Data and AI: Readiness, research and real-world impact

Regulatory Rapporteur

March 2025  |  Volume 22  |  No. 3

This month’s issue of Regulatory Rapporteur focuses on data and artificial intelligence.

Effective management of regulatory data has always played a critical role in maintaining compliance and accelerating product development. We are now in a period of significant evolution and growth in this space, with artificial intelligence (AI) and large language tools becoming increasingly available in the public domain.

In this issue, we explore how data quality can enhance regulatory intelligence and improve performance. We also look at how ready regulatory organisations are to adopt AI, as well as its potential use in post-market surveillance.

Our first article, by John Cogan of JPC Advisory Limited, looks at the challenge of ensuring high quality data in regulatory information management (RIM) systems and discusses how introducing a research and development (R&D) operating model which breaks down siloes across functions could improve data quality. It suggests that using a model which focuses on an end-to-end approach instead of a traditional functional set-up puts accountability under a single head and maximises efficiencies and data quality across multiple functions within R&D.

Our second article, by Steve Gens of Gens & Associates, analyses regulatory organisation readiness for AI adoption. It summarises the key findings of a survey that explores advanced technology status and investment priorities within the regulatory function for both pharmaceutical and medical device companies. The results show that there is growing optimism in the industry around the potential value of AI, with a number of companies conducting proof of concept activity and a growing number mapping out three-to-five year digital roadmaps to implement these new technologies.

The theme of AI is further explored in our third article by Mika Reinikainen of Abnovo Limited, which looks at the potential of AI for post-market surveillance in medical devices. The article discusses the potential benefits this can bring but also evaluates the challenges that need to be overcome, using practical examples of AI-generated text to illustrate possible issues.

Our final data-focused article examines how data can be used to drive regulatory performance. Written by Patterson Shafer of FTI Consulting, it focuses on regulatory intelligence and the different approaches of traditional knowledge management compared with regulatory analytics. The analytics approach mines and uses the data a company already holds within its data systems on submissions, such as quality, volume and average approval timelines, to aid future strategy planning.

Our next article moves away from data to look at immunological considerations in the development of novel vaccines. Part one of this two-part series, authored by Cecil Nick of Parexel International, explored the elements of the immune response that are important to vaccine effectiveness. Part two looks at how the enhancement in our understanding of the immune response allows for improved prediction of vaccine effectiveness and may negate, or at least limit, the need for large, costly and time-consuming clinical effectiveness trials.

Our final article this month looks at the European Union’s Health Technology Assessment Regulation (EU-HTAR). This regulation significantly transforms how health technology is evaluated across the EU. Effective from January 2025, it brings a partnership between the European Medicines Agency and Health Technology Assessment bodies. Authored by Rosa Willock, Sophia McGovern and Michael Harding of Decisive Consulting Limited and Tom Oakley of Somerville Development Partners, it discusses the considerations for regulatory teams.

I hope you enjoy this issue.