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International Clinical Trials

Under Control

In the advent of ever-more stringent regulatory requirements, and the need for more sophisticated shipper solutions for the safer transit of pharmaceuticals and biologics, temperature-controlled packaging manufacturers are required to be increasingly vigilant when it comes to mitigating cold chain risks.

When it comes to the transportation of clinical trial materials and pharmaceutical products – particularly in light of the significant rise of biologics and biosimilars within the industry – a minor temperature excursion during their journey can have costly consequences for patients and pharmaceutical companies. This is especially pertinent within the trials sector, where patient safety and efficacy are of paramount priority.

New Challenges


More than 50% of new drugs are going to be biologics or biosimilars in the clinical trials marketplace, which is a key driver in the increasing demand for tighter temperature control requirements. Within clinical pharmaceutical studies, there is an ever-greater need to protect more of the drugs with more stringent temperature-controlled ranges, due to them being based on biological, rather than chemical, compounds. This provides the industry with further challenges, including the following:

Growing Market
The clinical trials marketplace is a growing area within the temperature-controlled packaging industry, and currently accounts for approximately 20-25% of the overall market share. The larger volumes commercially are concentrated on when these drugs go to market and are being distributed globally.

While around a quarter of the market may be dedicated to clinical trials, it is a significantly more challenging sector to operate in, due to the temperature ranges required to ensure the safe transportation of these high-cost, high-value and often life-saving medical materials to emerging markets, which pose their own extreme temperature range risks.

Emerging Markets
The biggest hurdles facing the temperature-controlled packaging industry are more complex distribution lanes, far-flung global locations and increasing regulatory requirements. While the industry infrastructure within the regions of Europe, the US and latterly parts of Asia are acknowledged as being proficient when it comes to legislative compliance, emerging markets posing greater challenges include Brazil, China, India and Russia.

End of the Line

Last-mile pharmaceutical transportation is another growth sector requiring that stringent regulatory demands are adhered to, with an increase in ensuring the protection of high-value, temperature-sensitive pharma payload end-toend. These bespoke deliveries mean there is a heightened industry requirement for smaller sample shipments needing assured temperature-controlled protection throughout the entire supply chain.

Globalisation
In the current clinical marketplace, it is essential to know what is happening worldwide and to fully understand international processes and trans-requirements. With greater globalisation, it is vital to employ competent staff in these more remote locations that understand all the region-specific regulations, know what the trends are and explain what is happening in emerging markets. A global presence, and being in situ to understand regulations and transportation needs in different regions of the world, is also critical. Manufacturers can achieve this with representatives from their own business or, in some cases, companies will enter into partnerships to give them more global coverage or support.

Regulation
From Europe to America and Asia, there are now more and more agencies and organisations producing specific incountry guidelines and regulations that drug companies are required to support and be prepared for. These would be industry issues that quality assurance (QA) representatives within pharma organisations will be aware of, study and learn, then drive within their business. These regulations are driving demands that manufacturers are then supporting with pioneering temperature-controlled packaging systems, and the packaging industry works closely with the QA organisations within the pharma sector to meet the evolving challenges collaboratively.

From a manufacturing standpoint, the industry is virtually governed by medical device similar standards or Good Manufacturing Practice (GMP) guidelines. From a temperature-controlled packaging manufacturer’s viewpoint, there needs to be strict and thorough quality procedures in place, such as International Organisation for Standardisation or more akin to GMP quality standards, when operating in more remote regions.

Industry Innovation


The temperature-controlled packaging industry is moving towards the implementation of new and innovative technologies to successfully serve the clinical trials transportation sector and wider pharma arena. What is becoming more prevalent in particular is the rise of phase change materials (PCM) and vacuum panels for insulation. These innovative tools are the main drivers in mitigating cold chain risks of pharmaceutical payload transportation.

For clinical trial clients, key considerations are performance, ease of use and assurances that temperature-controlled vendors are engineering the most efficient and reliable shipping solutions to mitigate cold chain risks.

When it comes to the systems being utilised for clinical trial drug distribution and biological sample transportation, performance is being driven by the emergence of newer technologies. This is in conjunction with a focus on making functions and processes more simple and cost-effective from the outset, based on developing simple preparation and pack-out procedures.

Cost-Effective Solutions

As well as mitigating cold chain risks when shipping clinical trial materials, the ever-evolving nature of this specific sector means the temperature-controlled packaging industry must continue to strive to be one step ahead when it comes to producing pioneering packaging products to meet the demands of clients. Increasingly, the clinical trials biologics market is trying to learn from their commercial colleagues and deliver the prerequisite performance – and do it costeffectively, so it comes down to evaluating and addressing the overall total cost of ownership; not just the price of the physical packaging, but also of managing the cost of its transportation and distribution. Outer and inner dimensions, and the volumetric efficiency that newer technologies can provide, are important criteria for clinical trial clients for continuous consideration.

