Clarity Calls – Connected RIM

In the years to come, life sciences firms should shift their attention to new, improved RIM solutions. Here’s what’s next in RIM.

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 centralized 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 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.)

Speedy response times

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.

Adding a new variable: AI

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 analyzing where competitors are entering or exiting markets, and so on.

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.

About the author

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.