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Pharmaceutical & Medical Packaging News, November/December 2014

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27 November/December 2014 Pharmaceutical & Medical Packaging News • pmpnews.com capacities," he says, including specialty- handling experience and expertise. One trial, adds Bob Misher, senior vice president, global clinical trial servic- es for Packaging Coordinators Inc. (PCI; pciservices.com), might take place in 40 countries simultaneously, "and when you are managing, say, a refrigerated product around the world in 40 coun- tries," he explains, "that presents quite a challenge to move the product not only in its bulk form to a depot, but then from that depot to all the various sites in that region or country, and then the 'last mile' from the site to the patients' homes, particularly when certain coun- tries lack adequate infrastructure and patients could live more than eight hours away from the site." Thirty years or so ago, when Misher started in the industry, the emphasis was on packaging and labeling of product because clinical trials were much more regional. An "international" clinical trial in the late 1970s or early 1980s, Misher says, might involve the United States, Canada, and a few European countries only, with a short, simple supply chain to reflect that. Packaging and labeling are, of course, still important, but quality and the management of complexity in the supply chain are bigger issues now, with globalization of the whole drug devel- opment process. "And that's where the investments are being made" by pharma- ceutical packaging and logistics compa- nies, Misher adds, "because management of that supply chain is critical to the over- all success of the clinical trial." Cold-ChAiN MANAGeMeNT: A hoT ToPiC for iNduSTry One of the many ways in which the supply chain for clinical-trial pharma- ceuticals has changed over the years is the increasing need for maintenance of a very cold environment across manufac- turing, storage, distribution, and deliv- ery of particular products. This change results from the emergence of parenteral (typically injectable) biopharmaceuticals, or biologics, which generally cannot vary in temperature beyond 2° and 8° C, and in some cases must be kept frozen at tem- peratures as low as −20° to −70° C. Mat- thew Harrington, global brand manager, packaging & labeling, Fisher Clinical Services (www.fisherclinicalservices.com), cites a 2013 report from Pharmaceutical Research & Manufacturers of America detailing that U.S. biopharmaceutical firms are using biological processes to develop 907 medicines and vaccines tar- geting more than 100 diseases. "The challenge is that these products tend to be made up of large molecules," explains PCI's Misher, "and large mole- cules cannot be compressed into a tablet; they have to be in solution and packaged,

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