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Session 9: Harnessing AI and Emerging Tech to Transform Pharmacovigilance
Session Chair(s)
Ranjeeta Sinvhal, MD
Executive Medical Director, Medical Safety
AbbVie, United States
Balmeet Gurm, MD
Executive Director, Therapeutic Area Lead Cardiovascular and EBs, Patient Safety
Bristol Myers Squibb, United States
Session Description: This session covers the cutting-edge applications of digital twins in patient safety, especially where real-world data is limited or hard to obtain, such as in ethical constraints, small patient populations, or complex scenarios. It highlights work from major international collaborations like the EU Human Digital Twin (EDITH) and Virtual Human Initiative, enabling the audience to understand current uses and emerging opportunities for digital twins. Additionally, it showcases practical AI/ML tools in pharmacovigilance and risk management (PVRM), including predictive safety modeling, automated data extraction, safety hypothesis generation, and evidence triage. The session also addresses the use of real-world evidence (RWE) in regulatory submissions and post-authorization safety studies (PASS).
Learning Objective : - The audience will gain an overview of current and future uses of digital twins in patient safety and how the methodology is driven forward by international consortia
- Participants will learn how AI/ML methods can enhance early safety risk assessment in combination therapies and streamline safety data extraction using practical AI-driven workflows
- Participants will gain FDA perspective on use of real-world evidence in submissions and PASS
Speaker(s)
Unlocking Combination Therapy Safety: Integrating Multi-Source Data with Generative AI
Kate Gofman, MD, PhD
AbbVie, United States
Head of Predictive Safety
Speaker
Richard Forshee, PhD
FDA, United States
Associate Director of Benefit Risk Assessment, OSE, CDER
Speaker
Michael Forstner, PhD, MPH, MSc
Mesa Laubela-Consulting, Switzerland
Managing Director, Head of Pharmacoepidemiology Practice
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