Generative AI (GenAI) is not a theoretical game-changer in life sciences; the technology is already transforming everyday regulatory and safety processes. This is thanks to its ability to digest, assess, and summarize key insights and findings from across vast and diverse bodies of existing content, and data - even as this is being continuously refreshed.
Today pilot solutions are already available to help companies pre-empt agency queries and build stronger marketing authorization applications. Although a human review layer remains vital to maintain quality and trust in the technology, GenAI is proving to be a significant process accelerator and productivity tool. Across 23 different languages, initial 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 as is possible without GenAI use.1 (That’s without the need for AI ‘training’, thanks to the way generative AI benefits from exposure to vast amounts of data.)
The technology is also demonstrating powerful potential in monitoring and proactively using the latest global regulatory intelligence, for instance as part of regulatory impact assessment ift health authority requirements change or are updated). Early pilot projects here too have yielded 50- 80% faster processing and in this case half the handovers (compared to manual regulatory intelligence lookup and action).
And this is just the beginning. The most impactful scope is yet to come; likely to be realized within the next two years. This will be the point at which regulatory teams acanlean on the technology to collate and cross-check entire regulatory submissions automatically, with a quality review from regulatory professionals requiring just a fraction of the effort expended today. (Despite the increasing trend of data-oriented submissions, the reality of content-based submissions is here to stay for the foreseeable future.)
This capability will be particularly powerful in transforming regulatory submission lifecycle management, which today consumes significant time and budget. At a conservative estimate, large pharma organizations 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 by far the minimum saving that is expected once GenAI is harnessed in earnest to automate the collation and assembly of content, extrapolating from initial use cases of the technology in a regulatory affairs context.
GenAI’s Progress Waits for No One
Among the enablers of this automation leap, to the creation of complete submissions, are GenAI’s accelerating pace of advancement, its steady maturation, and the technology’s rapid acceptance and perceived reliability.
Already, the technology is being used widely and with confidence to analyze and infer meaning from data and content in a wide range and formats and distill what is needed into whatever the desired new format for the target context. This is true in most enterprise settings today – even, as we’ve seen, within the strictly regulated life sciences industry, where GenAI is already trusted to transform not only the cost-efficiency and impact of marketing authorization and license maintenance but also the affordability, speed, and precision of real-world product safety monitoring.
The next wave of developments will build on all of this important progress, to enable end-to-end process transformation. Next use cases will include the provision of inline regulatory guidance to help users in submission compilation; generation of new draft submission content based on existing content; and cross-validation of final content against regulatory guidance and data. (Each of these may be delivered at different times with different scopes.)
These targeted GenAI applications will be able to identify and draw from the latest correct sources, collate and repurpose the relevant information, and fill the respective submission outline. This will automatically involve cross-checking with the company’s regulatory information management (RIM) system, assessing what has previously been submitted, and ensuring that the new submission is accurate and consistent.
Better Submissions, Delivered More Cost-Efficiently
Through all of this lightning-fast cross-referencing (which will ensure that the correct excipient/ingredient information has been used, for instance), GenAI will not only expedite submissions compilation; it will also improve the quality, accuracy, and success rate of submission updates, reducing the ‘return’ rate, and boosting the company’s track record and associated standing with regulatory agencies.
In other words, on top of substantial time and cost savings, as GenAI does all the heavy lifting and content cross-checking, significant additional benefits will include a significant uptick in quality as accuracy, consistency, and submission success rates go up.
In the meantime, skilled teams will be free to focus more of their attention on scientific work – activities that add more value to the organization.
Adapting Quickly to the Diverse Needs of Emerging Markets
In addition to fulfilling the demands of agencies in mature regulatory markets such as the EU and North America, advanced automation in regulatory submissions generation could transform the efficiency of dealing with less developed markets.
Emerging markets together account for a sizeable proportion of the global life sciences opportunity.2 Growth in pharma sales in emerging markets is set to accelerate over the next decade, with medicine use in Latin America and Asia expected to rise faster than other regions over the next five years.3
As more mature markets lean toward well-defined electronic submissions, it is a stark reality that the rest of the world continues to rely heavily on non-electronic files; for submission to authorities whose requirements are less standardized. The ability to streamline associated submissions with advanced end-to-end automation promises to be very powerful in this context, to help companies navigate the differing requirements,4 deduce “what good looks like”, and swiftly collate and format what’s needed.
The Importance of Doing Good Groundwork Now
Additional opportunities for GenAI in a Regulatory Affairs context include automated cross-checks to identify discrepancies and anomalies in data and its formatting, as part of companies’ efforts to get their IDMP data standardization in order, by honing and formalizing associated data governance. Further possibilities include more efficient and effective maintenance of llabelingcompliance internationally across the product lifecycle, again boosted by automated, GenAI-enabled cross-referencing.
With all of this potential on the horizon, it is important that organizations across life sciences start to get to grips with GenAI technology now. Testing out the possibilities will give companies a feel for how far GenAI can go, how quickly results can be reliably honed, and how much time and budget this could buy back for hard-pressed Regulatory teams.
Of course, merely adding a GenAI capability alone is no magic bullet. In parallel, companies will need to bolster their regulatory intelligence knowledge bases (e.g. non-public information and soft intelligence that has accumulated within companies based on their experience and direct HA relations). They will also need to continue the good work most organizations are already doing to clean up, standardize, and unify their product data.
The better the assets GenAI can draw from, the more reliable and transformational associated process automation initiatives will be; and the more diverse the available checkpoints, the more confidence there can be in the nenewly generatedutput.
References
- This is ArisGlobal’s data from early customer pilots. Separately, McKinsey estimates that deploying next-generation AI to improve HA responses and their impact can reduce Agency follow-up by 50%.
- Emerging Markets Offer Pharma Its Next Growth Opportunity - National governments and global non-governmental organizations are trying to expand access to essential medicines and treatments in developing countries: Pharmacy Times, February 2024 https://www. pharmacytimes.com/view/emerging-markets-offer-pharma-its-next-growth-opportunity
- Latin America is one of the fastest-growing pharmaceutical markets in the world. With an increasing and aging population of 660 million people, it is forecast to grow at a compound annual growth rate (CAGR) of seven to ten percent between 2023 and 2027 (Statista, July 2024: https://www.statista.com/topics/12539/pharmaceutical-industry-in-latin-america/)
- In 2024, the projected revenue for the pharmaceuticals market in Asia is expected to reach a staggering US$238.10bn. The largest market within this industry is Oncology Drugs, with a projected market volume of US$40.67bn in 2024. (Statista, June 2024: https://www. statista.com/outlook/hmo/pharmaceuticals/asia)
- Navigating Global Regulatory Requirements for Generic Drugs: A Comparative Study of MIST, BRICS, and ICH Countries, International Journal of Pharmaceutical Investigation, December 2023/updated February 2024: https://jpionline.org/article/32579
Author Details
Renato Rjavec- Senior Director, Product Management, ArisGlobal
Renato Rjavec is Senior Director of Product Management at ArisGlobal, where he is shaping the future of regulatory information management as well as quality management for life sciences, with a keen focus on AI as a means for targeted automation of critical but labor-intensive processes where accuracy and precision are paramount. Renato has almost two decades of experience in ideation, development, and implementation of regulatory and quality solutions for the life sciences industry.
Contact rrjavec@arisglobal.com ; www.arisglobal.com
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 27, No. 7Nov/Dec 2024Pages: 50-51
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from American Pharmaceutical Review delivered to your inbox!
Sign up now!