Why agile transformation is a game changer in life science
There is a significant impact on both the finances of life science companies and the patients waiting for treatment if the time from when a drug is being patented to when it comes on the market is as short as possible. Every year, there is increased pressure to reduce the time-to-market in all parts of the value chain, while, of course, meeting compliance requirements.
In our work with the life science industry, again and again we see that agile tools provide the best answer to this problem, but also that speeding up all processes it is not without its complications.
An important lesson from the pandemic was the size of the impact when producers, authorities and research institutions worked closely together on common goals. First and foremost, the collaboration across the industry proved extremely effective, as manufacturers and authorities queued up to get products onto the market. But also internally in individual companies, cross-functional cooperation was intensified. Both across professional boundaries and divisions. This is precisely what agile transformation is all about.
If we zoom in on that learning, we must probably acknowledge that this development focus will be difficult to maintain for several reasons.
Even the most focused organisation will not become agile if management does not do away with sometimes disproportionately heavy governance requirements. These have been cultivated over many years and are often an integral part of the company's culture. Therefore, we often hear that agile methods do not fit the life science industry, because they are considered unstructured and chaotic. Thoroughness and quality assurance are of course cornerstones of any life science company, but the truth is that the way we execute our validation activities often precisely hinders the achievement of these two goals.
Work to the left in the V model
This is especially true of the long validation processes, which are often in the final phase before launch, and cause errors to be detected late and take up disproportionate amounts of resource to correct. One of the basic ideas in agile is to minimise the risk of frequent validations, not only to business value, but also to the final quality of the product.
Cooperation with QA
Of course, this requires QA to become an integral part of the project team’s work, but also an acceptance that ongoing validation efforts are executed efficiently and thoroughly enough to satisfy the validation requirements. To manage the frequent quality assurance activities, it is imperative that as far as possible the process is automated. The consequence of not investing enough in automation is that you get buried in manual quality assurance work. But on the other hand, a high degree of automation means that you can carry out your quality assurance activities repeatedly during the project and therefore catch any errors as close to the source as possible. This saves money and importantly time.
Changes to SOP not needed
It is worth noting that implementing agile working methods does not necessarily require a change in the company's "Standard Operating Procedures" (SOP). The reason for this is that SOPs often define an end scenario and since agile does not change the end scenario, just the way to get to it, it has no bearing on the SOP.
System support and obstacles
Fortunately, system support today is so good that even GxP regulated companies don't have to spend a fortune on tailored solutions. The systems can be set up quickly and made user-friendly to provide complete traceability between the different requirements levels, as well as associated results of validation activities. The biggest challenge here is the establishment of good data discipline and of course making sure that the use of the systems is understood and accepted widely in the organisation. Here, the confidence you have in the correctness of the systems is critical, especially because as the real value creation in an agile organisation becomes extremely clear, this can often be the biggest obstacle.
What it takes to succeed
It requires investment to implement agile tools – not necessarily financial investment, but time, dedication, and willpower throughout the implementation process. The results will speak for themselves in the form of a more focused and dedicated project culture that can navigate the span between regulatory requirements, ambitious timelines, and complex stakeholder landscapes to a greater extent than before.
Such change starts at the very top of the organisation and involves all parts of it, and management across the organisation needs to create the framework for change. However, that investment is quickly recouped in the form of a much more focused organisation and much happier employees.
As a top executive of a Danish company confided to us, "this is the first time I have ever really known what is actually going on in my company".