project management assignment
mohamedabbas77
covid.pdf
BBA222 Project Management Case Study 2
Task:
The following assignment is and individual task. Questions and Tasks
o In your own words, define what is a Critical Success Factor? To what strategic parameter of the project are linked the Critical Success Factors? In the Case Study of the project for a development of a SARS-CoV-2 vaccine, what are the Critical Success Factors that made it possible? How do you think these factors influenced in the following parameters: scope, time, cost, stakeholders and quality?
o As can be seen from the case study, the type of vaccine represents a key aspect in defining the project scope. What other restrictions could affect the definition of the scope that the pharmaceutical companies made? Apart from the type of vaccine that the pharmaceutical companies would develop, what other aspects should they define as included or excluded from the projects. Argue your answer.
o Based on the information provided in the Case Study and in your own research, explain how the schedule of a regular vaccine development could be reduced? Which techniques of schedule reduction where applied and why? What are the risks of applying these techniques?
o Considering Oxford-AstraZeneca as a pharmaceutical company in the “Big Pharma” subsector and assuming that all the economic resources received to finance the COVID-19 vaccine will be used in the Project, prepare the cost distribution of the budget of this project. In which category of the budget you have prepared would you include the following items: vaccine reagents, researchers' salaries, vial production, management team salaries, office and laboratory rental. Assuming a Management Margin of 5%, how much money would be allocated to cover unforeseen risks? Remember always to justify and argue your answers.
Contextual information o The case study recaps the current global pandemic situation since the detection of the first SARS-CoV2 case in December 2019 in
Wuhan (China). o The case describes the evolution of the pandemic, highlighting the most important milestones, as well as relevant information on the
scope, schedule and budget of the various projects carried out in order to develop a vaccine against COVID-19. o At the scope level, the main types of vaccines are described. At the calendar level, a comparison is shown between the process followed
for the normal development of vaccines and that carried out in the case of vaccines against COVID-19. In the same way, economic data of the sector and of the main pharmaceutical companies that are carrying out this type of projects are presented.
You must submit a formal document in pdf format.
Formalities:
Wordcount: 750-1000 Cover, Table of Contents, References and Appendix are excluded of the total wordcount. Font: Arial 12,5 pts. Text alignment: Justified. The in-text References and the Bibliography must be in Harvard’s citation style.
Submission: week 10 – Deadline for submission is Sunday 18th April at 23:59 CEST. – Via Moodle (Turnitin).
Weight: This task is a 15% of your total grade for this subject.
It assesses the following learning outcomes:
Outcome 2: Understand the role of project management as a strategic element inside organizations Outcome 4: How to select, develop, plan, schedule and measure its outcomes and risks.
PROJECT FOR A DEVELOPMENT OF A SARS-COV-2 VACCINE
By: Miguel Sánchez Araujo
BACKGROUND TO THE PANDEMIC The new coronavirus, first named 2019-nCoV (January 2020) and renamed SARS-CoV2 (the virus) and COVID-19 (the disease), it’s part of the family of coronaviruses. Its name comes from the “spikes” on the surface of the virus that resemble a crown. Most of the coronaviruses described have been isolated from birds or mammals, especially bats. SARS-CoV2 is named because it has a genetic sequence remarkably similar to that of SARS, another coronavirus that appeared for the first (and only time) in 2002. The first reported human cases were reported on December, 31st 2019 and are associated with a wild animal market in the city of Wuhan (China). On January 9th, 2020, China reported the first death and published the 2019 n-CoV genome. The main route of transmission of the new coronavirus is by air, through small droplets that are produced when an infected person coughs, sneezes or speaks. Aerosols (smaller droplets capable of remaining suspended for several hours) also appear to contribute to transmission, at least in some situations such as closed and poorly ventilated places. The virus can also be transmitted by touching the eyes, nose or mouth after touching contaminated surfaces, although this route of transmission does not seem to be very frequent.
Fig. 1. Microscopic image of the SARS-CoV2 virus. Source: Instituto de Salud Global de Barcelona
Just 13 days after the first case was detected in China, Thailand authorities reported the first case within its borders, implying that the disease had traveled more than 2,300 km from its initial focus. On January 30th, the World Health Organization (WHO) issued the Declaration of PHEIC. This means "an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response". It is formulated when a situation arises that is "serious, sudden, unusual or unexpected", which "carries implications for public health beyond the affected state's national border" and "may require immediate international action". (World Health Organization. "International Health Regulations and Emergency Committees". Retrieved 19 June 2019.) March 11, 2020 will definitely be a significant date in the history of mankind, since on that day, the World Health Organization officially declared a pandemic situation, after receiving an extensive report by the joint WHO-China mission, which included experts from Germany, Canada, the United States, Japan, Nigeria, the Republic of Korea, Russia and Singapore.
