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Pharmaceutical & Medical Packaging News, November/December 2014

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pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2014 30 Clinical Trials Packaging technologies and information systems to address the need for a "robust sys- tem for end-to-end clinical-trials man- agement." The company's Web-based, collaborative Fusion platform allows cli- ents to access real-time information for their entire clinical-supply chain, such as inventory and shipment data. Like- wise, Catalent's Clinicopia Labeling software provides complete functionality for developing, approving, and printing labels for clinical trial materials across all international sites. "It is essential to continue to invest in technologies such as these to support our clients' needs," Trochu asserts. Automation and technology have also advanced packaging of traditional dose forms, such as tablets, by making the pro- cess faster and less expensive, and have made it possible for companies such as Almac and Catalent to package potent compounds that require limited human exposure. reThiNkiNG reTurNS Returns, or leftover clinical-trials supplies that must be documented, managed, and processed, make up a less-glamorous link in the supply chain that nevertheless can't be overlooked. PCI has recently invested in a new facil- ity dedicated to this process. "What we wanted to do with this new facility was to build the appropriate capacity to be able to properly manage our clients' return- drug services, even if we did not package those products or do the distribution of those supplies," Misher says. "We rec- ommend and offer to clients consoli- dation of all their return-drug supplies at one location, so that they know it's getting done in a specific, detailed, and uniform way." Similarly, Catalent's Trochu describes his company's end-to-end Clinical Sup- ply Management Solutions returns pro- cess as "ever evolving to accommodate new trials' needs. "Our team can sup- port our clients throughout the complete clinical-supply project life cycle, from ini- tial packaging and distribution strategy to final drug returns, reconciliation and destruction," he says. ChAlleNGeS ANd oPPorTuNiTieS Clinical-trials packaging and supply present a dynamic, unique market to pharmaceutical packagers and labelers. It is a market that reflects the emer- gence of new, highly sensitive biologics and parenteral delivery forms, and one for which a global, full-supply-chain perspective is recommended. PCI's Misher points out that clinical-trials packaging is growing in scale because of the large number of patients involved in a study, while commercial programs are seeing smaller batch sizes and more targeted therapies, resulting in lower run volumes. Industry understands that clinical trials are only increasing in length and com- plexity; in fact, Fisher Clinical Services' Harrington points out, research from Tufts University Center for the Study of Drug Development shows that the clinical-trial treatment period increased from 140 days on average to 175 days over a ten-year period ended in 2011. That means drug supply must be main- tained over a longer period. The Tufts study also showed that the number of procedures per trial increased about 60% during the research period. While volumes and complexity of clinical-trials supply have grown, how- ever, the timeframes for these projects have not. Misher adds that companies have a "very narrow window" for get- ting supplies packaged. In addition, pharmaceutical companies have made an effort to "front-load their clinical research programs in an efort to more quickly select successful drug candi- dates," Harrington says, which "puts added pressure on clinical-supply teams" because decisions about how the drug will be packaged and labeled are made closer to patient enrollment. That's where automation and technology, as well as multiple global sites, come to the rescue. WorkS CiTed 1. Pharmaceutical Research & Manufac- turers of America. "Medicines in Develop- ment: Biologics, 2013 Report." (2013): 1. 2. Getz KA, Campo RA, and Kaitin KI. "Variability in Protocol Design Com- plexity by Phase and Therapeutic Area." Drug Information Journal, vol. 45, no.4 (2011): 413–420; excerpted in PHRMA's Chart Pack: Biopharmaceuticals in Per- spective, Version 3.0 (Spring 2013): 21. 0 regulatory/StaNDarDS DocuMeNtS relateD to colD-chaiN MaNageMeNt USP General Chapter <1079> Good Storage and Distribution Practices Location online: https://mc.usp.org/ sites/default/files/documents/General- ChapterPDFs/c1079%20USP36.pdf W o r l d H e a l t h O r g a n i z a t i o n ' s QAS/04.068/Rev.2, Good Distribution Practices (GDP) for Pharmaceutical Products Location online: h t t p : / / w w w . w h o . i n t / m e d i c i n e s / services/expertcommittees/pharmprep/ QAS_068Rev2_GDPdraft.pdf PDA Technical Report 39, Revised 2007, (TR 39) Guidance for Temperature- Controlled Medicinal Products: Maintain- ing the Quality of Temperature-Sensitive Medicinal Products Through the Transpor- tation Environment Location online: https://store.pda.org/ProductCatalog/ Product.aspx?ID=1154 Code of Federal Regulations, 21 CFR 211.94, Drug product containers and clo- sures Location online: h t t p : / / w w w . a c c e s s d a t a . f d a . g o v / scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?fr=211.94

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