Knowledge is power, and today life sciences organisations hold more knowledge about their product portfolios and business operations than ever before, thanks to the intense regulatory drives of recent years. These have forced them to collate cohesive, detailed, up-to-date global product data on an unprecedented scale: information which is now ripe for strategic exploitation.
In the case of one well-known brand, which has centralised all of its regulated product data internationally, the company now has on-demand access to the current regulatory and market status of all of its 14,000 products across the world. As well as being able to see, at a glance, where these are being sold, and the status of current licensing, the company’s business and operational teams are able to quickly discern ‘white space’: that is, currently untapped markets.
This same company has identified a further issue that can be solved with consolidated international product/market status data. While the firm currently supplies products to some 130 countries around the world, its manufacturing facilities are limited to just 20 or so locations. So, if a plant in Brazil is producing drugs for France, for instance, traditionally the company would have faced a considerable level of paper chasing/to-and-fro correspondence to determine and verify the latest specifications to meet the local regulator’s requirements. (Previously, relevant per-country information would have had to be collated manually from a series of separate repositories in disparate locations.)
Shortening safety response times
The ability to pre-empt market shortages, expiring licences, evolving local regulatory requirements, missed market opportunities and more, is considerable and it is this scope for transformed management information and strategic business insight which has ignited director- level interest in global regulatory information initiatives.
There is another considerable driver in all of this too, however, and this involves companies’ ability to act swiftly in the event of a safety scare. When, in the late 1990s, Mad Cow Disease (Creutzfeldt- Jakob Disease or CJD) was splashed across all the news headlines, health authorities experienced a crisis of nightmarish proportions. From a human medicines perspective, they needed life sciences firms to confirm as soon as possible which products contained bovine serum, and thus needed to be controlled/tested/withdrawn from the market. Yet, because details of the constituent substances of each drug were not readily searchable online, it took companies weeks to determine which medicines were affected and report this back to the relevant agency. In the meantime, no one really knew how significant the risk to patients was.
In light of the current global COVID-19 pandemic, a lack of connected information is likely to hinder the swift delivery of vaccines and effective treatments. Too often, regulatory affairs still handle information submissions to the relevant authorities as a distinct activity – unconnected from manufacturing systems.
As a result, up-to-date status information about each individual product is not readily accessible. In a sign of what’s possible elsewhere, a consortium of UK industrial, technology and engineering businesses has raised the bar by reverse-engineering breathing support apparatus to bring effective new medical devices to market within a matter of days. In pharma, even without any clinical trials/safety testing phases, this kind of agility and speed to market is unimaginable.
Beyond public health scares, persistent fragmentation of information renders even routine activities difficult. For example, if a substance or manufacturing process changes, companies can’t typically calculate the ripple effect, or answer questions such as ‘What’s the registered position for South Africa?’ without having to pick up the phone to call the relevant local expert.
It may have taken the current swathe of global regulatory demands to prompt new ways of managing product detail, but now that it has, it is heartening to hear life sciences companies beginning to proactively explore how far they could take this in their own business, to deliver against their own strategic priorities.
Instant status access offers powerful decision support
There is still a long way to go, but it should not be a stretch to imagine a future where it is possible to gain real-time updates about products anywhere in the world, or gain an instant snapshot of how an event or manufacturing change will affect current products and markets, so that informed decisions can be taken swiftly. And, with the right approach to data organisation, there is no reason at all why it shouldn’t be possible for responsible managers to be able to glean these insights via their smartphones, while on the go. In a world where consumers can control their heating systems from their mobiles, it seems unfathomable that managers within huge conglomerates can’t gain access to regulatory product information just as readily.
Disjointed regulatory information management (RIM) has been the barrier to the kind of progress outlined above – until now. As companies start to address this, to overcome their continuously evolving compliance challenges once and for all, a whole spectrum of new possibilities is opening up to them.
From a RIM perspective, for instance, there is an opportunity to plan more optimally for workloads associated with managing changes – allowing heads of regulatory affairs to anticipate demand and schedule resources in advance of submission and renewal periods. Meanwhile, a structured approach to content management and authoring could influence better impact analyses, so if there is a change in manufacture or to a substance, it’s easy to see at a glance the ripple effects – that is, how much will need to be updated in product information and labelling terms. The ability to make such calculations on the fly would enable early cost forecasting and decision-making about whether to proceed with the change, or the potential implications for patient safety if something goes awry.
Adding AI will accelerate discovery
In the future, the ability to combine definitive master data with artificial intelligence tools will enable companies to do even more with their regulatory/product data, whether that’s drilling down to discover less obvious missed opportunities (white space) or which registrations will expire soon, or anticipating bottlenecks by identifying key indicators which influence the speed of work throughput.
Over the year ahead, life sciences firms should continue to develop and expand their vision for how they might harness new regulatory/ product data insights to add new value for their businesses. For instance, another opportunity might involve supplementing current information with broader regulatory ‘intelligence’ – tracking and analysing where competitors are entering or exiting markets, and so on.
The key to all of this is the realisation that managing ‘data’ rather than static documents or paper files is not a like-for-like replacement, but a substantial facilitator for wider transformation and business enlightenment. Combining RIM data with unified processes involving automated data exchange creates possibilities for all sorts of improvements. It could also present new opportunities for role reinvention, or at least greater information fluidity and collaboration between manufacturing, regulatory affairs and other operational teams.
Generating data for its own sake can create more problems than it solves, of course, so being able to analyse certain data fields in a given context is critical to delivering results. This in turn demands that data can be segmented and presented in an intuitive way that meets a particular team’s needs – for instance a single-screen snapshot of the current global regulatory position, as a means of informing resource planning, containing the risk of registrations expiring, or identifying untapped markets.
What may prove most interesting of all, finally, will be charting how the role and status of the regulatory affairs team itself evolves, as the data and tools at its disposal enable it to add new value for the global business.
David Gwyn is VP of Life Science Solutions at AMPLEXOR in the US
