Industry Outlook 2025: Regulating Technology for the Future

For the bio/pharma industry, 2024 was an interesting year, remarks Kate Coleman, vice president regulatory affairs, quality, and compliance at Arriello, as pharma companies started to take stock of everything and identify the potential areas for value creation in the future. “There's mergers and acquisitions going on, you know, smaller companies looking for acquisition by the larger companies, larger companies trying to acquire pipelines of new drugs,” she says. “And so really, it is about that value proposition, and also about cutting costs and sustainability into the future.”

A hot topic for the global bio/pharma industry from 2024 was artificial intelligence (AI), Coleman continues. Although the technology has been available for some time beyond just the past 12 months, 2024 was really the year when AI was being implemented to help in the consolidation efforts and value creation, she asserts.

“So, you're seeing [AI] a lot in drug development, where [it] can be used to predict and model outcomes. You're also seeing AI being used right across clinical trials for data analytics. You're seeing [AI] in quality management systems, so things like data leaks and support with deviations, change controls, all of the different aspects,” Coleman remarks. “There's a huge amount of possibility with AI in terms of what it can do, even in daily work.”

Moving into 2025, Coleman expects AI to more than likely support the bio/pharma industry in some of the more mundane aspects, but it won’t be a replacement for people. “The other thing about technology, particularly with AI, is we're still in the infancy in terms of knowing how we're going to regulate it, how we're going to inspect it, how much validation is needed for AI tools,” she says. “You know, often people don't fully understand what an AI tool actually does and what the operations are behind the black boxes. So, I think there's a lot of discussion going on at the moment, a lot of difference in opinion, even across regulators, in terms of how it's going to be regulated in the future.”

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About the speaker

Kate Coleman, vice president regulatory affairs, quality and compliance, Arriello

Kate Coleman is vice president regulatory affairs, quality and compliance at Arriello. She has spent approximately 23 years in the pharmaceutical industry across a number of roles in quality assurance. Kate is a qualified person and has recently been working in the area of regulatory affairs and integrated service provision across the drug development life cycle.