After a Decade of Regulatory Transformation, What’s Next?

Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape—to transform process management; improve data exchange with the enterprise at large; revisit organizational structures and roles and enable greater patient access to information.

Steve Gens

It’s now 10 years since my company Gens & Associates began tracking the ambitions of life science organizations around the world in relation to improving the management of regulatory information, through our World Class RIM survey series. Our recently published 2022 research confirms that, as we predicted, a majority of companies are now at an important inflexion point, having largely completed important modernization work within the Regulatory function globally, and begun to enjoy improvements to day-to-day process efficiency, global access to real-time information, and reduction of manual work.

Those leading the way have also begun to deepen the strategic partnership with other functions such as clinical, quality, and manufacturing—to improve regulatory pathways/expedite new product approvals in all markets; to ensure compliance for existing products; and to harness regulatory information management (RIM) as an enterprise asset. They also believe that further digitization is required to fully unlock regulatory potential and contribution.

As others catch up, and as the leading transformers look to the next level for process optimization and more, a whole new chapter is going to unfold. But what is the opportunity that lies ahead, and what specific plans are emerging?

When we compare our very latest survey with previous ones, we see a number of clear trends emerging now as companies look to the next big phase of what we might call “Regulatory+ transformation”:

RIM-related investment is becoming more strategic and ‘outward looking’

As a critical mass of biopharma companies complete the groundwork of a process and system modernization program that started in earnest in around 2013, they are shifting their focus toward organizational priorities, advanced technology, and cross-functional information sharing.

Clear need now for ‘last mile’ innovation

Although a strategic priority, most organizations have yet to fully realize global RIM adoption, with just 32% claiming this in 2022 and another 54% still working towards this goal. Even with an increase in end-to-end process work and affiliate access to most global systems, there is a gap in the ability to deliver full-scale process transformation.

For this to be possible, innovation is now needed at an affiliate level:

1. in the way that local regulatory intelligence is shared globally and integrated to the global dossier process, to reduce time to submission and health authority approval;
2. in resource allocation, via improved submission planning and forecasting to better inform local teams to upcoming lifecycle management submission (typically accounting for 80% of portfolio work); and
3. in improved control of the deviation process for label management, to ensure proper label management.

Since the majority of local affiliates are infrequent users of RIM systems and processes, innovation promises to simplify complex regulatory activities requiring global coordination.

A data quality culture must be fostered across all users

As working with real-time data becomes the default, and as more teams look to share and work from the same agreed data sets, the responsibility for the quality and integrity of the underlying data becomes everyone’s responsibility—and on an ongoing basis.

On the one hand, there will need to be a rebalancing of roles to emphasize data custodianship/governance and data science. But, equally, a data quality/data-first mentality needs to be fostered across and between teams, with senior leaders advocating for a culture of quality. This is to ensure that there are no weak links, and that pivotal data can be continuously relied upon as a source of product truth.

In all aspects of associated transformation, innovation must begin with the organization supporting pragmatic experimentation; teams must also appreciate their responsibilities beyond their immediate function.

Digitalization plans need to be well coordinated to enable next-level gains

Technology alone cannot deliver the depth and scale of change and improvement now needed. Yet, without optimal application of transactional and advanced technology, transformation potential will be limited. Intelligent tools to manage, combine, interrogate, and share data cross-functionally will become ever more critical, for instance.

The vision is extending beyond basic systems and single-use automation tools to encompass a more ambitious and complementary application of smart technology, spanning three dimensions:

1. transactional (e.g., robotic process automation, natural language generation etc.);
2. strategic (e.g., data lakes, AI etc.); and
3. foundational digitization capabilities (e.g., master data management).

Combining these three strands offers the potential for a complete set of advanced capabilities to manage and achieve more with regulatory information—as long as there is a clear and coordinated strategy and plan.

Key to delivering this broader and more ambitious plan will be the involvement of regulatory, R&D and enterprise organization layers. Up to now, the pharma industry and many technology providers have focused their attention for information/process digitalization primarily on the transaction level to achieve quick wins, potentially sacrificing the long-term view and investment portfolio. The challenge and opportunity now is to fulfil all of the above through a single, coordinated roadmap.

In our 2022 research, looking at the more advanced end of the scale, we see 39% of companies now working toward data hubs; 32% on collaborative submission platforms; 24% on AI/machine learning; 18% on knowledge management; 15% on natural language processing, and 8% on natural language generation.

Capability cohesion will prove critical in facilitating next ambitions

It is no coincidence that most companies (~75%) have settled on a single-platform strategy for their RIM transactional systems to underpin all of their diverse ambitions, rather than persisting with what could be 5-7 different best-of-breed applications. We see this in automated document quality checks and document creation giving way to intelligent search of past health authority responses.

Investments are shifting too toward intelligent label management; to automated extraction of product metadata into RIM systems (so companies can find it more easily and do more with it); and to smarter resource planning (through the analysis of pipelines, submissions planning, etc.)

The best is yet to come

For most companies there is still a way to go with all of this. While the top performers have largely realized significant speed, quality, real-time information access, reduced complexity, and process integration benefits, most organizations are still at the beginning of that process of extrapolating the fuller benefits of their evolving RIM-based digital process transformations.

When we took a closer look at where the top-performing companies are really striding ahead from an organizational and culture perspective, we identified some common qualities which others can aspire to:

• a clear and well understood regulatory strategy and vision;
• a right-first-time data quality mindset, linked to rewards systems;
• a willingness to try new processes and technologies; and
• a strong willingness and ability to work across functional boundaries.

Role-wise, leading companies are ahead with the planned appointment of strong data skills, as well as regulatory intelligence strategy and analyst roles.

No one can be sure what the future will hold, but we can expect a lot of refinement over the next five years to maximize regulatory value. Much of this will be around increased cross-functional insight and capability, as well as organizational agility, complemented by a continued focus on and investment in data quality and related roles and responsibilities. We’ll be watching all of these developments closely as they unfold.

Steve Gens is the managing partner of Gens & Associates, a global life sciences advisory and benchmarking firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance.