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Digital transformation in life sciences: Regulations are not a barrier

How does a highly regulated industry like life sciences approach digital transformation? By developing the organization's digital ecosystem and competencies, seeing data as an integral part of the product and building up intelligent data platforms. Life sciences companies should rethink data as being part of the product – and not just a by-product of internal processes, or the result of ongoing requirements for data submission from the authorities.

Life sciences is just as exposed to digital transformation as other industries. Unless the established organizations manage to take advantage of digital transformation in their businesses, new players will enter the arena and take over significant market shares. The industry will have to transform itself to ensure its continued value creation and survival.

Regulations are a condition – not just a barrier

The life science industry is heavily regulated. There are, of course, good reasons for this, but it also means that organizations in Life Science are not able to move around as freely in the world of digital opportunities as others and so have to accept that digital transformation will to some extent take place at a slower pace than seen in other industries. However, this must never become a dogma; otherwise new players will exploit the situation.

Many believe that heavy regulation works against innovation. For this reason, updates are constantly being developed that modernize the set of rules to match an era when wearables, motion sensors and bio tattoos no longer belong to the category of science fiction.

The point is that the FDA, as with other regulatory authorities, is not put there to inhibit innovation and digital transformation – but rather to promote it within the prescribed regulatory framework.

Regulations must never act as a sedative. Even though the sector is highly regulated, with validation and documentation naturally affecting the agility and speed of organizations, there is still plenty of potential in new technological opportunities. We have already seen new players moving into the market with digital solutions to enhance patient experiences, or apps that are prescribed and considered as medicine (digital therapeutics).

Data-driven digital transformation: From Big Data to the Right data

At the moment, the industry has an obvious opportunity to take advantage of the regulatory break that will inevitably arise in the wake of EMA's relocation from London to Amsterdam. Here, companies have the chance to focus on seeing regulatory transformation as a value-creating process rather than pure compliance.

It is about finding the right balance between taking advantage of the exciting opportunities of digital transformation on the one hand, and of course retaining the license to operate and keeping on the right side of current and future regulations on the other.

Life sciences should take advantage of and develop the large amounts of data that are already collected for compliance purposes, and move data-driven digital transformation even higher up the agenda:

Data is the new fuel. Life sciences is a data-driven sector, but unfortunately data management is not always well integrated into the industry with the result that a lot of potential value is lost. By building intelligent data platforms, a pharmaceutical company can map its large amount of data, translate it into its own terminology and apply it to the rest of the organization. We are moving from Big Data to the Right data.


A new reality requires a new ecosystem
Life sciences can learn a lot from industries that are already deep into the "digital whirlwind" – such as companies in retail and finance. And inspiration is not only to be discovered in solutions. We urges life sciences organizations to complement their staff with employees and advisors from sectors such as the IT sector to help them see the business and its opportunities with a fresh pair of eyes:   

  • In many areas, life sciences needs a bit of a shake-up. This could be through recruitment of new profile types by working together with external advisors – such as NNIT – or by renewing their business ecosystem through acquisitions or collaborations with innovative start-ups.

Eight important steps
NNIT has built up a deep understanding of the industry, and recommends that companies in the Life Science sector follow these eight key Regulatory Transformation initiatives:

  • Transform and simplify your business processes – rethink them beyond your existing system constraints.

  • Deploy unified application platforms to support your simplified and converged business processes, application landscape, documents and data.

  • Deploy intelligent data management platforms to standardize and master your (product) data quality across your entire system landscape – unified or not.

  • Deploy intelligent data platforms that can find your “dark data” (structured or unstructured) and utilize artificial intelligence (AI) to catalog/describe your information in order to enable semantic search.

  • Deploy component-based structured authoring (CBSA) and natural language processing technologies (NLP) to simplify your challenges with unstructured information (i.e. human readable information only).

  • Deploy data governance technology to simplify and automate governance of your data.

  • Deploy “democratized advanced analytics” in order to put data in the hands of the end user.

  • Deploy intelligent data platforms in order to enable digital health services to patients. Either your own or as part of an ecosystem.

Are you ready for regulatory transformation?
The sooner you start working with digital transformation, the sooner you will be able to reconcile value creation and compliance. Data-driven transformation is happening now – with or without you. Would you like to know more about how your organization can get started, and what you need to consider before you start? At NNIT, we understand both IT and life sciences – and we know how your sector works. Contact us for a non-binding meeting about how your organization can develop its place in the digital era.



Article written: March 2018 



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