Ultimately, customers expect a great performance, ease of use and a reduction of their shipping costs, because they have utilised a box that is half the volumetric size, but the same or greater payload. However, what is becoming increasingly evident is that clinical trial managers are learning from colleagues in the commercial side of pharmaceutical distribution, and cost effectiveness is a key factor alongside the total cost of ownership.

Key Considerations

By reducing the number of components in a pack-out, the process of placing the payload and coolants within the thermal packaging would make compiling the package more straightforward. Having a single – rather than multiple – conditioning requirement also has an impact across the industry to combat cold chain excursions.

There is a further significant advantage to being able to have conditioning or packaging protocols in place for year-round use, instead of modifying from season to season. Some of these emerging technologies allow companies to accomplish this via easier conditioning or preparation methods, coupled with easy pack-out that is the same year round, not winter versus summer.

Creating a simplistic solution is equally as important as performance, because one of the biggest risks in the cold chain are temperature excursions – and the vast majority of those occur due to package pack-out errors, namely human errors, during the packaging process. Therefore, ease of use, performance and administering all these elements as cost-effectively as possible are the current drivers in the transportation of clinical trials products to further guarantee the integrity of temperature-sensitive medical materials along the cold chain.

Marked Shift

In a bid to simplify packaging procedures, and to ensure greater performance reliability within the packaging industry, there has been a marked move away from the older coolant methods, which utilise water. Previously, older technologies – such as water-based ones – would often require seasonal pack-outs covering all four seasons, thereby relying on seasonal instructions, which in turn drives the need for further training and additional warehouse personnel.

Cost savings can be made and passed on through the supply chain process by minimising the methods required and subsequent training. To achieve this performance and to mitigate the risk of the pharmaceutical payload being affected, damaged or perished by any excursions en route, manufacturers need to be able to repeatedly construct the packaging in the same way, every time.

The simplicity or ease of use becomes ever-more critical to driving that performance, which, in turn, pushes towards the efficacy of the drugs and patient safety: the ultimate goal.

Advanced Technologies

Some of the most recent developments within the industry include the emergence of pioneering tools that allow temperature-controlled packaging companies to manage this new technology better. In essence, they are technical tools that assist with performance modeling, and software tools that allow businesses to develop performance modelling more easily.

These testing techniques include software that enables companies to create a temperature profile easily and which they might want to test against a specific lane. Another new innovation is the introduction of indicators on PCM panels that allow the user to know when they are ready for pack-out, which can simplify standardised procedures.

These indicators on PCM panels and innovative software are some of the latest developments made by temperaturecontrolled packaging manufacturers. Technology supporting the best implementation of these new innovative tools, including software modeling, testing, managing the preparation process and indicators – which allow for understanding the temperature of the panels – are some of the major innovations happening at the moment to help clinical trial customers.

Currently, the industry is moving towards these newer technologies, looking at tools to assist in the management of more modern PCMs, which are more technologically advanced than water-based systems.

Reusable on the Rise

While single-use packaging still has its place and serves a purpose – particularly when it comes to more difficult to control or challenging lanes when the retrievable infrastructure is in place – reusable packaging, which is on the rise, can prove a more cost-effective option. Reusable technology is becoming more and more accepted, because it can really drive down costs per use. The packaging industry is working hard to try and change preconceived perceptions about reuse and its reliability.

Clinical customers can obtain access to advanced technology and make it much more affordable, thereby reducing the total cost of ownership by recapturing and reusing that packaging asset over and over again.

Future-Proofing

To best serve the clinical trial industry’s rigid requirements, packaging manufacturers must continue to strive to set and surpass standards, creating shipping solutions best placed to meet the evolving, exacting pharmaceutical protocols. The impetus is increasingly in industry innovation, and future developments will involve standards that demonstrate ways to guarantee multiple reuse packages are fully qualified, remaining fit for purpose after multiple uses.

The question currently facing the packaging industry is: how to test and qualify reusable packaging in order to know, one or two years from now, or 10, 20 or 30 uses from now, that it is still delivering the performance it was initially qualified for? As well as a shift towards reusable technology, the packaging sector is trying to ensure customers can leverage new technology, use it effectively and know that it is truly qualified years down the road.

Convincing clinical trial firms of the importance of having the right cold chain system as part of their overall operations and budget considerations is an ongoing challenge, alongside helping customers grasp the financial impact of temperature-controlled packaging and how vital it is within their organisation and its operations.

It comes down to helping clinical companies better understand the true cost of moving to newer technologies, and what impact that can have for their operations. Manufacturers ensure this is all transparent so the client can see, document, measure and understand it. The flipside is considering the impact of not managing their cold chain operations effectively.

What are the implications of clinical cold chain excursions and, crucially, what is the potential human cost of having inefficient transportation systems, which can render drugs ineffective and, ultimately, put patients' lives at risk?


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Kevin Lawler is the Vice President of Sales at Pelican BioThermal. With over 25 years of sales leadership experience, he has a strong history in building and leading sales organisations capable of producing strong and predictable growth. Kevin joined the company in 2009, which was previously known as Minnesota Thermal Science. He earned an MBA from the University of Montana, US.
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