Adents is a France-based provider of serialization and track-and-trace software solutions for the pharmaceutical and life sciences industries and recently opened its first U.S. location in Princeton, NJ. This opening comes just months after the company, which is headquartered near Paris, debuted its first North American subsidiary in Montreal, Canada. By the end of 2015, the company expects to have approximately 50 North American personnel.

In less than a decade—the company was founded in 2007—Adents has made a name for itself in the European serialization sector, where it handles track-and-trace not only for pharmaceuticals but also luxury cosmetics and high-end wine and champagne. For Adents, entrance into the U.S. market is a logical next step for continued growth, particularly in light of the pending, potentially rolling implementation of 2013’s Drug Supply Chain Security Act.

Adents’ serialization software is designed to operate with all existing Enterprise Resource Planning (ERP) and/or MES software systems and devices. According to the company, this hassle-free line incorporation is a key selling point because, in the continued march toward unit-level serialization, pharmaceutical companies and CMOs are increasingly in the market for efficient, globally applicable track-and-trace solutions capable of meeting immense logistical challenges, such as those pertaining to data exchange and management.

Adents has two primary product portfolios. The company’s suite of solutions for pharmaceutical companies and contract manufacturers (CMOs) identifies and affiliates each individual product unit, and can be modified to suit individual customer production lines. Adents’ pharmaceutical serialization software also is scalable, with flexibilities that help customers meet changing international regulatory requirements. The software also is compatible with a broad range of existing hardware, making it exceedingly easy to implement.

As part of the company’s new U.S presence, Adents will be exhibiting at the 14th annual Contract Pharma Conference, September 17-18 in New Brunswick, NJ.

Erik Bronander, senior director of sales, Americas for Adents, talked with Contract Pharma about recent news at the company as well as broader market trends.       —TW

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Contract Pharma: What are some of the key trends, issues, and processes pertaining to serialization of pharmaceutical and biopharmaceutical products, including primary, secondary, and tertiary packaging?

Erik Bronander: Clearly the unit of sale packaging is being serialized, or soon will be, virtually everywhere, regardless of an authentication model like the EU, chain of custody like the U.S., or Track & Trace like Argentina. While some tertiary is required in some markets—U.S., China, Argentina—it also can be driven by logistical requirements, especially when aggregation is required. True primary is still being driven by business cases where product protection warrants it.

CP: Adents recently set up shop in Canada and the U.S. Why the aggressive push to move into North America now?

EB: Currently the U.S. DSCSA act is creating an urgency to meet the 11/27/2017 deadline for item-level serialization. We believe as the date draws near there will be a lack of resources to meet the demand so we are scaling up in unison with our implementation partners to meet this looming need.

CP: How is the serialization sector different in Europe and North America?

EB: There are two significant differences. First is aggregation to allow for checking through the supply chain and second is the involvement of a government body as a reporting repository. This creates vastly different implementation requirements at all levels of the environment.

CP: What is the status of the 2013 Drug Supply Chain Security Act, and how has industry responded?

EB: The status from an implementation perspective is that it’s a federal law that the FDA must enforce. The program is still confusing to a great many people. The phasing of it can lead to elements being implemented at times without other dependencies, which creates more uncertainty.

The larger issue is what trading partners will require as they become liable. For example, all bottles must have a serial number, but they are in a sealed case. We expect that some trading partners will require compliance ahead of the deadlines or charge penalties for those not meeting their requirements. We also believe that some may require items above and beyond the minimum requirements in order to safeguard their own businesses.

As far as the industry response, it has been mixed, as one would expect, with leaders, fast followers, behind schedulers, and those who will need a miracle not to put their business at risk. One of the conundrums is some of the folks waiting until the last minute are the least capable of throwing extra resources at it to make up the time.

CP: How can Adents’ software help pharma companies and their service providers?

EB: Adents device independent serialization software provides the least disruptive path to serialization implementation for pharma companies to reach compliance. Our software-based approach is perfectly aligned with service providers’ business models.
Developed in compliance with GMP and 21 CFR Part 11 regulations and following GAMP5 guidelines, Adents’ serialization software solutions perform a variety of crucial track-and-trace capabilities, including: generation of unique barcodes and importation of serial numbers; affiliations management for origin identification—bundle, pallet, etc.—and distribution of various types of serialized code; facilitate and drive the printing of unit barcodes, and control their conformity; and data centralization and reports processing.

Adents Pharma Suite utilizes user-friendly, standardized turnkey software compatible with both information systems—ERP, MES—and existing production and packaging equipment. Easily upgradable, the software is designed to address both current and emerging regulations to help pharma companies remain in compliance long-term.

The Adents Pharma Suite software has several key differentiating attributes, including speed to deployment, with an implementation up to five times faster than competing serialization solutions; easy configuration, consisting of plug-and-play modularity for existing hardware; cost-effectiveness, as evidenced by a cost of less than $100,000 per line, service included; and maximum flexibility with easy, centralized changeovers.

CP: What are pharma companies and CMOs looking for?

EB: Compliance driven programs are always a cost to the client. Companies are looking for an effective solution that meets the requirements, with the lowest TCO and least impact to operations.

