Cold Chain Roundtable

1. What, in your opinion, is currently the single largest trend with respect to cold chain logistics and technology?

RG: Organizational Trend: Pharma is moving distribution, especially R&D clinical distribution and manufacturing to third parties. This includes transportation, cold chain packaging and shipping decisions and shipping qualifications for packaging. Along with this shift will be the loss of expertise in GMP compliance and cold chain to the pharma. An opportunity exists for these third parties to quickly gain expertise from the labor force being laid-off by pharma.

Third parties, in order to cut costs and cycle times, are questioning: packaging, procedures for shipping, the transportation, distribution methods and cost of components (packaging and monitors) and quality steps. Much different from the past, the third party is now the customer for the suppliers/ couriers and will make the decision on the requirements and procurement.

Technology Trend: New software developments are working with temperature monitoring, packaging and delivery services to integrate data; such as temperature, delivery times, locations and mode of transportation to track, and record: a shipment, shipments and/or shipping lanes. This information documents the shipment(s), provides rationale for the deviations that may occur and profiles the shipping lane with actual performance data.

In the future other information, such as, the type of shipping container used, outside ambient temperature, mode change or staging, destination and origin marking, can further develop the picture of the shipping environment. Other recordings of physical characteristics will be integrated in the system; such as relative humidity, vibration, tilt, etc.

Why record all this data and integrate?? … To support the container, transportation mode, the shipping lane decisions and processes that integration will eventually simplify and ensure quality.

KE: At UPS, our perspective is that information about a package is just as important as the package itself. Technology that allows companies to not just monitor, but provide data that enables it – or its 3PL partner – to intervene and rescue a distressed package before it goes out of temperature range is one of the most important tools in the arsenal of product protection. Real-time, or near-real time data, is important but at UPS we put emphasis on technology to aid in where it counts – intervention. Consider this: a company that receives real-time data about a package experiencing a temperature excursion without the ability able to intervene, only means they got bad news sooner.

What’s exciting is that today’s newest sensor technologies don’t just stop at reporting temperature, but they’re providing better information about critically important factors such as the shipment’s exposure to humidity, light, shock and vibration. Also, sensor technologies can help mitigate theft through geo-fencing to make sure a product is staying within its set transportation path.

RH: The industry’s transition into more biologically based pharmaceuticals is the single most important trend as it relates to cold chain logistics. This shift has added complexity to even early stage development initiatives. For instance, the increasing use of biomarkers and pharmacogenomics in routine clinical practice presents significant challenges, none more critical than the optimal preservation of DNA and RNA utilized for biomarker identification, assay development and biomarker testing. As such, we are seeing an increased need and a heighten emphasis on upstream processes that provide global visibility and control over the transportation and storage of patient samples during the clinical stage of drug development.

LS: The largest trend I see is the regulatory movement to suggest that all drugs and biologicals be transported under labeled conditions. Labeled condition refers to the temperature storage instruction that appears on the label and carton and is the storage temperature approved by the regulatory agency based on stability data; i.e., you will see “store at 15-25 C (59-77F).”

This is an expansion of the cold chain temperature range of 2-8C. The ability of regulators to raise the bar is a direct result of several technological improvements. First, there is the introduction of active heating and cooling air transport containers that can be without a power source for 72-96 hours. The older dry ice devices required a coordinated supply chain with up to 2-3 re-icings with a replacement of 16 “D” cell batteries on a threeday journey. Each stop was an opportunity for error.

For smaller shipments, manufacturers have introduced phase change materials with a phase change point of other than zero Celsius. In the past, all phase change materials have been water-based zero Celsius. The innovation of 4C, 6 C, and 22C materials means small package shipments can be designed for well beyond 48-60 hour ranges without the box being unmanageable for one person. I also believe there has been a revolution in data logger technology. Data can be instantly read and sent over the internet or by wireless device to systems capable of instantly identifying whether there are deviations. Devices under development today are being included in RFID tags. I have viewed manufacturer plans to have stability data programmed by the pharma company directly in to the data logger so they can be included in small shipments. Today’s challenge for the industry, “the last mile,” is getting closer to a solution whereby the person receiving the package will have an immediate “go/no go.”

RM: Specialization/Customization – We see an increasing demand for individualized solutions to transport specific payloads. Existing solutions and logistics don’t adequately meet the strict requirements for temperature sensitivity. In addition, logistic constraints (time, temperature fluctuations, handling) increase the difficulty of maintaining strict temperature requirements.

