Risk mitigation: mission critical

The globalisation of clinical trials and specialty pharmaceutical commercialisation along with the rise of complex biological-based drug therapies present a host of opportunities for manufacturers — to say nothing of the potential value they hold for patients. However, today’s mobile supply chain also harbors a well of risk; some hidden to the untrained eye, some obvious but overlooked, some wholly new and some yet to be discovered. Regardless of the risk, it leaves manufacturers, investors and an industry worth roughly $1.1 tn exposed to potentially significant loss.

While the cost of underestimating risk in logistics is not transparent, the cost of maintaining the logistic supply chain is. Data from Pharmaceutical Commerce’s annual Biopharma Cold Chain Sourcebook reveals that managing the transportation of biopharma logistics cost almost $79 bn in 2016, with temperature-controlled products accounting for almost $13 bn. With a growth rate of 8 to 9 percent year over year, spend on temperature-controlled logistics is predicted to rise to almost $17 bn by 2020, with non-cold chain estimated at $77 bn. That’s a logistics price tag of almost $100 bn. With numbers like this, it’s clear that manufacturers want to ensure a quality product upon delivery. These numbers might also suggest a need to identify and qualify more strategic investments to mitigate mounting risk.

These five trends have been identified as key industry forces influencing current risk management strategies.

1. Globalisation​

Today, drug makers in the US and other industrialised nations are producing more in emerging markets, as well as selling into more overseas markets. While globalisation has encouraged the development of dual-sourcing of biopharmaceuticals and helped make biosimilars a possibility in some markets, it has also increased security risk to shipments.

Global shipping lanes create longer supply routes, challenging transport packaging to maintain temperatures longer and through a number of different scenarios, from extreme climate conditions through various modes of transport (air, ground, ocean and hand). Globalisation also demands acute knowledge of the national regulations of each country.

2. Increased regulations​

The EU guidelines on good distribution practice (GDP) for medicinal products for human use, extend temperature requirements to transportation. They are used as the basis for many countries’ legislative framework throughout the world, not just the EU. After all, transportation is simply a mobile form of storage, with many more variables, and regulations not just limited to the traditional cold chain. GDP guidelines require control of even room-temperature product, which is essentially everything that isn’t refrigerated or frozen. With similar regulations coming to the US, pharmaceutical manufacturers are seeing an increase in the number of products requiring temperature controlled packaging (roughly 80 percent in the EU). This rising number significantly increases the opportunity for loss, should regulations not be understood or their protocols adhered to.

3. Product sensitivity​

The shift from small-molecule drugs to high-value productive intensive biopharmaceuticals is flooding the logistic supply chain with temperature-sensitive product. This trend along with a renewed investment in biotech R&D and a rise in biological clinical trials, including cell and gene therapies, has significantly increased the use of high-value ingredients. These ingredients have limited lifespans, stricter temperature requirements, and are more often than not, irreplaceable life-saving medications.

These scenarios, especially when paired with global shipping, create complex protocols and add even greater demand for vigilant monitoring, ensuring product stability and security. Product sensitivity is also what’s driving the demand for more advanced transport packaging solutions.

4. Technological advances​

Risk management strategies are getting an upgrade with innovative technologies designed to automate the management of cold chain logistics, reducing complexities and minimising human error. These tools include improved data mining and mobile cloud solutions that support real-time GPS location and temperature tracking throughout the chain of custody. End-to-end cold chain monitoring solutions not only enable visibility, they can also communicate breaches through automatic alerts, providing actionable intelligence to execute contingency plans.

Advances in thermal packaging design have also been integrated into risk management strategies. There are an array of transport solutions on the current market, including passive, active and semi-active containers, using phase change materials (PCMs), dry ice or evaporative cooling. There are a multitude of sizes going from individual-dose packets to carton to pallet, which address a range of temperatures too. Some can even be custom designed and tested to suit a particular product. The newest transport systems on the market also address weight, reducing total shipping costs while ensuring shipment security.

Additional innovations that support risk mitigation in clinical trials and direct-to-patient models are just coming into the mainstream, from RFID-enabled refrigerators designed to store product in patient’s homes to information management systems enabling real-time access to protocols and instructions necessary to undertake shipments. It’s important to note these technological advances can bring cost-efficiencies as well as risk mitigation. However, there is frequently a knowledge deficit between which solutions to apply based on the manufacturer’s needs, specifics of the drug program or transport logistics.

5.Transportation cost fluctuations​

Many factors can influence the types of transportation to be used in a logistic strategy, such as the time allotted between pick-up and delivery, the availability of truck drivers or product sensitivities to temperature, vibration or humidity. However, in the last few years, cost and environmental concerns have created a slight shift in transport mode used for commercial product, moving from truckload to intermodal (truck and rail), and from air to ocean. While intermodal transport is largely being used by pharmaceutical companies that want to reduce their carbon footprint, the increase in sea freight is largely attributed to manufacturers’ attempts to reduce cost and risk to product. Because, while ocean transportation tends to be slower and less useful for clinical trial supplies, it has fewer touch points than air freight, which commands more frequent handling — from loading, unloading and transporting on the tarmac to customs clearance.

And whilst sea freight might suit many large, heavy, temperature-stable shipments of active pharmaceutical ingredients (API) or bulk drug product, it seems a lengthy — and ultimately risky — route to take with cold chain products. But data suggests the shift does include temperature-sensitive shipments, though that might refer to those shipped at ambient temperatures. Some large pharmaceutical companies are planning to transport up to 70 percent of their international freight via ocean, including cold chain products. 

Faced with increasingly sensitive products, tightening global regulations and complex logistical protocols, pharmaceutical companies must focus greater efforts on risk management in the mobile supply chain. The key to dealing with unforeseen challenges is to be prepared — to plan ahead and to develop a robust risk management strategy supported by proven processes and technologies. And while it takes experience and resources, there are effective controls and procedures in place to proactively mitigate the potential risks to product, compliancy and ultimately, to patients.