Whether you are managing clinical or commercial supply chain activities, it is important to maintain situational awareness. To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation. Given the severity of the situation, here are some basic steps to consider: look at the present inventory and think longer term, assess resources, identify hazards, keep communication channels open, and perform against the plan.

1. Measure current inventory levels.

Preferably, well before the severity of the COVID-19 situation began to blanket the world, ample clinical supplies were provided to the various sites and depots to support ongoing patient enrollment. Through the commercial lens, enough product (i.e., many months’ worth on hand) resides in an accessible warehouse, third-party logistics (3PL), or sub-depot to support demand changes above normal conditions or to weather delays in production schedules should they occur. Navigating the situations arising from COVID-19 is unprecedented and likely few have developed a playbook that protects every aspect of the supply chain.

However, if a playbook was developed, the key is to follow it and make changes as the situation commands. Inventory management is central to the playbook. This inventory includes the raw materials to manufacture and package, the active pharmaceutical ingredients, intermediate products, and finished goods. Contents of a playbook include key supplier contact information, team contact information, contingency plans, backup contingency plans, and e-links to various files/folders team members can access remotely as needed in the event email goes down.

One of the key takeaways from a situation like COVID-19 is that you can never plan too far ahead.  Depending on the distribution and demand, whether clinical or commercial, a longer than usual planning horizon may be required to span the recovery period. Some companies will need to adjust from a just-in-time (JIT) model to a different approach where there is a high cost of a stock-out (potentially placing lives in danger). The more acceptable practice or approach will be to keep more inventory, not less; that is, inventory levels may need to be built and reserved in more locations than under normal conditions.

2. Maximize inventory reserves.

Before you can trigger a series of material and production orders to adjust the inventory positions, you need to assess several conditions. Some of these include the internal capacities and those of CxOs, changes in governmental restrictions, and enhanced controls or procedures that need to be created. As the demand for shared resources rises in areas less impacted, it is important to evaluate equipment capacity for key unit operations, take a wider view of known variables and begin to explore those less obvious, triage the work required to maintain sound inventory positions, streamline decision-making abilities, and look a little carefully in both directions – downstream and upstream – to maximize inventory reserves. Impulsive actions will only exacerbate a challenging condition. Stay calm, organized, and collaborative.

3. Assess potential hazards.

COVID-19 has presented a series of interpersonal hazards that have never been encountered. Many people may need or are wearing personal protective equipment (PPE), separating themselves by as much as 6 to 10 feet, avoiding spaces with more than three people, canceling meetings, and isolating themselves. All these actions are aimed at avoiding the further spread of COVID-19 while a vaccine is being developed. As they serve to protect the people, they have a profound impact on businesses and their operations. Companies need people to keep things moving, and when they are sick or in isolation, operations will slow or stop. The resulting hazard will depend on the ability of a business to recover. Some manufacturers and suppliers may not be able to navigate the financial impact of COVID-19, and companies may need to seek other manufacturers and suppliers. It is important to have backup manufacturers and suppliers in a position of readiness. Readiness could range from a point of identification or being cued for a quality audit and scope of work identified just in case swift action is required. It entails monitoring real-time trends, conducting a supplier risk analysis, forecasting the pricing trends, and watching the variable price indexes around the world.

Is Your Track & Trace Supply Chain In Compliance?

The process of tracing the path of drugs from the manufacturing line to the patient to ensure supply chain integrity is called “Serialization,” and non-compliance is not an option. If you’re looking for best practices to improve your serialization program then check out Jack Tarkoff’s webinar, “Key Elements of Pharmaceutical Serialization and Track & Trace Systems: Implementation and Compliance Best Practices”

4. Keep communication channels open.

Central to all actions is ensuring a robust communication process is in place, as a paucity of information can have profound and deleterious effects on supply chains. Referring to the playbook, a list of key contacts with names, email addresses, and mobile numbers is fundamental. However, other technical resources include voice over internet protocol (VoIP), also called IP telephony. VoIP is a method and group of technologies for the delivery of voice communications and multimedia sessions over Internet Protocol networks, such as the internet. Further, there are a handful of free smartphone apps used widely around the world that continue to help people share vital information during the COVID-19 pandemic and natural disasters; a few of these apps even incorporate end-to-end encryption. Please note that despite the impact of COVID-19, security and privacy should not be assumed with software outside those of your employer. If you are concerned about security and the privacy of your communications, prioritize communications solutions that always protect your conversations – controlling your information even after it leaves your device.

5. Measure against the plan — and revise it as needed.

Once the pieces of the plan are in place, the next step is implementing the plan and monitoring activities against the design. The plan provides a backbone to reference as actions are executed. While useful as a guide, it is important to balance detail and abstractness. Excessive detail in a project may be problematic and misleading in a dynamic environment: creating detailed long-term plans can waste time and resources and lead to false expectations. The key is to build a manageable plan that drives execution and assess conditions driving progress or creating hinderances; wasted efforts are those hyper focused on managing the plan versus using the plan to drive progress in the operations. As conditions change, reassess the validity of the plan and, if needed, revise the plan. If not, stay the course. Given that the COVID-19 pandemic is something nobody really expected, most plans will be under constant review and revision to ensure goals remain aligned and inventory is properly in supply.

About The Author:

Christopher Ohms is a San Francisco Bay Area native and serves as director of supply chain at Rigel Pharmaceuticals. Prior to joining Rigel, Ohms held positions at Gilead Sciences, Patheon, Stanford School of Medicine, Pain Therapeutics, and ALZA. His 27-year career in the medical and pharmaceutical settings has been in quality, project management, research, development, commercial operations, manufacturing, packaging and labeling, supply chain, sales and operations planning, and global clinical/commercial contracted relationships and oversight. Ohms has co-authored eight patents and holds a B.S. in biology and an M.A. in English literature.

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