Life sciences needs a solid data foundation to weather the era of uncertainty

In a short span of years, the life sciences industry has experienced a veritable digital revolution. Digitalization and data enablement have gone from a scattered collection of minor experiments and proof-of-concept projects to leveraging data across most of the value chain, including clinical trials, supply chain management and regulatory issues. Data streams are now an integral part of many processes, and they are vital in a new reality where numerous rapid changes challenge the status quo.

Factors like the increasing pace of regulatory changes, supply chain disruptions, regional unrest and the threat of cybercrime have created a perpetual state of uncertainty. According to Ricco Larsen, Senior Vice President, Head of Region Europe and Head of Global Solution Development at NNIT, embracing digital transformation as a necessity is the only way to maneuver in the new reality of multiple concurrent priority shifts:

"Everything is up in the air right now, which creates uncertainty in the industry. It is not uncommon for life sciences organizations to be dealing with multiple different agendas at any given time. Strategic priorities, business processes and cooperation with external stakeholders must all be reevaluated simultaneously, with data as the driving force for decision-making," says Ricco Larsen.

Companies struggle to enable data across business units

According to NNIT’s Expectation Barometer 2023 survey, only about half of all participating life sciences organizations have a corporate data strategy, and their ability to enable data isolated within business units is significantly greater than across the organization. And that is problematic, as Ricco Larsen cautions:

"Our survey shows that lack of cross-unit collaboration is the biggest barrier to leveraging data in business processes. But the real business potential in terms of increased efficiency, shorter time to market and greater resilience is only unlocked if your data streams are consistent, harmonized and have a high level of integrity. So, a lot of organizations must find a way to tackle this issue or, at worst, risk losing their license to operate."

The pressure is on the top management, because only they have the mandate to open the silos and enable transparency in the big picture.

"In many cases, lack of a clear business case and an imbalance between who bears the financial burden and where the benefits appear act as barriers for digital investments. If the CIO refers to the CFO and focus is on driving down IT costs, it’s difficult to tap into the benefits. It’s important to challenge the view of IT as a cost center. That’s why we’re seeing more CIOs transition into a CDO role sitting at the top table."

The #1 priority: Build a data foundation

Ricco Larsen has no doubt about what should be at the top of the to-do list for life sciences executives:

"The most important priority is clearly to invest in a strong data foundation. Get your data harmonized and connected across your entire value chain. Because that will be the glue, the fuel and the foundation for everything you do, whether it be AI, new platforms or something that you have no chance of predicting. Data is going to be the golden key to everything, from early discovery to when the products hit the pharmacy shelves," says Ricco Larsen and continues:

"Don’t wait for the authorities to force the issue by introducing new requirements. Get to work right now! IDMP is a good example of how data standards have led to new opportunities for building unified platforms and digitizing the supply chain. If someone had had the foresight to introduce those standards on their own initiative, they would have been in a much better shape to realign their business during Covid."

Finding the next blockbuster

Being able to tap into your existing data is vital for enabling new business opportunities, like finding the next headline-grabbing “blockbuster” product.

There are several examples in the industry of the value of data enablement. For example, by utilizing existing clinical data, new adoptions of existing molecules can be identified - and thus the time to market can be significantly shorter than it would be for a new product, Ricco Larsen points out.

Another area where good data enablement is vital is rare diseases. Because these treatments are targeted at much smaller patient populations, identifying suitable candidates for clinical trials and producing smaller batches requires greater digital agility and insights.

"Rare diseases have traditionally not been the primary focus for large life sciences companies. But since there are effective treatments for most major diseases already, there is increasing lead-time between the big blockbuster products. And because large pharma companies have already digitalized a big portion of their processes, they have the operational efficiency necessary to make rare disease treatments profitable."

Joint effort aims to streamline regulatory data

Parallel to the need to develop new products and the disruptions caused by an unstable supply chain, inflation and regional unrest, life sciences organizations are facing increasing regulatory demands, because the health authorities want more details, faster delivery of information and greater transparency.

These increased expectations have motivated competing pharma companies to join forces to reduce the regulatory burden and streamline the availability of regulatory data. One example is the nonprofit Accumulus Synergy, which is building a data-sharing platform that supports real-time exchange of information with regulators. This initiative is backed by several major pharma companies.

"There is an increasing willingness to accept that achieving a shorter time to market and meeting the demands of the health authorities requires flexibility and compromise on historically localized formats and standards. We can also see a movement away from the mindset that everything must be tested and validated to a more risk-based approach to enable speed," says Ricco Larsen.

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