Shabbir Dahod, TraceLink

Shabbir Dahod, President and CEO, TraceLink

 on the matter, the FDA recently announced a 12-month enforcement discretion and system stabilization period for the final phase of the US Drug Supply Chain Security Act (DSCSA), but the law will still take effect on Nov. 27, 2023. And whether you're a pharmaceutical manufacturer, wholesale distributor, or dispenser, organizations that delay their DSCSA projects risk failing to be ready for a complex regulation. Critically, they will also miss out on the strategic competitive advantage that other industry stakeholders are acquiring right now by using DSCSA to digitalize end-to-end supply chain operations and access industry-wide supply chain intelligence.

In guidance shared with the pharma industry in late August, the FDA stated that the enforcement discretion period is not a delay in the law and strongly urged supply chain stakeholders to avoid slowing or delaying DSCSA compliance projects. Instead, the 12-month stabilization period, which ends on Nov. 26, 2024, should be used to stabilize and mature DSCSA systems and processes with supply chain partners. But that's not the only reason to make sure that DSCSA compliance projects remain a top digitalization priority.

Ranging from advanced drug shortage predictions to item-level inventory management to the digitalization of the product recall process, many organizations are leveraging the information-sharing requirements of DSCSA to create business value right now. Organizations ought to be leading the end-to-end digitalization race, instead of standing on the sidelines.

Enacted by Congress in 2013 and designed to be rolled out in phases over a 10-year period, DSCSA seeks to prevent counterfeit, adulterated, and illegally diverted prescription medicines from entering the US supply chain and harming patients. The final and most complex phase of DSCSA requires pharma trading partners to implement a secure, electronic, and 100% interoperable digital system for tracking and tracing pharmaceutical products across the supply chain at the package level.

But as the November 2023 deadline inched closer, it became clear that many pharma supply chain stakeholders were not prepared to achieve full compliance. As a result, the FDA announced the stabilization period to ensure that products continue to move smoothly through the supply chain, and to give trading partners the extra time needed to finalize the implementation of DSCSA-compliant processes and systems.

Overcoming DSCSA challenges with a network approach

As many industry stakeholders have learned, the toughest challenge associated with the final phase of DSCSA is the 100% secure and interoperable exchange of data required among all trading partners. To facilitate this exchange, electronic integration with all partners—including both direct and indirect trading partners—across the end-to-end pharmaceutical supply chain is a requirement. Many organizations attempted to exchange this data through point-to-point integrations and other methods. However, they quickly learned that the process of building, operating, and maintaining expensive connections with partners was simply too expensive, complex, and difficult to manage, and have abandoned this approach as a result.

In searching for alternatives, these organizations have learned that a cloud-based, digital network platform solves the point-to-point integration problem by enabling every trading partner to connect to a single interoperable network once, and then use that one connection repeatedly to onboard, manage, and exchange information with all direct and indirect trading partners across the supply chain.

Taking DSCSA compliance to the next level

Once an organization is connected to the network, the stage is set to leverage the information-sharing capabilities and the anonymized, collective intelligence of the entire pharmaceutical industry to achieve business benefits that transcend regulatory compliance alone. With a digital network platform approach, your organization can:

Predict drug shortages up to 90 days in advance with a high degree of accuracy.

Digitalize, streamline, and speed up product recall processes.

Leverage item-level data and product verification to improve inventory management.

Confirm the legitimacy of products received with subsecond response times.

Rapidly resolve compliance errors with partners to keep products moving through the supply chain.

Manage complex shared tasks, issues, and change orders with partners in one interface.

Digitalize and improve the exchange of multi-enterprise supply chain business information, such as purchase orders, invoices, and logistics information, and inventory data.

In short, DSCSA is complex. But a digital network platform approach can make compliance simple; it can also enhance the way pharmaceutical supply chain stakeholders do business with one another, while also improving patient outcomes.

Shabbir Dahod is President and CEO of TraceLink.

Articles

A breakdown on the decision, and how to navigate these obstacles using a network approach.

FDA Offers 12-Month DSCSA Stabilization Period, but Urges Industry Not to Delay

The Internet of Supply Chains (IoSC) is a logical and powerful extension of current efforts to digitally transform what has long been an extremely manual and cumbersome process of communicating with partners through electronic data interchange (EDI), e-mail, phone calls, and spreadsheets.

While many organizations are digitalizing basic interactions with supply chain partners, too often the result is a hub-and-spoke architecture, leaving the organization a digital island with limited ability to collaborate even within its own constraints.

The Internet of Supply Chains links together all of these digital islands into an ecosystem that enables robust communication, collaboration, and orchestration of shared workflows across multiple enterprises. Organizations, their suppliers, and their suppliers’ suppliers, gain precision visibility into the flow of materials and processes because they are connected by interoperable networks that link companies, people, processes, and systems around common business purposes.

