As technology continues to evolve, and the datasphere continues to expand, the global life sciences regulatory landscape is growing increasingly challenging and uncertain. With mounting pressure on regulatory intelligence professionals, we sit down with Carol Stinson Becker (Senior Global Director of Regulatory Intelligence at AstraZeneca), Iain Todd (Principal Regulatory Intelligence Executive at GSK) and Immo Zadezensky (Head of Global Regulatory Policy & Intelligence at Moderna), to discuss their perspectives on the changing regulatory landscape.
Paint a picture of what the regulatory intelligence function looked like five years ago. How was it regarded by your organization?
Carol Stinson Becker: We’ve always had a regulatory intelligence function in some form. I think the basic premise has always been that we are there to gather that really important intelligence in support of our teams, to help them formulate their ‘right first time’ regulatory strategies. How has it changed over the years? Well, it’s certainly morphed from a very labor-intensive manual job of finding intelligence. I mean, I can remember the days when we used to circulate the pink and the gold sheet by paper around the department. It’s more about getting the intelligence in real-time today, not catching up with things as we did in the past.
Iain Todd: I started in reg intelligence 15 years ago. Back then, the emphasis was on being able to find and catalog information, rather than having a deep understanding of it. Over that time there’s been a shift to our professionals becoming trusted advisors, understanding information well enough that they can advise on its potential significance. Certainly, to Carol’s point, we’ve seen increasing digitalization of intel.
As companies move towards globalization, there are new things to factor, like digital health, for example. In your experience, what will be the greatest challenges facing regulatory intelligence in the next 12-18 months?
Immo Zadezensky: For me, I think it’s getting the right information to the right colleagues, breaking down silos, and not overloading people with emails. But I think regulators might now also have better access to their information within internal databases, looking into information not only on approved drugs which we see in publications, but also all the data of drugs that have made it into the system that didn’t make it to the market. That is something we have to keep up with – being able to somehow generate the knowledge internally, keeping up with knowledge that regulators have much more easily available than we do.
How will the implementation of technology change your regulatory workflow?
Carol Stinson Becker: We’ve had an explosion of technologies over the last 5-10 years. And we see it in our everyday life, whether it’s facial recognition that unlocks your phone, or cars that drive themselves – we almost take it for granted. I think the challenge in regulatory intelligence is how you separate the hype that surrounds technology from the reality of what it can deliver. You’ve got to understand what you really need to drive your organization forward, and then you have to do the hard work of investigating whether the technology that’s out there really matches up with what you want to do. There’s no substitute for doing that hard investigative work, and that’s the challenge – we’re going to be overloaded with so much new technology that we’re going to have to do some old fashioned legwork.
Immo Zadezensky: I would love to do the 80/20 approach. Instead of 80% search and 20% analysis, I’d rather do 20% search and 80% analysis. AI can help us find information and put it in a tablet output, so you can have a quick overview and identify patterns. I would rather spend more time analyzing than finding. AI won’t replace humans, but it can greatly assist.
If you’re going to buy technology from you know different vendors or build internally, why is that important to you for the systems to communicate?
Iain Todd: I think at the moment, because there isn’t one ‘all singing, all dancing’ magic system that does everything – at least I’m not aware of one – we are relying on systems talking to one another. Certainly, as we’ve moved to end-to-end intelligence management, that becomes increasingly important. You may have a system, for example, that is scanning public sources and pulling that data in, but then, of course, you want to have the business process management element, moving that intelligence to the right people and understanding whether that’s actually impacting on internal processes. So if you’re using a different system, you need to be confident that those two systems are talking to one another, that the information is finding its way to the right people and that the output is accurate.
What’s your key take home message?
Immo Zadezensky: I can do it in five words – automate, optimize, analyze, analyze, analyze.
Iain Todd: Greater automation, smarter single-integrated regulatory intelligence systems, artificial intelligence. However, be clear on what you want to use it for because you can be overwhelmed with data and then you can end up pleasing nobody.
Carol Stinson Becker: Be curious and open about digital transformation, but proceed with caution and so that you can be discerning.
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