Throughout the last decade, the pharmaceutical and biotech industry has increased investments, research, and development in personalized medicine. The first-ever FDA approval of two CAR-T therapies in 2017 and the sharp increase in personalized medicine trials in the past three years will translate into a more complex supply chain.
Today, clinical trials for cell, gene and immunotherapies are expanding to every corner of the world, which means there are more stakeholders involved in the process, from the sites to CMOs, CROs, and sponsors. As a result, the timing of patient procedures, manufacturing, logistics, chain of custody and collection of data require an ever-increasing degree of control and oversight.
Transparency and scalability in personalized medicine supply chain logistics require seamless connectivity and communication between all stakeholders.
The personalized medicine supply chain faces many unique challenges, such as the complexity of ever-evolving regulations that vary from country-to-country, precise time requirements, and strict chain of custody. Also, since it involves the transport of highly time and temperature sensitive materials, it requires specialized packaging and monitoring devices.
Transparency and Automation
From the collection of patient specimens (apheresis/leukapheresis) to the manufacturing of immunotherapy drugs, and finally to infusion, technology can provide real-time communication between medical professionals, hospitals, laboratories, sites, sponsors and CMOs.
When it comes to personalized medicine, all supply chain logistics elements need to be perfectly synchronized. It is also critical to ensure that commodity integrity is maintained and patient security is guaranteed.
Technology can play a significant role in the orchestration of a successful, transparent, and secure supply chain based upon a robust Quality Control Process.
Logistics partners that have sophisticated IT infrastructure, capable of integration across multiple platforms, can provide all stakeholders with:
- Control and visibility of all shipments, with real-time alerts, notifications and milestones updates allowing for real-time action to ensure they are on time and within temperature transport
- Individual tracking from the point of pick up through to final delivery
- The capability to monitor Dewar orientation and a shipments exposure to light, to ensure the security of supply chain and the ability to limit expedited vaporization rates caused by a tilted LN2
- Temperature monitoring throughout transit with the capability of intervening to maintain the integrity
- Ongoing communication and connectivity to all the stakeholders
- The ability to “blind” patient information and protect patient data
- Power to download data from cellular-based GPS and temperature monitoring devices and transmit this information via EDI or API
- Infrastructure to transmit data, such as time in transit, temperature, location, patient ID, Dewar orientation, and exposure to light
- Chain of custody at every milestone, making sure that each therapy is collected and delivered to the correct patient, pre and post-manufacturing
- Scalable IT structure to support commercial growth and increased volumes, allowing sites to schedule shipments easily
Cell and gene therapy trials are highly collaborative, but it is essential to plan and execute every step precisely. Commercial success for personalized medicine depends on robust IT systems that will create a transparent, scalable and synchronized supply chain.