The State of Track-and-Trace Today - Online Exclusive Content
Three companies share their approaches, strategies, and recommendations to implement pharmaceutical track-and-trace, e-pedigree, and authentication
At the FDA’s Anti-Counterfeit Drug Initiative Public Workshop in Bethesda, MD, in February, 27 companies were exhibiting their various electronic pedigree solutions, and many seemed similar to one another. Representatives from three of the exhibiting companies agreed to answer a few questions to help distinguish the differences between their solutions Our participants are Kevin Erdman, President and CEO of Verify Brand Inc.; Graham Clark, VP of Business Development of Cyclone Commerce; and John Jordon, President of Worldwide Field Operations of TAGSYS.
What steps does your company recommend that pharmaceutical manufacturers take to secure their supply chain and what RFID solutions does it offer?
Kevin Erdman, Verify Brand: We recommend a layered approach to product security within a larger brand protection strategy. Many pharmaceutical manufacturers are already there. But “mass serialization” or the unique identification of individual product units is a critical foundational component that not only adds a powerful new security layer, but also offers opportunities to enhance existing overt, covert, or forensic layers for purposes of authentication and real time alerts and event management. In a larger sense, item-level serialization and authentication provides the brand owner a previously unavailable level of visibility into and transparency of the supply chain that will better thwart the issues of counterfeiting, diversion, and other unauthorized activities.
RFID tags and infrastructure are tools that offer one method to serialize and authenticate products with Verify Brand. Mass serialization is already being accomplished using a variety of methods such as overt 2D barcodes, proprietary covert marks, and even human readable text. Some use a combination of several for redundancy and supply chains with heterogeneous infrastructure and requirements. No matter where on the spectrum a brand owner is ready to jump in (based on compatibility with existing production systems, suitability to specific business need, level of investment, etc.) Verify Brand can accommodate effective mass serialization on any level of product or packaging, from print on pill all the way up to pallets and beyond, with all of the appropriate nesting to create efficiencies where high speed infrastructure does not yet exist.
RFID utilization for this and other purposes can begin at a pallet level with other levels of packaging using say barcodes, but all levels of package serialization linked and associated together. At any time a brand owner wants to move RFID to a “lower” level of packaging say to cases or individual items, our platform adapts transparently.
Graham Clark, Cyclone Commerce: The first thing we would advocate to the pharmaceutical manufacturers is that they recognize that they have a lot of different forms of data coming into their business—EDI transactions, soon e-pedigree documents going in and out, interactions with the FDA, and with other organizations. We believe that companies need to think about the integrating way of looking at the data going in and out of their organizations. So, the first thing to do is to recognize that it’s not a case of just having one, two, or three applications that they buy individually from different players. They need to have a consistent view of the data that goes in and out of their business to trading partners up and down the supply chain.
Thinking about it like that, RFID data is just an incremental set of data that is coming back in the business. The opportunity that we see is that if you actually look at those different types of data and can correlate between the different types. It enables a business to build a new set of very high ROI-based applications, like fee-for-service. E-pedigree is not really like that because it’s essentially just a set of basic transactions that you have to do for compliance. It doesn’t directly drive a lot of value itself. But if you combine e-pedigree data with other data (like fee-for-service data), you can begin spotting product diversion, counterfeiting, and opportunities to drive higher margins in your business.
We offer support in two ways: the first way is that we are the trusted data transmission company for 7,000 companies. All of these companies trust Cyclone, who was recently acquired by Axway, to reliably and securely manage the delivery of their data. The second point is that we basically enable organizations to look at the RFID events they capture at various locations and filter and transmit those events back into the corporate enterprise.
John Jordon, TAGSYS: TAGSYS developed a methodology called P3: e-Xecute RFID that takes manufacturers through the process of evaluating and deploying RFID in their existing processes based on their specific business needs. The P3 methodology has proven very effective with our clients in the pharmaceutical space who understand that they need to look closely at the benefits that RFID offers but often don't know where to begin, or what it really means for their business. We call it the “deer in the headlights” look.
We take customers through a step by step approach that starts with understanding their business and technical needs; for example, do they need to be able to read through liquids at 99.999% read rate accuracy? Then, based on this analysis, we recommend, engineer and integrate the system, often with minimal impact on their existing lines. Finally, we deploy and perform onsite testing. l
What need is your company addressing in regards to the pharmaceutical industry?
