The pandemic’s legacy for Life Sciences and priorities has been saved
The pandemic’s legacy for Life Sciences and priorities
Our most notable developments and our biggest hopes for 2023
Here's a roundup of some of the most notable developments of the last year – on EU Clinical Trial Registrations, Shortages and the power of data, and our biggest hopes for 2023. The Life Sciences industry has been through a lot over the last year. 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.
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- EU clinical trial registrations
- Shortage mapping and management
- Harvesting the power of data
- Maintaining the pace of innovation, post pandemic
- Applying what we have learnt
Those companies that have managed to keep pace with the changes can look to start reaping some of the rewards of their efforts in 2023. 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.
EU clinical trial registrations
In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) have presented one of the main practical changes of 2022, and the transition to the new registration system has begun in earnest now. As of February 2023, all new clinical trials applications must be submitted via the new portal, yet a good number of companies are not yet fully prepared for this, leaving work still to do.
The aim of the EU developments is to harmonise and streamline processes in the region, making it more attractive to conduct clinical trials in Europe. Persistent anomalies between countries continue to trigger enquiries however, and in 2023 we’ll be helping sponsors to navigate the new requirements and overcome any residual complexity.
Shortage mapping and management
Supply chain issues, driven by the pandemic, continue to present problems - a situation exacerbated during the winter, when demand is at an all-time high. Even though the worst of the recent crisis appears to be behind us, EMA now has an extended mandate to monitor and manage any future shortages of medicinal products and medical devices.
The onus is on the industry now, to capture and provide the right data during major events and public health emergencies. It may require formal data mapping – to identify where the relevant data sits within a company, and who can provide this data. 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 companies will see this as an opportunity to review existing data governance, determining where the relevant data sits within their organisations, within different systems and departments, and how this data can be provided to the EMA most efficiently. To align product data (SPOR) with supply chain information (EMVS), might be a great opportunity to improve the data for both internal and external stakeholders.
Harvesting the power of data
The increased speed of regulatory assessment processes as seen during the pandemic has set a precedent, and the only way to maintain that pace over the longer term is to modernise. The use and exchange structured product data (such as ISO IDMP standards) remain pivotal to keep up with the pace required to develop, assess and approve medicinal products.
However, if companies and regulators are truly intending to harvest the power of their data, it is required to apply more proactive data governance and it’s something we’ll be helping them to navigate in 2023. The combination of our IDMP experts and our Operate team positions us well to alleviate the pain companies are experiencing with the increasingly critical but hugely labour-intensive burden of data management.
Maintaining the pace of innovation, post pandemic
Necessity being the mother of invention, we saw much faster regulatory processes materialise 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.
Ultimately, the pandemic forced out-of-the-box thinking and helped identify both 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 we raise the level of the conversation 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 is ripe for delivery now, 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 case of another pandemic, we would soon see the practical benefits of that improved exchange.
Applying what we have learnt
The overriding challenge for the pharmaceutical industry now is holding onto some of the great lessons of the last 2 years and using these as a springboard to reduce the time to patients of the latest advances in Life Sciences.
Something else that has had an exponential impact following the pandemic is the shift in focus toward wellbeing, mental health, and work-life balance. This has both increased the remit of Life Sciences, and caused the industry to look laterally at how it can respond to gaps in its own skillset – for instance, following significant shifts in individuals’ work-based priorities.
Take Regulatory Affairs where specialised knowledge is essential for meeting submission deadlines and planning for worldwide submissions, as well as in maintaining compliance and keeping products on the market. In the short term this is presenting a real issue for clients, but we’re several steps ahead of the issue and are already proactively providing support to organisations that find they have growing skills gaps.
As we look ahead to 2023, one thing is certain here at Iperion and Deloitte, and that’s the shared passion to have an impact on the future of health, as well as the energy and enthusiasm of us all as we stand shoulder to shoulder with our clients throughout this era of palpable change.
In specific terms, we hope that clinical trial innovation will continue a-pace; and that we’ll see defined next steps for IDMP implementation in the EU and US (beyond the immediate DADI-based variation submissions process); as well as further clarifications on ePI and serialisation. Ultimately, though, everything we’re all doing is for the patients, which can be easy to forget in the day-to-day discussion of data models and data rules.
A practical guide to IDMP preparations
Essential next steps to maximise the benefits of a data-driven future
EU Clinical Trials Regulation and the Clinical Trials Information System
Preparing for the implementation of CTR and CTIS go-live