Berlin, 10. February 2023 – For software development or any business, an agile working approach has become a central way of thinking and acting – directly influencing success. How important agile working can be, is seen in the success of the development of the Covid-19 vaccines.
Vaccine development is a highly complex process, and it can take years before a new vaccine is brought to market. Every vaccine development goes through phases, the “vaccine development life cycle”, and each step needs to be completed before continuing. It is only after the third trial phase and regulatory approval that manufacturing capacity is scaled up. The traditional method, although accurate, is not efficient enough for vaccines, where time is especially crucial.
Analysing the traditional vaccine development approach shows similarities to what project managers refer to as the sequential software development design method. In a sequential process, each phase follows the other only after completion. The last phase, testing and deployment, often happens months or years after the initial analysis. This sequential approach was too slow to be feasible for the development of the COVID-19 vaccine.
How did pharmaceutical companies develop a vaccine so quickly without compromising on quality or safety?
Characterized by an iterative and incremental approach, agile working is about staying dynamic and the ability to adapt to fast-changing environments. An excellent team and established frameworks enable success. A cross-functional COVID-19 Emergency Task Force (ETF) consisting of non-clinical, clinical, and quality experts from relevant disciplines was established. Developers were able to interact with the ETF via video calls as needed. The importance of such continuous and timely communication is also highlighted in the fourth principle of the Agile Manifesto for software development: work together daily.
Due to the ongoing support from able entities, all required resources were mobilized in a much shorter period. This allowed for the parallelization of phases – something else familiar to the agile approach. The phases were broken down into smaller steps. Instead of waiting, early results were already considered in later steps, which enabled an earlier start. Similar to the research and clinical trial phases overlapping, scientific evaluation and authorization by the European Medicines Agency (EMA) also started at the same time – this approach enables a much shorter development without sacrificing quality, safety, or efficacy.
The development of the COVID-19 vaccines has shown that agile methods can speed up any development process, without compromising on quality. These are the takeaways for any business trying to go Agile:
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