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European Pharmaceutical Contractor

Evolving Markets

The pharma supply chain is a $200 billion industry. The future of cold chain products and services is secure in the fact that experts estimate significant growth in biologics; it is predicted that the biologics industry will be worth $300 billion by 2018. In addition, 7 of the top 10 best-selling global drugs will be temperature-sensitive and require 2-8°C storage and handling. In the next four years, 24 of the top 50 best-selling global drugs will require 2-8°C storage and handling (1).

Supply Chain Mutations

When Charles Darwin was born in 1809, there was no international supply chain. If you were sick or hurt, help was likely to be several hours, if not days, away. In the wake of a pandemic or epidemic, hundreds or thousands of people might die. Twenty-two years later, Darwin boarded the HMS Beagle for a trip to the Galapagos Islands that would revolutionise the scientific world. Although scientists, like geologists, were questioning the age of fossils they were finding, this trip convinced Darwin to further explore his hypothesis of evolution occurring through a process of natural selection.

In the world of science and genetics there can be flaws, which are referred to as mutations. In the complex world of global distribution of high-value, temperaturesensitive and life-saving freight, mutations – or variations – of the supply chain can also be found.

Take the variety of challenges found in the BRIC countries (Brazil, Russia, India and China). Russia, for example, experiences extremes of both high and low temperatures throughout its nine time zones. China has developed its infrastructure, which is a great enabler; however, it also has very complicated customs regimes. Other countries are politically and economically volatile – all issues which do not make business easy, particularly from a physical distribution point of view.

As Darwin would recognise, there are opportunities for mutations and variations between each step. To discover what causes these, we must examine the most obvious reasons: natural causes and human error.

Natural Causes

A mutation in the supply chain is something that goes wrong or does not play out as planned. It could be an unexpected natural disaster, like the 2010 eruption of the Eyjafjallajökull volcano in Iceland. This had a huge impact on the aviation industry because there was an enormous area of airspace that no-one was allowed to fly through or near. In fact, according to an article in the Washington Post: “IATA [International Air Transport Association] said the scale of the disruption for the world’s airlines eclipsed the aftermath of the September 2001 terrorist attacks, when US airspace was closed for three days.”

From a clinical perspective, situations like this mean that outbound investigational medicinal product distribution is significantly slowed down, and there is a higher risk of delay to both trials and results. From a commercial product point of view, opportunities might be missed. With patients waiting at the end of the supply chain, it becomes necessary to make quick decisions. Do you fly via another route? Or put the products on a boat, train or truck? If changes to the mode of freight are needed, it will potentially be more expensive, and additional unaccounted-for risks may arise.

A more recent example of a natural disaster where some degree of notice was possible was the super typhoon Haiyan in the Philippines. Both citizens and government knew for some time that the typhoon was coming, so they are likely to have stockpiled supplies all over the country that would assist in the aftermath. However, it was still very difficult to minimise the adverse impact of the storm. There were no buildings built higher than a few feet above sea level, and the wind and water damaged or destroyed nearly every structure. According to a report by WGN TV: “The nation’s disaster agency said between 9 million and 13 million people were affected in 44 provinces, 536 municipalities and 55 cities” (2).

The rest of the world tried to help, but if an airport cannot accept aircraft, then ‘plan B’ must be put into action – in this case, this was to ship in bulk to a neighbouring country like Vietnam, and then drop supplies to a remote area within the country via helicopter.

Human Error

Other causes of mutation are a result of human error. This could mean a whole host of issues – from incompetence, to malfeasance, to civil unrest, or something as simple as including the wrong documentation. If the paperwork, customs invoices, commercial invoices or airway bill are wrong, it will cause a mutation. That mutation might mean that a shipment is rejected at customs, which may reduce the efficacy of the drug it contains – making it no longer fit-for-purpose.

Alternative mutations could be flight delays, cancellations or strike action. If there is strike action taking place within a country, other carriers are not allowed to fly through this airspace. Recently, as a result of truckers blocking roads while protesting fuel prices in one European state, havoc was wrought on the economy and supply chains, and a ripple effect of protests also spread to at least three other European countries.

