Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.
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Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.
Independent market research study shows that the complexity of new drugs entering clinical development will increase their use of dedicated supply chain providers with temperature control capabilities, on-time delivery, and real-time shipment traceability.