Earlier this year, at FutureLink Munich 2018, more than 200 pharmaceutical and healthcare executives from 100 companies were polled on a range of topics relating to serialization and the EU’s Falsified Medicines Directive (FMD).

Over 1,600 responses were submitted providing insight into the industry’s biggest challenges and opportunities with regards to serialization. Here, Staffan Widengren, director of corporate projects at Recipharm, and Jean-Marie Aulnette, vice president EMEA, TraceLink, discuss the key findings in the report, “EU FMD Readiness and the Future of Digital Drug Supply,” in an exclusive Q&A with Contract Pharma.

Contract Pharma: The report revealed that 28% of respondents said onboarding of contract manufacturing organizations (CMOs) was the most complex component of a track and trace program with 8 in 10 respondents believing most small CMOs are underprepared. Why is onboarding such a significant challenge?

Staffan Widengren: The on-boarding of some customers has presented major difficulties for CMOs. It’s complicated by the simple fact that few businesses are at the same level of preparedness in their serialization project as their partners when trying to connect. It’s also not just a matter of navigating through a technical connection process—there are financial elements to be discussed and agreed.

One of the major challenges comes from customers that are not using the same network-tenant approach Recipharm has adopted in partnership with TraceLink. Those customers that have opted for point-to-point connections have created additional layers of complexity and in some instances, it has taken over a year to on-board these partners. With a network-tenant approach, on-boarding in general takes three to four months per customer.

Jean-Marie Aulnette: It’s clear that partner readiness and on-boarding is the primary concern of most CMOs; 53% of the FutureLink poll respondents said partner readiness was the biggest risk to integration and 44% of respondents said they haven’t on-boarded any partners.

As companies make decisions that will dictate their readiness for the February 2019 FMD deadline, they need to carefully examine and discuss the capabilities of their partners. With such a tight timeframe for implementation, providers that can offer validated solutions quickly are better placed to alleviate the challenges that pharma businesses and CMOs are facing when they collaborate on their compliance efforts. Point-to-point connections are very high-risk options at this stage, due to the length of time required for implementation and onboarding of partners. 

CP: 54% of the poll respondents said they have contracted with one or more of the National Medicines Verification Organizations (NMVOs). How much work is there still to be done around on-boarding here?

Widengren: There remains a fundamental lack of knowledge about serialization in many areas which has led to many businesses failing to anticipate the complexity of implementing a solution—9% of the respondents in the FutureLink polls did not realize that they needed to work with NMVOs in each EU country.

Plenty of businesses have failed to appreciate the scope of the work and delayed their projects to the point where they may fail to be compliant in time. In January 2018, the European Medicines Verification Organization (EMVO) announced that the very last opportunity to on-board timely with NMVOs was June 2018. That date is now well past so any organization just starting to onboard with respective national systems risks not being able to comply with the FMD. 

Aulnette: In an announcement on August 6, 2018, the EMVO stated that only 106 of the EU’s 2000-plus pharmaceutical companies have completed the onboarding process with their NMVOs and developed their connection to the European Hub to be compliant with the FMD. Today, 56% of the companies connected to the EU Hub are TraceLink customers.

841 have signed the required Participation Agreement overall and 347 are in the technical on-boarding phase.

12% of FutureLink poll respondents said they had completed end-to-end testing with at least one NMVO. Given that this on-boarding process and connecting IT systems to the EU Hub can be challenging, businesses that aren’t using a pre-validated solution have a lot of work to do in a very short timeframe—it is likely that some will fail to be compliant in time.

CP: Where should CMOs be focusing their attention in the countdown towards the February 2019 deadline?

Widengren: For CMOs yet to start or in the early stages of implementing a serialization solution, they will have to focus on securing partners that offer standardized equipment and validated solutions. Customization is not an option at this stage.

Joint ventures may also be appealing for smaller contract businesses—most CDMOs have little expertise in packaging and they could feasibly seek out partnerships with better prepared CPOs to deliver serialization.

Ultimately, businesses must prioritize compliance above all else. There’s a lot of scope for creating additional value with the network developed by TraceLink to support serialization requirements. However, first businesses may decide to wait until a system has been implemented, partners on-boarded, the entire process is validated and that it is working as it should be.

Aulnette: The requirement around artwork changes is posing a problem for some organizations, only one in 10 of the FutureLink poll respondents had all their artwork ready and 15% had not prepared any.

Compared to the installation and validation of serialization hardware and systems, updating artwork may seem a straightforward requirement. However, some CMOs handle thousands of stock keeping units (SKUs) and each needs to be updated with the 2D matrix barcodes necessary for compliance. It’s a significant challenge.

CP: What should CMOs be exploring beyond compliance?

Widengren: Serialization has disrupted the industry in so many ways. At a company level it affects nearly every department and the way they operate, and it has the potential to have a detrimental impact on efficiency in some instances. Business and project leaders should have been mindful of this during the planning and implementation of their serialization program and developed a roadmap for returning to a business-as-usual state post go-live.

In the FutureLink polls, every respondent believed that the biggest challenge when it comes to handling serialized product is integrating use cases into current business processes to maintain efficiency. Companies are adopting different strategies to achieve this – many are recruiting specialists or training existing staff and developing capabilities within departments, others are creating new organizational structures, and some are outsourcing. Whatever the strategy, the outcome must be the same, manufacturers and their partners need to normalize serialization and keep driving operational improvements to maintain and then improve efficiency.

Aulnette: Serialization requirements inherently create a huge amount of data which can be leveraged by businesses to improve broader operational and supply chain processes as well as develop more engaging patient care initiatives.
  
To use serialization regulations as a catalyst to delivering true digital transformation, a network that allows companies to store, control access and freely exchange data beyond that needed for serialization is required.

A network approach allows integration between manufacturers and suppliers, creates a repository for master data and allows companies to discover new partners and configure business relationships beyond compliance requirements.

The industry is already exploring this kind of digital transformation—some manufacturers are getting closer to patients through online communities, others are using wearables to capture data directly from patients. This digitized approach now needs to be translated into the manufacturing and supply chain environments.

In the FutureLink poll, 63% of respondents said predictive analytics around supply and demand forecasting could have the biggest impact on decision making. When it comes to potential supply chain improvements, 35% said supply chain services, including recall management, would benefit the most. The same amount said supply chain analytics and insights would be greatly improved by the digitization of the supply chain.

Given that the industry loses billions every year due to supply chain failures, it is imperative that the pharma industry realizes the potential of these new data networks.

FutureLink Chicago
The next FutureLink event, taking place in Chicago from November 5-7, 2018, will bring industry leaders together for two full days of insightful, interactive discussions on topics that range from global regulations to business transformation through information-sharing networks. Attendees can register at: www.tracelink.com/futurelink-chicago/about. 

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Jean-Marie Aulnette, TraceLink Vice President of Sales, EMEA, Jean-Marie Aulnette brings to his role 20-plus years of experience in international sales and enterprise SaaS applications. Since joining TraceLink in 2014, he has been responsible for building and leading the company’s new EMEA sales operation, delivering track and trace solutions across EMEA pharmaceutical markets to ensure visibility, traceability, and compliance from ingredient to patient.

Staffan Widengren, Director of Corporate Projects at Recipharm, is program manager for the Recipharm global serialization program and part of a global steering committee that is working closely with clients globally to ensure they plan and implement changes that will comply with pending regulatory requirements for drug serialization. Staffan has been working as quality director/qualified person and general manager within Recipharm since 2002.