A new survey of senior US regulatory professionals has confirmed a direct correlation between unsustainable regulatory workloads and planned AI investment. That’s as long as the function can accept advances in the technology and its demonstrated applicability in a pharma regulatory context, says ArisGlobal’s Renato Rjavec.
For the pharma/biopharma industry to ensure affordable access for patients as well as commercial viability as products grow ever more sophisticated, companies must become smarter in how they allocate resources to routine late-stage 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), even though confidence in the technology is taking time to catch up.
To understand the evolving balance between AI appetite and barriers to adoption, ArisGlobal recently commissioned a Censuswide survey, with 100 senior regulatory professionals in US pharma and biopharma organisations.
Regulatory Inefficiency is Intensifying
The poll, conducted in September, found that almost all (97% of) respondents had seen their regulatory obligations swell over the last five years, with three in five (60%) citing the increase as beyond what might be expected as the result of company growth. The trend is almost unanimously expected to continue over the next five years, with 41% saying next increases will be significant.
Particular process challenges include excessive time spent producing submissions/dossiers; maintaining labelling compliance; inputting data/documents into IT systems; verifying submission correctness/completeness; performing regulatory impact assessments; and locating data or documents in existing IT systems. Further barriers to efficiency include responding to agency queries; inadequacy of current IT systems; and time lost to data quality checks, assessing submission readiness, and other administratively-demanding preoccupations.
A lack of qualified people was not identified to be a great concern; preferred strategies do not involve allocating more people to processing regulatory workloads. Rather, pharma and biopharma regulatory functions are looking to smarter use of technology to ease the impact of their rising workloads.