2. How, in your mind, has the landscape of cold chain logistics and technology shifted post-recession?

RG: First, I do not believe we will reach post-recession for at least another two years. EU debt, US debt must first be addressed and then the financial markets/ lenders must make cash available for businesses to use. Currently we are in a shrinking stage making it harder to get money and generate velocity to grow a business much less the economy. In addition, the return of military personnel, nearly 400,000 back into the US economy from the wars will also create an excess of unemployed in a market that today does not have enough demand to grow.

Second, the landscape has shifted; the government has tightened controls and slowed movement of commerce into the USA. Two years ago importing portions of the supply chain materials into the USA would take 2-3 days to clear customs, today it is not unusual to take 7-10 days and it now must clear customs and 2-3 other government agencies. More forms and supporting documentation are needed today and the agencies themselves are losing and rotating staff which further compounds the goal of efficient and/or effective processes.

The result is shipping system and arrangements into the USA must be designed and prepared to weather a 7-10 day trip rather than a 3 day trip. For cold chain this means robust shipping systems and detailed monitoring by the courier to take action if necessary.

Third, the landscape of logistics and technology has shifted to a focus on lowering costs. For big pharma this has also been a move to push the process and work away to a third party. The goal of trying to do more with less drives these processes. The results should be lower costs, elimination or reduction of older procedures and new streamlined procedures that challenge older principles. Compliance under the new Spartan methods may result in lower costs and speed up delivery but actual performance will prove whether compliance and quality can be maintained.

In line with this cost effort is a push to lower temperature monitoring device cost and pretend they are commodity items. This is a pre-mature move for the industry because more technology is being demanded (and needed) from temperature monitoring device manufacturers while a good portion of the biotech/ pharma industry is not exercising good distribution practices. Several approaches and technologies exist and are still being developed. The emergence of controlled room temperature CRT products in a monitored package will draw together the device for temperature and relative humidity monitoring.

Fourth, not related to the post-recession, is the movement of the CRT product into the realm of the cold chain packaging approach and qualification. The need for the shipping qualification and temperature monitoring now becomes part of the distribution cost for CRTs. Today 8 of 10 top prescribed drugs are CRT and do not bear the costs that cold chain products must bear. This foreshadows lower profit margins and more compliance for the CRT products. By 2015 it is estimated that 8 of 10 top prescribed drugs will be cold chain and the remainder will be CRT. This draws a bleak picture of higher product costs and compliance throughout the supply chain. The challenge will be to lower these costs while providing the compliance and quality. The solution hopefully will be delivered through new technology and innovation.

KE: In these recessionary times, I think companies have been cautious and are exploring what’s really worth investing when it comes to adopting new technologies to aid in product protection. They clearly want to see the value to the bottom line, how it might mitigate risk and better protect against product damages and loss. We understand that even a single kink in the cold chain may cause a risk to patient care and have a negative effect on revenue.

One thing is certain however, with the surge of high-value, temperature-sensitive products coming to market comes mounting scrutiny of product protection and increased regulations that impact the supply chain. Because variations in temperature or humidity during transit can transform modern medical miracles into spoiled materials, delivering medicines and therapies safely to patients has never been more challenging. These products are requiring sophisticated monitoring technologies and capabilities to ensure the protection of these high-value shipments. The stakes are high and the pressure is on in terms of preserving brand integrity, customer confidence, market share and patient health. An ineffective cold chain puts all these factors at risk. In the logistics industry, we see value to the customer in using technology such as sensors to expand the types of data that are available to build stronger links in the cold chain.

UPS’s own research found that overall, technology is still an area in which healthcare companies are driven to invest. This year’s UPS Pain in the (Supply) Chain healthcare survey of senior-level decision makers at nearly 250 pharmaceutical, biotech and medical device companies globally, tells us this with regard to technology:

• Investing in new technologies ranked as the top strategy companies have employed for improving competitiveness over the past 18 months as well as the top strategy they would employ over the next 3-5 years
• 72 percent of respondents said they had invested in new technologies in the past 18 months
• 86 percent said they would invest in new technologies in the next 3-5 years

RH: The logistics industry is looking for new, cost-effective methods to meet the increasing needs for compliant cold chain processes. Process methodology and regulatory changes have shifted beyond just the carriers, and have been extended to the sites and shippers. And, because companies are more cost-conscious many of them are looking for efficient ways to manage shipments, such as consolidation and batch shipping of patient samples.

