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David Gwyn is Vice President of Life Science Solutions at AMPLEXOR in the US.
Having invested heavily in new regulatory database systems, life sciences firms owe it to themselves to capitalize on the insights locked within those rich data assets, writes David Gwyn.
Having invested heavily in new regulatory database systems for compliance purposes, life sciences firms owe it to themselves to capitalize on the insights locked within those rich data assets in 2020. David Gwyn provides some pointers.
As the new decade dawns, larger international pharma organizations are waking up to the wider potential of capturing and collating regulated product data in a consistent electronic format - as increasingly required by regulators. In 2020 this ought to be the priority of all firms, as they seek to recoup their investments and tap into all of this invaluable live, consolidated global product data.
One major international brand, which has centralized all regulated product data, now finds itself with 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.)
The ability to pre-empt market shortages, expiring licenses, 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 ASAP 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.
If a similar international event occurred today, the same risk would remain in many cases, because of a lack of joined-up information. Too often, Regulatory Affairs still handles 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.
Beyond public health scares, this 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.
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 organization, 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 multi-billion-dollar 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.
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.
In 2020, it is hoped that life sciences firms will continue to develop and expand their vision for how they might harness new regulatory/product data insights to add new value for their businesses. Another avenue could be extending current information to include wider regulatory ‘intelligence’ - for instance, tracking and analyzing where competitors are entering or exiting markets.
The key to all of this is the realization 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.
Of course, generating data for its own sake can create more problems than it solves, so being able to analyze 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.
The overarching internal benefit from all of this, finally, is that the Regulatory Affairs team has a chance here to elevate its status, proactively helping the global business to manage its assets.