Supply Chain Innovations

Specialty Pharmacy Times, June 2012, Volume 3, Issue 3

Complex distribution challenges for manufacturers of specialty drugs require life science and cold chain experts to provide a faster, better way of distributing these life-saving medications.

Complex distribution challenges for manufacturers of specialty drugs require life science and cold chain experts to provide a faster, better way of distributing these life-saving medications.

As drugs and therapies become increasingly sophisticated, such scientific innovation creates complex distribution challenges for life science manufacturers. Because these advanced treatments are frequently temperature sensitive, they often must be delivered rapidly using technology capable of preserving their efficacy.

As life science and cold chain experts, the question for our industry is how to keep pace with the constantly changing demands brought on by this rapid scientific innovation.

For the specialty pharmacy industry, there are multiple challenges: therapies often are extremely expensive, temperature sensitive, and have short shelf lives, making it difficult and economically challenging for wholesalers to maintain an inventory.

A manufacturer may spend years developing a product that saves lives, but that product is useless unless it’s in the proper condition and arrives within the critical time frame necessary when medical emergencies arise. There always is a need for faster, better ways of distributing drugs—just as there always is a need for better, more effective medications.

NEW DELIVERY SOLUTION

Such a need resulted in a unique challenge for our company, DDN, in 2011. We received a request from a drug manufacturer seeking a solution to a very difficult problem—how could they deliver expensive, lifesaving products and therapies 24 hours a day, 365 days a year, in 8 hours or less, almost anywhere in the United States? And, in some cases, treatment was required as quickly as 4 hours after a diagnosis or request for therapy.

We researched the complexities of these types of products and the significant distribution challenges they pose. We mapped out major treatment centers in the United States, projecting estimated travel times and other complicating factors. Our response was to create a first-of-its-kind service called “DDN Urgent Access,” a configurable, end-to-end delivery solution. It consists of a network of strategically located sites capable of meeting the critical 8-hour window and ensuring the safety, efficacy, and quality of products. These specialty drugs are used to treat conditions such as methotrexate toxicity, insect bites, organ rejection, deadly toxins, overdoses, and infant illnesses.

Within 100 days of the launch, 39 lifesaving therapies were delivered in 8 hours or less.

DDN Urgent Access is the latest example of many solutions developed over the years to meet the increasingly complex distribution requirements created by new scientific innovation. As the number of specialty drugs grows, cold chain experts will be asked to answer these unique challenges by continuing to pioneer and launch innovative services.

INNOVATION IN COLD CHAIN

In the mid-’90s, only food and perishables were transported under controlled temperatures. Today in the United States, companies can ship full truckloads of product under controlled temperatures via truckload companies that have built that capacity over time. At the same time, companies that manufacture the air heating/cooling units for trailers have increased their reliability and added features that allow a visual reading by the warehouse prior to loading to ensure that it is capable of cooling at the target temperature.

The need for the truck owners to know where their equipment was during its route created demand for GPS domes on the roofs of tractors. These communication domes now allow for shipments to be tracked cross-country, and 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.

ECONOMY VS INNOVATION

Innovation, however, can be impacted by economics. The recession has affected the landscape of cold chain logistics and technology, and yes, all companies are always looking to manage their costs. But we 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.

Shipping cycle studies are a new type of study which regulators have begun requesting, especially for longhaul, international shipments during which there may be customs delays. Regulators are looking for temperature data that show that the box/container performed as designed for that specific route. They are also looking for that product to be put on stability, which means recovering the product used in the shipment and placing it ina climatecontrolled room where its shelf life is tested to demonstrate product efficacy.

There is no universally agreed-upon definition for a shipping cycle study; so, at this point, regulators have been accepting studies based on sound science. Some solutions command 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. Pharma companies, post-recession, have tighter budgets. They are looking to solve the problem with the lowest cost solution, such as substituting expanded polystyrene for polyurethane.

Transportation is an area where we have seen organizations find the most significant opportunity for cost savings. Companies using small package delivery and changing service level from overnight to second day is common. That presents an analytical challenge. Is it better to reduce packaging or reduce service level? It comes down to data. Are there shipping cycle studies that support the changes?

One alternative is shared services between companies. An example that comes to mind is in US 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 in the container. That is why some companies are using shared networks of climate-controlled trucks so they pay only for the space they use.

THE FUTURE OF INNOVATION

We believe we may be 5 years away from having a cost-effective data logger that will be able to track the mean kinetic temperature of a pallet of product from the pharma manufacturer to the pharmacy. However, 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, resulting in better and more economical solutions.

We also believe within 5 years we will have the ability to communicate with engineers on ocean cargo ships and link in with airlines to adjust container temperatures while in transit. 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— so supply chain partners need to develop the ability to raise and lower temperature while the product is in transit to provide the desired benefit of real-time visibility.

Another near-term opportunity will be to extend technology into customs areas. Today, in several large countries, shipments go into 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.

SPT

Larry Sweeney is chief operating officer at DDN, a Dohmen Company, which provides unconflicted business support services to global emerging, mid-tier, and large life science companies. DDN is uniquely aligned with manufacturers to create efficiencies, reduce cost, and solve complex business challenges within the health care supply system. The author can be reached at lsweeney@ddnnet.com, 414-434-4809, and www.ddnnet .com.