Greater data-centricity, supported by new technologies, is key to driving efficient product approvals and supply chains. Frits Stulp and Aida Demneri, partners at Deloitte (including Iperion – a Deloitte business), outline how life sciences companies can play their part in driving change.
In the past two years, EU regulatory authorities accelerated processes so that vaccines and medicines could be brought to market more quickly. The pandemic shone a spotlight on slow approval processes, revealing that the time taken to get a product approved and to market is too long and protracted in the EU. Now that the industry and patients have experienced what’s possible there is a real drive for lasting transformation.
This isn’t just about approving new products more swiftly. Supply chain vulnerability led to shortages of medicines and medical devices. Harnessing the potential of data has become critical. Enhanced data flows – internally and externally in exchanges with regulators, supply-chain partners, healthcare providers and ultimately patients – will pave the way for process transformation. This will include growing degrees of automation, for example through structured authoring of routine documents, whereby current approved data is combined to create narratives on the fly – even entire dynamic dossiers – with minimal manual intervention.
Harnessing data to its fullest potential will allow life sciences companies to transform not only their own operations, but also their role within the Future of Health. That could be through a keener focus on unmet medical needs, or by reducing the negative impact of ingredients and manufacturing processes on the environment.
It is important to keep in mind the bigger picture. There is a real danger for companies simply reacting to the latest EMA mandates, such as the specifics of how data will look under the EU’s eventual implementation of Identification of Medicinal Products (IDMP), and the perceived ‘watering down’ of data-driven process requirements via the shift to Digital Application Dataset Integration (DADI). Doing the bare minimum to meet the regulatory mandates may well compromise pharma companies’ ambitions at this crucial stage, if they focus solely on meeting immediate requirements instead of proceeding with their data preparations for internal system interoperability.
Making data rather than static documents the future of regulatory information management will transform how data can support new and existing processes. 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. For example, regulatory information management systems (RIMs) offer useful potential to track the status of marketing authorisation dossiers and manage their submission. Traditionally, Regulatory Affairs or the RIM lead would be owner of that data.
However, the issue with each function owning and looking after its own data is that there will 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. This has implications for compliance and patient safety, as well as for operational and commercial efficiency.
Vision for global standardisation
The WHO and its supporters have set out a vision for standardised data sets, which can be understood across the international ecosystem, transforming product traceability and transparency and providing assurance that the data and information is the latest approved truth about a product and its status.
The Global IDMP Working Group (GIDWG) – whose members include representatives from WHO, EMA and FDA – is 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.
Internationally agreed standards to underpin data-driven processes elsewhere in the product lifecycle are in prospect. At the DIA 2022 event, discussions pointed to shared plans by EMA, FDA and Japan’s PMDA to promote standardised data for Chemistry, Manufacturing and Controls (CMC) content. In one use case, this would pave the way for one part of regulatory dossiers to be created and managed more dynamically, and for more than one region, making variations management more straightforward.
It’s this kind of expanded vision for data use the major pharma companies are working towards today. To prepare for anything less would be unwise. Adoption of data standardisation 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’ with potential for more efficient assessments if elements of the workflow can be automated – such as checks for information consistency, and market authorisation holder (MAH) follow-up.
In future, data capabilities must transcend individual operational functions, teams and use cases. The goal is a non-proprietary, cross-organisation data layer which receives enterprise-level funding because this master data core will underpin the entire company, allowing individual functional systems to call in and work with the aspects of that data that are relevant to their respective activities.
An agile approach
Of course it makes sense to adhere to the core ISO IDMP standards being set out. But as these standards are continuously evolving, it is a good idea to start work on a master data layer right now, fine-tuning as needed, following an agile approach to adding functions or amending features as standards change. And of course one of the advantages of creating a master data layer is that each set of adaptations will only need to be made once, at the core.
With only a single definitive and standardised data layer to maintain, companies can focus their investment in data quality where it counts, while being able to provide consistent data across medicines and medical devices portfolios as national authorities strive work towards harmonising their treatment of medicines and medical devices. The real world benefits of a standardised data layer will include faster approvals, more accurate and timely medicines monitoring, all leading to the goal that matters most – enhanced patient outcomes.
About the authors:
Frits Stulp is Managing Director of Iperion, 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. With more than two decades’ industry and consultancy experience, Frits is regarded internationally as a subject matter expert on IDMP and he proactively shares his rich insights wherever he can. Iperion, now part of Deloitte, is a globally-operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardisation and ensuring the right technology, systems and processes are in place to support effective and innovative decision-making. Frits Stulp is also involved with CTADHL, the not for profit organisation Call To Action Delivering Health Literacy – www. CTADHL.org, as part of his efforts to support transatlantic data harmonisation based on IDMP.
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.