Jean-Marie Aulnette, vice president of EMEA Sales, TraceLink, reveals his thoughts on the challenges, opportunities and trends experienced over the course of the past 12 months.
2017
1. What has been the biggest opportunity of 2017 for your company/organisation?
New serialisation requirements in the US and Europe present a huge opportunity for our business, as the TraceLink Life Sciences Cloud platform is the world’s largest network for connecting the pharmaceutical supply chain, and is designed to help companies overcome the serialisation data management challenge.
As companies in Europe work towards compliance with the Falsified Medicines Directive (FMD), we have grown significantly in this market, with over 230 percent growth in EMEA from our most recent third quarter. To support this growth, perhaps the most significant development for TraceLink this year has been our investment into our European operations, with the relocation of our European headquarters to a larger space in Uxbridge, UK. The move accommodates our projected 207 percent year over year increase in European staff growth for 2017.
2. In your opinion, what has been the most important innovation for the year?
In June this year, we introduced our Pharmacy Compliance and Digital Information Platform to the market, which provides a single destination for pharmacies to meet their EU FMD requirements. The application aims to address the decades-old information gap between pharmaceutical companies, pharmacists and patients. The ability for real-time information sharing will transform how the industry provides care to patients. For example, pharmacists can receive specific and contextual pharmaceutical product information directly from the manufacturer – including details about indications, usage, best practices for product administration, and potential warnings, allowing them to optimise interactions with patients. Using the application, they can also benefit from dashboard analytics that provide insights into their pharmacy operations, including real-time information on product expirations and status of compliance information submitted to the EU hub.
3. Which factors have driven the biggest changes to the industry in 2017?
Lack of preparedness for serialisation requirements is already beginning to shape the pharmaceutical landscape, and the situation will heighten as we move closer to the regulatory deadlines in the US and Europe. Consolidation is likely among smaller industry players who lack the available resources to invest in new technologies and processes for compliance.
4. What market trends have been influential for 2017?
With new serialisation requirements in some of the world’s largest pharmaceutical markets, companies are being forced to handle large volumes of data, and overcome the associated challenges such as data integrity and security. As a result, cloud platform adoption is increasing, as companies realise that in order to simplify the exchange of data with supply chain partners, they need to be part of an established network. This is a trend that will only continue as new global regulations take hold and the supply chain becomes more complex.
5. What have been the biggest challenges of the year?
By 2020, over 80 percent of the world’s prescription drugs will be covered by track and trace laws; a challenge that involves massive amounts of data and a complex web of supply chain partners. As we have seen with the delay of the active enforcement of the FDA’s Drug Supply Chain Security Act (DSCSA), many players in the industry are struggling to implement their serialisation strategies, which is due to a number of factors, including cost, resource and simply not understanding the requirements and the scale of the task at hand. This is particularly the case for small and mid-sized manufacturers, including CMOs. As a result, many sponsors are beginning to rethink their outsourcing strategies in order to ensure continuous supply of vital medicines to key markets.