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However conservative and heavily regulated the drugs business, it too must transform itself to exploit digital opportunities - if only to ward off disruption, says Elvis Paćelat.
However conservative and heavily regulated the drugs business, it too must transform itself to exploit digital opportunities - if only to ward off disruption, says Elvis PaÄelat.
The life sciences industry, like so many other markets in recent years, is on the cusp of something big. But be in no doubt: change is coming, and companies need to get used to it.
Whether it is wellness, preventative healthcare and nutraceuticals that turns the pharma business on its head, or some other emerging trend, companies’ ability to exploit new markets and innovate will be severely limited as long as they remain restricted by current ways of operating.
Other industries, from retail to financial services, have long accepted the need to challenge and reinvent their operations, informed by closer connections with customers and the mood of the market. Digital transformation paves the way for step changes in how brands operate, engage with customers, build market feedback into development cycles, drive new and repeat business, and spot and exploit new market opportunities. So why should pharma consider itself exempt?
Deftness with data
Something all life sciences organizations struggle with is data, and visibility across processes. Whatever detail they are collecting, it is too often subject to proprietary formats and held captive in particular systems in designated departments.
These systems may enable certain actions to be taken, in line with ‘the way things have always been done’, but they rarely provide a strategic benefit or greater value to the business. They don’t contribute to end-to-end visibility across product lifecycles; they don’t serve regulatory requirements around transparency and pharmacovigilance; and they don’t inspire new thinking at a higher level in the business – for example by highlighting potential new business opportunities or customer propositions, or identifying problem areas or cost inefficiencies.
There’s a great deal of reinvention of the wheel too, as different teams collate overlapping data in their own way, for their own use.
This is a situation that is unsustainable in the current climate. If they haven’t already begun the process, life sciences companies should now be actively pursuing change - looking to align all of the existing, revised and emerging regulatory demands, and identify opportunities to blend these with their own internal priorities. These might include becoming more innovative, and reasserting their role in a market that is beginning to move seismically, if not at high speed.
As life sciences is inherently a risk-averse business, governed heavily by regulation that is widening in reach as well as becoming stricter, it makes sense to take these regulatory demands as the jumping off point for wider digital transformation. It is in this area that a lot of the data companies can leverage already exists – and where a lot of work has to happen anyway, for compliance purposes. The goal for organizations should be to try to achieve more from the same initiatives – by making sure these contribute towards new strategic business and market ambitions and plans.
The goal should be to achieve a robust and comprehensive source of information – a single source of ‘truth’ - which can be relied upon and repurposed for all sorts of different uses across the business: from regulatory processes, to decision support in business development and marketing, enabled by intelligent knowledge management, search and analytics.
Starting at the source
A big part of the transformation must be to harmonize existing and potential data sources – not just databases, but also document archives - so that all of the content and knowledge locked within them becomes a searchable, digital asset. One that helps tell the whole story: that single version of the truth that can support all sorts of different requirements, both inside and outside the business. Information must remain traceable back to its source, too: this means preserving links and including comprehensive tracking information.
Take the immediate challenge of regulatory submissions management. As companies apply for marketing authorisation in an expanding number of regions and countries, the relative requirements are becoming increasingly complex and laborious to manage. This can tie up a lot of people’s time, introduce risk (of error, or of failing to adhere to the latest demands in a given market), and delay market entry. If local affiliates are involved, this can add a further layer of administration and risk.
Visibility may be hampered too, if supporting data or documents can’t be readily accessed remotely. If there is a reliable master data set, accessible digitally (by anyone authorized to view and handle the content, wherever they are), the process becomes much more efficient and reliable. This also makes it easier for companies to test and enter new markets, without having to start from scratch in building up the information needed to satisfy local requirements. As well as saving on manual administration, it lowers the risk because the source (master) data has already been verified as accurate and up to date. With one system to track regulatory registration status and documents, whatever the market, and with automated prompts to ensure that no information - or stage - in the submission process is missed, everything is much easier to manage and with a lighter touch, removing some of the barriers to new markets.
None of this means that data needs to be physically centralised in a single location: consolidation can happen virtually, using connected databases. The key is that there is no duplication, and that data is definitive and easily accessible, searchable and extractable - to support the efficient collation of documents in required formats, for use in numerous different ways, whether to satisfy regulatory processes, inform manufacturing or CROs, or drive better business decisions.
From information to insight
For too many life sciences organisations today, data is limited in its usefulness, and users often lack confidence in what they can do with it because they cannot be sure it is the latest information or that it tells the whole story. Digital transformation, beginning with regulatory content, is about turning that situation around so that information is comprehensive and complete, and can be turned into intelligence through more detailed scrutiny (analytics).
This is not a journey that can be completed overnight. Effective digital transformation requires a roadmap, which is likely to differ for each organisation depending on the status quo and what its most pressing priorities are. But it is important that companies get a move on, because there are no shortcuts and the market won’t wait. Government emphasis, regulatory demands and customer preferences are changing now, and life sciences businesses that can’t adapt and keep up will suffer.
It is not enough to respond to trends that are already being seen in the market; long-term survival and prosperity (protecting market share, branching out and growing profits) depend on being able to anticipate what else might change, and creating a capability that enables firms to be ready for anything. This is what the market leaders, and some of the smaller and more agile players, are working towards.
For the majority, however, there is a danger of inertia. Companies may be aware of the need to change, but may not know where to begin - or lack the capabilities to start the process of transformation. Before they can get underway, they need to step back and do an assessment: establish their readiness for change. This is more than a need for training: what’s required is fuller organisational change management – defining and repeating the vision so that everyone accepts and buys into it.
A big part of what’s required is a shift in mind-set, towards a greater vision and a preparedness to do things differently – to break out of silos and embrace a purpose higher than the immediate function or task. Firms also need access to technical skills from the earliest stages so they have a clear picture of what’s possible, and what needs to happen practically to break down silos and create their own single version of the truth across their operational data.
At a practical level, companies may need to think laterally about how they provision suitable IT systems. If they want to encompass affiliates and enable secure remote access to master data as well as all other data, which they should if they want to maximise the benefits, cloud hosting may be the way to go. In their pursuit of agility, organizations need to view their internal IT departments more as a broker or facilitator – a link to external capabilities and service providers, rather than the start and end point for what’s possible. As long as the company retains control of the strategy, it can be more efficient and effective to use external experts and resources to deliver the mechanics of the change and the new way of managing data.
New year, new purpose
With a new year just around the corner, now is a good time for the pharma industry to take a good hard look at itself. However modest or ambitious companies’ plans, for example when it comes to new business models or dynamic industry partnerships, progress will depend on improved operational efficiency, visibility and timely intelligence which all comes back to better data discipline.
Ultimately, companies need to start doing things differently if they want to achieve different results.