By: James Kelleher – CEO – Generis, Remco Munnik – Associate Director – Iperion, and Steve Gens – Managing Partner – Gens and Associates
Compared to other industries, the life sciences industry has been slow to appreciate the benefits of information management fluidity. But that’s all beginning to change. In this roundtable discussion, Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis discuss the potential and the practicalities of building future regulatory and internal operational processes on a single, seamless data/documents platform.
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What’s driving the change in the way organizations manage their data and documents?
James Kelleher, CEO, Generis: 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’s the way technology evolved that created the restrictions and silos, but today it’s perfectly possible to unify everything on a single platform.
Remco Munnik, Associate Director, Iperion: Pharma generates a lot of data, but the industry still relies heavily on documents or PDF files to correspond with the health authorities. And as long as both regulators and companies are not working in data, they can’t easily exchange information so processes can’t be optimized. As a patient, I would like to be informed about possible treatments, side effects and availability of products through structured data. It’s 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.
Steve Gens, Managing Partner, Gens and Associates: Within Regulatory Affairs and Quality, systems and processes remain largely disconnected – and departments get caught in verification loops, because they don't have trust or confidence in the data. When we did some benchmarking on this topic from a regulatory perspective five years ago we found that up to 10% of people’s time is tied up in this way.
There’s also a big focus on reducing time to market now. Historically, the priority was first market approvals in the major countries, but now it’s getting new products or indications out to secondary markets much faster (i.e. by 3-6 months). From a business case standpoint, optimized 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 button click. The same improvements can be applied to many documents. That’s 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.
Munnik: In Europe, the implementation of new Pharmacovigilance 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. With 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 (e.g. changes to the name of a company), so that companies are just reporting something once. Currently this kind of admin is easily costing organizations billions of dollars in man hours across a period of a few years.
Why is there a particular urgency today to accelerate this kind of transformation?
Munnik: The pandemic has brought to life 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?”. And they’re starting to question why this important information isn’t readily available to them to search, compare and assess in an accessible, consistent, standardized and user-friendly way.
Part of the issue is that, unlike in other industries, there hasn’t been that same competitive imperative to trim administrative processes or create new customer-centric experiences.
Will international data standards such as ISO IDMP in the EU help to address that?
Munnik: Certainly it provides the language that will make it possible to optimize 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.
Gens: Encouragingly we’re seeing regulatory information management leaders take the opportunity to greatly improve the information management layer, rather than simply treat IDMP as a tactical compliance project. Our latest World-Class RIM study found two-thirds of the industry working actively on end-to-end processes.
Once pharma companies have identified that this is the path they want to take, what's next?
Gens: It’s not a case of ‘invest in this software and you’re good to go’. Our research suggests that the highest achievers are those companies with data quality sustainability programs, 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 optimization, 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 they had standard global systems and processes in place, and as long as team members had an internet connection, they could continue to contribute effectively.
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. And, during the pandemic, it’s allowed people to be a lot more mobile/virtual, so I think cloud adoption will further accelerate coming out of COVID-19.
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 standardization of information, what will drive that kind of innovation? Are initiatives like ISO IDMP enough?
Munnik: It’s certainly a great start, but more needs to be done and even IDMP initiatives are fragmented within geographical Europe following Brexit. 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.
About the Panelists
Steve Gens is the Managing Partner of Gens and Associates, a global life sciences consulting firm. [email protected]
Remco Munnik is Associate Director at Iperion, a globally operating life sciences consultancy firm. [email protected]
James Kelleher is CEO of enterprise information management specialist Generis. [email protected]
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