J.P. Morgan Healthcare Conference 2026: A Cloud-Based Future for Regulatory Submissions
The PRISM project has the potential to offer a fundamental shift to the way that regulatory bodies and industry collaborate and interact, according to Frits Stulp from Implement Consulting Group.
Over the past few years, the bio/pharma landscape has undergone significant change, with stakeholders now seeking out ways to de-risk earlier-stage innovations and improve clinical and commercial outcomes. “A key development that has taken place over the past few years has come from the so-called PRISM project in the U.S., which is a research collaboration between industry and FDA,” remarks Frits Stulp, Partner Life Sciences at Implement Consulting Group.
The PrecisionFDA Regulatory Information Submission and Management (PRISM) project was initiated to explore the potential use of a cloud-based platform, precisionFDA, in the regulatory submission process as a way of improving efficiency. In essence, the project is looking at the application of a cloud environment for industry and FDA to work together, adds Stulp.
“[This application] may sound very boring and very technical but, actually putting such a secure place together, where you can work on the dossier that you submit to the regulator to get your product on the market does change the ball game significantly,” Stulp continues. “I’m really eager to see how ‘trusted regulatory spaces’ are going to lead to actually very different ways of working and faster innovation.”
Artificial intelligence (AI) is also being employed by industry to help accelerate processes and is a highly discussed topic within industry at the moment. While there is a huge use for AI within the admin-heavy, regulatory space, there are also more challenging functions that will benefit from AI, Stulp notes.
“I think it is way more interesting to look at the power of discovery, so, where AI can actually look across big volumes of data, find trends, help researchers to find new things,” Stulp says. “But, I am not going to pass up the opportunity to come back to my favorite topic! This ‘trusted regulatory spaces’ initiative is actually very actively looking at AI, and I believe it is a key example of where AI is providing results for industry.”
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About the Speaker
Frits Stulp is Partner Life Sciences at Implement Consulting Group — a globally expanding management consultancy with Nordic roots that is focused on the human role in the consulting process. Frits has worked within the pharmaceutical sector for 25+ years, starting off in industry for 10 years and then moving over to consulting. He is particularly passionate about the collaboration between regulators and the pharmaceutical industry.
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