How have TraceLink’s operations evolved since the introduction of the Drug Supply Chain Security Act (DSCSA) in 2013?

TraceLink has grown significantly over the years, and we have expanded our team from 35 employees in 2014 to over 500 in early 2019. The company has also expanded globally and grew from having one single office in Boston to now having five global offices. We serve customers in over 45 different countries, including in Japan, China, India, Taiwan, Australia and across Europe, as well as all 50 states. The company’s main challenge has been to acquire, grow and service all our customers, both small and large companies within the life sciences industry, across every single segment of the pharmaceutical supply chain.

How is TraceLink readying its client base for the serialization requirements?

We have seen a significant amount of development with regards to serialization, and nearly all of our customers are live. The number of serial numbers being commissioned each month has dramatically increased from 60 million numbers in March 2018 to 300 million numbers in March 2019. Overall, nearly 1.5 billion serial numbers have already been commissioned, and more than 30 billion serial numbers have already been reserved. TraceLink handles close to a million files a week, which are processed through our system.

In order for all companies to go live, we have a network of over 274,000 entities that connect all of the contract manufacturers, pharmaceutical companies, 3PLs, wholesalers, repackagers, hospitals and pharmacies. In Europe, TraceLink launched Smart Rx Manager, an online solution for pharmacies to meet regulatory compliance deadlines. Within the first week it was available, we had over 100 customers signing up online.

Over the past three years, we have seen significant network growth, and our dedicated focus on our network and interoperability is what differentiates us in the market.  

TraceLink recently announced a US$93 million investment round to accelerate the expansion of your information-sharing network platform. What is your value proposition to the market?

TraceLink’s core value proposition is that we have a network platform, which means that companies can integrate once and interoperate with everyone, having access to hundreds of thousands of trading partners with a single connection. This platform offers significant time and costs savings compared to point-to-point connections while also ensuring quality. The cloud-based, multi-tenant platform was purpose-built to provide massive scalability and high quality for our customers. For instance, due to our multi-tenant architecture, our smallest customers have access to the same capabilities in the product as our largest customers. There are of course personalization aspects, which come into play through configuration based upon very specific system needs. We have capabilities within the product to let customers define their own workflows and integrations.

TraceLink has over two decades of expertise in standards-based compliance for track and trace within the pharmaceutical supply chain and is committed to servicing customers in every single country that has, or is, developing compliance requirements. Apart from the United States and Europe we have provided compliance solutions to China, North Korea, Taiwan, India, Brazil, and Russia and are in the process of building out solutions for Egypt and Saudi Arabia.

What is TraceLink’s long-term vision?

TraceLink’s mission has been to digitalize every single entity and business process onto a single integrated digital platform. We believe that end-to-end digitalization will yield better patient outcomes, lower costs and improve efficiencies throughout the industry. We are very committed to our vision and are investing heavily in R&D to carry out this mission.

Over the past year, we have identified different market focus areas that will contribute to the advancement of the industry as global track and trace regulations are producing vast amounts of serialization data that will be leveraged to help digitally transform business processes, including better supply chain visibility and communication between trade partners and more patient-centric engagement opportunities.  

One of our primary focus areas is to allow companies to rapidly digitalize all of their supply network processes through an extensible information exchange platform with applications that can be built and extended by third parties. Within the digital health area, TraceLink aims to connect pharma companies and healthcare providers with patients for them to exchange information in a bi-directional manner.

The advantage of having a single platform that accumulates data from across the industry is that it enables an intelligent supply chain that can improve processes to have better patient outcomes – something we are extremely committed to.