How to enhance traceability in the life sciences supply chain

There are three primary routes to market in the life sciences sector. The first is the Traditional/Wholesaler model, which involves manufacturers distributing their products through distributors, where manufacturers sell to wholesale distributors including specialty distributors, who then stock and ship medicine to pharmacies and healthcare providers. The second is the Direct Distribution model, where drug manufacturers ship their products to large pharmacy chains, hospital systems or government programs, bypassing wholesale distributors providers. Lastly, Direct-to-Patient (D2P) involves shipment from manufacturers directly to the patient.

• Traditional /Wholesale model:

In this model, pharmaceutical manufacturers send shipments to distributors, who then distribute them to healthcare facilities for patient treatment. This approach requires managing relationships primarily with distributors while ensuring traceability throughout the supply chain — from the manufacturer through the distributor to the healthcare provider. 

For instance, a vaccine manufacturer may ship large quantities directly to national distributors. These distributors subsequently deliver the vaccines in smaller batches to local pharmacies and healthcare centers, where they are administered to patients. It is essential for manufacturers to establish strong data exchange interfaces with distributors, ensure prompt verification of notices such as advance shipment notifications and maintain rigorous chain-of-custody protocols to prevent counterfeit drugs from entering the end of its supply chain. 

• Direct Distribution model:

In the model, pharmaceutical manufacturers ship directly to providers such as hospitals or clinics. These manufacturers need to ensure the transfer of accurate delivery information, including the correct lots with valid shelf lives. Accuracy at the item level and cold chain status are crucial, requiring robust tracking systems to monitor shipment integrity. This includes real-time communication with providers to facilitate effective tracking and verification, which helps mitigate the risk of disruptions. 

Both parties share the responsibility for tracking shipments and must be prepared for efficient data exchange and recall procedures. For example, a pharmaceutical company specializing in oncology drugs may ship directly to cancer treatment centers. In this scenario, providers administer the drug consumption and storage, and manufacturers rely on these providers to share information for precise reporting and traceability to drive patient safety. 

• Direct-to-Patient model:

This distribution model allows manufacturers to deliver medications directly to patients, improving accessibility and adherence. This model provides most control to the manufacturers but is very limited; only a small percentage of total distribution goes through D2P and is applicable only for maintenance drugs such as insulin and hypertension medications. In this model, the manufacturer has better traceability but struggles with quality control, as most medications require strict temperature control, employing insulated packaging with temperature monitors. For drugs like insulin, secure, contact-free delivery systems are established so that patients receive consistent quality and reliable refills directly at their doorstep; this comes at an added cost to the company.

All these distribution complexities that life science organizations face today also generate an opportunity to rethink and reimagine the sector’s entire supply chain, assess how it can be innovated and curate tailored strategies to address the unique demands of each scenario. Below are a few examples and use cases of visibility and traceability solutions that enhance both external and internal supply chain operations, delivering value and supporting high standards of patient care and service delivery.

• Vaccine  distribution inventory visibility:

A pharmaceutical client aimed to obtain real-time visibility into the status of vaccines within its distribution channels while complying with local serialization requirements. To address the complexities of involving an ecosystem of health collaborators, a blockchain-based network platform was designed and launched using product tokenization. This solution created a collaborative environment for entities within a single distribution channel to track product movement by converting physical assets into digital tokens for seamless transfer and custody management.

By integrating data from systems across each manufacturing and distribution collaborator, the solution provides comprehensive inventory visibility at each stop in a vaccine’s journey from manufacturer to patient. Once the product is dispensed, the token is removed from the network. The goals for this tokenization platform are to reduce waste, improve forecast planning, drive more predictive outcomes and set the foundation to scale to more products, collaborators and locations.

One organization aimed to improve traceability across the manufacturing lifecycle, from donations to finished products, addressing challenges due to multiple handoffs and disconnected systems. To tackle this issue, an end-to-end private blockchain solution was delivered that tokenizes units of blood plasma at various stages and tracks their movement throughout the collection, distribution and manufacturing process. This solution standardizes data across different stages, capturing essential information regarding state, timing and volume, which was previously fragmented. Blockchain technology provides the client with greater visibility both within their environment and externally to third-party collaborators, donors and patients. The client can now explore opportunities to improve inventory management, leverage provable custody of products for financial purposes, and develop new outreach programs to engage donors and patients.

Home dialysis empowers patients to schedule their treatments according to their individual lifestyles, offering them significant flexibility and control over their care. Recognizing the importance of enhancing the patient experience and encouraging the adoption of home-based care options, one organization embarked on a mission to improve its services.²

To facilitate this goal, a global health and kidney care company implemented a comprehensive customer portal designed to streamline the patient journey. This portal allows patients to easily place their orders for necessary supplies and equipment, ensuring they have everything they need for their home dialysis treatments. Additionally, the organization introduced a last-mile delivery solution, which enables patients to schedule convenient drop-off appointments for their products and also provides patients with the ability to track their deliveries in real time. They can monitor the status of their orders and receive updates on the estimated arrival times, reducing uncertainty and enhancing their overall experience. By integrating these technological solutions, the organization aims to foster a more supportive and efficient environment for patients, ultimately leading to higher satisfaction and increased adoption of home dialysis as a viable treatment option.³

Vein-to-vein therapies represent a groundbreaking approach in personalized medicine, requiring organizations to collect patients’ own T-cells, re-engineer them and then redistribute this highly time-sensitive, ultra-cold chain product back to the same patient for infusion. This intricate treatment process involves multiple steps and necessitates the exchange of T-cells among various stakeholders across the value chain, including apheresis centers, healthcare practitioners, manufacturers, cold chain shippers and treatment centers.

Given the complexity and critical nature of these therapies, organizations with cell and gene product portfolios are increasingly investing in the development of robust track-and-trace capabilities. These systems are essential for efficiently and effectively monitoring the chain of custody and chain of identity throughout the entire process. These control tower solutions help obtain and provide real-time visibility into the status of T-cells as they move through the supply chain. This visibility not only enhances operational efficiency but also helps mitigate risks associated with delays or mishandling of these sensitive products. These advanced tracking technologies play a pivotal role in ensuring that patients receive their therapies safely and promptly, ultimately improving outcomes in the rapidly evolving field of cell and gene therapy.

A biopharmaceutical company implemented an Internet of Things (IOT)- and artificial intelligence-powered temperature control logistics solution platform to ensure regulatory compliance, product integrity and patient safety for its cold-chain products.⁴ Through this platform, the organization was able to obtain real-time tracking information to monitor the condition of its products during  transit, and receive alerts in case of temperature excursions requiring intervention to mitigate product loss. By integrating this platform with its ERP and Transportation Management System solutions, this organization was able to enable integration with its shipping providers digitally, which resulted in a reduction in shipment cost and as well as shipment planning and scheduling efficiencies.