Deviations within the clinical trial or biopharma supply chain can arise at any time. However, a quality logistical partner will predict and strategize for such deviations, so that risks to the product and timelines are minimized. One of the best ways for a logistics partner to conduct contingency planning is to compose a protocol of instruction, customized to the particular operational undertaking at hand.
The protocol of instruction defines the process of how every component of the supply chain will be handled, where, and by whom. It also defines communication and escalation flows, so that any time a deviation is encountered, stakeholders will know the next steps for operational execution and communication. These documents are especially critical for cell and gene therapy (CGT) supply chains that involve many stakeholders and require perfect coordination. Here, we describe considerations for developing a protocol of instruction with appropriately embedded risk mitigation through a collaborative approach.
Protocols of instruction
A protocol of instruction lays out the precise plan for the logistics of a particular supply chain, leaving no room for ambiguity. This ensures that the product being transported is always handled appropriately, and on the necessary timeline. For many therapeutics, this is critical, as factors – such as temperature requirements and shelf life – must be accommodated with no room for error.
In particular, autologous CGTs necessitate rigor in the supply chain because they must coordinate a large number of stakeholders on a precise schedule. Each therapy is patient-specific, with an often critically ill patient acting as the source and recipient of a time- and temperature-sensitive product. On top of this, such therapies are often extremely difficult to replace, making each shipment highly valuable and vital to execute correctly.
No matter what product is being transported, however, it is important that sponsors and patients, alike, can trust that it is handled correctly at all stages in the process. A protocol of instruction provides this confidence, especially when it is created collaboratively, so that all involved parties have input on the outlined processes.
Facilitating collaboration
There are a number of stakeholders who might be involved in a biopharma supply chain, such as clinical trial sponsors or pharmaceutical companies, manufacturers, logistics partners, home care providers, hospitals, or trial sites. This means that the process of drafting a protocol of instruction should begin with open communication with each of the relevant stakeholders to gain insight into their capabilities, requirements, and concerns regarding the logistics of a particular supply chain. Further, if the project is ongoing, such as in the case of a clinical trial, it can be worthwhile to periodically check in with the relevant parties to ensure that the plan is being conducted satisfactorily and that there are no additional concerns that need to be addressed.
Working together with all of the relevant parties to create the protocol of instruction can be advantageous for several reasons. Gathering input from all stakeholders allows the plan to balance priorities appropriately, consider all potential perspectives and concerns, and establish shared objectives. Further, stakeholders can work together to identify potential scenarios that might put a product at risk, create strategies to eliminate or minimize them, and draft plans of action that lay out how to respond in a given scenario. For example, risks to a CGT supply chain might include issues carrying out apheresis, customs delays, or temperature excursions. Including all stakeholders in this discussion ensures that no reasonably foreseeable risks are overlooked, and allows for appropriate contingency plans to be created to mitigate them.
Escalation flows
Another benefit of drafting a collaborative protocol of instruction is the creation of escalation flows. An escalation flow provides a structure for identifying an issue, notifying relevant stakeholders, and escalating the issue to those who can resolve it, should it fall outside of standard operational capabilities. Moreover, it establishes clear routes of communication and information regarding who should be contacted, how, and in what situations.
To create an escalation flow, it is necessary to determine who needs to be aware of the issues, as well as who has the authority and ability to take specific corrective actions. For instance, if a shipment encounters an obstacle at customs, it may be important to know how to contact the Importer of Record, as well as what information to give them. It is also essential to establish a reliable communications channel that is easily accessible by the relevant parties, ensuring there are no obstacles to getting in touch with one another if needed.
When all relevant stakeholders are involved in drafting the escalation flow, each is made aware of their own role and responsibility in a given scenario, so that none will be taken off guard. This reduces the likelihood of miscommunications or errors if logistical obstacles are encountered, particularly given that these can be high-stress situations that require swift action. As a result, issues can be resolved quickly and confidently.
The role of a logistics partner
As the key party involved in ensuring a medicinal product is safely transported, a biopharma services partner takes on a great deal of responsibility in creating and carrying out the protocol of instruction. To provide the highest quality of logistical support, Yourway creates a customized protocol of instruction for each engagement, including multiple contingency plans to provide flexibility and redundancies — ensuring a shipment’s integrity in the case of disruptions outside Yourway’s control. Additionally, with a well-structured quality management system, Yourway trains all staff involved in the operational execution of the project on its specifics, as well as good manufacturing practices and good distribution practice guidelines.