Pistoia Alliance Launches New Initiatives to Enhance Pharmacovigilance

The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, is launching two complementary initiatives to transform pharmacovigilance (PV) in response to growing member demand.

First, a new dedicated AI in Safety & PV Community of Experts (CoE) will explore how to apply AI safely, ethically and effectively within pharmacovigilance workflows. Meanwhile, the Pharmacovigilance Systems & Processes Standards (PS²) project will establish a set of standard solution and integration requirements for PV systems to reduce duplicated effort and foster greater innovation in common PV workflows using AI.

The Alliance believes that AI holds huge promise for automating the capture and analysis of PV data but also poses significant risk around the reliability of AI-generated outputs. The AI in Safety & PV CoE will convene industry specialists to explore how AI can responsibly enhance drug safety monitoring, from automated adverse event extraction to causality assessment.

“AI is already reshaping early-stage R&D, but its use in pharmacovigilance demands a greater level of care and scrutiny. The consequences of errors in PV can more directly impact patients and lead to regulatory and reputational fallout. Therefore, a risk-based approach to the use of AI is required, and this new community will ensure AI adoption is grounded in ethical and technical best practice while maintaining regulatory compliance,” commented Thierry Escudier, Portfolio Lead at the Pistoia Alliance. “PV challenges are among the most cited concerns by our members, which is why we’ve launched these initiatives – marking the Alliance’s first move into the drug safety space. We’re now looking for life sciences and technology companies to provide funding and expertise so these initiatives can deliver practical solutions that will benefit the entire late-stage R&D ecosystem.”