Promising “frictionless data exchange between direct and indirect partners” who share serialization data to meet requirements of governmental mandates, TraceLink has begun marketing PIM, with a go-live date by the end of Q3, according to Shabbir Dahod, founder and CEO of the North Reading, MA, company. PIM is at once a master-data repository for product specifications and identity, and a means of networking supply chain participants to meet requirements of the Drug Supply Chain Security Act (DSCSA), Europe’s Falsified Medicines Directive (FMD) and other governmental bodies around the world. Near-term applications include providing a routing service (to connect manufacturer data with direct or indirect supply chain participants), managing product return information-sharing and transmitting some of the traceability data for DSCSA compliance.
Dahod says that PIM is a “network application” residing within the framework of TraceLink’s Life Sciences Cloud, where manufacturers can store or transmit product data to supply chain partners ranging from contract manufacturers to pharmacy clients. “The ‘network effect’ means that you can orchestrate a process with any trading partner who is also on the network.” Specifically, this should enable a high degree of interaction with supply chain partners like wholesalers, who are focused on meeting the November 2019 deadline for verifying the authenticity of product returns, so that those returns can re-enter commercial distribution. (This is the near-term goal of the Healthcare Distribution Alliance’s Origin data service, for which TraceLink engaged in litigation last year. TraceLink later withdrew its lawsuit, and is now working with HDA and the GS1 organization on this interactivity goal.)
PIM will have interfaces to other commonly used traceability systems (TraceLink’s competitors), so that product information can flow from Life Sciences Cloud into and out of PIM. TraceLink is generally acknowledged as the market leader in enterprise-level traceability systems; the company claims 930 clients in 39 countries currently.
In something of a first for DSCSA-compliant traceability systems, Dahod says that PIM network will eventually accommodate patients who might accept communications from manufacturers. “We’ve been working on a mobile app within PIM for patients for the past three years, and have piloted a version with a client,” says Dahod. “In effect, patients could eventually become nodes on the PIM network, receiving medication guides or other information from the manufacturer, or engaging in an adherence program.” On the patient side, the implication is that patients could be in communication with multiple pharma companies or healthcare providers through one interface—although the electronic health-record (EHR) vendors and other healthcare players are vying for that same position with patients.
In conversation with Pharmaceutical Commerce, Dahod had this to say about the growing efforts to build traceability systems on blockchain technology: “99% of these applications don’t acknowledge DSCSA, which requires interoperability among systems,” he says. “The biggest challenge is to be standards-based and interoperable.” Nevertheless, he hints at some blockchain-related news from TraceLink in 2019.