Management of information and traceability in the entire value chain contributes to safe regenerative medicine! (1/2)

The Hitachi Value Chain Traceability service for Regenerative Medicine (HVCT RM) facilitates connection of processes in regenerative medicine and enables successful completion of a cell’s journey

2023-06-29

Regenerative medicine^*1 is drawing attention as a new form of medicine that utilizes cells from a patient’s own body. In order to successfully complete a cell’s journey, which is a series of connected safe and reliable processes from collecting the cells to administering the resulting product (the therapeutic agent) into patients, medical service providers must centralize management of information about a regenerative therapy, establish traceability, and connect the series of all these processes. This article provides a customer case in which a medical service provider manages information and traceability in the entire value chain to maintain and improve the safety of regenerative medicine.

*1: Regenerative medicine is based on the idea that a tissue or organ lost as a result of a disease or injury can be regenerated by creating a therapeutic agent (such as a drug or tissue) through the use of cells or similar objects collected from a patient or donor, and then administering the therapeutic agent to the patient.

Key points of this article

Centralized information management and permissions management contribute to ensuring safe and smooth cooperation among stakeholders.
All the processes, from collecting samples to administering the therapeutic agent to the patient, are managed to ensure traceability.
Proposed schedules are automatically generated and modified and are efficiently coordinated in line with the current condition of resources.

For example:

Many stakeholders are involved in providing regenerative-medicine products^*2, including medical institutions, pharmaceutical companies, logistics companies, and manufacturing companies. If all these stakeholders use the same cloud service platform, they no longer need to separately use and maintain their own systems to share information such as patient information, planned schedules, quality information, or transportation results. Such a cloud service platform enables centralized management of information owned by all the stakeholders and thereby enables application of specialty drugs to rare diseases. Global deployment of such a platform will contribute to improving corporate value and lifting the quality of life (QoL) of many people.

*2: Regenerative-medicine products include cell therapy drugs, gene therapy drugs, and regenerative therapies. Cell therapy drugs are intended to transplant cells to the diseased area and then regenerate a tissue or organ that will work normally.

Co-creation with Lumada―Managing information throughout the entire value chain and ensuring traceability

Facilitating information sharing to provide safe and reliable regenerative medicine

Expectations for regenerative medicine are growing as it provides therapies that are the last resort for curing rare or intractable diseases for which there have been no effective remedies.

Drugs must be delivered and administered reliably

Regenerative medicine can restore a tissue, an organ, and the health of people who lost those functions as a result of a disease or injury. Matters related to safety and quality management of regenerative-medicine products are prescribed by laws^*3 to ensure that new therapies in this field will be delivered to as many patients as possible.

Regenerative medicine uses products tailored to meet the specific needs of one patient or a small number of patients. Although it is essential that regenerative therapies maintain the quality of conventional pharmaceutical drugs, it is also essential that information management be implemented in a way that clearly links the patient, cells, and the product manufactured from the cells.
Currently, however, stakeholders (such as medical institutions, logistics companies, pharmaceutical companies, and manufacturing companies) are sharing information by telephone, email, paper, or other means. Communication by telephone or email requires time and effort, and information recorded on paper is subject to the risk of inaccuracy, tampering, and leakage. There is a strong demand to resolve this undesirable situation in order to ensure safety and quality.

*3: In 2013, regenerative-medicine products were added to Japan’s Pharmaceutical Affairs Law. In addition, the Regenerative Medical Care Act was issued. In 2014, the Act on the Safety of Regenerative Medicine Products Safety was enacted and went into effect.

Centralized management of information on a shared cloud service platform

If all the stakeholders involved can share information about who does what and when, they will be able to communicate smoothly and closely and maintain and improve the safety of regenerative medicine.

Hitachi provides a service platform that can be used by all stakeholders, enabling centralized management of information throughout the entire value chain. Stakeholders can save time and effort when sharing information about work progress and coordinating schedules and ensure safety and quality.

Using centrally managed information to visualize the entire value chain

Hitachi’s cloud services can be combined to properly manage the permissions users need to access centrally managed information. These services can be used to manage records of business activities and verify samples in compliance with pharmaceutical regulations and personal information protection requirements.

Managing information without depending on a specific type of device
To enter and view information, users can use browsers on a variety of devices such as PCs, tablets, and smartphones. Data is easy to handle because it is linked with the customer’s system.

Making operations easier
By using a browser to perform the operations required for the processes in regenerative medicine, users can perform operations in workflow-like procedures.

Ensuring a high level of safety by setting access permissions
Administrators can set user permissions to restrict which features are available to a user. In addition, the system automatically anonymizes and encrypts data before saving and storing it, thereby achieving a high level of safety.

Data visualization
Users can check the business relationships among stakeholders and the work progress on windows displaying the value chain. The user can quickly identify the progress because data is visually presented.

These features enable visualization of the entire value chain and provide the following benefits.

Safety is ensured by rigorous traceability management
The traceability feature applies to the entire value chain that involves multiple stakeholders. The feature can define the relationships between a patient and the relevant product and thereby prevent mix-ups. If a problem occurs, you can quickly identify the causes of the problem.
Efficiency is increased by automated planning and sharing of therapy schedules
Semi-automation of schedule planning and coordination can be implemented in accordance with the status of resources. This reduces the burden on the stakeholders required to coordinate schedules. Therapy transparency is ensured if the schedule is shared with the patient. In addition, staff members in the manufacturing company can check the availability of equipment and facilities, and can formulate a maintenance schedule that takes into consideration how their manufacturing activities will be affected.

Our solution adopts IoT Compass, a cloud service from Hitachi, to centralize management and provide visualization of massive amounts of data. In the customer case featured below, IoT Compass linked with data in the factory, thereby improving traceability and improving safety and efficiency in production activities.

IoT Compass―A digital twin solution for production sites (Japanese)

Supplementary information: Characteristics of regenerative-medicine products and expectations for the future

Differences between usual prescription drugs and regenerative-medicine products: In general, prescription drugs are produced by mass production, stored in warehouses, supplied steadily, and prescribed to numerous patients.
On the other hand, regenerative-medicine products (in particular, those derived from autologous cells, which are mainly used today) can cause fewer side effects and must be administered only to specific patients from which the cells were collected. A regenerative medicine product cannot be replaced by other products and must be delivered without fail to the patients who need the product.
Situation surrounding regenerative-medicine products: The demand for regenerative-medicine products is expected to increase due to factors such as a significant increase in the aging population and recent advances in medical technologies. As the use of such products becomes widespread, these products are expected to provide permanent cures for intractable diseases and help recovery from pre-symptomatic diseases.
In light of recent trends and future expectations, we can assume that the smooth and secure supply of regenerative-medicine products will become increasingly important.

The next page introduces a solution that utilizes centrally managed data in order to facilitate smooth information sharing among stakeholders and to achieve high levels of safety.

*: The service (or solution) specifications are subject to change without prior notice due to reasons such as continual improvements.