Effect of Personalized Medicine on the Pharma Supply Chain
Personalized, precision medicine, and pharmacogenetics have recently revolutionized medical options for patients and opened new revenue streams for life science companies. Technologies like artificial intelligence (AI) and machine learning (ML) enable sensitive pharmaceuticals for oncology and psychotropics to be made available for wider distribution and new markets. These technologies are used to ensure medication is kept stable and secure throughout the delivery process.
Precision medicine can be extremely difficult to produce with a very small patient base, leaving many manufacturers to opt out of the production of these medications. For example, costs can rise to $38T, pre-insurance, for a 30 day supply of Vitrakvi, a precision medication for specific types of cancer, approved by the FDA in November 2018. While the production costs may be passed to the patient and payers, the use of the medication is limited to a very specific group fitting the same disease genetic markers, cutting further into the company’s potential profits. With such tight margins, pharmaceutical producers cannot afford to experience waste caused by delivery issues.
By definition, personalized treatments require one shipment per patient, preventing companies from obtaining logistical economies of scale. The majority of these medications are delicate in nature, requiring precise temperature control and gentle packing and shipping methods. The time frame to deliver most personalized medicines is also very tight—often less than two weeks from patient testing, drug development, shipping, and administration.
Precision treatments are most vulnerable during transport. With global delivery and highly delicate cargo, the only option to preserve medication integrity is through controlled and specialized shipping. Advanced technology can ensure personalized medicine is kept stable throughout transportation and delivered on time to the patient. Typical areas of vulnerability include cargo temps, theft, and time constraints.
“Speed and volume getting personalized medicine to individuals can be very challenging to accommodate; getting the medicine from a central location at the right temperature to a patient’s property can be very difficult.” Catherine Coppage, Supply Chain Planner of Personalized Medicines at Kiadis Pharma
The Three T’s of Supply Chain Transportation
Temperature and Time
Active cold chain (i.e. a refrigerated truck) and passive cold chain (polystyrene packing or coolers) are current options to address cargo temperatures for medications but can be ineffective for medicines requiring fixed temperature. Biologic drugs require precise temperatures and are sensitive to changes during shipment. If there are variations outside of the allotted range, drug efficacy will be diminished.
When transporting such valuable treatments, drug supply chain leaders must ensure perfectly controlled conditions. Using smart transportation and packaging with precise shipment tracking and internet of things (IoT) capabilities is the optimum way to continuously monitor costly medications. Smart technology via connected sensors and devices will control temperature within specified parameters to ensure the medications remain stable and efficacious.
Precision medicine is often also timebound—delays in transport can lead to an increase in drug wastage. Smart transportation can be used to track and monitor vehicles at every stage of the delivery process and offer adjustments to routes in real time.
Pharmaceutical shipping theft is an existing and growing concern. According to the Partnership for Safe Medicines theft during drug shipping and transporting can reach up to $30B a year, with averages of $4M per loss. Current solutions such as GPS-tracking for trucks, two-person teams, and hard-sided trailers offer some protection.
However, to address the bigger issue—why theft happens—manufacturers should install IoT enabled devices for remote monitoring and reporting and artificial intelligence solutions to analyze potential threats to transport safety. Devices can record and report human behaviors and network anomalies, signaling a threat in real time. For example, if a truck takes an alternate route without managerial notice, it may indicate concerns like a hijacked truck. Personnel can then take immediate action to track the vehicle and lock the cargo.
Interlocking links on the chain
As pharmaceutical progress proceeds with personalized treatments, the downstream drug supply chain must be prepared to meet the demands. An advanced data strategy plan can provide companies cost savings as prices for precision medicines rise. Using integrated technology like IoT, big data, and AI/ML will address ongoing issues with medication delivery and transportation.
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