironwood Pharmaceuticals (Vice President and Head, Global Quality). Kevin is an active and engaged member of MassBio, including co-chair for the DRUGMAN & SUPPLY working group and MassConnect mentor, and is very passionate about working with industry, academia and regulators to advance Quality Practices in education, innovation and new technologies across the life sciences. He is a contributor to IPQ (International Pharmaceutical Quality) – the publication that provides in depth coverage on CMC/GMP regulatory policy.