Amplexor’s David Gwyn reflects on what the last year has exposed in terms of RIM-related shortcomings, and how the Regulatory Affairs agenda should evolve in 2021 as pharmaceutical companies around the world reflect on a challenging nine months and face up to the prospect of continued disruption and uncertainty across all markets for some time to come.
If life sciences organizations had been more ambitious and proactive in their plans for holistic, unified Regulatory Information Management (RIM), they might have fared better in managing regulatory activities remotely as business-as-usual faltered in 2020, challenging entrenched ways of working and sharing information.
In the ‘old normal’, regulatory team members could simply lean back and call over their shoulder or stroll down the hall to get the answers they needed to complete documentation, build submissions or address health authorities’ questions. But as the world went into lockdown and teams dispersed to work from home, companies’ overreliance on these casual, manual processes was exposed. Suddenly collaboration and fact-finding became a much taller order.
Ironically, this came at a time when pharmaceutical companies needed to be at their most productive, efficient and agile: able to adapt sources of supply; switch facilities; ramp up volumes of indemand 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, anti-depressants – all experienced a surge in sales and prescriptions as populations tried to cope with not just the physical health risks but also the mental load of such dramatic changes to daily life.
Strategic Versus Tactical Responses
Systemic, unified regulatory information management based on pooled, authoritative master data could have helped enormously with all of the change thrust upon life sciences – enabling companies to track and get ahead of emerging situations and opportunities and their responses to them. And yet, IT projects already given the green light - and assigned budget - stalled in 2020. RIM transformation was put on pause while businesses focused on fire-fighting; reacting to each new challenge as it presented itself.
In 2020, RIM replacement strategies gave way to patchworks of tactical measures: the rest could wait, so went the thinking. Instead of striking now, to obviate the pain of disjointed systems, poor information access, and the immense manual tasks of finding, combining and preparing information for reporting or analysis, Regulatory operations just gritted their teeth and carried on. And yet, if they had pressed on with projects as originally scheduled, they might have been in completely new territory by now – benefiting from industry best practice, using a largely out-of-the-box solution implemented and delivered via the cloud, entirely remotely.
It is difficult to imagine how global life sciences organizations wouldn’t have come unstuck during 2020 where they have lacked unified, coordinated RIM. Old methods of manual data conversion, of Excel-based data analysis, and of trying to keep track of submission schedules - not to mention processing and seeking approval for all of the changes triggered by disruption to global markets and supply chains - must have presented considerable risk, as well as challenges to productivity and speed to market. This would have been true especially as teams fragmented physically, forced to take their work home with them.
Counting the Cost of Inertia
While it is understandable that companies may have been too distracted to prioritize RIM unification and transformation in 2020, failure to keep projects moving will not have helped them – precluding easy wins linked to having assured access to the latest submitted content and regulatory status information, and the means of collaborating on document authoring and content review in parallel rather than sequentially.
As 2020 draws to a close, everyone is working differently – with no sign of an end to the continued disruption caused by the pandemic. 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.
In situations like these, 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. And with a web-based solution, the IT implementation – even the business change management and team workshops - could be managed entirely remotely. Just as university and school classrooms have switched from the physical to the virtual, so it has become more viable than ever now to take organizations through change journeys and training programs online. (If it is possible to conduct entire MBA courses virtually, it is certainly achievable to migrate regulatory teams to a more unified way of working across distance.)
Preparing for Continued Disruption
As 2020 gives way to 2021, much uncertainty remains which means it is more important than ever that companies take stock of where they are, what is not working well, and what needs to happen to turn that situation around. The expectation is that people will not gather in large numbers for some time to come (we’re expecting our annual user conference, scheduled for late spring/early summer, to take place virtually again, for instance, instead of in the sunny climes of Seville, Spain, as planned).
Rather, remote working can be expected to become the norm. New York City is now a ghost town: companies are asking why they should spend $50 per square-foot of office real estate when people are staying away, and are safer and more productive doing their jobs from home. As much as they might miss the social element and watercooler conversations of the office, teams are taking these interactions online – cementing the case for a coordinated way of managing all of this.
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Collaborative authoring, already mentioned, is just one of the advanced ways remote teams can boost their output. This could be at an individual document level, or at a higher-level pulling data into spreadsheets. When all of the information is readily accessible – as a ‘corporate knowledge asset’ - and team members can work on it in parallel, sharing their edits and comments as they go, this drives much faster task completion (e.g. submission planning and building). That’s compared to traditional methods of circulating PDFs or individual spreadsheets for feedback, with the author eventually – and painstakingly - absorbing all of the suggested changes.
In the continuing context of the COVID-19 pandemic, these logistical considerations 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.
Instant Insight into Untapped Opportunities
The other substantial – indeed, crucial - benefit to a more coordinated approach to RIM is the opportunity 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 licenses 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 anti-depressants, 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 swing into action, targeting resources and accelerating marketing approvals wherever possible.
With change really the only constant now, 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. The information management challenges that existed before COVID-19 haven’t gone away; if anything they have been magnified by the disruption of the pandemic. To maximize market opportunities, companies need to be able to navigate and manage change in ever more effective and efficient ways - and unified global RIM is the best way means to do this.
Readying Rapid Reactions
If the current crisis deepens further, or as next waves come, emergency authorizations and other special measures from health authorities around the world are likely to feature strongly in 2021. For affected pharma organizations, an effective response requires an accelerated view across all of the contributing information, and the ability to vet its quality, combine and prepare it for submission – within a tighter timeframe than would usually apply. Again, a unified global RIM platform would help enormously here.
So, to reiterate, there is no better time than now to effect positive, lasting change to the way global pharma manages its regulatory information. Whatever life sciences organizations’ immediate agenda, a prudent plan for 2021 as regards RIM transformation should take into account 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.
It is not too late to bring good intentions back on track. On the contrary, the current conditions demand it.
Author Biography
David Gwyn is Vice-President of Life Science Solutions at Amplexor in the US. He has more than 25 years’ experience in the life sciences industry, delivering high-impact content management and collaboration solutions for clients.
[email protected]
www.amplexor.com