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<\/strong><\/p>\nDigitalization crucial for managing manufacturing capacity<\/strong><\/p>\n Given the convoluted manufacturing and shipping process, strict quality and safety requirements, and T-cells\u2019 short shelf-life, the structure and logistics of the supply chain will be particularly complex. Of key importance will be capacity management. Hospitals and providers will need to be given advanced notice of when a patient\u2019s cell needs to be collected and this must be conducted at a time when capacity is available for all other stakeholders responsible for downstream activities (e.g., manufacturers must be alerted when material is on its way to set aside necessary capacity). [3]<\/p>\n Unlike typical drugs that can be mass produced based on estimated demand, cell therapy production will be heavily dependent on patients\u2019 highly variable schedules. Additionally, as more cell therapy treatments are approved and marketed, the supply chain will become significantly more complicated and competitive. The numbers of patients, samples and treatment centers will rise, and the steps along the chain may be magnified as hand-offs increase from nurses to couriers, expanding the risk for mistakes or losses. [4]<\/p>\n Today\u2019s pharmaceutical supply chain is too siloed across different stakeholders to effectively manage this complexity, resulting in an open-ended system that provides massive room for error. Technology in the pharmaceutical supply chain will need to evolve and digitalization will be key. Processes must transition towards a fully connected and closed system in which every aspect of the drug, from sample collection to manufacturing to infusion are tracked from end to end. [5]<\/p>\n <\/p>\n Deep pockets allow for an end-to-end solution<\/strong><\/p>\n Novartis, with its existing in-house manufacturing capabilities and access to significant capital, has taken steps to build a system that anticipates potential supply chain challenges.<\/p>\n Reimagining the supply chain into healthcare service<\/em><\/span><\/p>\n Novartis believes its ability to build a sustainable manufacturing process and supply chain is one of its key differentiators against competitors [6]. It has focused on providing an end-to-end solution that is more akin to a healthcare service than traditional drug delivery. At its 180,000 sq-ft facility in Morris Plains, NJ, Novartis has designed “a robust, reproducible and scalable manufacturing and supply chain platform to provide this individualized treatment approach on a global scale\u201d, encompassing facilities, equipment, personnel, and logistics rolled into one. A digital solution will employ end-to-end tracking as well as integrated planning and execution systems, logistics visibility, and advanced analytics to properly monitor the manufacturing pathway and anticipate fluctuations or variability in demand. [6]<\/p>\n Cryogenic support and premium couriers<\/span> <\/em><\/p>\n Novartis has also contracted with 35 treatment centers for distribution of Kymriah in the US and signed a 3-year deal with Cryoport, a cold chain logistics solutions provider, for cryogenic support. \u201cThis partnership personalizes the process for Kymriah and will help facilitate a more efficient and straightforward process between Kymriah\u2019s manufacturing facility in Morris Plains, New Jersey to its 35 treatment sites in the US.\u201d With this deal, Novartis will be able to access Cryoport\u2019s shipping containers, digital condition monitoring system, and advanced logistics management platform. Additionally, cryopreservation can prolong the shelf life of cellular material and provide physicians and patients with flexibility when considering treatment sequencing. [7]<\/p>\n <\/p>\n Considerations for the future<\/strong><\/p>\n Novartis should also consider ways to connect and manage data flow. Potential solutions include the ability to monitor shipments with real time, GPS-enabled data as well as consolidation of multiple variabilities in the system such as temperature, location, equipment qualification, and validation in order to have a robust quality management system. Partnerships with major digital players will also be important in the mid-term, and special consideration should be given to companies such as GE Healthcare\u2019s Cell Therapy Technologies, which has built digital platforms (e.g., Vitruvian network) and developed software and tools to solve data problems specifically related to digital supply chain management of complex therapies. [5]<\/p>\n Key questions – Can Novartis increase the number of treatment centers significantly beyond 35, or will maintaining sustainability and efficiency on a large scale be impossible with this type of therapy? How will the supply chain be impacted as this drug expands internationally and faces geographical shipping challenges and regulations?<\/p>\n <\/p>\n [800 words]<\/p>\n <\/p>\n <\/a>[1]<\/a>\u00a0Novartis.com. (2017).\u00a0Novartis receives first ever FDA approval..<\/em>. [online] Available at: https:\/\/www.novartis.com\/news\/media-releases\/novartis-receives-first-ever-fda-approval-car-t-cell-therapy-kymriahtm-ctl019 [Accessed 15 Nov. 2017].<\/p>\n <\/a>[2]<\/a>\u00a0Bioprocessintl.com. (2015).\u00a0The Cell Therapy Supply Chain<\/em>. [online] Available at: http:\/\/www.bioprocessintl.com\/manufacturing\/cell-therapies\/the-cell-therapy-supply-chain-logistical-considerations-for-autologous-immunotherapies\/ [Accessed 15 Nov. 2017].<\/p>\n <\/a>[3]<\/a>\u00a0BioPharma-Reporter.com (2017).\u00a0Dude where\u2019s my Car-T?<\/em> [online] Available at: https:\/\/www.biopharma-reporter.com\/Article\/2017\/09\/01\/Novartis-must-prove-it-can-handle-complex-CAR-T-supply-chain-TrakCel [Accessed 15 Nov. 2017].<\/p>\n <\/a>[4]<\/a>\u00a0Nature, Cancer Gene Therapy. (2015). Towards a commercial process for the manufacture of genetically modified T cells for therapy<\/em> [online] Available at: https:\/\/www.nature.com\/articles\/cgt201478 [Accessed 15 Nov. 2017].<\/p>\n <\/a>[5]<\/a>\u00a0Bio Insights. (2016).\u00a0Visualizing the cell and gene therapy supply chain of the future<\/em>. [online] Available at: http:\/\/insights.bio\/cell-and-gene-therapy-insights\/?bio_journals=visualizing-the-cell-and-gene-therapy-supply-chain-of-the-future [Accessed 15 Nov. 2017].<\/p>\n