Fig. 2 shows a timeline with the evolution of the pandemic since the first case was detected in Wuhan (China).
Fig. 2. Covid-19 Pandemic Timeline
SO… DO WE NEED A VACCINE? At a certain point in the pandemic, people may wonder if what we needed was a treatment or a vaccine. This doubt was resolved relatively quickly, since in a few weeks the popular clamor for a vaccine was more than evident.
It was particularly important to know what the project wanted to achieve, what was its purpose. This obviously represents the project scope. Companies know that the scope will define the size of the project. Once the pharmaceutical companies decided that they wanted to focus on developing a vaccine and not on drugs to treat the disease, it remained to define what type of vaccine they wanted to develop. Currently, most vaccines can be cataloged or classified into one of the following 4 types:
Inactivated or attenuated virus vaccines: use a previously inactivated or attenuated virus, so that it does not cause disease, but still generates an immune response.
Protein-based vaccines: use innocuous fragments of proteins or protein structures that mimic the virus that causes COVID-19, in order to generate an immune response.
Viral vector vaccines: they use a genetically modified virus that cannot cause disease, but can produce coronavirus proteins to generate a safe immune response.
RNA and DNA vaccines: a pioneering approach that uses genetically modified RNA or DNA to generate a protein that alone triggers an immune response.
But, defining the type of vaccine to be developed would not be the only aspect to be considered in the scope. It was also important that companies define what was not included in their project. THE RACE TO DEVELOP A VACCINE In late February 2020, the World Health Organization (WHO) said it did not expect a vaccine against SARS-CoV-2, to be available in less than 18 months. Seeing the magnitude of the pandemic that the world was facing at the end of March 2020, the pharmaceutical industry and the most prestigious universities launched themselves in search of a vaccine that would protect the population. The development of traditional vaccines in regular circumstances can take 15 years or more. It begins with a protracted discovery phase involving the design and performance of exploratory experiments. This is followed by preclinical experiments and toxicology studies, as well as the development of production processes. During this process, an Investigational New Drug Application (IND) is submitted and Phase I, II, and III trials begin sequentially.
Fig. 3. The COVID-19 vaccine developed by the University of Oxford-AstraZeneca. Source: Atalayar
Upon completion of Phase III trials, and if predetermined end points have been met, a Biologics License Application (BLA) is submitted which is reviewed by regulatory agencies and ultimately authorized. After that point large-scale production begins. As of April 2020, 115 vaccine candidates were in development, two organizations initiating Phase I-II safety and efficacy studies in human subjects and five vaccine candidates were in safety studies Phase I.
Fig. 4 shows a comparison between the schedule for the development of a vaccine under normal circumstances and the schedule for the development of vaccines against COVID-19
Fig. 4. SARS-CoV-2 vaccines in development. Florian Krammer (Nature, 2020)
FUNDING THE PROJECT Finding the resources to finance the research and manufacture of a COVID-19 vaccine is undoubtedly one of the greatest challenges faced by all the teams working on these projects. At present, and according to the scientific data analysis from Airfinity for the BBC, in total, governments have provided US$ 8.6 billion (62%) of the economic resources. Non-profit organizations have awarded almost US$ 1.9 billion (14%). Particularly, the Bill and Melinda Gates Foundation
donated 680 million dollars. Only US$ 3.4 billion (24%) have been provided by the pharmaceutical companies' own investment, and many of them rely heavily on external financing (bank loans and other sources). Sometimes pharmaceutical companies use part of their profits from previous projects on new developments. Doing this, they can finance new projects without depending exclusively on the intervention of the public administration, private investors or non- profit organizations. But there is a small condition for them to act in this way, the new project must represent a low risk for the company. This seems quite logical, since no one would risk a large capital in a project that initially appears as highly risky. So why haven't pharmaceutical companies invested so much in developing the COVID- 19 vaccine? The following are probably some of those reasons:
Vaccine development, especially in the event of an acute health emergency, has not proven very profitable in the past.
The discovery process takes time and is far from secure. The poorest nations need large supplies but cannot afford to pay high prices. And vaccines generally need to be given only once or twice. The drugs that are sought in richer countries, especially those that require daily
doses, are more profitable.
