AGNES CWIENCZEK
Director of Product Management, ArisGlobal, Croatia

Abstract

Three in five life science regulatory professionals are now experiencing an increase in day-to-day work throughput that far exceeds what would be expected with company growth. A new survey of senior regulatory professionals at US pharma/biopharma organisations identifies a direct correlation with planned AI investment – now seen as their best bet to stay on top of escalating workloads. Yet closer analysis also reveals that attitudes to AI’s suitability in a regulatory context may need updating. ArisGlobal’s Agnes Cwienczek unpacks the findings.

If the pharma/biopharma industry is to maximise affordable access for patients and maintain commercial viability as products grow ever more sophisticated, companies must become smarter in how they allocate resources to routine R&D processes, including regulatory workloads.

It is in this context that organisations are turning towards artificial intelligence (AI), and in particular next-generation technologies such as Generative AI (GenAI) powered by large language models (LLMs) - albeit that there often remain questions they need to resolve first. To understand the evolving balance between AI appetite and barriers to adoption, we recently commissioned a survey, by Censuswide, with 100 senior regulatory professionals in US pharma and biopharma organisations.

Regulatory inefficiency is spiralling

In the survey, conducted in September, almost all (97% of) respondents had seen their regulatory obligations swell over the last five years, with three in five (60%) putting the increase beyond what would be expected as the result of company growth. Expectations are that this growth in work throughput will continue ...