CP: What are the top questions you receive from pharma companies and CMOs who are beginning their serialization preparation and/or implementation?

EB: “What do I need to do?” is clearly number one. Especially in the CMO/CPO space where so much of it depends on their customers. Of course, there are a host of follow-up questions to this, including,”Who is generating the serial numbers?,” “In what format?,” “Do You aggregate right away?,” and “What data gets transferred and when?”

Second is how much will this cost, which truly needs to be evaluated by the total cost of the implementation, not simply the upfront equipment or license cost, as these are mission-critical systems that will require changes as regulations and products change.
The third—and perhaps most undervalued—is, “How long will this implementation take?” Here, there is not just the timeframe for a system implementation to be considered, but all of the tangential items that will be required. Understanding the possible downtime to a production line has made more than one client change their mind from upgrading something to a complete replacement due to the reduced impact to production.

CP: Is Congress or the FDA imposing a nationwide track-and-trace system anytime soon?

EB: There is currently no indication of this being considered.

CP: What are your biggest concerns about the readiness of the nation’s pharma companies and CMOs regarding serialization track and trace?

EB: The multiple delays in previous mandates have created an atmosphere of delay. The splitting of requiring serialization without data exchange for several years has confused the market. This is leading up to the realization that people who are waiting to the last minute are going to be putting their business at risk. This is a very niche market, which has been negatively affected by the delays. A great number of resources left the market due to the instability and the demand will clearly outstrip the supply as we get closer to the 2017 deadline.

CP: How do pharmacies come into play with serialization implementation?

EB: The pharmacies are at the end of the implementation in the U.S. They play a more significant role in the European model in performing the authentication at the point of dispense. This is what we call the book-end approach in that it is serialized at the plant and not tracked through the supply chain and only tested at the point it is about to be dispensed to the patient. This is much easier to do in environments with socialized medicine.

In the U.S. it is really a chain of custody traceability, not a full tract and trace by definition. It is only the change of ownership that causes the exchange of information that is required to be maintained and reported to the FDA on demand. So a large pharmacy chain can receive the product from their distributor and that will cause an “event” that needs to be recorded, but they can then ship it internally from warehouse to warehouse and from store to store ad nothing is required to be captured. This puts the traceability ending at the receiving dock, possibly across the country from where it is dispensed.

CP: Where is a good place to start for life-sciences companies who want to get the ball rolling in setting up a serialization initiative?

EB: There are only a few months left in 2015. There is a firm law requiring that no distributor accept any products without a serial number by November 2017. If the ball isn’t already rolling your business is in jeopardy. That doesn’t mean all is lost, it just means you are already in line behind a great number of people, many of whom have signed multi-year contracts to ensure the skilled resources that both truly know what they are doing in serialization and have learned that client’s business will be available to that client throughout their implementation. With that context companies must meet with the vendors that have the capacity, partner, tools, or a combination of these items to deliver in a time frame that meets the requirements. There are a multitude of webinars, conferences, trade shows, etc. covering the topic and they need to get alignment internally to their plans. A great many things are affected by this and a last minute push is going to be risky not just in the level of resources available at the 11th hour but also the expected inflated costs, the impact to production output and operational disruption.

CP: What are the implementation challenges?

EB: Time and resistance to change are the single biggest hurdles to implementation. Far too many clients have tried to force a vendor to implement something outside of the designed or intended functionality and have found themselves regretting their decisions. Serialization by its nature is going to change some processes. One should really evaluate how stringent they are in not altering their processes to fit this new model. It is a compliance item and so the risks have to be weighed against trying to maintain the status quo without a significant reason and quite frankly, the “we’ve always done it that way” attitude just doesn’t make the cut.

CP: How would you describe the current state of security in the pharmaceutical supply chain?

EB: The California Board of Pharmacy did an outstanding job of highlighting and documenting the security shortcoming in the pharmaceutical supply chain. While far better than many other parts of the world, the CA BOP clearly showed everyone the challenges and dangers in illegal activity affecting the chain. A large factor is the high profit and low risk in this illegal activity. Criminal organizations can make significant sums of money in this sector with comparatively low possible penalties compared to other types of criminal activities.

CP: What are the regulatory changes from point of manufacture throughout the distribution chain? What’s coming down the line?

EB: First is the data exchange requirements of Transaction Statement, Transaction Information, and Transaction History. This was put in place this year and while the data exchange method is very liberal for the first 2 years, the storage and retrieval on demand requirements complicate this. The item serialization requirements for 11/27/2017 will not affect that from a TS/TI/TH perspective yet.
While full aggregation and data exchange of that information is not required for a number of years beyond 2017, there is a very strong likelihood that many major supply chain participants will require it sooner and most likely enforce that through additional costs.

The largest area of change will be in the area or reverse logistics. Currently it is a complete disaster for manufactures and the large distributors as well. Item level serialization provides the mechanism to discern if a product is authentic, legitimate for return, being returned compliant to the supply chain network constraints (e.g. was that product available though that returning partner), and for many manufacturers being credited at the proper price point.