Sean Werner is President of Sexton Biotechnologies, a manufacturer of processing and handling tools and reagents for the development and manufacture of cell and gene therapies. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Prior to his current role he spent 11 years with Cook Medical and Cook Regentec filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.
How can innovations achieve the cost reductions, accelerated results, reduced risk, and increased safety that they need to make car t cell therapies practical
Adopt strategies for transitioning from a good lab process to a good clinical process to overcome significant challenges. How can challenges in scale-up and scale-out be overcome to implement fundamentally solid, repeatable, foundational process development from preclinical, to clinical, and beyond? Explore novel technologies and innovations to secure the necessary level of quality, control and certainty to inject GMP throughout the phases of drug development for Car-T therapies