Fig. 5. Who has funded the Covid-19 vaccines? Source Affinity for BBC
Fig. 6. Cost breakdown of combined industry profit and loss. Pharmaceutical Industry subsectors. McKinsey&Company. Source: Corporate Performance Analytics by McKinsey
Fig. 6 shows a comparison between the cost breakdown of some pharmaceutical industry subsectors. Considering that the pharmaceutical companies that are producing the vaccines against COVID-19 are on the subsector “Big pharma”, the information provided by McKinsey&Company estimates the profit around 27% (in 2014) As it is reflected in this comparison, no Contingency or Management Margins are considered in this study. The experts consulted agree that, although contingency plans are drawn up and quantified, they are not directly included in the particular budget of each project. The reason is that pharmaceutical projects have a large R&D component (between 6-19%), and this usually makes budgets very tight. There are many opportunities to develop projects in this sector, so pharmaceutical companies do not want to miss any opportunity, just because they do not have competitive budgets. So, if the risks detected finally occur, where does the company get the money to face the corrective measures?
Questions and Tasks
1. In your own words, define what is a Critical Success Factor? To what strategic parameter of the project are linked the Critical Success Factors? In the Case Study of the project for a development of a SARS-CoV-2 vaccine, what are the Critical Success Factors that made it possible? How do you think these factors influenced in the following parameters: scope, time, cost, stakeholders and quality?
2. As can be seen from the case study, the type of vaccine represents a key aspect in defining the project scope. What other restrictions could affect the definition of the scope that the pharmaceutical companies made? Apart from the type of vaccine that the pharmaceutical companies would develop, what other aspects should they define as included or excluded from the projects. Argue your answer.
3. Based on the information provided in the Case Study and in your own research, explain how the schedule of a regular vaccine development could be reduced? Which techniques of schedule reduction where applied and why? What are the risks of applying these techniques?
4. Considering Oxford-AstraZeneca as a pharmaceutical company in the “Big Pharma” subsector and assuming that all the economic resources received to finance the COVID-19 vaccine will be used in the Project, prepare the cost distribution of the budget of this project. In which category of the budget you have prepared would you include the following items: vaccine reagents, researchers' salaries, vial production, management team salaries, office and laboratory rental. Assuming a Management Margin of 5%, how much money would be allocated to cover unforeseen risks? Remember always to justify and argue your answers.
Rubrics
Exceptional 90-100 Good 80-89 Fair 70-79 Marginal fail 60-69 Knowledge &
Understanding (20%)
Student demonstrates excellent understanding of strategic concepts (objectives and critical success factors), schedule, scope and cost management concepts. Uses vocabulary in an entirely appropriate manner.
Student demonstrates good understanding of the task and mentions some relevant concepts regarding strategy (objectives and critical success factors), schedule, scope and cost management. Demonstrates use of the relevant vocabulary.
Student understands the task and provides minimum theory regarding strategy (objectives and critical success factors), schedule, scope and cost management. and/or some use of vocabulary.
Student understands the task and attempts to answer the question but does not mention key concepts regarding strategy (objectives and critical success factors), schedule, scope and cost management or uses minimum amount of relevant vocabulary.
Application (30%) Student applies fully relevant knowledge regarding strategy (objectives and critical success factors), schedule, scope and cost management.
Student applies mostly relevant knowledge regarding strategy (objectives and critical success factors), schedule, scope and cost management.
Student applies some relevant knowledge regarding strategy (objectives and critical success factors), schedule, scope and cost management. Misunderstanding may be evident.
Student applies little relevant knowledge regarding strategy (objectives and critical success factors), schedule, scope and cost management. Misunderstands are evident.
Critical Thinking (30%)
Student critically assesses in excellent ways, drawing outstanding conclusions from relevant authors.
Student critically assesses in good ways, drawing conclusions from relevant authors and references.
Student provides some insights but stays on the surface of the topic. References may not be relevant.
Student makes little or none critical thinking insights, does not quote appropriate authors, and does not provide valid sources.
Communication (20%)
Student communicates their ideas extremely clearly and concisely, respecting word count, grammar and spellcheck
Student communicates their ideas clearly and concisely, respecting word count, grammar and spellcheck
Student communicates their ideas with some clarity and concision. It may be slightly over or under the wordcount limit. Some misspelling errors may be evident.
Student communicates their ideas in a somewhat unclear and unconcise way. Does not reach or does exceed wordcount excessively and misspelling errors are evident.
