30-31 - ROTY - Planning for the unpredictable

The unprecedented disruption to global life sciences and public health triggered by COVID-19 has exposed some gaping holes in drug companies’ product insights and regulatory responsiveness. In this article, David Gwyn draws on some of the lessons learnt in 2020 to assess how companies might transform their regulatory operations in 2021, to improve their adaptability and become better equipped for continued uncertainty.

It’s hard to imagine global life sciences organisations not finding themselves in logistical difficulty in 2020 where they have lacked a unified, coordinated approach to regulatory information management (RIM). Traditional methods of manual data conversion, Excel-based data analysis, and attempts to monitor submission schedules – not to mention processing and achieving approval for all of the changes triggered by disruption to global markets and supply chains – will have presented considerable risk, on top of the inevitable challenges to productivity and speed to market.

This will have been true especially as teams fragmented physically, forced to take their work home. Previously, regulatory professionals could simply lean over and ask a colleague for missing information as they sought to complete documentation, build submissions or respond to health authority queries. But as the world went into lockdown, companies’ over-reliance on casual, manual processes was suddenly exposed.

Ironically, these challenges presented themselves at a time when pharmaceutical companies had to be at their most productive, efficient and agile. Now more than ever, drugs companies need the ability to adapt sources of supply, switch facilities, ramp up volumes of in-demand drugs and accelerate speed to market with new products – or expand sought-after lines of supply into additional markets.

Even those companies without a direct COVID-19 hook to their portfolios will have felt the effect of the pandemic in changes in demand for their products. Painkillers, flu remedies, antidepressants – all have experienced a significant uptick in sales and prescriptions over the last nine months or more.

Unified regulatory information management, based on pooled, authoritative master data, would have helped significantly with all of the change thrust on companies. Yet many organisations had other ideas about budget prioritisation in 2020.

Many IT projects already given the green light (and assigned budget) stalled in 2020, despite the intensified need to take a more holistic approach to regulatory information management – and access. More often than not, RIM transformation initiatives were paused while businesses focused on firefighting. And yet, if they had pressed on with projects as originally scheduled, they might have achieved a better vantage point by now – with access to industry best practice in the form of a robust cloud-based global RIM platform, rolled out and accessible entirely remotely.

Failure to maintain momentum with RIM transformation will not have helped companies – limiting access to the latest submitted content and regulatory status information, and any logical means of collaborating on document authoring and content review. With no end to the pandemic in sight, regulatory teams must continue to connect remotely, working round the clock/following the sun, and cooperating more closely than ever with distant affiliates to address supply issues and changes to product demand. If alternative sources of raw materials or manufacturing capacity become necessary, companies need a way to manage all of this from a quality/safety and marketing approval perspective.

A unified global RIM platform would help to keep everyone in the loop, without the need for continuous communication back and forth between the different parties. Meanwhile change requests and alerts to emerging issues could be issued automatically, triggering early action. Disruption to team members’ locations, meanwhile, would prove no barrier to progressing work – particularly with a cloud-based global RIM platform. Even the IT implementation – as well as the business change management and team workshops – could be managed entirely remotely.

In the continuing context of the coronavirus, tighter control of information and its creation could make all the difference each time there is a change in the manufacturing process or supply chain. This could be to the stopper in a bottle of medicine, to the sourcing of active ingredients or to the production line itself (across all kinds of industries, COVID has spread through plants where workers are in close proximity, causing facilities to be shut down). The alternative is to continue with endless email traffic and dialogue in the preparation of every new regulatory submission.

A more coordinated approach to RIM also provides another valuable opportunity for life sciences companies, and that is to gain a 360-degree perspective of regulatory activity and product/market status globally. The ability to spot untapped market opportunities, or potential red flags as licences come up for renewal or safety updates are due, is almost impossible to quantify, but it is significant.

Whether companies are bringing to market novel COVID-19 therapies or potential vaccines, or have useful ancillary products such as analgesics or antidepressants, a unified global RIM platform would help identify and highlight markets where demand is particularly strong, or where products are not currently being sold – so that the teams responsible can more effectively target resources and accelerate marketing approvals.

Practically, there is no time like the present for pharmaceutical companies to get their global operations in order and render their regulatory information more tightly interwoven. It is not too late to bring good intentions back on track. Indeed, the current conditions demand it. Whatever organisations’ immediate agenda, an effective plan for 2021 in relation to RIM transformation must take into account the following:

• Long-term remote working/team fragmentation

• The relative ease of managing regulatory processes across distance when all contributing systems are tightly welded together in a unified manner

• The scope for leveraging a unified RIM solution to accelerate the drug development process and scope for maintaining production during periods of disruption.