Q&A: Talking serialisation and digital transformation of pharma with TraceLink

In this exclusive interview, we discuss the digitalisation of the supply chain, compliance with European Falsified Medicines Directive and TraceLink’s Product Information Manager with the company’s vice president, solutions marketing, Dan Walles.

Q: Why has TraceLink developed the Product Information Manager application?

A. The expansion of TraceLink’s network-based information sharing platform will allow drug makers, their trading partners and solution providers to revolutionise the industry through the digitalisation of the supply chain.

Compliance with approaching regulations such as the European Falsified Medicines Directive (FMD) and US Drug Supply Chain and Security Act (DSCSA) are just the first step towards a revolutionary and much-needed digital transformation in the pharma industry.

Until a few years ago, the pharmaceutical supply chain was a point-to-point sequence of handoffs with much of the industry working in siloed segments. Even with serialisation regulations, a lack of communication between trade partners and archaic processes for documenting transactions make basic supply chain processes and patient-centred services cumbersome. Fundamentally, a lack of information, integration and access to data, combined with a proliferation of data sources, is putting people at risk and costing the pharma industry billions of dollars every year.

By sharing more and better data in a more efficient and unified format, businesses throughout the pharma supply chain can develop collaborative solutions that will fundamentally change the way the industry operates.

Global serialisation regulations have pushed the industry towards the creation of a digitised information sharing model but there remains a portion of the sector that is relying on point-to-point connections to deliver a compliant solution. To deliver true digital transformation, a network that allows companies to store, control access and freely exchange data is required

Q: What will Product Information Manager mean for the EU industry?

A. The requirement to comply with the EU FMD has spurred a wave of digital transformation in the industry. Now, with serialised product flowing through the supply chain, the value of product information, coupled with the ability to seamlessly exchange this information with trade partners, has opened a new door of opportunity.

With Product Information Manager, TraceLink’s 250+ EU customers, will be able to bake their serialisation initiatives into their everyday operations, not only for compliance reasons, but to achieve operational efficiencies and through information-sharing with direct and indirect trade partners.

Q: What projects are businesses looking at to drive value beyond compliance?

A. At FutureLink 2018, industry leaders from across the sector discussed the ways they plan to drive increased business value from their serialisation solution. In a series of polls at the event, attendees were asked how they will use serialisation data and TraceLink’s network platform to improve their operations.

When asked in which areas they would use predictive analytics to inform their decision making:

• 63% of respondents said supply and demand forecasting

• 16% said inventory management

• And 13% said it will influence decision around operating costs.

Attendees were also asked what areas of the supply chain would most benefit from serialisation data, 35% said supply chain services including recall management.

Product Information Manager will allow businesses to drive these value-based initiatives by enabling seamless and real-time information sharing between direct and indirect trading partners.

The network application is designed to use serialised product information to deliver a range of offerings such as rich media product education, patient engagement and digital recalls. The additional capabilities available within Product Information Manager and other network applications built on TraceLink’s information-sharing network platform will be rolled out over the next 12–18 months.

Q: How will Product Information Manager improve patient engagement?

A. Leveraging serialised data and product information, Product Information Manager will allow manufacturers to securely share more sophisticated educational materials with patients. Digital content in the form of product descriptions, administration instructions, photos, education videos, and more can be shared with patients at the point of medicine consumption. Medicine disposition details (information on absorption, distribution, metabolism, and excretion; known as ADME) can be shared with patients.