Highlights from DIA 2015: Focus on the Role of Social Media in PV Posted July 30, 2015DIA’s 2015 conference highlighted the increasing urgency and rapid evolution within the pharmacovigilance (PV) space. There was a great deal of discussion around the use of social media for PV purposes. Certainly, the audience’s reaction to the presentation given by Ran Balicer, MD, PhD, MPH, demonstrated the urgency around social media. Dr. