How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva

Hello, everyone. Welcome to the life science rundown, where we discuss current regulatory complexities facing the life science industry and explore innovative ways to overcome those challenges. I'm your host, Nicholas Catman, president and CEO of the FDA Group. Before we get started, here's a quick word about who we are. The FDA Group is a consulting firm that helps life science companies in the areas of regulatory submissions, audit projects, mock inspection, staff augmentation, and remediation. So if you ever find yourself in need, just head over to the feagroup.com to check us out and get in touch. So today, I am speaking with Maria Vasileva. Hello, Maria. How are you? Hi. I'm great. How are you? I'm doing excellent. Thank you so much for for joining the podcast. Before we jump in for the topic today for today, would you kindly introduce yourself? Sure. I'm the chief science and regulatory officer at DIA, and I'm based in Washington, DC. DIA is a leading global multidisciplinary life science membership association, and we drive collaboration that can speed up innovation in the space of drug, drugs, biologics devices, and diagnostics. Of course as all other non profits in this space we're really dedicated to improving patient outcomes and dream of a healthier world so I'm very excited to be here today and to talk to you since we have a lot of stakeholders including industry and regulators that we very commonly interface with. So I'm looking forward to our discussion. Okay. Excellent. So I understand. So the topic today is how are regulatory agencies, particularly the FDA, navigating the opportunities and challenges of incorporating artificial intelligence into the regulatory review process while maintaining public trust, scientific rigor, and human oversight? So, with that, that statement, the first question that I would have for you is what are the most common current applications of AI in regulatory review, and how are they streamlining workflows to agencies like the FDA? That's a great question. Of of course, just like other regulatory agencies, the FDA is increasingly integrating artificial intelligence into their regulatory review processes for all medical products. And, that includes, utilizing AI to assist scientific and safety evaluations of drug biologics and medical devices and diagnostics, but also to streamline the actual, regulatory review process itself. So because, this AI application is very new, primarily AI today is being used to automate repetitive tasks, accelerate review timelines, and reduce the administrative burden, on the FDA staff so that way they can be freed up as experts to focus on the signifies, kind of a shift to because that is a whole signifies, kind of a shift toward more efficient and data driven decision making. And actually, as you mentioned in the intro, all global regulators are now thinking about and talking and and discussing how to evaluate the level of risk, of applications of AI and take more of a tailored approach. So there's always a human in the loop, for …