Serialization: Scaling Down for the Final Stretch

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For the past few years, it has been no secret that many small to mid-sized pharmaceutical companies in the United States, the European Union, and beyond have not yet begun to prepare for serialization deadlines set by the US Drug Supply Chain Security Act (DSCSA), the EU False Medications Directive (FMD), and other traceability directives around the world (1).

In the US, this compliance gap led FDA to postpone by one year the implementation deadline, moving it to November 2018 (2). The FMD’s deadline still stands at February 2019. 

However, in the second quarter of 2018, Tracelink’s 2018 Drug Supply, Safety, and Traceability Report found that only one-third of 660 pharmaceutical manufacturers, contract manufacturing organizations (CMOs), wholesale distributors, hospitals, and pharmacies were confident that they were ready to meet requirements, and only half had prepared their internal packaging lines of serialization or projected the number of units that would need to be serialized each year.  The survey found that, at that time, only 8% of pharmaceutical manufacturers had integrated serialization processes with their CMOs and only 11% said their CMOs were ready to ship serialized product (3). Where executives from half of CMOs in the US felt ready, only a third of their counterparts in Europe did.

EU behind schedule

Manufacturers and CMOs in Europe are well behind schedule, according to recent reports (4). Second quarter 2018 data from the European Medicines Verification Organization (EMVO) suggested that 50% of countries whose manufacturers sell pharmaceuticals in the EU will be too late to meet the FMD deadline. Even for all European suppliers to comply would require equipping some 10,000 packaging lines at 1500 pharmaceutical sites in a matter of months (5). Getting EMVO approval is itself a process that can take several weeks. First, a series of transactions must be submitted and reviewed before the company is allowed to submit relevant production and other data to the EU Hub.

At the Serialization Innovation Summit, held on June 20, 2018 in Philadelphia and sponsored by the serialization IT supplier Adents, Maarten Van Baelen, market access director for Medicines for Europe, a generic-drug trade association, revealed the scope of the challenge. As of May 2018, he said, out of the 2200 pharmaceutical companies that will need to submit serialization data to EMVO for FMD, only 749 had done so. Meanwhile, further along the supply chain, only 10% of wholesalers were connected to the EMVO system, although they were working very hard to solve the “considerable technical challenges” involved, he told attendees at the June Summit.

Faster data submission

Solution providers have responded to these issues with a number of “quick compliance” tools-modular, template-driven approaches designed to help companies meet serialization requirements quickly. In May 2018, TraceLink, a cloud-based IT serialization solutions provider, introduced the EU FMD Express platform, designed to help smaller manufacturers and CMOs in Europe meet requirements and send serialization data to EMVO (6).

As of June 2018, TraceLink reported that 34 companies had completed conformance testing using TraceLink’s kit. Of these, 11 companies received EMVO approval to submit data to the EU Hub and 14 companies were awaiting review. Biosyn is one company that reported good results from the program, while, in June, IBI Lorenizini, an Italian CMO and supplier, signed up.

Adents, another cloud-based IT vendor, is approaching the serialization readiness gap with programs of its own. Started up in 2007 in France by specialists with experience handling provenance and serialization issues in the fine perfumes and champagne markets, the company introduced Serisa, a line-level serialization solution supported by Siemens, in 2010. In 2014, Adents released Prodigi, a cloud-based system designed to facilitate serialization data exchange. 

In 2017, the company established a collaboration with Microsoft, and the two partners introduced NovaTrack to the US market in June 2018 (7). The approach, utilizing Microsoft’s Azure Cloud technology, is designed to incorporate blockchain and artificial intelligence, and to bring Internet of Things (IoT) technology to bear on cold-chain and other supply chain issues. Julien Faury, vice-president of operations for Adents Americas, says that the program features open architecture and works both at the centralized IT level and at the line level, using a “top down” approach and a cloud-native, vendor agnostic approach. 

The company offers users a certified gateway to enable faster transmission of data to EMVS. It has integrated with the Origin database in the US, operated by the Healthcare Distributors Association, and is developing a gateway to Russia’s serialization database.

The company is working with Microsoft to develop and optimize blockchain solutions using Microsoft’s Cocoframework, which offers 20,000–50,000 transactions per second. This speed is considerably faster than solutions based on Ethereum, according to Tianna Umann, cross-domain solution architect with Microsoft, who spoke at the June summit. 

Both partners have assembled an industry workgroup lead by the Healthcare Distributors Association to evaluate different approaches to blockchain.  In addition, Adents and Microsoft are working on systems that would use Microsoft’s Hololens technology to train operators on serialization and make relevant documents accessible to them in their workspace via a wearable device. Hololens is based on the concept of Mixed Reality, which incorporates some of the digital elements of virtual reality, but operates in real space (8). Adents’ operations manager, William Minaeff, senior project director, shared some insights into pharmaceutical serialization with Pharmaceutical Technology. 

