2.1: Introduction

Operation Warp Speed, the United Stated federal government project that managed the development and mass production of the initial COVID-19 vaccines, was occurring in real time in the fall of 2020 as the CIS 79 Managing Technology Projects course was in progress. While creating the CIS 79 course from scratch that summer, Operation Warp Speed and the projects at pharmaceutical companies to develop COVID-19 vaccines seemed like it would be a good case study.

Note

Operation Warp Speed was a public–private partnership, initiated by the federal government of the United States, to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.[1]

This case study provided students with exposure to an important project while it was happening in real time, with outcomes far from certain. This helped simulate the uncertainties faced by real project managers when they are managing their projects.

Even as new vaccines are being developed to address evolving mutated strains of the virus, the original project remains of high interest due to how a project addressing a worldwide emergency was handled from a project management perspective to aggressively accelerate schedules from normal 5-10 year pharmaceutical development timeframes to something on the order of one year.

For those of us who have worked in project management for years and in conversations with those in the pharmaceutical field, the successful development of the vaccine, manufacturing scale-up for billions of doses, successful execution of the complex logistics of distribution of vaccines that required low temperature handling, was quite remarkable.

In this chapter we will take a look at:

• the organization of Operation Warp Speed and the scope of its activities
• traditional pharmaceutical development cycles
• what mRNA vaccines are
• project management considerations, including schedule acceleration techniques and
• legal considerations, including looking at emergency powers, contracts between the US government and pharmaceutical companies, and handling legal liabilities.

Aside from the impact on human health, government measures to contain the spread of the virus had a significant impact on the economy, on livelihoods, and personal freedoms. In Silicon Valley where De Anza College is, Santa Clara County health officials were the first to impose lock downs. Workers could not go to work unless their work was classified as "essential." Grocery stores erected plexiglass barriers to protect cashiers. Footprints were place on floors of business establishments that were allowed to remain open to help enforce the six foot spacing guidelines. Watching the news and reading the news were sobering if not terrifying.

This resulted in a lot of pressure around the world for the scientific community to develop, test, and deploy a vaccine that would be effective and safe, and to do it as quickly as possible.

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