In the track-and-trace trenches

Fig. 1. PCI Services FlexSuite serialization platform allows for converting from one client’s serialization requirements to another’s. credit: PCI

By all counts, the global pharma traceability initiative—driven by the Drug Supply Chain Security Act (DSCSA) in the US, and the Falsified Medicines Directive in Europe—is moving ahead, with equipment and software contracts being placed, and project managers getting to work on implementations.

There is a core group of companies that have been carrying along traceability work since the early 2000s, and have lived through the lean days after California dropped its “electronic pedigree” deadline of 2008, and then bloomed again after DSCSA was passed in late 2013. (While most serialization and traceability work is driven by regulatory mandates, all along there have been pharma companies deploying traceability solutions to meet business needs). Now, companies like TraceLink are touting a doubling and redoubling of staff at its new headquarters in North Reading, MA; Optel Vision, a provider of packaging-line visibility solutions, has added several hundred staff and opened a center in Europe, and Systech International has also opened a new headquarters and is building up both its domestic and international business.

Fig. 2. IDC Health Insights’ ranking of traceability vendor capabilities. Credit: IDC

Barcode-marking and machine-vision equipment providers like Domino Amjet, Videojet, Cognex and others are seeing a pickup in business from pharma. Industrial automation vendors like Rockwell and Siemens are incorporating traceability work into their overall industrial automation business. Some combined equipment and software companies, like Mettler Toledo and its PCI Services unit, are in the fray. Companies with a strong base of traceability business in Europe, such as Antares Vision and Adents, have opened US offices and supply centers.

Some recent news announcements from these and other vendors:

• Verizon Enterprise Solutions, which provides broad-based communications services to corporations, has partnered with rfXcel, one of the longtime traceability software providers, as the foundation of Verizon’s Intelligent Track and Trace offering. The unusual pairing (most traceability vendors specialize in what amounts to a niche in the overall enterprise IT field) makes sense when FDA settles on a guideline for how pharma companies and their trading partners are to manage the massive data-handling burdens of commercial drug distribution under DSCSA.
• Acsis, a provider of “edge solutions,” specifically for managing the coordinated flow of data from a packaging line, into and out of a warehouse, has announced winning the business of American Health Packaging (a unit of AmerisourceBergen that repackages drugs, typically for hospitals). Data in the warehouse will be captured with scanners and then stored as events in a DSCSA-compliant database; AHP says it will realize time and effort savings in shipping-related processes. The application includes printing shipping labels from the stored data.
• TraceLink is partnering with ROC IT Solutions, another edge-solutions provider, to extend traceability functions into the warehouse and beyond. ROC IT’s EdgeTRAC and TraceLink’s serialization solutions are already live in production together, notes Larry Hall, ROC IT founder, “demonstrating the simplicity of the system integration and sub-second response times between the EPCIS repository and the edge system.” (EPCIS is the acronym for the serialization standards promulgated by the GS1 organization, and are the de facto standards for DSCSA compliance.) “We’re excited to partner with TraceLink and tap into the largest global sales team that is exclusively focused on track and trace for life sciences, which will enable us to accelerate worldwide adoption of ROC IT solutions across the industry," adds Hall.
• Almac Group, a sizable contract development and manufacturing organization (CDMO) based in Northern Ireland, had built its own serialization solution for operations there, but has chosen Optel Vision for a US implementation. “To expand the solution into our US operations, we decided that we needed an experienced partner that could integrate with our innovative product-serialization site-level software,” said Grainne Hughes, Almac operations manager. “The partnership with Optel Vision has provided our US commercial packaging facility with a truly flexible and adaptable solution to readily meet specific country, market and client requirements whilst ensuring serialization to GS1 Standards.”
• Adents, now with a New Jersey US HQ, has announced partnerships with LMN Services, a North Carolina-based systems integrator for pharma, and with Clarke Engineering Services, a manufacturing and packaging technology solutions provider, for Adents software implementations. Adents, according to James Cummings, VP Americas, emphasizes open-standard implementation of its software.
• Systech International has announced two partnerships with equipment vendors Omega Design, which manufactures a range of materials-handling and marking equipment in pharma and consumer healthcare; and Etipack, a global labeling and coding equipment supplier based in northern Italy. In addition to UniSolve offering for traceability, Systech has been actively marketing UniSecure, its proprietary technology for authentication of packages.
• 
Recipharm, a contract development and manufacturing organization (CDMO) in Jordbro, Sweden, is deploying packaging line equipment from Marchesini, the Italian producer, machine vision technology from SEA Vision, another Italian company, and enterprise traceability software from TraceLink across its network of 15 plants in Europe, representing more than 75 production lines. The company already provides serialized product in Turkey, China and South Korea (countries that have had mandates comparable to the US’ and EU’s). “At an early stage, we took the decision to lead the market and make a significant investment into state-of-the-art solutions to actively help pharmaceutical companies meet new drug serialisation requirements,” said Staffan Widengren, Recipharm director of corporate projects.
• Arvato Systems, a business unit of Germany’s Arvato supply-chain management company, is partnering with Systec & Services (not to be confused with the US’ Systech) to perform implementations of Arvato Systems’ CSDB (Corporate Serialization Database) solution. Both are major pharma IT players in Europe; CSDB is the designated solution platform for the traceability initiative of the European Medicines Verification Organisation (EMVO), which is coordinating industry response to the Falsified Medicines Directive.

The most active part of the serialization mandate at the moment in the US is equipping packaging lines to provide item-level serial codes; these codes need to be in place by November 2017 (deadlines for actually using the codes to confirm shipments comes later). All major pharma manufacturers are engaged in this activity; but there remain worries about the energy that CDMOs are dedicating to the effort—ultimately, someone is going to have to code the packages coming from the CDMOs if they themselves are not so equipped. The serialization effort has also been going on with distributors and logistics providers; if they do repackaging for a client, a code will need to be generated, and even if they don’t, they’ll need the system in place to receive serial code information and store it for use by downstream customers. Major CDMOs like Sharp Packaging and PCI (along with above-mentioned Almac) have been public about their efforts. Distributors like Woodfield Distribution and LifeScience Logistics have also announced their implementations. “This is not a trivial investment,” notes Richard Beeny, president of LifeScience Logistics.

And while it’s hard to define where the hardware costs are in relation to the software costs, the latter tend to draw significant attention from market analysts and consultants, perhaps because the implementations are a relatively complex undertaking with uncertain outcomes.

IDC Health Insights, one such market analyst, published a report this spring (see figure) giving a snapshot of where the leading enterprise traceability vendors are, and assessing TraceLink, Axway and rfXcel as market leaders. IDC analysts note that SAP has made a major foray into the market with Advanced Track and Trace, a dedicated IT solution specifically for DSCSA and FMD compliance, but that industry experience in implementing and using the technology 
is still being developed. “It’s a snapshot,” says Michael Townsend, IDC research manager, noting that that market is very fluid at the moment and will continue to evolve as the regulatory mandates 
get closer.

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