The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis discuss the drivers for digital transformation of data and documents management in life sciences, the practicalities of delivering it and the new opportunities it presents.

European Pharmaceutical Review (EPR): What is driving the change in the way organisations manage their data and documents?

James Kelleher: It makes no sense to treat them separately. Documents contain data and data is used to populate documents, so ideally these assets should be part of the same continuum. It is the way technology evolved that created the restrictions and silos, but today it is perfectly possible to unify everything on a single platform.

Remco Munnik: Today, everything is data driven. Certainly, as a patient, I would like to be informed about possible treatments, side effects and availability of products through structured data. It is far more efficient to start with the data and use that as the basis of the actions we take, than rely on static documents – moving information in and out of them for each purpose.

Pharma generates a lot of data, but the industry still relies heavily on documents or PDF files to correspond with the health authorities. So long as both Regulators and companies are not working in data, they cannot easily exchange information and therefore processes cannot be optimised.

Steve Gens: Within regulatory affairs and quality, systems and processes remain largely disconnected – although this is changing. There is still a lot of manual pushing of information, driven by local spreadsheets and file shares, resulting in struggles to obtain high data quality levels – which takes away from a function achieving high operating performance.

For example, departments get caught in verification loops – because they do not have trust or confidence in the data. This has a direct impact on productivity in the organisation, because of the volumes of information involved. When we did some benchmarking on this topic from a regulatory perspective five years ago, we found that up to 10 percent of people’s time is tied up in this way.

There is also a big focus on reducing time to market now. Historically, the priority was first market approvals in the major countries, but now it is getting new products or indications out to secondary markets much faster (ie, by three to six months). From a business case standpoint, optimised global processes are largely self-funded.

Kelleher: Once they manage all information and content together across a common architecture, teams can see how long things are taking – and make improvements. That could be linked to the speed of compiling and submitting responses to health authority queries, delivering translated materials to Brazil, or gaining approvals for an order of test tubes.

Merck, which has transformed the way it manages Safety Data Exchange Agreements, has brought the generation of submission-ready PSMF Annex PDFs down from three weeks of manual effort to three seconds and a single click. The same improvements can be applied to many documents. That is because the teams involved can automatically pull in correct data from a wide range of sources to create documents – collapsing lifecycles and reducing manual rework, as well as the scope for errors, data inconsistency, etc, in the process.

Munnik: The implementation of the new European pharmacovigilance and veterinary legislation highlights how companies can gain from more efficient, data-driven processes. Under EU legislation, a company has to have a named qualified person responsible for pharmacovigilance. If that person leaves, the company would have to submit a variation to its information for every product. If there are 20,000 registrations, that ‘simple’ administration change will take a huge amount of time at both the industry and the regulator side. Time which could be better spent assessing the latest applications for new treatments. Thanks to Article 57 and XEVMPD, this kind of change becomes a simple data update via a computer and internet gateway.

The idea now is to apply the same principle for other straightforward administrative changes (eg, changes to the name of a company), so that companies are just reporting something once. Currently this kind of admin is easily costing organisations billions of euros in man hours across a period of a few years.

How data integrity is your first step toward a Pharma 4.0 strategy…

EPR: Why is there a particular urgency to accelerate this kind of transformation today?

Once you simplify and standardise, the information will flow much more readily, enabling new experiences”

Munnik: The pandemic has brought to light some of the limitations in information flow for customers, including pharmacists, healthcare providers and patients. People are asking, “Which medicines can I take?”, “What clinical studies are available?”, “When will I get the vaccine?” and “If I have the vaccine and experience any adverse effects, where and how can I report them?”. They are also starting to question why this important information is not readily available to them to search, compare and assess in an accessible, consistent, standardised and user-friendly way.

Part of the issue is that, unlike in other industries, there has not been that same competitive imperative to trim administrative processes or create new customer-centric experiences. Moreover, frankly, regulators have shown a lack of leadership in really driving and aligning everyone behind a data-first approach.

EPR: Will the implementation of the International Organization for Standardization standards for the identification of medicinal products (ISO IDMP) in the EU help to address that?

Munnik: Certainly it provides the language that will make it possible to optimise different systems, for example the delivery and management of electronic patient information or reporting of product shortages. Without agreed master data (SPOR) in place, it will be hard to benefit from the potential.

It does not help that many software vendors choose to do the bare minimum – providing individual ‘point solutions’ designed for submitting dossiers electronically, for example, instead of looking at how they might transform end-to-end processes. Every stakeholder group across life sciences has a responsibility to drive more comprehensive transformation.

Gens: Encouragingly we are seeing regulatory information management leaders take the opportunity to greatly improve the information management layer to better retrieve, connect and consume information – rather than simply treat IDMP as a tactical compliance project. The other driving force is the scope of better end-to-end processes, specifically in the change control, variation management and labelling processes. Our latest regulatory information management (RIM) study found two-thirds of industry working actively on end-to-end processes. From a software provider standpoint, the progressive players are those that have identified the need for greater data connectivity and cross-functional platforms; they will be the winners.

EPR: Once pharma companies have identified that this is the path they want to take, what next?

Gens: It is not a case of ‘invest in this software and you are good to go’. Our research suggests that the highest achievers are those companies with data quality sustainability programmes, a data governance structure and new roles like data stewards, data scientists and even Chief Data Officers. They have thought through their information flow and process optimisation – and have truly global systems.

Interestingly, when we conducted our COVID-19 regulatory impact study in September/October last year, we found these companies had had an easier time with transitioning to remote work because that had standard global systems and processes in place. As a result, so long as team members had an internet connection, they could continue to contribute effectively.

EPR: How important is the cloud in enabling the kind of transformation needed?

Gens: The cloud plus a SaaS [software-as-a-service] delivery model gives companies earlier access to the latest capabilities. Additionally, during the pandemic, it has allowed people to be a lot more mobile/virtual, so I think cloud adoption will further accelerate coming out of COVID-19.

EPR: When it comes to the kinds of new real-world experiences that could be enabled by a better flow of data between functions and greater standardisation of information, what will drive that kind of innovation? Are initiatives like ISO IDMP enough?

Munnik: It is certainly a great start, but more needs to be done and even IDMP initiatives are fragmented. EMA, for example, is setting up an EU-wide database but following Brexit the UK is not part of it, so we are still seeing silos – even within geographical Europe.

It might take a disruptor (Google, Amazon, etc) to step in before we see serious transformation from a consumer perspective. The hope is that it will just take one innovative leader to step out and do something new and then others will follow.

Gens: Yes, if you look at how Amazon works – it delivers experiences and does not just focus on data or documents: in three clicks, you get to what you want to buy. To achieve that kind of scenario in life sciences, it is a matter of overcoming disjointed systems and being able to trust the information sources. Once you simplify and standardise, the information will flow much more readily, enabling new experiences. Fortunately we are well on the way to this kind of scenario, with some of the newer platform capabilities that are coming through.

About the panellists

Steve Gens is the managing partner of Gens and Associates, a global life sciences consulting firm.

Remco Munnik is Associate Director at Iperion, a globally operating life sciences consultancy firm.

James Kelleher is Chief Executive Officer of enterprise information management specialist Generis, whose CARA™ Life Science platform is helping to transform business processes in life sciences and other regulated industries.

This article was published in the European Pharmaceutical Review.