The trouble with working inside the usual boundaries is that companies don’t know what they don’t know. This means they go on doing what they have always done, unaware of opportunities they might be missing. In the consumer world, smartphones and clever apps are transforming people’s visibility and providing new insights (i.e., into personal spending or consumption habits), which in turn helps people change their behavior and make better choices. Now the same needs to happen in life sciences, from identifying where pharmaceutical and medical device companies are missing opportunities to market their products, to optimizing submissions planning right back to R&D/clinical trials activity.
The key to achieving this is unifying regulatory information management right across the global organization— encompassing all regional affiliates—to create a clear line of sight across all current product registrations and marketing authorization submission activity, for instance. As long as companies retain one means of managing data, documents and submissions at a corporate level, and individual approaches at a country level, enterprise-wide visibility will be compromised.
Too often, however, this remains the case. Core data sheets and safety information is set down centrally, and then it is left up to each affiliate to create and do what is needed to get a product approved in the local market; the global HQ has no sight of what has been submitted and what ensues in the interim. This hampers not only the brand’s compliance position, but also their understanding of how they are performing in distant markets and what it would take to improve success.
In the 2020s, breaking down walls, consolidating disparate applications, and behaving more cohesively as a unified global business with end-to-end operational visibility, is a commercial imperative. Whatever the short- and longer-term fallout of Covid-19, organizations will need to come back fighting—with new tools at their disposal, ready to raise their game.
Below are five strategic areas where life sciences organizations could transform decision-making and operational processes, if they were empowered by rich new insights, enabled by a unified global regulatory information management capability and the impact these could have commercially.
1. Identifying ‘White Space’
As long as corporate head office continues to hand off regulatory and safety information to subsidiaries and local affiliates to do with as they need to in their own respective market, without any link back to HQ, strategic decision-makers have no clear or direct visibility of all of their product registrations across the globe and where there may be gaps/untapped opportunities. It could be that certain variants of a product are not yet licensed in a particular territory, or that approval of a marketing authorization submission has been held up; or that a whole category of product is missing from a market— for reasons not known to head office.
Central teams can only take action based on the information available to them. Without an end-to-end line of sight across all international operations, and the ability to compare, analyze and probe back into historical trends, strategic teams will be limited in their ability to maximize revenues globally. Although it might be expected that sales teams would have this kind of visibility, this is often not the case where there are complex distribution networks in place—making it hard to understand where products actually end up and who is using them.
The extent of companies’ lack of visibility has been exposed in recent years as companies have started to capture, consolidate and clean up product data in preparation for compliance with ISO IDMP and other regulatory/market transparency initiatives. Discovering where brands or particular SKUs are or aren’t present has been a revelation for more than one major player in global life sciences.
2. Ensuring Global Regulatory and Safety Compliance
Having visibility across global operations is only as valuable as the action companies are able to take on the back of those insights. If a substance or manufacturing change necessitates edits to registered information, and/or to safety instructions included on a product’s packaging and labeling, companies need the assurance that these changes are being rolled out globally with efficiency, accuracy and speed— keeping the company within its regulatory obligations and ensuring that patients stay safe.
With a unified information and content management capability, built on data assets of consistent quality and integrity, life sciences organizations have a better chance at achieving actionable visibility and control. They are able to see, for example, that the last few times a change was required, it took a particularly long time for updates to happen in Argentina, or in South Africa.
Spotting this kind of anomaly, corporate teams can begin to drill down into why that might be, and what extra support or amended workflow might be needed to shorten those lead times in the future—reducing the risk of non-compliance across all markets. If something falls between the cracks and products are shipped without being compliant in certain markets, the cost of retrospective correction could run into millions, just to restore order—and that’s before any fines have been taken into account. So transforming their ability to act sooner and in a targeted way is an investment well worth making.
3. Accuracy of Affiliate Data
Too often, small and distant affiliates are left to their own devices when preparing local adaptations of regulated and safety information—whether for local registrations, or for the preparation of labeling and patient advice/instructions for use.
These outlying operations may be using largely manual processes and spreadsheets to document and keep track of this activity—information that may never find its way back to the mother ship. If actions and outcomes are not reported back to head office; if incomplete/inaccurate details are shared or head office cannot access reliable approval dates (to release clinical supplies or marketed products) along with details of what was approved on local labeling, companies will be compromised in their ability to produce and ships goods and labels to that market in a timely fashion. This in turn will have a detrimental effect on stock levels and revenue.
Enabling affiliates to submit accurate data directly via a unified global system as developments happen, rather than relying on after-the-event reporting to HQ, will keep everyone in the loop and enable more effective planning.
4. Smarter Planning
Once corporate HQ has a direct line to products’ registration status all across the world, teams can start to plan submissions and product maintenance/updates activity in smarter and more effective ways. For instance, with a clearer understanding of where submissions have been delayed previously, or where country inter-dependencies exist for approvals, planning teams can start to build in contingencies.
Project tracking, comparative analyses of historical registrations, and the ability to predict outcomes of approvals cycles in particular markets, can help to inform next actions. That is, they can contribute to more optimal workflow—to ensure that product X is made available in market Y with a shorter lead time than might have been the case otherwise: One that is more in keeping with top-performing geographies. This knowledge in turn can inform resource management, clinical trials activity and more.
As companies become more confident in the value of the global data, the ability to link approvals to sales performance more directly, among other business-supporting cross-analyses, begins to look very attractive, too.
5. Regulatory Intelligence
Whatever plans national and international health/regulatory authorities have to introduce global harmonization of regulatory requirements, for now there remains substantial variation from region to region and from country to country. It is important, then, that life sciences companies are able to keep track of evolving requirements in each market.
A platform designed to manage regulated content and processes and publishing, on a unified, end-to-end basis globally, should be able to incorporate these information feeds—to keep track of, and alert teams, to the latest requirements. As well as providing an at-a-glance understanding of which information requirements apply in each market, this intelligence could also cover respective expectations around specific safety studies. Desired studies might be linked to certain populations, or the potential for drug interactions if the target market has high use of a particular product—an anti-malaria treatment in African countries, for instance.
The Transformation Imperative
The ability to distill all of these new insights via business intelligence capabilities and dashboard displays, underpinned by reliable and complete data from across global operations, promises to be very powerful for life sciences firms.
Certainly, in the new decade, isolated guesswork pieced together from unreliable reports, hearsay and assumption, does not cut it. To remain competitive and risk-averse in an unforgiving global market, companies need to be able to look at the evidence and see at a glance how they can achieve maximum impact with a new blockbuster product; be right first time with submissions activity; produce accurate and compliant labels on demand for every market; and so on.
Future benefits could include the ability to take advantage of structured authoring/modular assembly of packaging and labeling content; more confident and better planned change management; accelerated and optimized supply and release cycles; more efficient use of resources; and smarter decisions about product portfolios. As is so often the case when creating a new normal, successful transformation is down to people/change management more than the technology. Once the appropriate leadership is engaged and motivated to make the leap, deploying a unified global content platform and achieving data standardization and workflow harmonization should follow relatively painlessly.
The important thing is to keep being curious about tricks they may be missing. In the wake of COVID-19, companies’ future prospects are likely to depend on it.