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Navigating the Data-driven Future of Life Sciences Regulatory Processes: Who Will Take the Lead?

Generis hosted a live video discussion with a panel of industry thought leaders from BioNTech, Bayer, Iperion – a Deloitte business, and Beczek. COM to discuss the critical next steps for the Life Sciences industry as it embraces a future of data-driven information management and business processes. The panel was chaired by Generis COO Max Kelleher, who led the discussion to determine who is ultimately responsible for the quality and consistency of the data, and how it can be achieved.

Trends in Regulatory Data

The panel began by reflecting on the current state of data management, particularly around regulatory data, in Life Sciences – and where this is all moving.

Frits Stulp (FS), Iperion – a Deloitte business: “The visibility of the Life Sciences industry has been elevated tremendously over the last three years, due to COVID and the direct and immediate value of emerging medicine to quality of life for many people. But the pandemic also shone a light on archaic registration processes which today still involve the exchange of PDFs. Stakeholders across the industry have begun to see that there is a better way to manage this.

“If the financial services sector was subject to the same rate of innovation that we apply to Life Sciences regulatory processes, people still might not even be using an ATM at this point. In other words, we have a lot of work to do as an industry. Yes, there is a huge passion for science, but because it’s such a regulated environment we tend to avoid risk and need to be told what to do. The trouble is that regulators are not necessarily innovators: that’s not their job.”

Who Will Ensure Data Quality?

As processes become more data-driven, though, who will drive all of the necessary rigour around data quality? The regulators, via compliance?

FS: “A joint innovation initiative would be most productive. Regulators are not necessarily there to drive innovation but do need to pave the way for new ways of working. Despite a great deal of drive by the industry, there can be paralysis when new initiatives centre around a legal mandate. It makes sense for both parties to work together.”

Vada Perkins (VP), Bayer: “From an industry perspective, the regulator’s role is more about fostering opportunities. Look at what the pharmaceutical industry is doing with investments in AI to support novel ways of doing things and advance the pipeline. There’s a lot of momentum in the industry; what we require from the authorities is that they are open to this kind of innovation.”