Compliance outlook for 2018

PharmTech: What changes have you seen in the industry’s approach to serialization in 2018, as the DSCSA and FMD deadlines draw near? 

Minaeff: We have seen several changes since FDA offered a year-long extension in 2017. FDA recognized that solution providers were finding it difficult to scale up to service the number of production lines required by the various pharmaceutical companies. As a result, many serialization service providers have had to hire hundreds of employees in a short time frame to meet demand. 

The major hubs in the United States are in the San Francisco Bay Area, the Northeast, and of course, Research Triangle Park. Additionally, we see a large opportunity for external manufacturing in the Midwestern US. The beauty of cloud solutions is that they have unlimited scalability, so we are able to work with companies of all sizes and customize our solutions according to the size of the business. Further, Colombia and Brazil are emerging markets, while Canada will adopt serialization within the next five years due to changes in regulations. 

PharmTech: Just a few months ago, many small to mid-sized manufacturers and CMOs had not even started formal serialization programs. Where are you seeing the greatest challenges?

Minaeff: Serialization implementation faces the following challenges:

• Collaboration between thousands of parties

• An unstable regulatory landscape 

• Management’s view that serialization is a cost, not a benefit

• The need to share billions of terabytes of data.

PharmTech: There are already a number of cloud-based data management systems available for serialization.  How is Adents’ different?

Minaeff: Adents was established to explore the new generation of serialization software. The major challenge with serialization is not the actual marking or reading of serial numbers but rather the data management expertise that backs up the serialization. Over the past few years, Adents has created a new software suite, with an open architecture. 

The first part of this software was released in 2010. This software-driven serialization solution took off very quickly in the European market. The solution is not only used in the pharmaceutical sector but also in the wine and spirits, and health and beauty sectors. 

In 2012, pharmaceutical companies in the United States and Europe started to implement these processes and began to look into cloud-level solutions. Adents partnered with Microsoft in 2014 to codevelop Adents Prodigi, which was released in 2017. Adents has since grown to nearly 100 employees and more than half of its customer base consists of life-science companies. 

Leveraging serialization efforts

PharmTech: What is needed to help more companies leverage the work that they have done to enable serialization to achieve broader business benefits?  

Minaeff: As a serialization project progresses, there are many challenges that need to be faced and many sources of complexity. Serialization failures most frequently come from a failure to understand the scope of a serialization project, for example, failing to identify all stakeholders and their requirements (e.g., packaging, label change, supply chain, IT, and Enterprise Resource Planning [ERP]).

Essentially, five key elements are required for a successful track-and-trace serialization solution for the pharmaceutical sector:

• Configurability, so that no specific software development is needed, in a platform that can be easily updated and upgraded, reducing human error.

• Scalability, so that after initial rollout, additional lines can be deployed seamlessly without having to duplicate the entire process.

• Interoperability (i.e., increased flexibility) so that users can choose the hardware that fits the best with their objectives, use existing equipment when possible, and minimize costs and delays in delivery.

• Site-level management capabilities to cope with change management. One centralized point from which configuration and processes can be managed can help to facilitate configuration management, data exchange, reporting, change management, and validation support as well as IT governance. Site-level management capability minimizes risks and help users prepare for future track-and-trace challenges.

PharmTech: How is the industry moving beyond serialization to the larger goal of traceability?  

Minaeff: Modern software companies rarely look past three-to-five-year planning cycles, due to the rapid change of technology and business requirements. However, if we look at the current pace of change in automation, robotics, regulatory requirements, consumer demands (from both customers and manufacturers), we begin to see the increasing role that software must play in manufacturing, to provide lifecycle management and support ‘right first time’ production goals.

References

1. A. Shanley, “Pharma Serialization Nears a Tipping Point,” pharmtech.com, January 2, 2018
2. PharmTech Editors, “FDA Pushes DSCSA Serialization Enforcement Deadline Back to 2018,” pharmtech.com, July 5, 2017
3. A. Shanley, “Serialization: So Close and Yet So Far,” pharmtech.com,  April 5, 2018.  
4. S. Milmo, “Meeting the EU Serialization Deadline,” pharmtech.com, June 1, 2018. 
5. Press Release, “TraceLink Customers Receive EMVO Approval for Data Submission to the EU Hub,” prnewswire.com
6. C. Henry, “Concern Voiced About Pharma’s Serialization Readiness,” April 12, 2018, pharmalogisticsiq.com
7. Press Release, “Adents and Microsoft Introduce Blockchain Serialization Solution,” adents.com, June 20, 2018.
8. Serialization Innovation: Latest Technologies for the Pharmaceutical Industry, adents.com, May 24, 2018. 

Citation

When referring to this article, please cite it as A. Shanley, “Serialization: Scaling Down for the Final Stretch" Pharmaceutical Technology 42 (7) 2018.