I recently researched the future of AI in pharmacovigilance, analyzing relevant literature and discussing with three top AI models (GPT-5.1, Claude Opus-4.5, and Gemini-3.0). Here is the realistic roadmap and the critical focus areas that emerged from my research stripped…
I recently read about the FDA’s investigation into a reported pediatric death in a patient treated with Adzynma. Situations like this are always difficult. At the same time, they remind us why post-marketing safety work is so important for the…
I attended a great panel discussion at WDSC2025, moderated by Lucinda Smith with Julie Thomas, Mariette Boerstoel, and Ellen Mishalov. I took some notes and here is my summary of the discussion. What we heard • Foundations first: Governance and…
After three days at the World Drug Safety Congress 2025, I left with many thoughts about where AI is heading in pharmacovigilance (PV). Here are some of my key takeaways and beliefs about what’s next: 1. Broader adoption of AI:…
Many pharmacovigilance (PV) professionals still think AI is limited to search or summarization. But in reality, AI can support every step of the AE literature monitoring workflow. Here’s how it works in our IPV system: 1️⃣ Document Retrieval Given a…
We recently put this to the test. In a pilot study, our team compared Insilicom’s IPV platform with traditional Boolean keyword searches for detecting adverse events (AEs). We focused on three well-known post-market drugs: 💊 Nivolumab, Dupilumab, and Semaglutide. ________________________________________…
