Pre-Emptively Satisfying Agency Queries and Other Concrete Use Cases for Regulatory AI
Today, everyone has something to say about the potential for artificial intelligence – including Generative AI - in transforming Life Sciences companies’ use of regulatory data. But where could technology play a role and deliver tangible everyday benefits? One emerging example is in searching and distilling insights from across companies’ global regulatory exchanges. Another is in monitoring and more proactively harnessing the latest global Regulatory intelligence, e.g. as part of the regulatory impact assessment. Here, ArisGlobal’s Agnes Cwienczek & Renato Rjavec explore these promising use cases for RIM-based AI and their potential impact on Life Sciences companies today.
As life sciences companies’ investments in regulatory data capture, enrichment, and exchange continue to rise in line with agency mandates, the potential scope for artificial intelligence (AI) and Generative AI in particular seems limitless in its promise to transform labor-intensive processes while maintaining high accuracy. But where could this technology deliver tangible everyday benefits?
One emerging example is in capturing, searching, and distilling insights from across companies’ global regulatory exchanges, going back several years. Here, Regulatory Affairs teams can pre-empt agency queries in their initial submissions and/or when trying to provide consistent replies to questions globally – thereby increasing their chances of new products clinical trials, or changes thereto, being accepted quickly, and first time. Another is in making prompter and more value-added use of Regulatory intelligence. That’s as agencies around the world continue to refine and update their requirements, with a bearing on development, marketing approval application, and license maintenance processes. These highly tangible use cases, which are characterized by intense work volumes, are already being transformed by AI today.
Automating and Accelerating Agency Exchanges
In the case of agency queries and information exchanges, all Life Sciences companies must capture and process high volumes of interactions around the world, as follow-ups to initial authorization applications or as part of registration maintenance. Additional or updated information may be required, concerns might be raised, or the query might seek specific clarification, for instance.
Keeping track of these interactions, wherever they might take place across the global organization, can be a logistical challenge. Correspondence could come in different formats and languages, and be channeled via email, web form, letter, or phone call. If local affiliates are involved, those stakeholders may be juggling query resolution alongside a host of other regulatory tasks, so manual intake and processing of each agency inquiry presents a significant burden for them. Given that there is only a short window to respond to agency queries, potential administrative backlogs can present a risk to authorization.
On top of this, there is a further risk of inefficiency and inconsistency, as well as omission, if queries and their resolution are not recorded centrally. Ideally, all regulatory exchanges should be routinely and systematically recorded and logged. There should be proof of their handling and any associated outcomes and, crucially, the knowledge (of the additional input that was needed, and how that query was answered) can be fed into Regulatory submissions – ideally heading off similar queries in the future, and accelerating the approvals process.
Unless agency interactions are stored as a searchable record within the central company regulatory information management (RIM) system, and unless everyone (including multi-tasking teams within local affiliates) has access to this, authorizations could be significantly delayed or their long-term maintenance at risk.
So how does AI help?
Intelligent automation in this use case involves scanning incoming queries and associated responses for metadata, and making that information searchable and reusable so that the responses can be preemptively added to future applications.
Take the example of a response from the US FDA to a certain New Drug Application (NDA) for the registration of several new products. That letter is likely to contain several data points that could be captured as metadata within the RIM record. An optimized AI tool, overseen by a professional, could process all of this, to import, process, verify, and record the relevant knowledge - first classifying the correspondence (e.g. that it signals a deficiency in the application), who it’s from, the relevant application number, and how soon a response is needed, then generating a summary of all of this (using Generative AI) and relating this to other applicable registration processes.
Associated alerts are triggered automatically, meanwhile, trend analysis can be drawn from across all regulatory exchanges, to drive better regulatory applications next time around. As a final performance-boosting stage, Generative AI can be used to collate and re-use accepted content from positive responses. Although a human review layer remains vital, AI acts as a significant process accelerator and productivity tool. Real applications of the technology in this context to date, across a sample of 23 different languages, have extracted up to 12 fields of data, with 90% accuracy, 80% faster processing, and three times fewer handovers - and with no need for AI ‘training’ thanks to the way generative AI ‘learns’ from vast amounts of data.1 In short, it’s making a huge and tangible difference to busy teams’ working lives, while boosting overall output and efficiency.
Smarter Application of Regulatory Intelligence
Linked to the transformation of health authority exchanges is another use case with similarly significant potential. This involves the tracking and proactive harnessing of the latest global regulatory intelligence to improve the first-time success, and speed of approval of, development or marketing authorization applications.
Still, today, health authorities distribute news about updates to regulatory requirements in hugely diverse ways, ranging from website posts to postal or email circulars. Again, these are likely to appear in local languages. Keeping track of all of the changes, internationally, can feel impossible – again, especially if this relies on overstretched local affiliates updating a central repository with the latest developments in their country. China’s eCTD implementation guide, for instance, contains important information on how to compile, publish, and submit eCTD sequences to the National Medical Products Administration (NMPA), the Chinese Agency for regulating drugs and medical devices. The guidance is provided in simplified Chinese.
Optimized AI tools offer an important solution here. That’s not only in monitoring for emerging updates, in any language and format, and via any channel, or capturing this intelligence centrally; but also in proactively flagging the impact of those considerations and exposing it for further consumption – via the global organization’s central RIM system, and alerts to the relevant stakeholders.
Meanwhile, as Regulatory teams compile new content for health authorities, they can ensure that the proposed new requirements are factored in from the outset, by simply asking their RIM system’s GenAI-enabled chatbot a direct question about the latest relevant requirements. To avoid any concerns about AI getting it wrong, human team members are encouraged to validate any Regulatory updates, while the GenAI chatbot provides complete links to its information sources (even down to the specific document, and page number so that the findings can be verified.
Initial pilots have again yielded 90% accuracy, and 80% faster processing, with half the handovers of manual regulatory intelligence lookup and implementation. Improved efficiency in capturing, processing, and distribution of regulatory intelligence. Direct benefits include reduced risk of non-compliance with new or updated regulations, improved clarity, and faster decision-making thanks to automated summarization, translation, and analytics.
Anticipating Future Needs
These regulatory use cases are just the tip of the iceberg of what’s possible in a discipline that is so detail-conscious, and so dynamic in terms of its continuous exposure to change. The obvious next step, which isn’t at all far away, will be for Regulatory AI tools to proactively suggest improvements to submissions while they are still a work in progress, based on automated lookups of previous Agency correspondence, and of the latest Regulatory intelligence.
Life Sciences’ application of AI is a fascinating space to track for its extensive potential, but the real transformation will come from tangible, specific use cases linked to Regulatory Affairs’ everyday pain points.
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%.
Author Details
Agnes Cwienczek- Director of Product Management, ArisGlobal; Renato Rjavec- Senior Director of Product Management, ArisGlobal
Agnes Cwienczek is Director of Product Management at ArisGlobal, with a remit including the provision of business process and data management expertise in the areas of Regulatory Information Management, Document Management, Submission Management, and Labeling Management. Agnes has previously worked at Merck in its Global Regulatory and Quality Assurance department, a milestone in a career spanning nearly two decades at the frontline of regulatory information management. acwienczek@arisglobal.com
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 the ideation, development, and implementation of regulatory and quality solutions for the Life Sciences industry. rrjavec@ arisglobal.com
Publication Details
This article appeared in American Pharmaceutical Review: Vol. 27, No. 5July/Aug 2024Pages: 81-82
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