Harsh Parikh - Case Study #1
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Feb 20, 2024
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Case Study #1
Harsh Parikh
Regulatory Affairs, Conestoga College
MGMT8920: Project Management of Regulatory Submissions
Nadiya Samaroo
24/01/2024
2
Case Study #1
Question One: Briefly describe the COVID-19 global pandemic.
As of March 11, 2020, the World Health Organization (WHO) declared the new
coronavirus illness 2019 (COVID-19) to be the pandemic of the twenty-first century. A
new strain of the Coronaviridae family, Severe Acute Respiratory Distress Syndrome
Coronavirus-2 (SARS-CoV-2), which was first recognized in Wuhan, China, following a
series of outbreaks, was the cause.
(Annals of Clinical Microbiology and Antimicrobials,
2021)
.
The impact of COVID-19 has affected thousands of people who are either sick or are
killed due to the spread of this disease. The symptoms include fever, cold, cough, bone
pain, and problems related to breathing, ultimately leading to pneumonia. Healthcare
professionals face many difficulties in maintaining the quality of healthcare these days
.
It affected our daily routine, businesses, world trade, and the Economy of individual
countries. It was a highly contagious disease so its early detection is the only key to
stopping its spreading. Most countries announce lockdowns and enforce strict quarantines
to control the spread of this highly contaminated disease
(Current Medicine Research and
Practice, 2020)
.
The primary solution to this pandemic was to maintain social distancing and restriction in
gathering people, Vaccinating, using face masks, communicating with the public,
quarantining and isolation, and treating moderate or severe cases.
3
Question Two: Explain the risks and complexity of the challenges faced by AstraZeneca to
address the vaccine problem related to the COVID-19 pandemic.
The following are the risks and complexity of the challenges faced by AstraZeneca to address the
vaccine problem related to the COVID-19 pandemic
Clinical Trials
Manufacturing Capacity
Regulatory Requirements
Project Management Clinical Trials
: Carrying out such a large-scale clinical trial within a limited period was quite
challenging for both Governments and developed during a pandemic. Furthermore, in April 2020
AstraZeneca collaborated with Oxford to make a meaningful difference and save life.
Investments are carried out after years of work and risk mitigation rather than within weeks of
observing the initial clinical results in Phase 2. The primary customers of AstraZeneca were the
Government and they have their regulatory requirements and compliance framework that adds
more challenges to the clinical trials
(Project Management Institute, 2021)
.
Manufacturing Capacity: AstraZeneca faced significant risks and complexities related to
manufacturing capacity during the COVID-19 pandemic which includes ensuring equitable
vaccine access globally, manufacturing sufficient quantities, and maintaining supply chain
capacity. More challenges such as a shortage of raw materials, transportation delays, and
logistical bottlenecks could impact the timely production and distribution of the vaccine.
Moreover, vaccines require special storage conditions such as cold temperatures, however, not
all countries have the right machines to provide the required conditions or they have machines
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that are old, broken, or not properly working so, which leads to conflicts or natural disasters,
where supply chains are messed up.
(London School of Economics & Political Science, United
Kingdom, 2021)
Project Management: “
It identified three gaps
1.
Internal project managers experienced in Vaccine development 2.
Project management processes fit for moving at the speed the vaccine project requires
3.
An internal government contracting organization that could support the project”
(Project
Management Institute, 2021)
.
Question Three: Discuss the project management infrastructure developed by AstraZeneca
to overcome the challenges identified in Question 2 and the results obtained.
PMO Establishment: Before, the COVID-19 pandemic they did not have a PMO
because they worked on different types of projects which does not require office however,
the vaccine project was a different project. They prioritized the main roles of the PMO,
which included integration of schedule and budget, contract management, team process
guidance, and risk management.
Experienced project managers:
Hiring people externally would have been a time-
consuming process
so they searched internally existing team of 80 project managers
furthermore, seeking people with relevant experience from outside in this same field.
They formed the vaccine team with people who had worked on Government contracts or
vaccine projects in the past.
5
Internal Government contracting organization: “
It was essential to have a separate
office that could enable the focus on contract deliverables rather than running the project
and managing the team because it takes a different mindset”
(Project Management
Institute, 2021)
. Question Four: Based on your Project Management (PM) knowledge from the course and
the case study, what additional PM a manufacturing organization could employ
methodologies or functions to adapt or prepare for an emergency like the COVID-19
pandemic?
Regulatory Frameworks
: It determines the appropriate pathway for the submission of
the product whether it is a New Drug Submission, Abbreviated New Drug Submissions,
and Supplementary New Drug Submission. It also reviews the requirements and
expectations of Regulatory authorities such as Health Canada, FDA, or EMA.
Documentation and Data
: Identify and collect all necessary details and documentation
relevant to the submission, including pharmacovigilance, preclinical, clinical trial, and
manufacturing information. Furthermore, ensure data authenticity and complexity with
Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Timeline
: It's necessary to submit the regulatory work to the appropriate regulatory
authorities on time and also monitor and track the application’s process and address any
queries and questions raised by regulatory authorities.
Communication and coordination
: It is really important in project management because
it helps in preparing and participating in any meetings, teleconferences, or written
6
communication with regulatory authorities. It helps address any queries or questions the
regulatory agency raises promptly and effectively
(Nadiya, S., 2024, Jan 16)
.
Reference
Annals of Clinical Microbiology and Antimicrobials. (2021). COVID-19: breaking down
a global health Crisis. Annals of Clinical Microbiology and Antimicrobials
. Retrieved
from file:///C:/Users/arunm/OneDrive/Desktop/covod%2019%20article.pdf
Current Medicine Research and Practice. (2020). Effects of COVID-19 Pandemic on
daily life. Current Medicine Research and Practice
.
London School of Economics & Political Science, United Kingdom. (2021). COVID-19
vaccine challenges: What have we learned so far and what remains to be done? Elsevier
,
6-10.
Project Management Institute. (2021). AstraZeneca Fighting a Global Pandemic. Project
Management Institute
.
Nadiya, S. (2024 Jan 16). Week 2 (PowerPoint slides).
eConestoga.
Balkan, İ. İ., Dinç, H. Ö., Can, G., Karaali, R., Özbey, D., Çağlar, B., Beytur, A. N.,
Keskin, E., Budak, B., Aydoğan, O., Mete, B., Ergin, S., Kocazeybek, B., & Saltoğlu, N.
(2023). Waning immunity to inactive SARS-CoV-2 vaccine in healthcare workers:
Booster
required.
Irish
Journal
of
Medical
Science
(1971
-).
https://doi.org/10.1007/s11845-022-02984-1
The worst nightmare of COVID-19. The current situation of the world is… | by
ReferIndia | Medium. https://referindia.medium.com/the-worst-nightmare-covid-19-
213f219b28c7?source=user_profile
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LSE
Research
Studentship
—
King's
College
London.
https://kclpure.kcl.ac.uk/portal/en/activities/lse-research-studentship