The pharmaceutical sector has a keen interest in enhancing supply chain efficiency because ingredient and material suppliers, contract manufacturing organizations (CMOs), contract research organizations (CROs), and third-party logistics (3PL) providers need to be integrated, managed, and monitored to ensure quality, efficiency, and on-time performance and delivery. The Internet of Supply Chains makes all of this and more possible by harnessing the collective intelligence of an entire industry, enabling organizations to identify, predict, and resolve issues before they can adversely affect production.

, billed as the Fourth Industrial Revolution. Industry 4.0 is often seen as the emergence of Internet of Things (IoT), allowing smart devices to communicate while integrating machine learning and artificial intelligence to enable automated processes and other efficiencies. These advances will bring exciting opportunities.

A foundational enabling element to all of this, however, is the creation of a robust infrastructure to support machine-to-machine communication, network creation and management, and the orchestration of critical business processes. The IoSC is built on one network platform that allows companies with diverse ERP and other management systems to seamlessly communicate around common business processes. It frees organizations, their suppliers, and other partners from the enormous task of integrating disparate systems. Companies only need to integrate to the IoSC once and they will be connected to all other partners on the network.

The scalability and interoperability allows participants to seamlessly interact as if they were under one roof, so they can focus on collaboration and enjoy the benefits of orchestrated workflows.

The IoSC will give all participants visibility that simply has never been possible. A pharma company, for example, would be able to see across the operations of its multiple CMOs or 3PLs—including visibility into the supply chains supporting their needs, as well as the supply chains supporting their partner needs, and beyond.

Based on a common data model, network members—collectively—benefit from an intelligence far greater than any individual person, group, or computer has ever experienced before. The collective intelligence that emerges from such wide and deep visibility can have a profound impact. For example, because the TraceLink network, built on Opus, tracks the movement of over 30 billion product serial numbers across a vast network of pharma supply chain partners, we can predict drug shortages up to 90 days in advance with greater than 80% accuracy.

When I ask organizations about their biggest supply chain needs, the answers come down to: more visibility, greater data accuracy, and the information required to make the right decisions faster. The IoSC enables these critically important elements and allows organizations to eliminate shortages, prevent supply chain disruptions, improve launch performance, reduce inventory, anticipate demand, and ultimately improve profitability. Potential problems can be identified and remedied before they become blocking issues. The same is true for an organization’s 3PLs, its customers, and every other stakeholder and participant.

The platform makes it easy to onboard suppliers and other supply chain and distribution participants. The resulting visibility and capability to collaborate and orchestrate processes—including autonomous machine-to-machine automations—combine to provide internet-level scalability. This is essential because traditional enterprise-level connectivity is too time-consuming and expensive to scale.

Turning again to the pharma sector, the sheer number of CMOs, suppliers of suppliers, 3PLs, and other partnerships can simply become too overwhelming for traditional oversight management. The internet-level scalability of the IoSC provides a powerful and much-needed tool for those responsible for managing CMO and other supplier and partner relationships, particularly given the increased reliance on outsourcing. There are some problems which don’t scale well by just assigning more headcount.

A faster route to digitalization through hybrid connectivity

The common communication backbone enabled by the IoSC—in addition to all of the other benefits already mentioned—also provides a faster route to digitalization. This is especially true for CMOs and similar organizations that have high-value expertise and capabilities in their domains of focus, but may be just beginning their digital transformation journey. The IoSC provides a hybrid connectivity model, with some partners connecting their systems for full B2B interoperability, and others inputting information manually. This allows all supply chain partners to participate at their level of readiness to speed the process of digitalizing end-to-end supply chain networks. The interoperability enabled by the IoSC allows a fluid flow of information that is opening a new era of supply chain collaboration, visibility, and workflow automation.

This all sounds great, but can it be done? The answer is yes. The IoSC is not just a vision, it is the foundation of TraceLink track-and-trace solutions. The Opus platform is currently connecting 290,000 network members to meet pharma industry regulatory requirements. We’ve seen how well an internet-level of scalability works in real-life scenarios, and it is a great place to start a digital transformation journey.

By connecting and collaborating with all tiers of direct suppliers on the IoSC, for example, our customers can leverage real-time visibility into purchase order and production status, capacity, and inventory levels, to collaborate and resolve issues as they arise. Tasks can be assigned to stakeholders across partner companies, enabling multi-enterprise teams to quickly and efficiently manage cross-enterprise work processes.

These are exciting days because we have the technology to make the IoSC a reality that will massively benefit manufacturing and distribution across the globe.

No longer just a vision, the technology exists today to make an internet-level of scalability in pharma track and trace a reality

Creating the Internet of Supply Chains

Supply chains around the globe should soon be getting an enormous boost thanks to advances in machine-to-machine communications, the internet of things (IoT), artificial intelligence (AI), and immersive networks, which are all part of what is referred to as the Fourth Industrial Revolution, or Industry 4.0.

