July 10, 2020

The near real time visibility of events, assets, products and their attributes is reasonably adequate in an enterprise but it proved to be an abysmal failure during the COVID-19 pandemic when the links of the supply chain of Life Sciences were found to be standalone entities in an interdependent network. The reality of the existence of fortified silos of businesses and operations rendered decision makers totally blind as they tried to connect the dots of patients infected and medical equipment required to be delivered. After all the pharmaceutical industry has a multi-step supply chain of Drug Manufacturer, Distributor, TPL (Packager, Freight forwarder, Airline or Ocean Liner, Customs and Ports) and recipient Customer of the drugs, namely Pharmacy, Mail Order Service Provider, Hospital, Doctor and Patient. The idea of sharing data from end-to-end has never been viewed as a compelling need for saving human lives had never been the super-ordinate goal. What has exacerbated the problem during the pandemic is the reality that pharmaceutical manufacturers operate under strict regulatory oversight and control. Stakeholders in the supply chain have safeguarded their information as proprietary IP assets and a few are willing to offer it for a price but who is asking. The inadequacy of inventory, the breakdown of the transportation network and the emergence of the bullwhip effect made it difficult to deliver medical service to those in dire need.

As the Drug Supply Chain Security Act (DSCSA) of 2013 phases in, manufacturers will have to be able to track and trace every drug from origin to consumer. To comply, manufacturers are building the capability to identify a batch of powder from an individual supplier and trace that all the way through the process to a pill that is packaged and shipped to a pharmacy. However, major retailers and suppliers will have to share demand signals to monitor inventory flow through the respective supply chains. Technology must be deployed to integrate systems of a drug manufacturer with that of its suppliers and distribution agents and healthcare providers. Regulatory barriers which constrain coordination among business partners must be modified. Until the unprecedented crisis of COVID-19, the need to synchronize the end-to-end supply chain with information has not existed. Today, the urgency to connect data points across the supply chain cannot be overstated. As a matter of fact, it should be mandatory for the life-saving industry to ensure visibility across discrete systems of business partners.

The requirement of visibility for real time decision making has gone far beyond the quantity of inventory of a product at a moment in time to its condition, location, environment and related contextual metadata. The pharmaceutical industry involves complex systems that consist of interrelated and interlocking subsystems. Factors such as environmental conditions, particularly temperature could greatly affect drug potency. Hence, failure to provide the right temperature during storage and shipment of pharmaceutical products may result in major product wastage. Refrigerated containers or storage rooms might be available in the warehouses. However, there are chances of gaps in ensuring and monitoring of temperature level. So how well are the temperatures being monitored and information shared? Fortunately, very powerful tools have emerged for displaying Visualization of Data which make understanding of patterns and cause-effect intuitive. Tableau and Resilinc are two diverse tools which make Visualization very impactful. While the former processes any kind of data, the latter identifies the intelligence of supplier patterns.

Thomas Panzer, the SVP and Head of Supply Chain Management at Bayer AG, has stated, “We have transparency of transport lane deliveries to our direct customers (wholesaler, retailer, in some cases hospitals and pharmacies) up to the point of sale. While the systems can be further integrated and improved, the issue is the downstream channel inventory visibility from the point where the goods arrive at the wholesalers/retailers until they are delivered into hospitals/pharmacies and until point of treatment. The lead time can be up to 2 months (or in some cases even longer) where most pharma companies have no visibility at all.”  His visionary goal is to optimize the entire end to end supply chain from supplier over production network through the distribution network down to the point of treatment. Imagine if we had visibility of the time of delivery at every stage of transportation!

If we had visibility in the overall network, we could assess the costs of product damage, magnitude of expired and counterfeit drugs, impact of delayed delivery and product out of specification, and extent of excess inventory and out of stock. It has been said that you cannot control what you don’t measure. Visibility in the end-to-end links of the transportation network is critically required to ensure Integrity of Product, Integrity of Process, Authenticity of Drug, and Compliance with Governmental Regulations. Governmental interventions to enforce ePedigree, Serialization and DSCSA for Life Sciences have been viewed as regulatory hurdles and not necessary business innovations for enhanced profitability and patient care.

The last major innovation to achieve visibility in the supply chain was when bar codes were assigned to products in the 60s and FedEx decided to use it to monitor status of a parcel in its delivery life cycle. Today we have the promising technologies of IoT, AI, Machine Learning, Blockchain and Data Analytics which can transform the overall supply chain for cost efficiency, lead time reduction, asset utilization improvement, waste reduction, and product quality assurance, overall integrity and real-time decision making. Tracelink, with its suite of solutions, has demonstrated that technology is the unique enabler of visibility and accountability. IoT allows embedded sensors in the product, package, pallet, truck or aircraft and the warehouse. Platforms are being built to gather event data along with conditions of product and location which provide intelligence for real time decision making. What limits deployment of IoT is the fear of exposing the adverse conditions and causes of problems. The transportation agency has no incentive to surface the operational problems unless being demanded and paid for providing temperature incursions, for example. The insurance companies have a financial incentive to receive and analyze the temperature-related or vibration-related data in understanding the incidents and causes of product damage. I am encouraged by what Rich Kilmer, CEO of CargoSense, observed, “What’s changed recently is an advance in sensor technology. We now have disposable, real time, cellular sensors. Couple that with artificial intelligence, and we can transform the world of today into the world of tomorrow. This is the essence of the CargoSense platform.”  How serious is the logistics problem when there is a deviation from a planned event? The challenges of the current pandemic may alleviate some of the fear and inertia among service providers and forge an industry alignment of objectives.

In order to address the above, we must have information from the partners in the supply chain concerning Product Quality (package level and Pallet/container level), Timeliness of Scheduled Events, Temperature Control results from end to end, Process Deviation from Standard, Degree of Compliance with Govt. Regulatory Guidelines, Geo-Positioning Data, to name the major data required to be measured at the  nodes of the lifeline. A Sharing Community with Real Time Transparency must evolve so that we are better prepared for the next Black Swan health crisis.

Submitted by Devendra Mishra, Executive Director, BSMA