FutureLink

TraceLink plots a course for traceability beyond compliance

Connectivity will extend to patient engagement, when permitted


At FutureLink, a combination of user conference and thought leadership positioning put on by TraceLink in Chicago (Nov. 5-7), CEO Shabbir Dahod outlined the company’s direction for what the life sciences industry will be able to do with its now-substantial investment in serializing saleable units of its products in the US and around the world. Dahod premises this future on TraceLink being the preferred choice for collecting and distributing this serial data—something that the dozen or so competitors to Level 4-5 serialization management would argue about—but with 1,037 companies as customers, including many of the top global pharma companies, and with a recent injection of $93 million in private-equity capital, TraceLink appears to be pulling well away from the pack. (TraceLink says that 380 of the 1,037 are currently sharing serial data; it also claims over 270,000 trading partners that are linked to the TraceLink Cloud—including numerous contract manufacturers, wholesalers, hospital systems and pharmacy networks, which are an essential part of the overall pharma supply chain.)

The foundation of TraceLink’s (and everyone else’s) efforts in this area is to bring pharma manufacturers into compliance with the US Drug Supply Chain and Security Act (DSCSA), the EU Falsified Medicines Directive, and similar national initiatives at some 40 countries around the world. By the end of this month, all US products going into commercial distribution are supposed to be serialized, and by February 2019, the same is true for Europe. This part of TraceLink’s business will be called Track and Trace Compliance. On top of, or alongside, this capability with be four other activities:

  • Smart Supply Chain, primarily to use the serial data within the four walls of an organization to manage workflows, inventory in process and related internal operations, in near real-time;
  • Digital Supply Chain Platform, for essential trading-partner communications such as resolving product recalls and returns, monitoring cold-chain shipments and the like. The service will include an application development platform to enable third-party software vendors to connect to TraceLink’s platform.
  • Digital Health, to connect patients with their products, and possibly back to the manufacturer or other stakeholder, for purposes like adherence programs, patient education and the like (as well as the ostensible purpose of traceability—to authenticate the product).
  • Intelligent Supply Network, through which TraceLink intends to create data lakes for clients that would enable analytics to be performed on product movement through the supply chain and into commerce.

“This is a journey that we’re all taking together,” Dahod told FutureLink attendees, “that requires all of us to work together.” And that is the rub of Dahod’s vision; will there be collaboration not only among software traceability vendors, but also among trading partners who would need to share their data with each other? TraceLink maintains that it is open to connecting to other vendors (and there are various standards-setting activities going on that TraceLink participates in), and that the Intelligent Supply Network could, in part, become a marketplace where participants sell their data to mutually approved customers. Such transactions occur today, especially with retail pharma sales; it will be up to the trading partners to decide on how far they are willing to go in this direction.