A major global pharmaceutical company recently realised, following the digitalisation and centralisation of its regulated product data, it now has unprecedented insight into the relative regulatory and market status of all its 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’: markets in which certain products are not currently being shipped, and therefore which opportunities are potentially being missed.
The company 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. Therefore, if a plant in Brazil is producing drugs for France, for example, the company would traditionally have faced a considerable level of paperwork and correspondence to determine and verify the latest specifications to follow to meet the local regulator’s requirements.
The potential from new data-related insights is vast. The ability to pre-empt market shortages, expiring licences, evolving local regulatory requirements, missed market opportunities, and more, is considerable, and is now igniting director-level interest in global regulatory information initiatives.
Another significant business driver involves companies’ ability to act swiftly in the event of a safety scare. In the late 1990s, when Mad Cow Disease (Creutzfeldt-Jakob Disease or CJD) was splashed across the news, health authorities needed life sciences firms to confirm ASAP which products contained bovine serum, and thus needed to be controlled, tested, or withdrawn from the market.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.
With advances in technology, 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 made swiftly. With the right approach to data organisation, there is no reason at all why responsible managers shouldn’t 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 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 this – 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.
The hope for the year ahead is that life sciences firms will continue to develop and expand their vision for how they might harness new regulatory or product data insights to add new value for their businesses, and elevate their status as a partner to R&D and the wider business. Life sciences firms must facilitate this kind of data-enabled business transformation in 2020, as an integral part of their ongoing regulatory compliance planning.
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.