Among the many highlights of Breakthrough 2025 will be the lively panel debates. Here, Steve Gens previews some of the new research findings he’ll come armed with to a discussion panel on the future of Regulatory operations in an AI automation context.

By the time our esteemed panel assembles to discuss the future of Life Science Regulatory Operations in the context of AI, on Day 1 of Breakthrough 2025, my organization will have finished crunching the data from a brand-new AI / Automation Pulse Survey. I’ll be ready to share some of the key findings, hot off the press, and provide a real-time update about where life sciences organizations have got to with AI / Automation now – both within and beyond the Regulatory function.

From expectation to reality: what’s working best?

This latest Gens & Associates regulatory study, which has 41 companies from industry and 17 software providers participating, not only captures the insider Regulatory Operations view, but also reveals the viewpoint and predictions of the sector’s key technology providers. It is starting to pinpoint what actual AI success looks like in a Regulatory context, and the key contributors to that.

The AI / Automation Pulse Survey spans priority investment areas; expected implementation tipping-points for the different AI technologies over the next 1-3 years; prerequisites for successful benefits delivery; and expectations for extending the benefits of Regulatory AI-based process automation to adjacent functions, most notably Safety. (It makes perfect sense to use GenAI to streamline reporting and follow-up between Safety, Regulatory and Health Authorities, for instance).

The study also tracks evolving sentiments about the scale of impact AI technologies like GenAI will have on people’s jobs within the next few years.

Building blocks for success – and what that means practically in 2025

At Gens & Associates, we view AI and Automation as pieces to the digital umbrella which require foundational work in place to enable success. These critical preparations include establishing strong data management / governance practices that result in high data quality; as well as data science skills. While organizational change management is important in any change or transformation, AI-based change requires a different approach.

Again, we have looked into all of this in this latest Pulse survey. Incidentally, improving data quality and accuracy is actually something AI could help with, which makes for another potential discussion point during this much-anticipated panel session.

Interestingly, we observed a disparity in some of the perceptions and conclusions between those working in industry, and those representing the technology and service provider community – something that again I’d be happy to delve into, if there is interest.

ArisGlobal Breakthrough: brainstorming at its most productive

Breakthrough 2025 is ideally timed within a busy conference season (I look forward to riding the ‘bullet’ train between Zurich and Basel where the season’s DIA Europe takes place during the same week), affording us all a great opportunity for fresh networking and ideas exchanges.

I always look forward to ArisGlobal’s annual Breakthrough event, with its high levels of engagement and energy as industry’s big thinkers share their latest thinking. The depth and quality of the presentations and discussions is top notch.

I look forward to seeing you there.

• Steve Gens is Managing Partner at Gens & Associates, based in Newtown, Pennsylvania, USA.
• At Breakthrough 2025, at 10:50 the morning of Day 1 – Tuesday March 18 – Steve will take part in the panel debate, Regulatory Operations: Driving Progress and Preparing for the Future. The session will cover the expanding scope of regulatory responsibilities, highlighting hot topics such as GenAI and advanced automation, and their potential to enhance compliance and efficiency.