LS: All companies are always looking to manage their costs. I believe there is a balance point in cold chain logistics between lower-cost solutions and solutions that protect the safety and efficacy of the drug based on shipping cycle studies and product stability data. I should begin by commenting on shipping cycle studies. This is a new type of study regulators have begun asking for, especially long haul international studies where there may be customs delays. The regulators are looking for temperature data that shows the box/container performed as designed for that specific route. They are also then looking for that product to be “put on stability”. This expression means, that drug will be returned to the Manufacturer’s Quality Assurance group under labeled temperature, where the drug will be stored under labeled temperature for the remainder of the product’s shelf life. The product will be tested by the QA group under the same procedures they follow for accelerated stability studies. There is no universally agreed upon definition that I am aware of for a shipping cycle study, so at this point regulators have been accepting studies based on good science. There is a PDA (Parenteral Drug Association) task force working to define shipping cycle studies in a technical report.

The solutions that I mentioned in my answer to the first question sell for a premium price. Manufacturers of data loggers, phase change materials and other technological solutions recognize the value of their innovation and look to recover the costs of development in their product/service pricing. Pharma companies post-recession have tighter budgets. They are looking to solve the problem with the lowest-cost solution. I have noticed pharma companies look to substitute EPS (expanded polystrene) boxes for PUR (polyurethane) boxes.

Transportation is an area where I have seen companies find the most opportunity for cost savings. Companies are looking at small package delivery. The change of service level from overnight to second day is common. That presents an analytical challenge. Where is there a greater cost savings - in reducing packaging or in reducing service level? It comes down to data. Do they have shipping cycle studies that support the changes? I have also seen shared services between companies. An example that comes to mind is in U.S. or EU truckload movements. Companies may have pallet quantities to move long distances but may not have enough freight to fill all the pallet positions. I see companies today using shared networks of climate-controlled trucks so they are only paying for the space they use.

RM: Shipping customers are increasingly looking at the costs of logistics concurrent with demanding a higher level of temperature control and measurement. The sophistication of transportation has extended to the individual payload level and down to the “last mile”. At the same time, pressure from transportation vendors to increase prices due to higher costs (fuel, labor, etc.) means that a greater emphasis must be placed on obtaining the most efficient shipping solution.

3. What country/region, in your opinion, is currently leading the way in cold chain technology and why?

RG: In packaging and monitoring in motion it appears to be the United States. My reach for 2011 only extends to US and EU. There are several advances in pieces of processes in EU but not for an entire product development.

KE: Currently, our observations of emerging sensor technologies tell us there are some strong players from North America and Europe, though we aren’t ignoring emerging markets in Asia and other parts of the globe. There are a number of traditional enterprises that are active in developing sensor technology; however, there are an increasing number of new start-ups in the market as well.

As with any technology start-up, there is a drive to capitalize and build a business around an idea. At UPS we continuously explore in this arena, and often engage with young companies with new ideas. We internalize this research as well to help us to develop in-house solutions.

RH: In terms of growth, the BRIC countries are leading the way in the amount of samples being shipped via cold chain. But, volume and quality is still in Americas and Western Europe.

LS: From a regulatory perspective, I see three countries taking the lead role. Ireland’s IMB (Irish Medicines Board), England’s MHRA (Medicines and Healthcare products Regulatory Agency) and Canada’s Health Canada are pushing the industry to implement tighter controls of the supply chain door-to-door. For example, the regulators will present at conferences that in the next year they will be focusing on a specific change. Then 12 months later, you will see that agency citing companies for being deficient in that area on their inspection reports. I see Brazil’s Anvisa taking stronger positions on imports. For example, in my previous role, I saw Anvisa ask for shipping cycle studies, a type of study still being defined. Then there are countries like Austria and Saudi Arabia who have specific laws for imports to their countries. Their requirements are absolute, product needs to ship door-to-door under labeled conditions to be released in country. From a technology perspective, I have seen innovation come from both the U.S. and the EU. Whether I am looking at data loggers, packaging solutions or air containers, the development of these solutions are led by U.S. and EU companies. This may be coincidental with the fact that many of the largest pharma and biotech companies are located nearby. I know from my years in pharma that I always suggest unmet needs to my supply chain partners.

Early data logger development was funded by pharma companies. Today, I am not aware of any pharma companies funding development of data loggers, packaging and PCMs (Phase Change Materials) or containers. Their spend is in validating the technology, which does point out weaknesses and, by default, is supporting development. But most of the capital is from private equity firms who take an ownership in the technology suppliers. I see a potential funding gap if the time for return on investment becomes too long.