Kevin Erdman, Verify Brand: Verify Brand has developed what it believes is the most effective product authentication solution available today to brand owners/manufacturers, distributors, retailers, and consumers in their escalating battle against the proliferation of counterfeit and diverted goods. Using the company’s proprietary software, Verify Brand’s solution 1) enables the integration of serialization in production and distribution facilities and thereafter, 2) every entity along the length of a supply chain to proactively authenticate products, and provides the consumer/end-user with the opportunity to confirm that a product is authentic immediately before using it, 3) captures all verification activity in real or near real time, unauthorized events are immediately detected, managed and alerts provided to the brand owner, and 4) makes available real time reporting and analysis to the brand owner ad hoc and on a scheduled basis.
The Verify Brand solution generates unique, random alphanumeric or numeric codes (“Verification Codes”) or, when necessary, imports codes generated in some other manner that are then applied to and carried on products or product packaging in a variety of forms including human readable, barcode, RFID, and covert physical security. Verify Brand generates or imports into and (post application) stores the Verification Codes in a secure database and makes them available for round-the-clock authentication over the Internet or by phone. The critical end result is that brand owners can quickly and proactively detect unauthentic codes and counterfeit products or determine that codes/products are in the wrong location.
Verify Brand provides open standards based, Web based product security platform that dovetails effectively with existing layers of covert, overt, and forensic defenses. In addition to helping with the initial unique identification of products, Verify Brand provides a low cost bundle of real time verification, event management, reporting, alerts, and analysis capabilities that can dramatically improve detection and deterrence of diversion, counterfeiting or other issues anywhere within the supply chain – whether used covertly as a robust auditing tool, comprehensively for pedigrees within several layers of distribution, or extended overtly to the end consumer. Depending on the short and long term business requirements, the mass serialization and supporting data and authentication services can be used to support a whole range of brand owner initiatives, including targeted auditing of customers, return verification, stock sampling, diversion control, direct to consumer marketing, physical security testing, to name a few.
Graham Clark, Cyclone Commerce: We believe that Cyclone is the only company that is offering a complete set of supply chain compliance applications. The other companies you may have met at the FDA Workshop that are working to achieve ePedigree with RFID offer “fee-for-service.” This is a change in the way the companies have contracted relationships in supply chains. Cyclone provides the complete suite of business to business (B2) commerce infrastructure and provides a complete set of integrated applications for pharmaceutical companies supplying supply chain compliance needs.
John Jordon, TAGSYS: TAGSYS is a leading provider of item-level RFID infrastructure. We have developed solutions that secure the pharmaceutical supply chain and help prevent counterfeiting and black marketing of drugs. Our end-to-end systems solutions include RFID tags, hardware, and consulting services that assist customers in developing and integrating RFID into their manufacturing and distribution processes. Because we focus exclusively on delivering item-level RFID solutions, we look at the problems that the industry faces from that singular perspective, and we have created solutions based on the specific needs of the industry. For example, we are completely frequency agnostic in our approach and have equally strong products based on both HF and UHF technologies. In terms of life science industry needs, particularly in the pharmaceutical sector, we have found that HF delivers Six Sigma levels of reading at 99.9997% taken together with product quality that satisfies the most stringent requirements.
Through the use of RFID, the industry can create a way to track-and-trace and authenticate drugs throughout the supply chain, i.e. from the point of manufacture to dispensing (whether from a retail pharmacy or hospital pharmacy). Examples of what we've provided to the industry to date include our work with Pfizer on RFID-enabling Viagra shipping to the US market. By applying an item-level RFID tag to each bottle, the supply chain is able to track-and-trace every bottle as it moves through the supply chain. Eventually, consumers and pharmacists will be able to authenticate the product using the technology. Also, we are working with West Pharmaceutical, the manufacturers of flip-off seals for injectable vials. TAGSYS worked with West to RFID-enable the seals to provide an added layer of protection and security against counterfeit drugs. Using this technology, West's customers can track & trace the drugs all along the supply chain and also verify the authenticity of the drugs using RFID.
What makes your company different than other companies that offer authentication and track & trace technologies?
Kevin Erdman, Verify Brand: We believe that Verify Brand provides the only comprehensive platform for enabling serialization, authentication, event management, tracking, and reporting. In particular, we have found no other company introduce a system for enabling serialization in a third party label printing operation, manufacturing, or distribution facility at all, much less in as comprehensive a fashion.
Verify Brand also has significant “knowledge-of-need” based on our founding company’s years of experience in secure mass serialization for some of the world’s most recognizable brands. Since its inception, Verify Brand has been extensively involved in the deployment and activation of our platform inside major healthcare companies
In our view, authentication is critical to successfully tracking & tracing product. It all begins with what some call “mass serialization,” uniquely identifying products as close to the item or “each” level as possible. We help, pharmaceutical companies and other brand owners to initially implement the ability to put a unique code of some kind on each of their products. Then, and even more importantly, we help them enhance, compile, and use that information in real time to address numerous possible business requirements.
