REMS Technology Of Today And Tomorrow - Transformative Solutions To Help Reduce Burden And Improve Safety

By Natalie O’Donnell, Corporate Vice President and Justin Wilson, Director of Software Development and Technology

During the 12^th REMS Summit in Virginia, UBC’s Natalie O’Donnell, Corporate Vice President, Safety, REMS, and Strategic Engagement and Justin Wilson, Director, Software Development and Technology, presented a session on the impact technology has had on REMS and the potential effect it can have in the future. They discussed how technology has become transformative, reducing patient and health care professional burden and improving compliance with REMS requirements. The presentation included an overview of key drivers in REMS technology:

• Cloud Computing – Offers incredible computing power and scalability, on-demand support, and ability to handle intensive workloads without any upfront investments
• Data Network Effect – Utilizes real world data (RWD) that already exist - critical to program  efficiency (cost/time)
• Artificial Intelligence (AI) and Automation – Offers ongoing interpretations of data for developing insights and evidence generation
• Intelligent Interfaces (IoT) – Provides ongoing patient communication with new ways of engagement such as virtual assistants, creating new data sets for better analysis of the engagements

With the emphasis on reducing stakeholder burden and minimizing barriers to access, innovations in REMS technology are ever more important. Three examples of technologic innovation that impact REMS are automated AE reporting, the use of RWD and RWE, and virtual assistants.