The Life Sciences industry has faced unprecedented challenges in the wake of the pandemic. 2023 is set to be a crucial year when companies must develop strategies to capitalise on the emerging opportunities of data-driven technologies to streamline regulatory processes and reduce time to market. Frits Stulp of Iperion – a Deloitte business – predicts that this new wave of data-based transformation will be the driving force behind the Life Science industries in the coming year.
Last year was another challenging one for the Life Sciences industry. On top of residual pandemic-related challenges and supply chain issues, the ever-adapting Regulatory environment has continued to set new standards and enforce new requirements. Those companies that have managed to keep pace with the changes can expect to start reaping some of the rewards of their efforts over the coming year. Others still have work to do, but as new waves of digital transformation promise new process efficiency burdens should start to reduce and improved patient experiences will gradually become a reality.
Here’s a roundup of some of the most notable developments of the last year, and what’s likely to be a growing focus in 2023.
Getting up to speed with CTIS
In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022, and the transition to the new registration system has begun in earnest now. From February this year all new clinical trials applications must be submitted via the new portal yet a good many companies are not yet well set up for this, leaving work still to do.
The aim with the EU developments is to harmonise and streamline processes across the diverse region, making it a less daunting location for conducting clinical trials. Persistent anomalies between countries continue to trigger enquiries however, and this year all kinds of companies will be trying to figure out how to navigate the new requirements and overcome any residual complexity. This area also screams for further integration with related overall (master) data, such as related (active) substance, organisational info, and other product related information that is shared with the regulator.
Supply chain issues continue
Supply chain issues, driven by the pandemic, continue to present problems – a situation that has been exacerbated during the winter, when demand has been at an all-time high. The onus is on the industry now, to capture and provide the right data during major events and public health emergencies. This may require formal data mapping – to identify where the relevant data sits within a company, and who can provide it. Given that efficiency and accuracy of these insights are critical when public health is at stake, it is essential that the industry is prepared. Forward-thinking life science companies will see this as an opportunity to review existing data governance, determining where the relevant data sits within their organisations, for instance, and how it might be provided to the EMA most efficiently.
Speeding regulatory processes
The increased speed of regulatory processes seen during the pandemic has set a precedent, and the only way to maintain that pace over the longer term is to modernise. ISO IDMP standards remain pivotal to the expanding and transforming role of data – so that it becomes a lever for improvement.
But this requires more proactive life science data governance, if companies are to truly harvest the power of their data, and it’s something they’ll need to navigate this year alongside other internal and external pressures – alleviating the increasingly critical but hugely labour-intensive burden of data management.
Necessity being the mother of invention, much faster regulatory processes materialised during the pandemic – from rapid access to scientific advice and rolling reviews, to accelerated assessments and other possibilities under compassionate-use programmes. Improvements were also seen in the drug development process itself.
Standardising life science data
Ultimately, the pandemic forced out-of-the-box thinking and helped identify weaknesses in existing systems. We’ve seen old norms being challenged in clinical trials, for instance, as the result of issues that peaked in the pandemic, including those linked to subject recruitment. These issues have helped inspire alternative approaches to trials and their design – including decentralised trials, faster data sharing, and increased collaboration across parties.
It’s when the level of the conversation is really raised that we begin to really see how far standardised data can take us as an industry. Having an agreed model for the data that multiple stakeholders and collaborators can work with is potentially transformational in a great many ways. The European project on substances (the EU-SRS database), which went live on January 24, illustrates what’s possible here. Using the same data model, software and also scientific standards per substance class enables increased exchange with FDA, WHO and other regulators. In the event of another pandemic in the future, we would soon see the practical benefits of that improved exchange.
A focus on the future of health
The overriding challenge for this industry now will be to hold onto some of the great lessons of the last 2-3 years and use them as a springboard to reduce the time to patients of the latest advances in Life Sciences.
As 2023 gets going in earnest, the real sign of commitment to a transformed future will be a passion not just to improve compliance and operational efficiency within and across Life Sciences stakeholders, but also to have an impact on the future of health.
As escalating cost and resourcing pressures threaten safe access to healthcare for all, the drive for new care models is strong – and data lies at the heart of many of the proposed solutions. These include increasingly sophisticated patient self-care propositions (using devices for condition monitoring and management), and selective first-line care provision by high-street pharmacies.
The higher purpose of transformation – patient outcomes – is easy to forget in the day-to-day discussion of data models and data rules. High quality, standards-based data that everyone can trust is a foundational building block for automation, efficiency and better patient care. Of course, details may need to be refined in the specific data requirements for data-driven marketing authorisation applications, or clinical trial administration, but the reality is that most of the important parts of the puzzle are in place and companies need to act now.
About the author
Frits Stulp is managing director of Iperion – a Deloitte business, and Life Sciences partner within Deloitte where he leads a team of regulatory/IDMP experts to deliver value to both pharma companies as well as regulators. With a background as Program Manager and Advisor in information management, process design and regulatory compliance, he is an expert in the implementation of both XEVMPD and ISO IDMP requirements and the digitalization of regulatory data and processes. Frits works within the broader Life Sciences/risk division of Deloitte in the Netherlands. This article combines the latest opinions and insights from across that team.