RM: North American customers have a lot of activity in this space driven in large part by the location of so many customer headquarters. The EU also has a lot of activity driven by higher logistics costs and greater regulatory pressures. These regions currently lead the rest of the world.

4. If things progress as they have the past five years, what can we expect in the next five years, with respect to cold chain logistics and technology?

RG: Technology of packaging thermal performance (new materials), monitoring/ data recording, remote data retrieving (such as RFID or like) and data integration will advance in the next five years. Counterfeit and pedigree markers will also emerge as part of the future hardware. Economies of scale may drive costs down. More supplier businesses will emerge as the options for many more diverse devices and approaches are developed.

There will be a need to harmonize/ standardize but not until the technology reaches a settling point where the processes and supply chains are stable. Competitors may attempt to buy others to increase the market share. However the cost of entry should allow many players in the supply side.

Speed, quality, improved capacity per packaging space and knowledge of key performance indicators will continue to be a driver for the industry. This will actually become more evident as the pharma will want to know more about the product the third parties are managing for them.

The market will attempt to bring some type of common approach as key players will emerge on the supply side in an attempt to capture large volumes from the Big Pharma. Price, size, capacity, multiple feature function, integrated with package, courier, and other special applications will be factors in customer selection. Many niche suppliers will have space in the future market.

KE: Cost containment initiatives coupled with shipment security, insurance and assurance will be critical over the next five years. No one would argue we’re still dealing with and emerging from a down economy, which is forcing companies to look at each link in their supply chain to drive efficiencies.

An exciting possibility to think about involves leveraging the wealth of data that’s gathered by sensor technology and monitoring of shipments in-transit. Over time, this knowledge collected post-shipment can be examined through analytics which can identify patterns and pinpoint operational inefficiencies in a company’s supply chain. This kind of information-gathering could be a powerful tool for companies wanting to strengthen the cold chain and provide more assurance for product protection.

Another contributor to the bottom line is the active prevention of lost shipments, which could also mean spoiled or damaged shipments. Another exciting aspect of sensor capabilities is that it expands our ability to know the condition of the shipment in real-time which allows UPS to leverage its intervention and shipment rescue capabilities via its global network– thus reducing or preventing loss of this nature.

Lastly, in five years we see the sensor technology in this arena becoming smaller and less dependent on being reusable.

RH: The movement of the pharmaceutical industry to biologically based pharmaceuticals is the single most important trend as it relates to cold chain logistics, and it would appear this trend will grow even larger over the next 5 years. As part of pharmaceutical development, regulatory agencies are increasingly requiring drug developers to assess the possible link between genetic variations and the safety and efficacy of new medicines. Because of this, we will continue to see growth in pharmacogenomics, which means we will need to manage more shipments of genomic biospecimens (DNA and RNA). These materials are more fragile in nature than standard blood samples; consequently there will be a greater need for newer and faster logistics and technologies to support this trend.

Additionally, in the next five years, I would expect the trend of research in emerging regions to continue and intensify. Because of this, better logistics processes and technologies will be needed to assist in the expedient and efficient transport of patient samples. Technological tracking of samples from site to bench via RFID can assist biopharma companies in understanding more quickly where samples are in transit and what may have been missed in collection at sites.

LS: I have been involved in cold chain logistics since 1994. In 1995, I attended my first industry conference sponsored by USP (US Phamacopeia). The topic of MKT (Mean Kinetic Temperature) was first discussed. I remember returning and discussing the topic with my peers. At that time we felt the technology and infrastructure was 20 years away. Back then, data loggers were basic with a high and low reading, but with a much larger variance than we have today.

In the past 16 years, the cost of data loggers has dropped and at the same time their accuracy and their ability to provide more detailed information about the time and location of a deviation has increased. Today I believe we are five years away from having a cost-effective data logger that will be able to track the MKT of a pallet of product from the pharma manufacturer to the pharmacy. The cost-effectiveness of current data loggers is also allowing pharma companies to increase the number of shipping cycle studies and route design studies they are performing.

Our challenge as an industry is that the technology is not yet able to take us the last mile. The initial discussions of the early ‘90s on cold chain came about from discussions on product complaints from consumers. There were numerous complaints about insulin products not being effective. Investigation revealed that consumer behavior post-pharmacy was the root cause for the product failures. Consumers do not routinely read “package inserts.” These inserts advise to not store near heat, light and humidity. Yet how often do we still see product stored in bathroom medicine cabinets, on window sills or left in cars during errands?

