The Role of Project Management Professionals in Development of COVID-19 Vaccine

COVID-19 Vaccine is what the world is waiting for now, and the global pandemic is clearly unprecedented. The uncertain situation had put the world at a halt. The sense of fear has spread like a fire. The release of the COVID- 19 vaccines will be the biggest relief in the coming years.

The development, manufacture, distribution of the vaccine is highly challenging, and many pharmaceutical companies are encountering an enormous challenge in developing the vaccine. The time is at stake. Scientists, drugmakers, and project managers worldwide are working 24/7 to develop and manufacture the successful COVID-19 vaccine.

Project management professionals are playing a vital role in facilitating the whole process. Production of covid vaccine within time constraint is a complex project. At all the stages, project management is of utmost importance from planning the whole process step by step, initiating the procedure according to plan, executing the tasks according to plan, monitoring the performance, and reporting. The COVID-19 vaccine is challenging and demands a quick product launch.

Challenges in developing COVID-19 Vaccine:

The development of COVID-19 in a short time is really challenging. The biggest challenge is time constraints. It involves many processes and phases. The challenges being faced by project managers is a high stake mission.

The role of project managers in the pharmaceutical industries is really vital because it is not business. It is a global health crisis, and lives are at stake. Leadership and resilience are the major characteristics of project managers in successfully delivering the covid 19 vaccines.

“One of the challenging things about COVID-19 is that the objective is clear but how to get there is murkier than ever,” Jenny Ottenhoff, project leader for health and education programs, said at the ONE campaign.

The project leader also said, “Making decisions when you aren’t positive that you have the right information is challenging.”

Role of the Project Manager in each phase of COVID-19 vaccine development.

COVID-19 Vaccine development: The development of the COVID-19 Vaccine is a complex process. The time management and risk management capabilities of project management professionals are of utmost importance in this process. The main role of project managers is to support and facilitate the whole process.

Image source: WHO

• Preclinical Stage: Selection of Antigens
• Screening and evaluating the effectiveness of the vaccine
• Regulatory approval and licensure
• Scaling up the manufacturing process
• Quality control and safety checks
• Packaging, storing, and shipping of the vaccine.

Preclinical Stage: Selection of Antigens:

In this stage, the pharmaceutical companies go through intensive research of antigens, which generates an immune response. It is a key ingredient of a vaccine. Along with antigens, preservatives, stabilizers, surfactants, residuals diluent, and adjuvant are also added to produce an antidote of the vaccine that triggers the immune system. The time constraint is the biggest challenge in this phase; the project managers' role is to coordinate regulatory preclinical development studies, define the strategies, ensure the effective selection, manage development issues, review and validate the studies, and develop the regulatory documents of the preclinical stage.

Screening and evaluating the effectiveness of the vaccine:

Once the specific antigens are identified that triggers an immune response, human clinical trials are carried out. Screening and evaluation involve many trials and procedures. Many project management tools and techniques are used to carry out seamless clinical trials. Role of project managers in this phase, selecting the vendors for Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS), determining and controlling the budget and time oversight, electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment, managing the time and budget accountability, creating the progress report, communicating the progress to key stakeholders.

Regulatory approval and licensure:

Once the vaccine's screening and evaluation are done for a large number of volunteers, it is sent for the approval stage. It is estimated for its quality, safety, and efficiency criteria. The project manager's role in this stage involves providing support to the drive and managing regulatory activities, providing specified input documentation, and ensuring high standard regulatory requirements, tracking delivery and approval of submissions.

Scaling up the manufacturing process:

Once the vaccine is authorized, the manufacturing process is scaled up for the authorized vaccine. In this phase, a project manager's role is to develop and maintain strategic relationships with all the stakeholders aligned with requirements, Identify and implement new technologies in manufacturing large quantities, manage vendor service relationships, etc.

Quality control and safety checks:

Quality control and safety checks are an essential part of pharmaceutical projects—national authorities and WHO constantly monitors the quality of the vaccine. The project manager's role in this phase is to lead and manage compliance activities in quality control, lead and coordinate test protocols, conduct self-audit and drive remediations through area managers, develop and manage compliance programs for control tests, establish KPIs regularly identify and support continuous improvement, etc.

Packaging, storing, and shipping of the vaccine:

Distribution of the COVID-19 vaccine is going to be a complex process. As soon as the COVID-19 vaccine is out for delivery, it needs to fulfill the world’s demand. The project management professionals need to plan every step of the delivery process within the time constraints. The role of project managers in this phase is to identify the key decision-makers to address the decisions, define and plan ultimate goal, lead the execution and implementation of vaccine, develop and maintain project plan up to date, serve as a point of contact for all the stakeholders, collaborate and establish a relationship with cross-functional teams, etc.

CONCLUSION:

Development of the COVID-19 Vaccine is speeding up worldwide, and it is definitely a race against time. Until the distribution of vaccine begins, complete data will be a well-guarded secret. According to research, the overall vaccines market is likely to top the US $ 105 billion with a 10.7% CAGR between 2020 and 2027. Demand for project management professionals is high in pharmaceutical companies. Get certified in Project management Certifications to fill the gap.

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