The rise of personalized medicines and their impact on the supply chain

The personalized medicines market – which tailors drugs and treatments to the individual patient – is expected to reach revenues of $149 billion by 2020, according to Pharmaceutical Commerce.

The rising use of biosimilars – a biologic medical product that is a near-identical copy of an original product by another company – is expected to result in the near doubling of the size of pharma cold chain logistics business over the next three years.

This shift presents many opportunities and challenges. Live materials used in cell and gene therapies and personalized medicines need to be transported quickly and safely within the correct temperature range from the lab to clinical site to ensure their effectiveness. Everything from the weather, to traffic jams, to customs regulations can disrupt such high volume and high value shipments.

The delicate stability of the products – which have tight turnaround times – in addition to their expensive price points mean that supply chain mistakes cannot be afforded.

Ahead of the 15th Annual Global Forum for Temperature Controlled Life Science Supply Chains, we spoke to Catherine Coppage, Supply Chain Planner of Personalized Medicines at Kiadis Pharma and a logistics expert from one of the top 10 in Big Pharma look at how cold chain processes need to adapt for this fast-changing frontier of medicine.

What are the relevant cost hurdles when transporting personalized medicines?

There are significant costs to dispersing your shipment out to multiple sites and countries. This requires the capabilities of getting the product within the countries, then distributing it to a vast number of different locations. The tighter control needed for cold chain, the more cost is required in whatever form you send it –whether it’s active or passive or by truck, air or ocean.

Catherine: “We’re in our final phase of clinical trials and we’ve noticed that logistics costs are incredibly high, because we cannot really jeopardize the quality, we have to demand a very high level of service due to the strict time and temperature requirements.

“We’ve got the risk of last minute shipments because our shipments depend on the patient and if their condition changes then we have to adjust our supply chain accordingly. If you send shipments very late to the logistics service providers then you can incur extra costs.”

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What is the biggest challenge blocking the market’s progression regarding the transportation of personalized medicines in the commercial supply chain?

The speed and volume required when 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.

A big challenge is trying to decide what distribution channel – such as going to consumers, the retail chain or the hospital chain – makes sense for the patient and the product. There are costs. There are also challenges in the patient taking the medicine.

Some medicines are injectable and not everybody is comfortable administering injections on their own.

What is holding back market development on the transportation of personalized medicines?

Catherine: “Our biggest challenge is to scale up to commercial growth because we are very much focused on the clinical trial phase. We are looking to create a supply chain where we can scale up and standardize it. But with personalized medicine, it’s difficult to scale up because it is so unique to the patient.” 

What hurdles do commercial supply chain professionals face with personalized medicines?

Patients and consumers are requesting more data on their supply chain updates which will provide more challenges as the pharma industry develops more personalized medicines and patient delivery processes.

Catherine: “The final product is a unique preparation – hence the term personalized medicine – it’s not an option to deliver to the wrong patient. “Another challenge is you cannot obtain economies of scale for the logistics. It’s usually one shipment per patient, there is no consolidation. A lot of the flows have really tight timelines (sometimes within 24 hours) and have to be transported across continents.

In this case, our only option is to transport the shipments via hand-carry, which is very expensive. Shipping globally is really an issue but it is something that we have to face. Customs officials are sometimes not veryfamiliar with the concept of personalized medicines and that adds time.”

How are cold chain processes adapted for personalized medicines and biologics?

Catherine: “When transporting personalized medicines it’s really important that no temperature excursions occur. It needs to be tightly managed and temperature monitoring is vital because there is no room for error. You cannot go back and take new patient samples because often patients are very sick. It’s a one chance opportunity.”

How does the manufacturing process impact the supply chain?

Catherine: “It’s always one batch per patient and one clean room per patient. You can only manufacture for one patient at one time and manufacturing lead times are fixed, thus cannot be shortened. It’s very labor-intensive in terms of resources and capacity – we need extremely trained and specialized personnel for our products and that costs time and money.”

What technology needs to improve to support the transportation of personalized medicines?

Catherine: “If you’re in your clinical trial phases it can be difficult to afford the more expensive technology needed to transport the medicines.

“We need more transparency across the whole supply chain from end-to-end. We typically use our own systems to track and trace but it’s not integrated. It’s crucial for us to know where our product is at any given time in the supply chain.”