"The patient is waiting"

Dr Sean Smith

The year 2011 saw Japan brought to its knees by a massive earthquake and subsequent tsunami, citizens in Arab countries protested against years of government oppression, and Thailand fought to contain massive flooding that cost lives and brought the country’s transport infrastructure to a standstill. Nobody can accurately predict natural disasters or political revolutions, but the logistics sector must fulfil its pharmaceutical clients’ goals, whether that is storing, handling or understanding GMP requirements, whatever stands in its way.

Dr Sean Smith, vice-president of logistics for Fisher Clinical Services, part of the BioPharma Services division of Thermo Fisher Scientific, has worked with many trial sponsors over the years to plan what with increasingly frequency is becoming one of the most expensive portions of a clinical study – the ongoing logistical support. While emerging regions are proving to be good sources of clinical trial subjects and sites, they are often the most difficult regions to reliably reach and maintain. Dealing with these challenges, as well as the unexpected political or natural events, can all significantly impact the overall clinical budget. Effectively supporting clinical sites throughout the world has become a matter of experience over adversity; and experience of working on a global basis is something that Dr Smith has by the bucketload.

There are many risk mitigation policies that Dr Smith uses to ensure that, even in such difficult situations as those detailed above; clinical trial materials are in the right place, at the right time.

Reaching New Markets
"Every country is unique," he says, and with markets that are difficult to access, you can minimise risk by using a local partner you can rely on, or ideally have your own people on the ground. He concedes that it can be extremely difficult if there is a fractured traffic infrastructure or communication network. Often in those situations Fisher Clinical Services will send one of its own team to the trial location to ensure that logistics are set up correctly and stay while the first few shipments come through, to make sure that the process runs smoothly for all stakeholders.

Dr Smith explains that Fisher Clinical Services’ standard process is to ensure that all parts of the infrastructure are capable and everything works well from a logistics standpoint. "We look at the proposed supply route and then make sure that we examine that supply plan with rigour, identify any potential challenges, develop proactive alternatives and therefore mitigate that risk for the customer," he says.

The customer is of course the trial sponsor, the bill payer in that sense; however, Dr Smith says it is important to also think of the clinical site staff as the customer also, as the end-user of the products, which leads the logistics supplier to think about the process in a different way. But of course the key stakeholder in the business of logistics has to be the patient. These are the people who play the most critical role in helping new therapies advance. Throughout the Fisher Clinical Services business, the mantra "the patient is waiting" underscores the urgency for company employees to find new ways to reach patients whose lives may be resting on the import of new and transformative drugs.

Mitigating Risk
Finding new ways of reaching and opening up clinical sites is both a commercial and logistical risk that is fundamental to growing the global clinical supply chain. However, in markets that have the most experienced network of carriers, there are still risks that the logistics agent must be aware of, says Dr Smith, and new ways of carrying out clinical trials are making these more prominent than ever.

Alongside the use of emerging markets, there are changes in the process of clinical drug development itself – the change from huge fixed Phase III trials to the emergence of adaptive trials, for example. "Changing the nature of clinical trials has an impact on our business," he explains. "We are seeing shifts in the traditional large Phase III studies for which the sponsor has to manufacture very large quantities of drugs. Today, for our clients it’s about getting to that endpoint in a smart way, but also in a cost-efficient way."

And of course, the pendulum has now swung from small molecule pharmaceuticals to biologic pharmaceuticals which have to be temperature-controlled. Dr Smith says that these types of shipments now represent about 45% of everything Fisher Clinical Services supplies. "The business we see coming from temperature-controlled drugs has grown about 20% year-on-year. This adds a layer of complexity; you have to think about how you’re going to manage that when supplying drugs, especially to emerging regions," he explains.

Managing the drug supply is about expecting and managing risk. To do that, Fisher Clinical Services uses Total Transportation Management, a system most readily embraced with smaller biotech and pharmaceutical companies who often have limited resources to oversee the day to day aspects of their clinical programme. Larger customers may already have a contract with a carrier in place, but wish to link into Fisher Clinical Services’ network. However, a smaller customer may need Fisher Clinical Services to help them decide which carriers and logistics providers are best, this is where Total Transportation Management comes into play.

The service identifies the best means of managing risk at every step of the logistics chain. As a fourth party logistics provider (4PL), Fisher Clinical Services manages these steps, and the team takes the responsibility of managing multiple couriers and providing its customers with reports and data on performance, allowing them to focus on clinical concerns of the trial. To work with its competitors in such a specialised market place is a surprising move, but as Dr Smith explains, it is about getting the best service for the customer. "You can’t be an outsourcing company that doesn’t believe in outsourcing!" he exclaims.

A significant part of managing risk is deciding which type of logistics provider is appropriate to use, advises Dr Smith. When using an integrated supplier, if the material goes missing you might not retrieve it quickly, meaning the patient might not receive their treatment as planned. Using a specialised supplier that timeframe can be reduced. The real difference is that if a speciality provider misses, it may miss by a shorter period of time, but the cost goes up, says Dr Smith. "You have to think about how much risk you can accept and what the budget can accept. We help our clients understand the complete landscape and share data that we collect to help advise them on a solution that fits their objectives," he explains.

Cost Saving
The issue of budget management is never far from a trial sponsor’s mind. Dr Smith explains that in the past clinical trials have seen 200% overage, i.e. 200% more drugs supplied to the trial than were needed. In today’s environment, not only are budgets tighter but materials are exponentially more expensive. He says that to navigate this new landscape, the supply chain has to work for the customer in a smarter way. Fisher Clinical Services uses a system called Clinical Supply Optimisation to address this, it takes data from where the drug is going and records how much of it is being used to try to manage down how much of the drug will be used in the entirety of the study.

"We often take overage by half which means phenomenal savings for the pharmaceutical company, not only do they have to manufacture less, they don’t have to buy the same amount of comparator drug if they are doing an efficacy study. It doesn’t take a mathematician to work out that you can make substantial savings," Dr Smith explains. In addition, if you have a paper inventory this can be outdated and inflexible. It is important to have electronic Interactive Response Technology, which allows the sponsor or CRO to manage the supply chain tightly. This means moving fewer products around or moving in different ways. Dr Smith explains there are lots of ways to optimise the supply chain at the beginning, and then during the process of the clinical trial to manage risk and cost. "All of this requires a shift in planning the supply chain alongside the clinical considerations of the trial which is a new way of working for the industry. In the most extreme cases, we have been able to deliver significant savings – even half of what the client had originally budgeted through this type of management and oversight."

Fundamentally it comes down to forward planning and inventory management, he says. "The key to this type of logistics management is to be able to foresee issues earlier. So the quicker you can see what the horizon looks like, the better chance you have of managing that study and budget effectively. What drives and connects us all is the recognition that somewhere today, a patient is waiting. It could be a patient hoping to begin a clinical trial, or one already enrolled waiting for the next dose in their regimen or even the larger group of patients, waiting anxiously for new therapies to help them with their condition. Having this type of imperative makes us all realise every day that what we do matters and push ourselves to constantly identify new and better ways of doing our jobs."