Question: I need to extract possible questions from this case study and know-how to answer it please provide me questions based on this study with answers
I need to extract possible questions from this case study and know-how to answer it please provide me questions based on this study with answers the more the better thank you
This story is COMPLETELY fictional (not true). Any resemblance to actual people or events is completely accidental with the exception of Pfizer and BioNTechs partnership and Pfizers creation of a Covid-19 Vaccine.
Linda has been a project manager at Pfizer for over 15 years. She has been successfully brought a number of new medicines and vaccines to market. In 2020 she managed the biggest project of her career which was the Pfizer Covid-19 vaccine.
In 2018 Pfizer started a partnership with a company called BioNTech to create an influenza vaccine. BioNTech was bringing the technology to the partnership and Pfizer was bringing their expertise in product development, approval and production management capabilities.
In early 2020, Pfizers top priority shifted to the development of a Covid-19 vaccine so they put their top project manager, Linda, on the project. Linda experience was essential. She brought calm, focus, energy, and exceptional project management skills and leadership.
The projects objective was to get the vaccine approved after development and trials were complete. The project phases were the same as other projects but the timelines were shortened and a number of activities were done at the same time.
Phase 1: Vaccine Development
Scientists develop the vaccine in their labs and initial testing
Phase 2: Clinical Trials
3 phases of trials on humans to prove the vaccine is safe and effective.
The vaccine development was going to be completed by a joint team of Pfizer and BioNTech scientists. The Pfizer scientists were based in the United States and the BioNTech scientists were in Germany. Initially, Linda thought that the time zone difference was going to be a problem but it ended up being helpful. The BioNTech scientists did their work and near the end of their day they would meet over zoom with the Pfizer scientists, who were starting their day. Then when Pfizer scientists were finishing their day, the BioNTech scientists would be starting theirs. Between the 2 labs, there were scientists working 24 hours a day.
After the vaccine was developed, the next big hurdle was completing the trials. There were 3 phases to the trials. During each phase Linda had to update Pfizers executive, contacts at the U.S. Food and Drug Administration (FDA), the World Health Organization, and US Center for Disease Control (CDC). The key concerns were:
- How many trials were being conducted?
- What were the results?
- What was the timeline to the next phase?
Usually vaccine trials take years and Linda knew this was not an option. Instead of using only Pfizers clinical research unit to do the trials, Linda contracted 4 research trial companies, 2 in the United States, 1 in the South Africa, and 1 in Italy. Speed and safety were both top priorities for this part of the project. People were dying every day due to Covid-19, but the team also had to be certain that the vaccine was safe for people to take. As a result a number of project activities had to be done in parallel.
At the same time, Linda was working with a second project team that was planning how to make large quantities of the vaccine as soon as it was approved. The factories had to meet very strict standards, pass inspections and be approved by the government. The world would need billions of doses of the vaccine as soon as possible. The second team was coordinating with 6 new factories as well as the 3 regular factories the Pfizer used. Linda had to make sure that the second project team knew the requirements for production so that they could meet their project goals.
The world was watching and waiting.
Once the vaccine was approved by the FDA for emergency use, and production facilities were operating, Linda got to take some well-deserved time off.
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