From smartphones to automobiles to knowing who rings your doorbell, society is embracing innovation – permeating nearly every aspect of our lives. But even innovations such as cell and gene therapies require a ramp-up in not just in product development and market acceptance, but also in the capacity and capabilities of entire supply chains.
Nowadays, innovations come at a high cost when supply chain efficiencies have not been prioritized when developing such products. But with these three priorities of digital transformation, businesses can deliver innovations that matter at an affordable cost, even immunotherapy that uses specially altered T cells to fight cancer (CAR-T).
End-to-end visibility is a necessity
In conventional supply chains, end-to-end visibility is seen as a way to make better decisions, such as when and where to move inventory and how much.
In cell/gene therapies, end-to-end visibility is a crucial component of saving a life. Some of these personalized therapies require a very specific temperature range during the entire “u-2-u” lifecycle. And in some cases, cryopreservation is required.
Is the temperature range violated? If so, for how long and how much? This knowledge can help determine if a newly manufactured therapy maintains viability and potency for the patient.
However, it cannot be an automated decision. All members of the supply chain must be consulted to make the decision, and all members may require access to information across the supply chain. For example, are email and spreadsheets appropriate, according to HIPPA guidelines? Over time, can applying machine learning concepts enable automation and help make the right decisions?
A real-time, secure, and collaborative mechanism with exception-management capabilities and a control-tower integrating information from demand planning, manufacturing, and supply processes and systems is necessary.
Costs need to drop to achieve broad-scale adoption and success
The cost for treatments – which range in the United States from $373,000 to $475,000 – include everything from specialty logistics and temperature control to specialized materials to specialized equipment. Selecting suppliers, sourcing supply, and monitoring the quality and consistency of this supply will help.
As treatment scales to help more patients, meeting demand and ensuring consistency and quality will be crucial. This is where balancing costs and quality become very delicate. Costs may, in fact, stay the same to maintain quality. However, with more treatments, keeping some costs flat may provide scale to eventually lower costs over time.
As the manufacturing processes and technologies continue to improve, suppliers of key materials can be included during the design phase of a therapy. During the operational phase and the u-2-u cycle, suppliers can be included to provide the entire ecosystem requirements, including manufacturing capacity, material needs, and transportation needs.
Scaling requires a different way of thinking
Simply making more of the same product will not suffice for gene therapies, since each patient requires their own hyper-tailored product. For example, apheresis – or the sample collection of blood cells from the patient – can be scaled by offering numerous collection centers.
Can we distribute manufacturing sites, where the magic occurs, geographically, reduce transportation time, and thus reduce the need for longer-term temperature control? This strategy increases complexity in the supply chain, nonetheless, it should be assessed for scaling.
Across the life science supply chain, the primary raw material and end-consumption come from the same source: the patient. While some supply chains exhibit issues such as customization and hyper-tailoring, gene therapies of this nature require a batch size of one.
The ability to scale these therapies and lower costs with a more efficient supply chain will pay benefits to our society for generations.
Discover the latest innovations that are leveraging the digital supply chain to deliver personalized patient solutions. Join SAP at the 12th Bio Supply Management Alliance (BSMA) Annual Conference” on October 15, 2019. Register today.