Global trials call for increased speed and accuracy in the supply chain.
By Ann Neuer
May 12, 2008 | The logistics of performing complex clinical trials beckons companies to improve their supply chain operations. That is the conclusion of a recent benchmarking study of 107 biopharmaceutical companies conducted jointly by BearingPoint, a provider of management and technology consulting services, and AMR Research, a consulting firm with supply chain expertise. The study, entitled "Managing the Clinical Trial Supply Chain," took place in late 2007 and focused on the growing challenges of delivering clinical trial supplies to investigative sites in many countries, each with its own set of regulations.
R.S. Kumar, senior manager, life sciences for BearingPoint, says the survey results confirm that supply chains are faltering. "The current supply chain network is stretched because of the global nature of clinical trials, making it harder to get the right supply kits to the right place on time. The problem is compounded by the fact that clinical trial protocols are changing constantly, making it more difficult to forecast and plan for deliveries," he explains. The study further indicates that by 2010, the complexity of clinical trials is expected to rise dramatically due to continued globalization and the shifting of testing models to adaptive trials.
BearingPoint defines clinical trial supply chain management as an integrated process and metrics-driven approach that brings together functions from clinical research, product development, sourcing, manufacturing, packaging, labeling, and distribution to enable an efficient and responsive supply chain that addresses key business drivers. Using this definition, 23 percent of respondents reported having a highly functional clinical trials supply chain. The remaining 77 percent are either implementing their strategies or are taking nascent steps to develop one. Companies with self-reported strong supply chains had nearly twice the perfect order performance than the other respondents.
Overall, the study showed that just 13 percent of clinical trial products shipped to investigative sites are received on time and are 90 percent complete. These dismal results are not surprising to Kumar, who comments, "Most current supply chains are entirely inadequate for the realities of global trials today. Many pharmaceutical companies did invest in improving the supply chain when testing was easier, but many new testing locales have poor infrastructure, causing even more delays."
Pfizer recognized the need to improve its process for shipping active pharmaceutical ingredients (APIs) internationally, and engaged BearingPoint to analyze its clinical supply chain activity. After three months of interviewing stakeholders at Pfizer to gain a solid understanding of the many issues involved, BearingPoint provided Pfizer with a business implementation roadmap and collaborated to develop recommendations to redefine the supply chain process for moving APIs across the globe.
Pfizer expects to see improvements in shipment lead times, cost reductions, and compliance enhancements as it begins implementation this year. Donald Freeman, continuous improvement lead at Pfizer, says, "We are just beginning implementation and are targeting third-quarter for implementation of the short-term and medium-term recommendations." The company is starting by targeting execution of its plan - shipment of API for on-time delivery - to a seven-day timeframe, compared to its current range of seven to 45 days.
The process change is meant to drive enterprise value for Pfizer. "We want to make sure that the solutions we implement touch other aspects of the broader supply chain, and are scalable. We don't want to implement a solution in a vacuum," says Freeman.
This article appeared in Bio-IT World Magazine.
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