It is now imperative for life science companies to optimize Regulatory Affairs resources using next-generation technology if they are to ensure affordable patient access to treatments and achieve commercial viability, new independent research finds.
ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today confirmed that while unsustainable workload increases have created an irrefutable urgency around advanced AI adoption in Regulatory Affairs (RA), many life sciences companies are standing in the way of their own progress. These are the findings of new independent research.
The study, conducted by Censuswide in September, is striking both in its confirmation of how vital AI-powered process change has become, and in its revelations about persistent barriers that are compromising companies’ regulatory transformations. That is as soaring workloads overwhelm already-overstretched teams.
ArisGlobal commissioned the exclusive survey of senior US regulatory professionals in pharma/biopharma companies to examine the growing appetite for AI within an RA context.
Key findings
- Process inefficiency is out of control: workloads have soared beyond the pace of company growth, a rate that will not slow any time soon
- Dossier production, maintaining labeling compliance, managing data, document checking, and performing regulatory impact assessments, are major challenges
- Allocating more people is not an option: 96% say AI is needed to solve RA bottlenecks
- Interest is high across a range of specific automation use cases:
- Maintaining labelling compliance and deviations;
- Managing Health Authority interactions;
- Creating regulated content translations for different markets;
- Suggesting improvements to submissions/dossiers;
- Performing regulatory impact assessments;
- Authoring and summarizing submission documents; and
- Generating entire regulatory submissions.
BUT: outdated mindsets are standing in the way of progress
The survey identified a series of perceived barriers still holding RA departments back from investing or expanding their investments in AI, even where these are now unjustified, e.g.
- Unfavorable existing IT landscapes (45%);
- Risks still outweighing the benefits (44%); and
- Data/content not being of a sufficient caliber to see value from AI (42%).
Budget, on the other hand, is far less of an issue.
Confirming that companies’ perceptions have not kept up with AI’s progress, respondents said they would be more proactive about adopting AI in RA if:
- They found their competitors were using the technology (41%);
- Existing resource pressures continued (40%);
- The technology became more mature and proven (36%);
- Specific tools became available geared to the tasks regulatory teams find most challenging or expensive (35%); and
- Relevant IT systems were easier and more affordable to deploy (33%).
AI is the future
Senior regulatory professionals DO see AI in their futures, meanwhile:
- Almost half (48%) of respondents believe AI will transform routine regulatory work and considerably streamline processes
- Over 2 in 5 (43%) believe AI will drive up accuracy and quality in the information they produce for regulators and patients
- Almost 2 in 5 (39%) see AI as critical to the regulatory function’s ability to keep pace with market demands
- Over a third (35%) say AI will save a lot of time and money.
Commenting on the research findings, Ann-Marie Orange, ArisGlobal’s CIO and Global Head of R&D, said: “The pressure from regulators to drive up product quality and safety cannot be ignored, but nor can the drive to bring critical treatments and therapies to market more swiftly and cost-efficiently.
“It is why the industry must now double down on its adoption of AI, especially next-generation technologies such as Generative AI and machine learning. Up to now, life sciences companies have been standing in the way of their own progress, not appreciating what is already possible. But now the urgency to find step changes in process efficiency make it imperative to overcome those barriers and transform the way they work.”
Preeya Beczek, a respected regulatory consultant and founder and CEO of Beczek.COM, said: “AI is coming into its own in the life sciences regulatory space now, and companies ignore its potential at their peril. Think about it: R&D organizations must be both stringent in their regulatory compliance, and hyper-efficient in securing and maintaining marketing approval in order to get products to patients faster. That requires a gear shift which next-generation automation and AI can help deliver.”
The full survey report, The Imperative to Automate: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption, will shortly be available to download from the ArisGlobal web site at https://www.arisglobal.com/. As well as a full analysis of the findings, the report includes practical recommendations on how life sciences regulatory functions can embrace AI capabilities today within their existing IT environments.
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