The concept of a Fourth Industrial Revolution was popularized by the founder of the World Economic Forum, Klaus Schwab, in 2015. The impact on global supply chains and manufacturing should be substantial as self-monitoring systems, intelligent machine-to-machine communications, and a network of networks open a new world of deep and broad process visibility and cross-functional, cross-enterprise communications.

To better appreciate the promise of Industry 4.0, it is helpful to look back at the first three waves of the Industrial Revolution:

Generally delineated as spanning 1760 to 1840, this revolution was powered by steam and advances in manufacturing technologies that reduced the physical labor and time required to create products.

Spanning 1871 to 1914, this revolution was powered by the building of railroads, creation of telegraph networks, the increasing use of electrification, and development of factory production lines.

Sometimes called the Digital Revolution, this era began after World War II, and extends to the present day. This revolution has been powered by the growth of computer technology and all that our ever-more powerful computers have brought to the world.

Without a doubt, Industry 3.0, the Digital Revolution, has carried us to amazing heights. The revolution began with room-filling mainframes, progressed through supercomputers, and along the way gave us what used to be supercomputer capabilities on the smartphones we carry in our pockets.

Given all of the above, why has the birth of the Fourth Industrial Revolution, Industry 4.0, been proclaimed? The answer is both logical and stunning. We are beginning to create networks of networks—with machine learning, expansive communications, and precision process visibility baked in—that will transform how businesses communicate and interoperate.

The textbook example for Industry 4.0 is supply chain management (SCM). How many partners does an organization have? This can range from dozens to hundreds to thousands. In turn, each of those partners have their own partners and suppliers. Now imagine the Industry 4.0 concept of creating a network of networks, securely connecting all of these participants, each permitted to see the data relative to their own needs.

This brings extreme visibility to all supply chain participants. With such a network of networks, one could see an overview of not just their own supply chain needs, but dive deeper to ensure their partner supply chains were also flowing properly. Add to this, machine-to-machine communication, AI, and you can understand how significantly supply chain operations can be enhanced by the network of networks of Industry 4.0.

TraceLink’s traceability and compliance solution for the pharmaceutical industry is a prime example of Industry 4.0 connectivity. Our network of networks links 286,000 members to supply chain partners and manages 31.3 billion serial numbers, providing a digital twin for the life science industry.

The foundation: Creating a network of networks

The challenge, of course, is to actually 

 a network of networks, especially when unifying communications across multiple companies, each with their own enterprise resource planning (ERP) and SCM systems, their own custom applications, and work processes. How do we integrate these disparate entities into a network of networks that lets us access information in a manner that enables us to develop intelligence, share execution, and work as an integrated organism?

The answer is to create a central network platform on which organizations can create a digital twin of their networks without changing their internal architecture. Such a network platform would enable the creation and running of multi-enterprise applications with business objects and business processes as a harmonizing layer—essentially translating between disparate applications to allow seamless communications and processes across and between organizations.

Basic elements of such a network of networks would include:

Creating a standardized digital representation of a firm’s own processes that can be extended to partners.

Sharing processes and applications across the network, including appropriate security and access controls among partners.

Supporting cross-functional and cross-company execution with a shared, but customized, application that enables the company and its partners to participate based on their own workflow and data requirements.

Providing a common data model for information in the network, with a system that auto-translates each other’s data into a common language.

Generating collective intelligence from across the network to predict shortages, anticipate supply disruptions, and identify shifts in demand.

Such an Industry 4.0 network of networks would connect people, processes, data, and systems with digital networks that could break down the barriers to digital supply chain transformation. The results could help us meet some of the major challenges supply chains face, including:

 A network of networks will enhance traceability and provenance to defend against counterfeiting and diversion in pharmaceuticals and a spectrum of other industries.

 Recent supply chain disruptions underscore the need to adapt and adjust to fluctuations at a very rapid rate, made possible by the visibility and communications inherent in a network of networks.

 Environmental concerns require traceability. For example, the US Environmental Protection Agency’s Scope 3 on carbon emissions basically says that you need to not only be able to certify that your own products meet certain sustainability requirements, but that all the raw materials that your suppliers are using also meet the requirements.

A network of networks provides the transparency companies require to work in a more orchestrated manner and to ensure accountability to each other in order to achieve goals—and mandates—for social responsibility.

These are exciting days. We are witnessing the dawn of the Fourth Industrial Revolution, and because of the network of networks that is forming such a foundational element of this revolution, supply chain management will be one of the earliest beneficiaries of Industry 4.0. This capability is no longer theoretical, but in action today and providing immeasurable value to customers and their patients. To ensure availability and visibility to critical drugs, TraceLink’s network, for example, is able to successfully predict product shortages 90 days in advance with over 80% accuracy. This is the kind of revolutionary impact interoperability and end-to-end digitalization can have on society.

Shabbir Dahod is President and CEO of TraceLink.

Pharma supply chain management will be one of the earliest beneficiaries of the Fourth Industrial Revolution, and the potential of ‘networks of networks’