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Pharmaceutical & Medical Packaging News, November/December 2014

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pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2014 28 Clinical Trials Packaging typically, in a vial or syringe." And these drugs don't usually have good stability, which is why they require refrigeration or even freezing. PCI's recent acquisition of Biotec Services International expands PCI's ability to manage controlled tem- perature products, which can be "very challenging" and expensive, he says. Likewise, Fisher Clinical Services has significantly expanded its cold-chain operations in anticipation of rapid growth of biologics, and the company now claims 1.5 million cubic feet of cold storage and packaging space spread across its facilities around the world. Richard Segiel, Jr., vice president of business development for the United States for Almac (www.almacgroup. com), explains the cold-chain challenge: "The rise of biologics and more targeted medications requires more complexity in executing supply-chain activities and in most cases more unit cost. Sending a patient kit under ambient conditions around the world is easier from a logis- tical standpoint than sending a paren- teral material that needs to be stored and monitored at a 2°-to-8°-C condition during manufacture, while in transit, at the clinical site, or, in some cases, during transport to the patient." Segiel makes the argument that a com- pany working within the clinical-supply market should be able not only to store product in an environment that is mon- itored in a compensatory way, but to manufacture and package in that type of environment as well. He cites increased regulatory attention toward distribution management, including good distribu- tion practice (GDP) documents that are beginning to emerge from regulatory agencies such as FDA that are changing the way clinical supplies are being moni- tored and distributed. (See sidebar p. 30.) helP froM AuToMATioN ANd TeChNoloGy This sea change taking place in phar- maceutical packaging for clinical trials, toward full end-to-end drug-development, packaging, and distribution services, relies heavily on automation and technology to succeed. For instance, Almac has "a full suite of technological services around temperature management," Segiel says, "which allows us to provide a compre- hensive record of a clinical or commer- cial material's temperature profile from manufacture, through transit, to final patient dispensing. Collected temperature data resides securely within one database, which allows for afective evaluation to regulatory compliance as well as adjudica- tion of temperature excursions. The main objective of Almac's temperature man- agement is to ensure that out-of-specifica- tion study drug is removed from the field and not administered to patients." Almac looks to automation in particu- lar for ensuring efciency and speed in its management of biologics and biosimi- lars supply. "For example, for prefilled syringes, we have invested significantly in the technology needed to label and package those materials to ensure patient kits are ready to distribute to meet the aggressive timelines associated with many biopharmaceutical trials," Segiel says. Door-to-Door Service: the New Direct-to-PatieNt Delivery MoDel for cliNical-trial MaterialS The past 18 months or so have seen the emergence of a new model for distribut- ing clinical-trials materials to their final destination: the patients. Whereas tradi- tionally a company would package, label, and distribute clinical-trials supplies to depots or clinical sites, one method being tried now among some companies is deliv- ery directly to a patient's home. Almac's Richard Segiel explains: "There are laws, of course, regarding physician supervi- sion and consultancy for certain clinical studies. But for studies that have the right trial characteristics and patient needs, we can do direct-to-patient shipments. We will ship materials to the clinical site, then manage the process to get the patient sup- plies picked up by a courier and delivered to the patients' homes." Such a model addresses the problem for patients of a long commute time to a clinical site, Segiel says, and that con- venience can increase the willingness of patients to participate in a trial. Addition- ally, there is a cost advantage to pharma companies to go this route because the companies can reduce patients' reim- bursement costs associated with travel- ing to the clinical site as well as costs connected with clinicians' fees for patient visits. On the other hand, though, this model is only likely to work for certain trials in which the medication is self-administered and is not a narcotic or controlled sub- stance. "And what happens if you pick up the material from a site and transport it to a patient's home, and the patient is not there?" Segiel posits. "You can't leave it on the doorstep. So there are some nuanc- es and challenges" to this type of model, he says. No gold standard exists yet. Registered clinical studies have grown from 10,000 trials in 2004 to 178,000 in 2014 (ClinicalTrials.gov.) Image from Fisher Clinical Svs.

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