By Micalyn Harris, President and CEO of ELPRO Services, Inc., a subsidiary of ELPRO-BUCHS AG, serving the Americas.
Imagine what could have happened if 300 million medication doses were ineffective because they were distributed at the wrong temperature or to the wrong population. It would have been a complete disaster. To avoid such a catastrophe, the United States government relied on leadership and data to solve the most complex cold chain jigsaw puzzle in history.
Data form the foundation of ELPRO's DNA, providing our customers with the necessary information to make informed decisions. Whether it's strategy, packaging, equipment replacement, or product viability, data are king. However, having access to all this data is useless unless two essential things occur. Firstly, the right data must be collected and presented with integrity. Bad or incomplete data leads to incorrect decisions. Secondly, a leader must determine how to use the data and when. In other words, the right information must be combined with the right people.
The connection between leadership and data is subtle but crucial. I had the opportunity to speak with Major General Chris Sharpsten (Ret. U.S. Army) about his leadership and use of data during one of the most critical periods in our country's history. With public health at stake during the COVID-19 pandemic, unprecedented leadership was required for coordination. Most importantly, what data was used and why?
A Career in Leadership
Leadership can be developed, but certain traits are inherently natural. Sharpsten served as a Delta Force Officer (Special Forces) from 2001 to 2007. Describing himself as "driven," he mentioned that not all peers are selected for officer roles. Before the pandemic, one of Sharpsten's career milestones involved addressing sustainment practices in the Middle East. He worked in the U.S. Central Command area with responsibilities in a 20-country region of the Middle East. Political and economic issues in that region necessitated logistical risk mitigation.
Through his work, it was determined that the majority of support for that region came via ships from the East Coast of the United States and some from the Pacific. These ships traversed through the Mediterranean, the Suez Canal, the Red Sea, and around the Saudi Arabian peninsula. One particularly challenging area was the Straits of Hormuz, where the Iranian navy would swarm ships and cause problems, especially considering that 90% of sustainment was by ship. Under Sharpsten’s lead, the military mitigated risk by adding a new sustainment route beyond the decades old South to North passage through the Straits of Hormuz. He added a new West to East route, bypassing problem areas entirely and opening ports in Israel, Jordan, and the Red Sea. Goods were shipped over land into Iraq and Kuwait via Israel, Jordan, and the Kingdom of Saudi Arabia, mitigating Iranian risks and threats.
Sharpsten utilized this experience when he was called to the Operation Warp Speed team. Led by General Gustave Perna, Sharpsten was tasked with solving the "wicked hard problem" of distributing 300 million vaccines by December 2020. During the pandemic, the military was at the forefront of tactical requirements with significant participation from the Army, Air Force, and Navy. Multiple organizations worked together to achieve a common objective. Later in Operation Warp Speed, commercial and industry partners collaborated with the military to accomplish the mission.
Solving a "Wicked Hard" Problem
Sharpsten collaborated with companies to develop a vaccine distribution system and an integrated network for data sharing between counties, states, territories, the federal government, and Indian tribes. Sharpsten explained that data played a crucial role in solving the puzzle. They needed to agree on a common set of accepted data and how to use it. For instance, they needed to determine how many vaccines where available and who would receive them. These questions presented a constitutional dilemma. At the federal level, they required a data system that could share information down to the state, county, tribe, and territory levels. However, the U.S. healthcare system is driven by private industry and managed by individual states. That presented the need for federal integration.
As with any business model, data needed to flow both ways. Memorandums of agreement with each state and territory enabled joint access to a federal data lake, which served as the central data source related to acquisition contracts, doses, and more. The government needed information from customers, or in this case, the states, counties, tribes, or territories. The two-way data exchange involved uploading administration data to track where the vaccines were produced and delivered. This way, the White House could respond promptly if a particular state or community wasn't receiving the vaccines they needed. The data system enabling users to extract information from the data lake was called "Tiberius."
The use of data and sharing information through Tiberius was crucial for success. To inspire confidence, the data had to be transparent and accurate. Erroneous data would have eroded trust. Therefore, using data and sharing information was of utmost importance. To ensure accurate data, every piece of information, including FedEx and UPS data, was input into the system. One key aspect was understanding what was happening not only during distribution but also afterward. The data was so comprehensive that they could monitor the amount of vaccine on the shelf at pharmacies, with all of it tracked through Tiberius.
Another vital aspect of useful data is transparency. No entity was to receive more vaccines than allotted, and the algorithm itself had to be transparent, fair, and equitable. Each state had arguments for why they should receive more vaccines based on demographics and population, among other factors. The CDC devised an extremely complex formula with 24 variables to determine distribution. However, the average American would not comprehend the concept. The recommendation from the U.S. Department of Health and Human Services, the Department of Defense, and Operation Warp Speed was to use a simple population-based formula, which undermined arguments from everyone. In this instance, less data provided better results.
In addition to population data, temperature data played a critical role in distribution. If a medication becomes unsafe or ineffective due to exposure to certain temperatures, distribution efforts would have been meaningless, compromising population safety. Given the substantial financial investment made by the government to accelerate vaccine development and distribution, efficacy was paramount and could not be compromised. Temperature data was crucial in proving vaccine effectiveness, presenting an unprecedented cold chain challenge.
The distribution system in the U.S. was ill-prepared to handle licensed pharmaceutical products, especially those requiring storage at -80 °C. With few facilities capable of storing products at ultra-cold temperatures, they had to rapidly scale up that capability to proceed. For example, Pfizer identified distribution networks and collaborated with companies such as Thermo Fisher and Stirling Ultracold for distribution and facility solutions. These solutions encompassed the entire supply chain and involved companies like ELPRO, which could remotely monitor ultra-cold temperatures.
Another complex requirement was delivering vaccines to far-flung regions of the globe where Americans lived and worked, such as combat zones, embassies and consulates. Coupled with the stringent temperature requirements, vaccines were transported via international flights and over land routes to embassies, where they were stored at consulates. Each consulate had to have -80 °C storage, which posed significant challenges. To further complicate matters, consulates in countries such as Chad, Niger, and Cambodia, with only small populations, had to ensure proper storage resources and efficient distribution of the allotted doses. This required precise coordination to minimize waste, ensuring that the right type and quantity of vaccines were distributed. Administration sites had to receive timed deliveries of vaccines and administration kits within 24 hours of each other, with all the necessary storage resources. The collection of this data was imperative for successful distribution.
The Operation Warp Speed team communicated a mission statement unlike any other: to accelerate the manufacture, certification, distribution, and administration of 300 million doses of COVID-19 vaccine to the American people no later than December 2020. The team was laser-focused on delivering vaccine doses to the American people. How? Through data collection, the proper use of information, and evidence-driven leadership decisions. Sharpsten left me with this image: there was a news article on March 1, 2020, with a photo of one of the first casualties being wheeled out of a nursing home in Oregon. Every step of the mission was aimed at preventing such widespread occurrences, and they succeeded.