The breakneck pace of digital transformation spurred by COVID-19 continued to reshape the life sciences landscape in 2023. Rather than a single watershed moment, this year marked an inflection point as companies begin to move from reactionary adoption to the deliberate integration of advanced technologies across the value chain.
Over the year, the focus once again remained on advancing R&D and process efficiency, improving data quality in an effort to become more data-driven and driving greater productivity from fewer resources.
The overnight digital transformation sparked by the pandemic has cleared the path for life sciences leaders to reach the next level in 2024, where data and technology amplifies human potential rather than displaces it.
Let’s reflect on the key events that defined this transitional year and glimpse the future digital strategies that will separate the thriving from the surviving.
Dallying with Data and Digital Transformation
Throughout 2023, the life sciences industry has focused on leveraging advanced technologies like Artificial Intelligence, Machine Learning, and automation to drive innovation and accelerate research and development.
Organisations have been applying these tools and technologies to challenges like R&D, drug discovery, personalised medicine, and enhancing clinical trials. However, the industry is grappling with low quality, outdated, and incomplete data, hindering progress towards newer systems that rely on this data.
In response to a greater understanding of data’s critical role in innovation and reduced time to market for new products, a wave of data-centricity across life sciences opened up many new challenges. Particularly in the way of master data management, data governance, and data interoperability.
The challenge manifested in understanding who owns what data, how the data items link together, how to track and trace this data, and how to perform impact analysis on changes to that data.
Some companies have made strides this year in tapping into data’s potential to accelerate discoveries and outcomes; organisations are becoming more aligned with common definitions (defining single consistent Dose Strength in your organisation that are ready for IDMP, for example), and there has been an increase in adoption of cloud-based systems and platforms to consolidate, analyse, and share data. But, these organisations are battling with data lacunae, cross-business data ownership, and a standard of data quality that is, in some cases, terrifyingly inconsistent. Is there the will – or the financial backing – to address this?
Part of the challenge is that large pharma companies have a significant amount of legacy data, and the clean-up or rationalisation of that data is far more tasking, or perhaps impossible, and may not bring a large return on investment for older products. Small to medium pharma companies on the other hand look to stand a better chance at getting their data organised and aligned going forward.
Similarly, regulatory requirements and initiatives like SPOR, IDMP, FHIR, and ePI, may drive companies to make changes in their master data in ways that meet the scope of those initiatives and regulations, but this does not give them time to step back and look at the bigger picture, which could give rise to different and more efficient long-term solutions and master data design.
Pressures for decreased time-to-market
The pandemic accelerated drug development timelines and heightened expectations for faster access to new therapies, while intense competition and the high costs of drug development have motivated companies to try to recoup investments faster through quicker product launches. But, startups and smaller biotechs with leaner organisations and more agile processes are disrupting the market,setting new speed norms that large pharma is struggling to keep pace with.
However, patient safety remains paramount. While the pressures for speed have intensified, quality must be maintained. Striking this balance has been a key focus across the industry in 2023. One of the ways we’ve seen this come to fruition is through a greater focus on collaboration with industry partners.
Many companies have moved from the art of the possible in collaboration with other companies to kicking off those initiatives and actually making the investment. The increased squeeze of competition is making time-to-market an even bigger deal, and some of the ‘great firewalls’ of larger life sciences companies are beginning to modernise to allow more rapid collaboration with new partners (suppliers, manufacturers, CROs, CMOs, co-development partners, auditors).
While the level of collaboration looks to have increased, the traditional ways of doing this – through tools like SharePoint, Box, and email – are continuing to add to the pain of data and document duplication, lack of security, auditing, and versioning. In the coming years, life science organisations will need to begin the move to purpose-built, cloud-native collaboration solutions to connect partners in a unified ecosystem; breaking down silos, while increasing security and compliance. This will be essential to compressing development timelines and accelerating speed-to-market in today’s competitive climate.
The impact of budget constraints on efficiency and innovation
So – have budget constraints in key areas of the business slowed progress and innovation in 2023? Or, have they instead forced decision-makers’ hands into investing in more strategic and efficient domains?
Humanity’s collective short-term memory means we’re eternally and irrationally sceptical of the repeating patterns of both war and recession, especially following major global upheavals like the pandemic. But they’re almost as sure as the sun rising. The smart money would be investing in automation and efficient structures / processes in order to weather the continuing storm, and that’s exactly what a number of organisations have been doing in 2023.
The most forward-looking companies paired fiscal restraint with targeted investments to reshape operations for lasting efficiency. They automated repetitive tasks to boost productivity beyond headcount, while cloud initiatives and digitisation reduced IT infrastructure and security burdens.
There has certainly been progress in innovation, yet our technical team have witnessed first-hand that the post-pandemic technological boom is being focused down to only strategic projects with the greatest ROI, which might not always be the most efficient long-term. This prioritisation risks neglecting foundational enhancements that, while less glamorous, better position organisations for the future. Investments like automations, data management and governance may not directly drive revenue in the short-term, but are crucial to compete in the coming years.
As we enter 2024, life science companies will need to find the right balance between fiscal prudence and continued investment in growth. The impacts will linger even as the economy recovers.
Looking to life sciences in 2024
With the waters tested, 2024 is the time for life sciences leaders to dive fully into digital transformation, not just dip their toes.. In the coming year, efficiency and automation will take centre stage to maximise constrained resources, but balancing sensible financial management with strategic investments will remain key.
Partnership ecosystems will continue expanding, and quality, reusable data will be the component that differentiates organisations that can drive progress and innovation. The industry is sure to see rapid expansion in terms of data-driven automations. There is a general buzz in the air that structured data is the future, rather than document-driven workflows, which means there are a lot of exciting opportunities to revolutionise business processes at every step from trials to safety monitoring.
However, existing data is currently ‘trapped’ in documents at most organisations, so there is a pressing need for tools which can extract that trapped data and move it to a structured model. Once such a model is in place, there are many clear gains, from the ability to automate the generation of submissions to Health Authorities, to huge increases in pattern-tracking for areas like Pharmacovigilance and Regulatory Intelligence.
For life sciences leaders, 2024 is time to move beyond tentative implementation of new processes and technologies, confidently reshaping operations for the next normal. Companies that strategically harness data-driven, digital capabilities will propel the industry into a more innovative, resilient and patient-centric future.
About the author
Max Kelleher is Chief Operating Officer at Generis. He is passionate about providing a viable, pragmatic path for modernising enterprise information management in regulated industries. His close work with both pharma companies and specialist solution partners has afforded him deep insight into the critical modern-day challenges that traditional approaches to business processes and information use in complex industries like Life Sciences do not fulfil.