How digital innovation is helping to drive transformation in regulatory affairs 

The role of regulatory affairs is pivotal in helping to bring new products to market swiftly, so in the pursuit of operational excellence it’s a sensible place to start when applying intelligent automation technologies. Venu Mallarapu of Cognizant Technology Solutions outlines the possibilities and the potential impact.


he pace of technological change is accelerating and, although the life sciences industry may have been slow to get going, it is now increasingly open to the potential of digital transformation across many of its activities, including routine processes. From robotic process automation (RPA) and machine learning (ML) to blockchain, there is now a multitude of options to choose from to drive operational improvements in addition to more strategic innovation.

This was something that was discussed in depth when I recently presented at AMPLEXOR’s BE THE EXPERT 2018 training and conference, and while the everyday activities of regulatory affairs may not seem the most ambitious starting point for digital transformation, the function’s fundamental importance - in getting products to market and keeping them there - makes for potentially significant ROI if associated workloads can be processed with greater speed and accuracy. This is especially the case as the function comes under growing pressure from a number of different angles.

The stars are aligning 

Globalisation and market consolidation are adding to regulatory workloads, at a time when more stringent international safety and transparency standards are already creating additional demands, and when skilled professionals are in increasingly short supply. To contain the pressure on existing teams and increase productivity when additional resources may be hard to come by, regulatory functions have little choice but to rethink the way they do things.

The likelihood is that competitors may be making use of advanced technologies already too, which could give them an advantage. At the same time, and as has been confirmed by repeated market research - by specialist market commentators such as Gens & Associates - there is an acceptance now that regulatory information management practices need to change and become something more dynamic, and data-driven.

Life sciences organisations need to identify how best to focus their ambitions so they do not exceed budgets.

Harnessing technology to deliver the scale and depth of change needed isn’t straightforward, however. With so many potential opportunities to tap into, life sciences organisations need to identify how best to focus their ambitions so they do not exceed budgets, and so that any investment delivers tangible results within an acceptable timeframe. So brainstorming (ideation) needs to progress efficiently towards incubation (feasibility studies, prioritisation and ownership decisions, and pilots and quick wins). Once there is a clearer idea of where the best successes will come, companies can look at industrialising their plans, putting together a broader strategy and benefits case, executing the new plans and measuring outcomes.

There are four identifiable levers companies can use to drive innovation:

Digitisation of content 

Moves to digitise content will have benefits in functions right across a life sciences firm. Digitised content lends itself to more complete and better-quality information, and greater availability and insight into the content, allowing teams to respond to needs and requirements faster and more efficiently. Methods such as structured content authoring (automatically populating routine documents with already-approved sections of content) are taking roots across various functions that create and update content, enabling more collaborative contributions and promoting re-use.

Managing business processes across functional teams

Most organisations are striving to break down functional or departmental information silos. If each part of the company has its own systems and ways of doing things, the chance to share information and insights, and work together towards shared goals is much more challenging. Cross-functional collaboration is becoming increasingly important in life sciences, to drive greater productivity, efficiency and insight, but to achieve this companies need to get to a place where they can instinctively work together in frictionless ways. Managing CMC product variations depends on line functions coming together, but often the requisite integration of business processes and systems is awkward and cumbersome, resulting in potentially costly errors and compliance issues.

Cross-functional integration of systems and processes

Integration of the multiple systems that exist across life sciences organisations can only have a positive impact on regulatory affairs teams. Regulatory Affairs cannot function without interchangeable collaboration between line functions including Product Supply, Safety, Clinical, etc. But this requires that the systems used by these teams are well integrated - enabling improved information exchange and a clearer end-to-end view of processes and data. Cross-functional integration of functions such as manufacturing, regulatory and safety present a clear opportunity to leverage data and content more efficiently and productively, to the company’s advantage.

Technological innovation

Technological innovations itself is a substantial lever for innovation in regulatory transformation, because of everything it now makes possible. Artificial intelligence (AI) including machine learning and intelligent automation, offer considerable scope for transforming if not reinventing processes – i.e., not just replicating what humans do, but coming up with new and better ways of executing critical tasks. Blockchain’s potential in life sciences process innovation, for instance, is only just becoming apparent. The technology, originally made popular by the Bitcoin cryptocurrency, is rich in potential for innovation in life sciences, as well as the broader business world. It promises high levels of information security, and the ability to track the provenance of any transactions, while facilitating secure and immediate collaboration between different organisations along a supply chain.

Applying advanced digital aids

In terms of specific use cases, innovation opportunities in regulatory affairs span everything from global labelling management (a potential candidate for blockchain) and creation and proof-reading of documents, to automated artwork generation. Other significant candidates for transformation through digital automation include managing health authority queries (e.g. using query ‘bots’ to answer questions using structured – pre-approved – blocks of content and database links) and auto-filling regulatory forms for the EMA or FDA.

There’s considerable scope for applying advanced technologies to broader regulatory intelligence.

Then there’s the considerable scope for applying advanced technologies to broader regulatory intelligence and information management. One strong case is for training AI/machine learning tools to identify what constitutes a successful regulatory submission, based on historic and recent experiences, so that automated systems can improve the company’s first-time-acceptance rate, and accelerate speed to market in new territories or with new products.

The exciting part is that we’re still at the early stages of understanding what’s possible, and of testing the technology in real use cases. As the results come through and companies begin to see more clearly how all of this might work in their own operations, we can expect to see momentum behind regulatory innovation soar.

About the author

Venu Mallarapu is head of regulatory affairs advisory consulting at Cognizant Technology Solutions. He is responsible for the team that works with 27 of the top 30 pharmaceutical, nine of the top ten biotech, ten of the top ten medical devices companies’ regulatory affairs groups. Venu has extensive experience in clinical, regulatory, safety, quality & compliance space in life sciences R&D.

This article is based on a presentation given at AMPLEXOR’s Be The Expert training and conference in June.

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