A pair of announcements involving TraceLink, a leading provider of software for compliance with the Drug Supply Chain Security Act (DSCSA) point to the future value of DSCSA’s original purpose: to more closely track pharmaceutical packages as they flow through supply chains to market. Earlier this month, at TraceLink’s annual FutureLink meeting, the company announced a new layer to its Digital Supply Network, the community of manufacturers who have installed TraceLink’s software, and the contractors and trading partners that those manufacturers connect to. (Cumulatively, TraceLink says that 276,000 entities are connected to this network globally, including many non-US companies complying with various national mandates for supply chain traceability.) The new layer is called the Digital Network Platform (DNP), and is said to enable users to “rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration.”
Over the course of 2020, DNP will get built out with a variety of capabilities, including:
● Serialization Process Intelligence, providing automated reporting of supply chain activities.
● Experience Design Environment (XDE), enabling customized interaction with network data, based on user roles. A related functionality will be the TraceLink Development Environment (TDE), where users and technology partners can develop apps.
● Smart Supply Manager, for sourcing, centralizing, and distributing real-time, product-condition information relative to serialized medications sourced from a network of connected IoT devices and sensors. A subset of this is Smart Product Excursion Tracking, to collect edge information associated with real-time product conditions (including temperature and environmental excursions). Smart Excursion Tracking is said to encompass “patient “context associated with the consumption of specialty medicines.”
● Digital Recalls – empowering users with a streamlined platform for real-time updates on product recalls and coordination.
Shortly after the FutureLink meeting, a Wall Street Journal article appeared, “Drugmaker to Test Machine Learning to Prevent Drug Shortages,” in which a semi-hyped claim is made that TraceLink will enable drug shortages—a running theme in the US for the past several years—to be minimized. A client, Merck KGaA, will pilot machine-learning technology currently under development at TraceLink to better manage its supply chain of immuno-oncology drugs. The TraceLink platform will act as “a central hub for information about the status of drugs at every phase in the supply chain,” according to the WSJ article. Merck KGaA’s current forecasting is about 85% accurate; the new software will aim to sharpen that accuracy.
The hype comes in here because in most cases, endemic drug shortages are caused by a combination of manufacturing upsets, and the limited number of suppliers of some generic products, especially injectables. (There is a looming shortage of vincristine, a generic injectable oncolytic that is critical to a variety of childhood cancers, according to a recent New York Times article.) All the same, better accuracy in forecasting and market demand signals will be beneficial to everyone in the pharma supply chain.
The bigger question is whether TraceLink’s customers—indeed, any supply chain participants—will willingly share their data with each other, which has been a cloud hanging over DSCSA since it was conceived. The law enables FDA to step in and demand trade information, but only when an investigation of counterfeit product is in question. Beyond that, pharma trading partners will need to have collaborative agreements with each other to share data on inventory and related supply details.