| | AUGUST 20198CIOReviewPIONEERING PRODUCTION AND DELIVERY SOLUTIONS TO ADDRESS THE COMPLEXITIES OF CELL THERAPYBy Christina Yi, Chief Operations Officer, DendreonRegardless of your industry, one of the most exciting and sometimes scary aspects of creating something that has never existed before is determining where and how to begin the process ­ as well as how to evolve and maintain the relevancy of what you are creating. In the early days of cell therapy, one of the biggest challenges was the management and streamlining of a process that required a very rigorous timeline in order to be effective. More than a decade ago Dendreon Pharmaceuticals (Seal Beach, Calif.) set out to create an infrastructure system that would do just that, thus establishing a process to deliver complex therapies that serves as a blueprint to this day. We created an entirely new therapeutic category in 2010 with FDA-approval of the industry's first personalized cell therapy (also called immunotherapy) for men with advanced prostate cancer. The immunotherapy treatment process begins with collecting a patient's own immune cells. After being shipped to a manufacturing site, a custom treatment is created by programming a patient's immune system to find and attack cancer cells. This custom treatment is then transported to a medical facility andinfused into the patient. Note that all of these steps must occur within 72 hours or the immunotherapy cannot be used. Each patient repeats this treatment process three times over approximately 4-6 weeks.But the process of delivering this treatment began well in advance of the FDA's nod. In 2007, without any blueprints, we embarked on a journey to create a system called Intellivenge to manage the execution of the entire immunotherapy treatment process from "arm to arm." Our process is multifaceted and requires precision logistics, timing and resources to be successful. We also set a goal of ensuring that it could scale to a commercial level. This required the ability to manage the ever changing volume and infrastructure needed to handle every detail, from scheduling the patient's cellcollection and IN MYOPINION
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