It would be a great shame if life sciences organisations had put extensive effort into building comprehensive drug profiles, in line with mandatory requirements, purely for the sake of regulators. To what extent are firms themselves extracting, interpreting, reporting and acting on the newly available insights contained in all of this data they are now collecting and organising – and at not insignificant expense? And if this is something that companies have not yet delved into, what might good look like?
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Some of the top-tier pharma organisations have now begun to recognise the wider potential of capturing and collating regulated product data in a consistent electronic format. And little by little they are coming to understand that, somewhere within these increasingly comprehensive product records, lie insights of great commercial and operational value to the global business.
Dynamic data as a powerful tool for change
This breakthrough realisation could be transformational for those companies, and lend a new return-on-investment angle to the huge rounds of compliance-related IT system and data transformation spending they continue to endure.
The great thing about data over static documents or, worse, paper files, is that it can be called up, combined and repurposed in numerous ways – potentially by different teams in different locations to support a broad and diverse range of use cases.
Quite recently, it dawned on one of the world’s largest pharmaceutical companies that, having centralised all of its regulated product data, it now has unprecedented insight into the relative regulatory and market status of all of its products across the world. In total, that’s around 14,000 products globally. As well as being able to see, at a glance, where products are being sold, and the status of current licensing, the company’s business and operational teams can also identify ‘white space’: in other words, markets in which certain products are not currently being shipped, and therefore opportunities which are potentially being missed.
Accelerating information discovery
The ability to pre-empt market shortages, expiring licences, evolving local regulatory requirements, missed market opportunities, and more, is considerable. It is this scope of 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 unified 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.
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 uncover 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 “20-20” 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 analysing where competitors are entering or exiting markets.
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.
With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.