The challenge of the next five years is the last mile, maintaining the safety and efficacy of the drug to point of use. Will that be better packaging, such as temperature-sensitive labels that change color after exposure to X hours of heat units? The current recession is working against this outcome. Five EU governments have forced pharma companies to reduce their pricing. If that continues, the question will be: From where will the funding for these advances in technology come?

RM: The last five years have seen a lot of new technology options and solutions. The next five years should see a consolidation of these technologies as the winners outpace the losers and obsolete older tech. The high cost of electronic tracking technologies should decrease just as they have for similar technologies such as RFID. Customization will be ubiquitous and provide for a high degree of temperature control for smaller payload volumes. The amount of energy used per volume/mass of shipped payload (e.g. shipping efficiencies) will be less than half what it is today.

5. In your opinion, what research field currently benefits the most from cold chain technology development and why?

RG: Cold chain technology has benefited biotech the most because the materials used in the supply chain and finished product are cold, cool or controlled room temperature. The development in packaging, PCMs and new hi-tech insulators has made the delivery of products more reliable. Progress in the temperature monitoring arena has also provided tools to ensure the packages are performing properly. By 2015, 8 of 10 top prescribed drugs will be cold chain. With movement of CRT into the same technology with cold chain packaging and (phase change materials) PCMs, at least 9 of top 10 drugs will be under some type of special packaging and monitoring.

In the academic area field research is on-going into:

1. The characteristics of combinations of materials for phase change applications, additionally the research into more green materials beyond vegetable oils. Leachable and extractible will continue to be a concern as reusable containers/ pouches/ covers will be pushed to longer service life.
2. Further work on high performance insulators. The effect of changing density /thickness and layering combined with air gaps or no air gaps has moved thermal performance to higher levels of performance. Particularization, bonding, encapsulation, and layering are all applications that will require further study.
3. Nanotechnology has developed devices that transmit, record and perform higher level functions. The application of temperature recording and transmission is in the near future. The issue of price comes to question in the short term but the many practical applications will drive this creation.
4. Software will develop in academic and industry:
   1. Allowing hardware to be self-interactive, giving and receiving information to move to the next higher level of decisions. Devices that detect other devices, energize, transmit and then act on the information. RFID is a recent example.
   2. Bringing data from different vendors/devices/languages to integrate to provide more data of the environment for better decision-making. The real-time and speed features of transmission may be added to this activity.
   3. User friendly interaction by either: visual, oral or tactile signals will alert the human interface to take some type of action. This will be on a broad scale communicating at the lowest grade level practicable broadening the number of potential users. .
   4. Training will be iterative, building complexity levels and providing positive feedback. Most of the techniques will come from a huge growth market of virtual gaming. Academia will study and categorize the psychological and technical science that makes gaming such a successful market. This will be transferred to use in cold chain and logistics technology.

This question is a good topic and should have more points. I have not done the research outside my own sphere of influence to serve it justice.

RH: Biopharmaceutical research and development is highly dependent upon cold chain technology due to the global nature of their clinical trials, and the ever-increasing need for cold chain solutions that fit their biologically based products. However, because biologic molecules are generally larger and more fragile than their pharmaceutical counterparts and more sensitive to temperature fluctuations, they present new storage and handling challenges, even in the early stages of development. For example, the patient samples collected for biopharmaceutical research are oftentimes non-reproducible, and are therefore highly valuable to researchers from a cost and scientific standpoint. Consequently, we are finding that companies are taking more of a strategic approach to their cold chain management earlier in the drug development process.

6. What recent improvements/methods have been implemented to make a temperature-monitored supply chain a viable option?

RG: The technology for temperature monitoring a supply chain has been around for many years. Today at most sites the monitor is manually started goes in the container and is not read or seen until it is unpacked at the destination. Traveling enroute there is little means to detect if the internal near the product temperature has went out of range or if the product has moved/ changed orientation.

Today only after working with several and up to many parties can a proper investigation and detective work determine what happened for a significant temperature deviation along a shipping lane. This is discovered only after the monitor is removed, after the shipment reaches its destination well beyond its temperature and/or time limits.

