With the astounding success of some of the new personalized medicine therapies in treating incurable diseases, the emphasis on research and development of cell, gene and immunotherapies is gaining momentum. Some of the more promising cures for cancer are now in late-stage development, with two expected to be FDA approved by the end of 2017.
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Logistics is complex for all types of medical shipments, however, gene, cell and immunotherapy medicines present their own challenges. To maintain the integrity of a therapy in transit and ensure the overall safety of the patient, there are strict regulations that govern the life science industry – which can be even more stringent and urgent for personalized medicine.
With more and more therapies nearing their final stages of development, the industry is turning to logistics to heed any challenges that commercialization of the therapies will bring, such as increased shipment volumes or geographic reach. The supply chain developed must support both clinical development and commercialization of a personalized medicine, taking into account:
- Scalability for commercial growth
- Time and temperature sensitivity
- A strict and transparent chain of custody
- Connectivity and communication between all stakeholders
- Regulatory compliance
Effective commercialization requires end-to-end turnkey capabilities for personnel and customer service as well as scalable and repeatable infrastructure to support the supply chain expansion.
Learn more about creating a sustainable supply chain with the flexibility to grow quickly. Download our industry guide: Commercialization of Personalized Medicine – Supply Chain Solutions