Sponsors for a Phase 2 clinical trial needed an expensive, time-sensitive therapy transported to investigator sites at -80º C. Further, when reaching out to cryogenic shipper rental companies, the sponsor found they often transport regionally and do not operate 24/7. The sponsor needed to procure ready-to-use cryogenic shippers, suitable facilities and global supply chain management to ensure safe, reliable transport and storage under specific time constraints for the clinical trial to be successful.
This example illustrates the pressures that are being placed on clinical drug distribution — particularly with personalized medicines, such as cell and gene therapies — and the changes taking place in current development pipelines. Situations, such as the one described above, will continue to be brought to the attention of vendors and outsourcing partners as the need for transparent, closely controlled global supply chain demands rise.
This growth is demonstrated by the value of the global market for cell and gene therapies, which is predicted to expand at a compound annual growth rate of nearly 22 percent, increasing from $6.02 billion in 2017 to $35.4 billion in 2026 (1).
The need and demand for a transformation in supply chain operations
While personalized medicine holds great promise for transforming the treatment for many diseases — including cancer, sickle cell anemia, beta-thalassemia, multiple sclerosis, and HIV — many challenges can thwart their success. Cell and gene therapies are more sensitive to temperature and other environmental factors. In addition, they face a greater time-pressured set of logistical factors than other treatment modalities. Other complexities and risks lie within different points along the supply chain, such as:
- Scheduling, planning and orchestrating the cell journey and material across multiple entities
- Ensuring chain of identity and chain of custody of expensive, highly sensitive biologics to sites around the world
- Optimizing manufacturing capacities, such as the need for long-term replicate storage on each patient.
Mistakes that occur within the supply chain can be potentially devastating for patients and costly for clinical trial sponsors. Successfully bringing personalized medicine to the market requires industry expertise and a rigorous control process coupled with advanced technology.
Smart tech and IT solutions ensure product integrity and quality control
A critical element of supply chain solutions for personalized medicine is smart packaging. Monitoring and tracking systems embedded in the shipping solution provide real-time access to shipment data such as location, temperature, shock and orientation. When activated, a predefined alarm can trigger automated messages, permitting interception of the shipment and initiation of actions required to keep everything under control.
Also, harnessing GPS technology allows for geo-fenced locations, such as airports or clinics. As shipments enter or leave geo-fenced areas, automated notifications can be sent, assuring that sponsors and others in the supply chain are aware of arriving shipments and notified of any transport changes.
Moreover, advanced information technology (IT) solutions are required. For instance, one of the biggest challenges in autologous cell and gene therapies, where each therapy batch is produced for one patient, is scaling up. Rather than producing more volume in terms of quantity, scaling up translates to the number of batches. So, scheduling and coordinating requests from clinics, in addition to managing the different interfaces that connect the various elements throughout the supply chain, add further complexity. Having an effective IT system that properly links to logistics systems, allows for available data to be utilized for automation and forecasting of upcoming requests.
Finding an agile, experienced supply chain solutions provider
To master this increasingly complex supply chain, biopharma companies should consider finding a partner that has expertise and knowledge of the criticality of a vein-to-vein, or needle-to-needle supply chain.
The implementation of smart technologies and advanced IT, along with an extensive global network, can provide comprehensive, agile solutions and the opportunity to address cell and gene therapy supply chain issues before they occur. When adopting a partnership, the provider should have the technology and resources for handling a lower volume of product and temperature-controlled packing and storage.
Having a partner that is committed to continually expanding and adapting to meet the complex and evolving needs of personalized medicine supply chains is no longer an option, it is a requirement for the success of clinical trials and, ultimately, of treating the patient.