Generating Entire Regulatory Dossiers – The Logical Next Step for GenAI in Life Sciences?
Generative AI (GenAI)’s ability to digest, assess and summarise key insights and findings from across vast and diverse bodies of existing content, and data – even as this is being continuously refreshed – make the technology ideal for high-volume everyday tasks completed by regulatory affairs teams. As it is, GenAI is already making its mark with some impressive early pilot solutions.
For instance, initial GenAI applications have demonstrated the ability to pre-empt agency queries and build stronger marketing authorisation applications, by applying insights gleaned from historical health authority (HA) interactions, where these have been put into an accessible knowledge base – serving as a significant process accelerator and productivity tool. Across 23 different languages, pilot applications have seen more than a dozen fields of data extracted with 90% accuracy – with up to 80% faster processing and three times fewer handovers than if teams were trawling through agency correspondence themselves.
The technology is also demonstrating powerful potential in monitoring and proactively using the latest global regulatory intelligence, for instance as part of impact assessment/change management. Early pilot projects here too have yielded 50- 80% faster processing, and in this case half the handovers compared to manual lookup and intervention.
But the truly transformational potential is still ahead – on course to be realised within the next two years. This will be the point at which regulatory teams are able to lean on the technology to generate and cross-check entire regulatory submissions automatically, with a quality review from RA professionals requiring just a fraction of the effort expended today. This capability will be particularly powerful in transforming regulatory submission lifecycle management, which today consumes significant time and budget.
Despite the increasing trend of data-oriented submissions, the reality of content-based submissions is here to stay for the foreseeable future. At a conservative estimate, large pharma organisations typically generate around 600–800 submissions per month. Even a very modest time saving, of just 1–2 hours per submission, would make a substantial difference to associated resource allocation, and that is the minimum saving expected once GenAI is harnessed in earnest to automate the collation and assembly of content, extrapolating from initial regulatory use cases of the technology.