Graham Clark, Cyclone Commerce: The first thing is the history – the fact that we are reliably handling data for 7,000 companies. If you look at it in the pharmaceutical space, 18 of the top 25 pharmaceutical manufacturers use Cyclone for data transmission. Three of the big pharmaceutical distributors also use us for data transmission. Six of the top 10 retail pharmacies use Cyclone for their data transmission. So, we have a history of reliably and securely transmitting data for these companies. This is not a start up with a set of flashy user interface grids and no robust delivery capability. We’re a proven and trusted entity for these companies. We’ve heard back directly from these companies that we are unlike a lot of the smaller start-ups because we don’t rely just on one revenue stream. The history of the computer industry is littered with multi-million dollar organizations that have purchased some verification from a software start-up that may have $10 million to start their business; the venture fails in one, two, or three years, leaving the enterprise high and dry with a software but with no company to run the software still in existence. Cyclone is part of a $1 billion organization called the SOPRA Group. We have the financial where-with-all, diversified revenue string, and history of being a trusted provider.
We are in the Gartner B2B gateway vendor Magic Quadrant. So, it’s not a case of, “Hey, there’s a company called Cyclone that can sell you all of these compliance applications in an integrated form but you’re better off going for the specialized vendor because they can give you better functionality.” Gartner has basically put us in the Magic Quadrant of every space that they actually monitor that we play in. And in the recent quarter, we have beaten both ePedigree and fee-for-service, we have beaten the start-ups that existed in this space before we entered the market – we’ve beaten them in a one-for-one functionality comparison basis. We believe we’re best of breed but integrated in a complete suite of applications as well as having that financial security.
John Jordon, TAGSYS: We specialize exclusively in item-level RFID infrastructure, and in doing so we have a singular focus on developing solutions that solely meet the needs of item-level RFID. We've also spent a lot of resources on R&D developing solutions that meet the business requirements for the pharmaceutical industry. The drivers for the industry differ significantly from others like consumer packaged goods or fashion. The margin of error is much smaller in the pharmaceutical industry. This translates into having products that perform extremely well under some very challenging conditions, e.g. hot, cold, pressure, etc. All this while delivering extraordinary read rates with upward of 99.9997% accuracy with no more than three in a million product failures. We've invested heavily in developing our solutions to meet these requirements and the industry is responding.
What is holding this industry from moving forward?
Kevin Erdman, Verify Brand: (No comment.)
Graham Clark, Cyclone Commerce: People in the computer industry like to come up with new things. Remember the first time around with the Internet? The Internet was set to wipe out existing businesses, etc. The new things are always overbaked. The hype that surrounds any new technology is always way more than it’s actually capable of delivering, potentially and initially. Some of the hype in some of the cases in actually justified. There’s no question that being able to have greater visibility in what’s going on in the supply chain is going to be incredibly useful.
We believe that RFID is very real and people are seeing true ROI coming out of it. The technology is improving and, more importantly people are only beginning now to understand the true ROI returns that they’re going to get from RFID investments. In our opinion, you’ll see it happening to probably three industries first. The one is the movement of expensive spare parts in the supply chain, for example, if you are working on aero engines, aircraft parts, or parts for oil refineries. In those cases, running with counterfeit spare parts, the damage you can do is just so bad that people will be prepared to pay the price of RFID. We’re already seeing a lot of projects in those places. The second area is the pharmaceutical space and the somewhat related space of food traceability – that is, anything that a customer consumes that could potentially cause serious harm. There it is not just a simple ROI case, but you’re talking about potentially life or death situations. The third case is large government institutions. The military will use RFID pretty extensively for the way they handle munitions.
John Jordon, TAGSYS: As a whole, RFID is still in a relatively infantile stage of growth and it is moving through the expected cycle of education and deployment. The pharmaceutical industry is one of the few where we see adoption at an item-level occurring quite rapidly over the next few years. The reason for this is that this industry in particular is driven by the need for anti-counterfeiting measures and not just economics. This is good for the industry as it will drive scale, which will drive down costs for all. The early adopters like Pfizer and West are already seeing the benefits and this will lead to greater adoption throughout the industry. We need to be realistic about how the industry will adopt the technology. Will it make sense to tag individual sticks or even packets of gum? Probably not. Rather, we could realistically see RFID used on some OTC drugs as an added measure of authentication.
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