In 2012, the annual ‘Pain in the Chain’ snapshot of the market by logistics giant UPS identified security and integrity of the drug supply chain as being one of the key concerns of life sciences. In 2008, when the survey first began, 13% of those polled put this as their number one priority; in the 2012 poll, this percentage had risen markedly to 57%.
"Environment is a huge issue when it comes to cold chain management," says Chioma Mensah-Bonsu, head of CTS outsourcing and distribution at UCB Pharma in Braine-l’Alleud, Belgium. "If you go from one region to another, as cold chains increasingly do these days, you have to understand the challenges posed by each region, and risk-manage and anticipate that."
Here, it’s important to be seen as being proactive about risk and developing action plans for each region or link in the cold chain.
"It is not even about having an action plan to deal with what’s happening daily; you need to be planning for and anticipating what alternatives you’ll need in place for if, or when, something unexpected happens or goes wrong," explains Mensah-Bonsu. "You also need to be looking for and analysing any gaps, and then work to plug them."
Challenges of cold chain risk management
Cold chain risk management is not a one-size-fits-all entity; it is constantly changing, whether it’s in a commercial environment or a clinical trial. Clinical trials is particularly challenging as firms are entering more countries further away from their original market, which, depending on the region, can be more difficult.
"Asia can be a challenging environment unless you have good local knowledge and experience," Mensah-Bonsu adds. "If you don’t, you might find yourself in a position where you are relying on your vendor for support, but that may not be something they want to take ownership of.
Globalisation is one of the major challenges in this context, but there is also a growing hurdle posed by the complexity of new drugs, particularly biologics, which can degrade quickly and be vulnerable to changes in temperature or environment. It all has to be controlled and, if it’s not, it can quickly become a ‘touch and go’ situation.
"If you have a problem, it can be really damaging and may result in the need for another shipment," explains Mensah-Bonsu. "But it is not just about the cost of resupply; reputational damage can be significant. If you lose a batch you can lose credibility and that is probably worse than just being unable to deliver.
"The notion that you have not done your homework can be very damaging. You need to make sure something like this won’t happen. It is much harder to correct something that has gone wrong than to stop it going wrong in the first place."
One of the crucial considerations from a very early point is researching the geographical area of a new market; for example, in an area like India, China or Africa, the temperature can be different and even vary markedly as you travel across the region.
"Drugs nowadays are not cheap and so it can be very challenging to establish, manage and sustain an effective cold chain," says Mensah-Bonsu.
Cold chain game plan
So, what’s the answer? Mensah-Bonsu breaks it down into three key elements: strategy, managing and anticipating risk, and developing the right protocols, relationships and partnerships.
"First, it is essential to have a clear, well-defined distribution strategy that outlines the type of shipping or container," she explains. "It will depend partly on whether the cold chain is a commercial one or one for clinical trials. With a commercial cold chain, there may be a longer time frame overall to get a drug into a country, but with a clinical trial, it is more likely to be based on enrolment, so it may well be a question of finding an effective vendor that can give a quick turnaround. In a clinical trial, there is a risk of not having a drug available or in enough quantity, so you lose the time limit and even the whole opportunity.
"Expertise is required within the packaging and distribution space as it will need to be appropriate for each stage of the cold chain – for example, does it have or need air gaps?
"The second requirement is to build risk into cost planning and forecasts. Risk has to have visibility and be an active, ongoing part of the planning and management of the supply chain.
"Third, it is important to have specific protocols for each area, in particular, ports and entry points. Do you have someone on the ground who knows the country well enough so that they can go into port X and be recognised for their expertise and be able to bring you through those entry points smoothly?
"Within this, using the right courier is crucial; you need to trust them, because they are your strategy on the ground. You need a specialised courier who has experience of the region, and who understands your needs and can share your ideals. You need to talk to each other constantly and be a true partnership."
The regulatory side is important in the sense that you have to make sure you have got things right to ensure you get approval to go ahead, but this is more something that needs to be agreed at a much earlier stage, adds Mensah-Bonsu.
Pharma supply chain’s growth in risk
Given that the globalisation of the pharmaceutical marketplace is, if anything, accelerating, especially as the emerging economies of the BRIC nations become increasingly lucrative for the manufacturing and distribution of pharmaceuticals, it is clear these are challenges that won’t go away any time soon. In fact, Mensah-Bonsu predicts that cold chain risk management will become even more imperative as new generations of drugs enter the marketplace.
"In the future, we will become more reliant on a reliable cold chain," she says. "Drugs, as they become more complex, are having a shorter shelf life. There will be an increasing requirement for managing the process and the risk.
"However, if you get this right, and you can prove that you have got it right, there can be real opportunities in terms of positioning yourself to capitalise on a new, untapped market and be ahead of the pack."
