Ivan Lim, partner, Kingsley Gate, assesses the effect that AI is having on regulatory professionals in the life sciences sector.
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Is any job safe from the impact of artificial intelligence? According to a study on the impact of robotics and artificial intelligence (AI) on the job market by HEC Lausanne, the business school at the University of Lausanne and EPFL's Laboratory of Intelligent Systems in Switzerland, even specialist roles such as medical appliance technicians, neurodiagnostic technologists and medical equipment specialists run the risk of being impacted fairly significantly by AI-based automation.
But what about regulatory and medical affairs professionals? As advances in AI start to impact more junior roles in these fields, what knock-on effects might be seen on career development and what potential risks and opportunities are likely to emerge as a result?
Just as we are already seeing the potential of AI in the drug discovery process, in predictive modelling and streamlining business development spend, it will also start to have an impact on medical and regulatory affairs as both functions continue to grapple with ever-growing levels of complexity.
In regulatory affairs, this complexity is driven by factors such as the emergence of ground-breaking cell and gene therapies, the significant increase in the volume of datasets available, the number of drugs under clinical investigation and the sheer volume of material published by regulatory bodies. According to a report by Seagate, the healthcare “datasphere” is expected to double every couple of years, growing at 36% CAGR between 2018 and 2025. As a result, medical affairs professionals will find themselves analysing more data than ever before.
From an operational perspective, AI is currently impacting more junior and middle-level roles, particularly those that include the management of data (eg trial data), where it is increasingly being used to reduce repetitive tasks. This trend of automating the way that data is gathered, collated and analysed will only accelerate.
But it isn’t just data analysis that is being impacted by AI. For many medtech and healthcare innovators, AI already plays a central role in their business. Companies such as Intuitive, for example, a market leader in robotic assisted surgical systems, healthcare technology company Medtronic or medical device manufacturer Stryker would expect job candidates to possess a level of awareness of AI and I would expect to see AI-related skills listed on job specifications in organisations such as these.
Another sector where we’re seeing a demand for medical and regulatory affairs professionals with an understanding of AI is in the technology space. Alphabet (Google’s parent company), Amazon, Apple, IBM Healthcare and Microsoft are all investing in niche healthcare sectors and all will need to attract medical affairs experts with data/AI experience. Needless to say, this is only exacerbating the talent shortage, particularly since the tech giants are often prepared to offer higher salaries than traditional medical device, life sciences or pharma businesses.
Since data science skills are only going become more important, I’d certainly advise anyone in the early or middle stages of a regulatory or medical affairs career to explore AI-related courses or qualifications as a career investment. And while a candidate’s overall career experience remains key for senior roles, that will also change in future as AI and data tools start to play an ever-larger part in the operational life of global organisations. Therefore, my advice to anyone in medical and regulatory affairs is to try to stay abreast of recent developments in data science and AI, whether through formal learning, reading media articles or just talking to well-informed colleagues in the industry.
When it comes medical affairs professionals, the pool of talent is smaller and individuals with the relevant expertise are in high demand irrespective of their familiarity with AI. This also means that a CMO might expect to earn 15-25% more than the equivalent Chief Regulatory Officer. That said, a CMO candidate who can demonstrate an understanding of the potential of AI and how it might help the medical affairs function deal with complexity or support agile decision-making would certainly find themselves at an advantage over those that cannot. Fast forward a couple of years and there’s no doubt that having a good grasp of evidence-driven analytics, data tools and their implications for healthcare will become an increasingly important part of the CMO role.
If I’m interviewing a CMO today, I would certainly expect them to be in a position to share their thoughts about the ways in which data and AI might impact their role and the broader medical affairs remit and to have some understanding of how particular tools can be used in an operational context. If they can point to examples of a couple of projects they’ve been directly or indirectly involved with, so much the better.
Conclusion
At the most senior level of Boardroom appointments - CEOs, Chairs, NEDs - business leaders should be able to demonstrate that they understand how AI might impact the operating models and processes of the business. But when it comes to the regulatory function of the future, there’s a debate taking place about the longer-term impact of AI and the degree to which it will replace the human element of various tasks and responsibilities.
This was a theme discussed by Sorcero, who specialise in medical affairs and regulatory affairs knowledge, in their White Paper, AI in Medical Affairs and Regulatory Affairs Trends for 2022. Here, they draw upon research from Bain and Company in predicting that increasingly sophisticated digital tools will result in a bolder and more agile generation of medical affairs leaders. And that this will in turn, transform medical affairs from a support function in the biopharmaceutical industry to one of strategic value.
It’s clear that AI will enhance the role of the regulatory professional working their way up the career ladder by enabling the automation of mundane tasks, so that there’s more scope to develop the less technical aspects of the role. In terms of attracting and retaining talented regulatory professionals this can only be a good thing.