So the key points of future improvements would be:

1. Monitor can be read outside the container by a handler or read electronically at reading/ transmission points.
2. Monitor starts and stops without manual touch, electronic signal activates and tests with feedback. Stop at pre-determine time or electronic or manual command. This occurs without opening the container to get the monitor.
3. Monitor signal to courier at key times, mode changes, to mark route changes, time/date stamping, temperature, and trends for reports. This can be triggered electronically without removal of the monitor.
4. Monitor is unique (serial #) and calibrated, record data, also higher features, extended memory, multiple alarms, MKT and graphic software.
5. Database that can pull multiple monitors data, courier delivery data, airline/ airport data and report statistics, trends, scatter diagrams, graphs, etc. This would be integrated, web-based and secure.
6. Monitor alarm sends signal to devices but also sends e-mail, WIFI, text, to key contacts for action.
7. Monitor records temperature of product inside the container and displays/ transmits temperature outside the container. The temperature monitor would send data to a considerable distance away from the shipping container.
8. Monitor, once communication capabilities are achieved, can measure temperature, relative humidity, vibration, tilt, etc.
9. Size and shape of monitor will be non-obstructive and reusable. It may even be part of the packaging or shipper.

Note: There are monitoring systems today that achieve some of these points. The goal of the list is synergy of hardware, software and players in the shipping lane.

KE: The market for temperature-sensitive products is fast-growing and there is no shortage of emerging technologies, improved packaging and container solutions for healthcare companies to consider.

UPS has worked closely to understand our healthcare customers’ temperature-sensitive needs to develop the latest solutions and services to ensure the protection of high-value products across the supply chain. So, in September UPS recently introduced an innovative air freight container called the PharmaPort™ 360, which is specifically designed to transport temperature-sensitive pharmaceuticals, vaccines and biologics required to stay within 2-8 degrees Celsius. This container’s unique heating and cooling technology offers an even more reliable way to transport temperature-sensitive products globally and it addresses a critical challenge for healthcare customers to more securely manage these products in the supply chain. The unit's technology replaces the need for dry ice, which eliminates the associated handling fees and hazardous materials charges. It allows the unit to hold critical 2-8°C temperatures 38 percent longer than current dry ice container solutions.

The PharmaPort 360 also includes built in GPS/GSM (Global System for Mobile Communications) capabilities which enables near-real time visibility and monitoring. Data is monitored by UPS’s global network of control towers to not only track location, but more importantly to enable us to act on in-transit shipment alerts such as low battery life or temperatures that are going out of range, which helps protect against product loss. UPS is able to give companies precise, measurable operating procedures backed by dedicated support and contingency plans for unexpected situations.

Innovations like these give healthcare companies more options to consider, even as cold chain regulations evolve and continue to become more stringent.

RH: A temperature-monitored supply chain has always been an option, but the technology was passive and only provided after the fact data reporting. New “active” technologies allow for monitoring and temperature-tracking en-route, which allows for proactive action to be taken if it appears a shipment will not meet the temperature control requirements. This technology is most applicable for the highest valued shipments.

LS: In the United States, it is now viable for companies to ship full truckloads of product under controlled temperatures. In the mid-‘90s, only food and perishables moved under controlled temperature. Truckload companies have built that capacity over time. At the same time, companies that manufacture the air heating/cooling units for the trailers have increased their reliability and added features that allow a visual reading by the warehouseman prior to loading to ensure it is capable of cooling at the target temperature.

The need for the truck owners to know where their equipment was brought the addition of GPS domes on the roofs of tractors. These communication domes now allow for shipments to be tracked cross country, for shippers to see the temperature in the trailer in real time and to speak directly with the driver to make corrections to the set point if needed. I believe in the next five years we will see the ability to have similar conversations with engineers on ocean cargo ships and to link in with airlines to adjust air container temperatures. For the manufacturer, the ability to see data in real time but not be able to influence a change in temperature is of no benefit. Supply chain partners need to develop the ability to raise and lower temperature concurrently with the product to provide real-time visibility.

The next opportunity will be to extend technology into customs areas. Today in several large countries, shipments go in to a customs hold where visibility is lost for several days. Pharma companies need their supply chain and transportation partners to not only develop devices that can communicate by satellite from Russia or Brazil providing real-time data, but to be able to correct the deviation before product quality is affected.

RM: Lower cost electronics and a highly mature wireless electronics industry have driven down the prices for this type of tech. Communications and monitoring have come down to the device level and we should see a continuation of this trend. This will make individual/last mile tracking cost effective.