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[BIO Korea 2026 Attendee Insights] 2️⃣ The Evolution of Medical AI — How Will Pharmacovigilance Change?

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Insight
2026-06-04
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At BIO Korea 2026, we observed that medical AI has moved beyond a supporting role and is now being utilized as Agentic AI — actively intervening in real-world decision-making and task execution.


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The emergence of Multi-Modal Foundation Models capable of integrating and analyzing imaging, text, and EMR data, along with the adoption of AI-powered surrogate prescribing systems in parts of Australia, signals that AI has begun embedding itself deep within healthcare systems.

This shift also signals meaningful change for pharmacovigilance (PV) practice.


Automated AE Detection and Seriousness Classification

As large language models enable the analysis of unstructured medical data, more efficient case processing and automated detection of Adverse Events of Special Interest (AESIs) are expected to become a reality.


AI-Driven Automation of Literature Surveillance

The rise of medical AI is bringing a wave of automation to PV literature surveillance as well. SeltaSquare has proactively responded to this shift by developing and operating LITUS, a proprietary literature surveillance solution purpose-built for PV. LITUS systematically searches vast volumes of literature for safety-relevant information, reducing the time and resources required for signal detection by more than 278%.


Growing PV Complexity for Genomic-Based Therapies

Advanced biologic therapies — including cell and gene therapies — that operate through mechanisms fundamentally different from conventional medicines are increasingly entering the market. PV professionals and regulators now face a new challenge: how to incorporate the novel and complex multi-modal data these therapies generate into Risk Management Plans (RMPs).


AI will not replace PV professionals — it will serve as a companion technology that amplifies their expertise. What matters most is building AI systems tailored to individuals and organizations so they can take the lead in this era of AI transformation. SeltaSquare, through LITUS and its full suite of PV-specialized solutions, is committed to co-designing the future of pharmacovigilance in the age of AI.