The age of a US-centric vertically integrated life-sciences industry has, for the most part, come to an end. During the past several years, executives have seen the need to move sourcing and manufacturing overseas in an effort to lower costs. In the process, many companies have recognized the potential of these emerging markets for creating and growing their own product pipelines and reaching new consumers. With these changes, however, come increasing demands on life-sciences manufacturers to manage and control their supply chains, which are now longer and more complex.
Axendia, an industry analyst and strategic consulting firm, recently conducted research on current trends in the life-sciences global supply chain. The study incorporated data from three sources: an advisory council, which provided background and perceptive on key issues; a survey of industry professionals; and individual interviews to review and refine the findings. Our research has shown the need for companies to shed the view of supply chains from a supplier–buyer mentality and to shift to intelligent supply networks that can provide information "on-demand." In this model, collaboration occurs during the entire product life cycle, from the raw-material supplier to the distribution company that delivers the final product safely to the end user. The model also supports the need for industry to view "competitors" as potential allies with whom information can be shared and leveraged to keep products safe and effective while managing costs. Finally, this model supports the need for industry and regulatory bodies to continue to work together to find practical and cost-effective solutions to ensure the quality, safety and efficacy of products.
Based on this research, titled "Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity," this article reviews current industry challenges and trends in managing global and outsourced supply chains (1). The authors also propose best practices, including the implementation of technologies, for improving visibility and control of life-science product supply chains.New risks, new demands
A recent report by the US Intellectual Property Enforcement Coordinator (IPEC) points to the US government's eagerness to address some of these supply-chain threats (2). The report, for example, recommends modifying the Food, Drug, and Cosmetic Act to require that manufacturers, wholesalers, and distributors implement a track-and-trace system to allow for authentication of products. The report also recommends the creation of a standardized electronic pedigree (ePedigree) using unique identifiers. Finally, the report calls for increased enforcement efforts to guard against the proliferation of counterfeit pharmaceuticals and medical devices. Although FDA has initiatives underway to require serialization of pharmaceuticals, specifically Standardized Numerical Identifiers (SNI) that are based on a serialized National Drug Code (sNDC), the US IPEC report goes further by recommending the implementation of ePedigree. Several states and countries have begun the process of mandating their own track-and-trace, serialization, and ePedigree systems, including California, Turkey, Brazil, and France.
New approaches. While local and national governments work to clarify and harmonize requirements and guidance for supply- chain tracking systems for pharmaceutical products, industry can also take steps to make the best use of current technologies to better manage and control their supply chain. Axendia has identified three key approaches in this regard: increase on-demand visibility; change the view of your company's supply chain to a supply network; and strengthen collaboration.