Risk Management

If we send a shipment from London’s Heathrow airport to Indianapolis in the US on Monday, and then again on Tuesday, will the circumstances ever be exactly the same? With all the potential factors involved – being re-routed, for example – it is unlikely. The destination might be the same, but the way in which the shipment’s journey evolves may not be. Therefore, when planning your supply chain – taking into account packaging, temperature control needs, data monitoring and mode of freight – the risk of such mutations and variations should be addressed in your risk management strategy.

If you know your normal supply chain for a shipment from London to Buenos Aires is a direct flight, and you know it is usually complete in fewer than 48 hours, do you choose a 72-hour qualified solution? There may be some chance of mutation, due to any number of factors, and plan B may involve changing flights at Madrid, which will take longer. Do you then also take this longer timeframe into account in your choice of packaging?

You can choose the best packaging, air freight, logistics partner and monitoring for your needs but, when you put them all together, are they still effective? Does one organ in the human body work without another? If your packaging provider works closely with the logistics coordinator, and determines that 98% of the time your delivery is made within 48 hours, and plan B only takes 56 hours, from a risk-based point of view, do you really need a solution for 72 or 96 hours? If the answer is still “yes”, you must consider the cost increase; or alternatively, you can choose to manage that risk.

Regulatory Requirements

Temperature excursions are responsible for the degradation of up to 35% of the world’s vaccines (3). Temperature-related damage to drugs is not easily visible and can occur at any point in the supply chain. The new EU Good Distribution Practice Guidelines fit into its overall evolution by advising the use of risk-based methodologies to evaluate the integrity of the supply chain.

Improving patient treatments and/or outcomes is the basis for implementing the new guidelines. Using a risk-based approach to drug protection will reduce counterfeiting and environmental exposure. The guidelines are designed so that a product does not just make it to the doctor’s office or pharmacy, but is maintained at the appropriate temperature throughout its journey, ensuring its safety and efficacy when it reaches the patient.

Cold Chain Progress

It is hard to believe how the cold chain has evolved in the last 20 or 30 years, let alone over the two centuries since Darwin was born. This is particularly true in terms of the technologically advanced, temperature-controlled, regulatory compliant packaging we use today to safely ship pharmaceuticals and samples around the world.

This industry has evolved immensely from where it started with a box, a water-based chilling component and some simple thermodynamics. Now there are virtually limitless configurations with which to accommodate any size of payload and keep it at any temperature from -190°C to 25°C. In the last few years, new outer materials, phase change materials and data loggers can now keep track of shipments in real-time around the world. Where are we headed next?

There are still challenges to overcome in the supply chains of traditional pharma markets through regulatory changes, natural disasters, or other problems. But just as with science, successful distribution supply chains can be replicated, much like a gene can be.

Communication can also mutate. The key stakeholders need to work together as a team, not in isolation – if one part does not get the required information, or it changes as it is passed down the line, the knock-on effect can be disastrous. When you try to create supply chains to meet the business needs of new products and new growth markets, this does present challenges – which, as we have seen, can prove extreme. But just like Darwin’s On the Origin of Species, advances will be made based on the anticipated evolution of the market.

References
1. Pharmaceutical Commerce, The Biopharma Cold Chain Sourcebook 2013, 4th edition, pp12-13
2. Visit: http://wgntv.com/2013/11/17/death-toll-continues-to-rise-in-phillipines
3. Matthias DM, Robertson J, Garrison MM, Newland S and Nelson C, Freezing temperatures in the vaccine cold chain: A systematic literature review, 2007. Visit: www.path.org/vaccineresources/files/coldchainarticle.pdf



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Stephen Healy joined Intelsius as European Sales Director in February 2013, and was named Global Director of Sales in May of the same year. He has extensive industry experience, and is considered a thoughtleader in the temperature-controlled, regulatory compliant packaging field. Stephen was a featured presenter at the Biopharmaceuticals Good Distribution Practices Summit in Bethesda, Maryland, in March 2013. He also recently moderated a panel discussion at the IQPC Cool Chain Europe show in Luxembourg.
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