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International Clinical Trials

Risky Move

Most pharmaceutical organisations employ specific strategies based on ICH guidelines Q8-Q10, which provide high-level guidance outlining a risk-based approach to evaluate processes and implement strategies to control and improve pharmaceutical quality throughout the product lifecycle. The majority of firms rely on these guidelines to help mitigate risk in their supply chains, including manufacturing, suppliers, sales and product design, as well as logistics activities such as bulk packaging, transportation and distribution strategies.

However, these conventions must be challenged and restructured to incorporate the latest technologies and processes when distributing the new, more temperaturesensitive regenerative therapies. The reason for this is both vital and straightforward: a single temperature deviation during transit can destroy a $750,000 product and potentially lead to the death of a patient. Even if a temperature deviation does not have such a dramatic result, it may still lead to seriously compromised data and clinical trial outcomes.

Supply Chain Quality by Design

Companies transporting these sensitive materials must consider employing a proactive Supply Chain Quality by Design (SC-QbD) process for the distribution of clinical and commercial materials. QbD is driving new guidelines in the industry – including the soon to be published ICH Q12 – which deals with pharmaceutical product lifecycle management and is intended, in part, to strengthen proactive planning of supply chain adjustments (1).

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With more than 15 years’ experience in the pharma and biotech industries, Mark Sawicki, PhD, serves as Chief Commercial Officer at Cryoport, a company that provides end-to-end cryogenic logistics solutions to the life sciences industry. He holds a Bachelor’s degree in Biochemistry from the State University of New York at Buffalo, US, and a PhD in Biochemistry from the University’s School of Medicine and Biomedical Sciences.
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Mark Sawicki
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