Aida Demneri is a Partner in Deloitte’s Risk Advisory practice based in the Netherlands. She leads the European and the Netherlands’ Life Sciences and Health (including MedTech) Risk Advisory and Regulatory practice. She has over 20 years of experience in Risk Management, Regulatory and Compliance. With her team Aida works to help clients overcome challenges in their journey towards a responsible Future of Health. Specific topics include Regulatory Excellence & Transformation, Extended Enterprise Risk Management, Cyber/Security/ Data, and IT Quality.

Aida Demneri

As became only too clear at the peak of the pandemic, the time taken to get a product approved and to market is too long and protracted in the European Union (EU). Although extraordinary measures have been taken over the last two years so that vaccines and critical medicines could be brought safely to market at greater speed, this was achieved largely by extending the working hours of assessors, a practice which is not sustainable. This has prompted a new sense of urgency for the Euroean Commission (EC) and the European Medicines Agency (EMA)around transforming approval processes, in a way that does not compromise quality or safety. Now that the industry and patients have experienced what’s possible under emergency conditions, a return to pre-pandemic processes would be hard to stomach.

The need for lasting transformation isn’t just about approving new products more swiftly. The pandemic also highlighted entire populations’ vulnerability to breaks in supply chains and shortages of critical medicines, and indeed medical devices, and the need to be able to track and manage inventories and stock movement across multiple geographies in ever more agile ways.

The answer to all of these real-world challenges lies in greater data centricity supported by the adoption of new technologies, and life sciences companies must play their own part in driving change. But this requires the right mind-set, and that conversations and plans are happening and being enacted at the right levels.

It’s all too easy to become caught up in the finer details of what EMA is or isn’t mandating at any given time. That includes the specifics of how final data will look under the EU’s eventual implementation IDMP, and the perceived “watering down” of data-driven process requirements via the shift to Digital Application Dataset Integration (DADI, as the means of inputting information to the regulator’s central database initially).

But keeping in mind the bigger picture will help pharma companies ensure that they don’t compromise their ambitions at this crucial foundational stage (by doing the bare minimum). This is a very real risk, if they focus solely on meeting the immediate requirements—instead of progressing with their data preparations and efforts towards internal system interoperability. After all, the whole point of making 

 the future of regulatory information management (and beyond) is to transform what can be done with that data, 

. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data.

Consider this perspective, for instance. Transactional IT systems such as regulatory information management systems (RIMs) offer useful potential to track the status of marketing authorization dossiers and manage their submission. But does it then automatically follow that Regulatory Affairs or the RIM lead should be the owner of that data, which is just one aspect of the product lifecycle/business process continuum?

The trouble with each function owning and looking after its own data is that there will always be disharmony and overlap between the information and the way it is recorded and formatted between respective systems and teams. As well as the doubling-up of effort, this creates the risk that the overall product ‘story’ has breaks or inconsistencies in it or is difficult to piece together. This has implications for compliance and patient safety, as well as for operational and commercial efficiency. (Ultimately, a life sciences company asset is its intellectual property, which needs to be strongly reflected in its product information.)

In the bigger picture—the vision the World Health Organization (WHO) and its supporters have set out—standardized data sets, which can be understood by 

 system across the international ecosystem, transform product traceability and transparency. They inspire confidence in all users that the information in front of them is the latest approved truth about a product and its status at any given time.

The Global IDMP Working Group (GIDWG)—whose members include representatives from WHO, EMA, and FDA are advocating increasingly loudly for patients, ensuring that they see the benefits of international activity. It is proposing a global, algorithm-based identifier for every product, as well as global pharmacovigilance traceability. WHO, as a neutral party, would coordinate such a platform, one that physicians, pharmacists and patients around the world could trust.

Development of internationally agreed standards to underpin data-driven processes elsewhere in the product lifecycle is on the cards, too. At the recent DIA 2022 event (Innovation through Collaboration), discussions pointed to shared plans by EMA, FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to promote standardized data for CMC content, something akin to a global take on Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC).

It’s this kind of expanded vision for data use the major pharma companies are working towards today. Even if regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing towards. So, to prepare for anything less would be unwise.

And actually, adoption of data standardization is already filtering down to a national authority level in some cases. In Europe some National Competent Authorities have hinted at plans to change their primary system for dossier review, for something that’s ‘data ready’. It sees the potential for more efficient assessments if elements of the workflow can be automated—such as checks for information consistency, and marketing authorization holder (MAH) follow-up. And perhaps most importantly, one version of product truth across the MAH and all involved regulators.

Maximizing the future potential is about creating a product data capability which transcends individual operational functions, teams and use cases. Ideally, it means creating a non-proprietary, cross-organization data layer which receives enterprise-level funding because this master data core will underpin the entire company. Like DNA, it will contain the details of its material make-up, the very essence of the business. With one transcendent, definitive and standardized data layer to enrich and maintain, companies can focus their investment in data quality where it counts, while individual functional systems can call in and work with the aspects of that data that are relevant to their respective activities.

To maximize the value of today’s data investments over the long term, life sciences companies should adhere to the core standards being set out with ISO IDMP. But waiting for the day that individual variations of this have been finalized makes no sense, as this is a continuously evolving environment. Future-proofing, then, should involve adhering to the agreed core, and tweaking as needed, following an agile approach to adding functions or amending features. And of course, one of the advantages of creating a master data layer is that each set of adaptations, when they 

 needed, will only need to be made once, at the source.

The ambition is to deliver patient benefits. Whatever the particulars of IDMP and other data-based initiatives around the world, this must be the strategic goal of plans for data and process transformation.

, a Deloitte company, where he leads a team of regulatory/IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Aida Demneri is a Partner in Deloitte’s Risk Advisory practice based in the Netherlands. She leads the European and the Netherlands’ Life Sciences and Health (including MedTech) Risk Advisory and Regulatory practice.

Articles

Faster approvals, more accurate and timely medicines monitoring—all enabled by harmonized, consistent and reliable data—will drive improved patient outcomes.