Author: Hans van Leeuwen, Global Head of Regulatory Affairs Data & Systems at Astellas Pharma

At Breakthrough 2025, Hans van Leeuwen, Global Head of Regulatory Affairs Data & Systems at Astellas Pharma, will take part in a panel discussion on the pursuit of greater interoperability between Regulatory and Safety systems. Here, he shares some insights into the reality of converged product data.

During my keynote and panel sessions at last year’s Breakthrough event, I spoke about our planned journey toward closer collaboration between Astellas Pharma’s Regulatory and Safety operations, supported by a single, consistent data source.

This time, I’ll be part of a panel alongside my pharmacovigilance colleagues, discussing the aims and practicalities of achieving system and data interoperability between our respective functions, via ArisGlobal’s cloud-based LifeSphere platform.

Aligning SOPs

There are a number of ambitions associated with these plans, which include substantial savings in the speed and cost of managing routine processes such as safety reporting.

The challenges in getting there include data standardization, and alignment of our respective standard operating procedures (SOPs). Regulatory timelines traditionally allow longer for Product Information data updates than Safety. With interoperability between the systems now within reach, we also need to align processes.

Establishing boundaries, bridging differences

Another consideration is the scope of the new upgraded, shared system. Some of our oldest products have been around for several decades, and have been subject to a whole raft of regulatory changes over time.

It will be hard to capture all of that in the new system. But this is unlikely to be necessary, where those products are out of date, or where we are no longer have a safety responsibility for them. We plan to proceed prudently, by focusing first on new and current products.

ArisGlobal is helping us bridge any differences in requirements between the functions, for instance around data granularity. Making sure that each department’s needs are met is important.

Keeping an eye on AI

Beyond this immediate session, I’ll be listening out for the latest AI-based developments at this year’s Breakthrough.

At Astellas Pharma, our PV colleagues have already started to evaluate LifeSphere NavaX, and we expect to follow suit. AI-powered automation presents an effective way to fine-tune processes involving data, so that they are even faster and even more efficient – and, crucially, consistent.

As an industry, pharma has barely scratched the surface of AI’s potential, but it’s clear its impact will be huge – not least in our Agency interactions as data-based submissions become the focus.

Given that one of our main aims, through our digital transformation plans, is to ensure patients gain earlier access to the latest safety information, the prospect of harnessing AI to turn that data into something each patient cohort can readily understand is very interesting to us.

• Hans van Leeuwen is Global Head of Regulatory Affairs Data & Systems at Astellas Pharma. He is based in Leiden, the Netherlands.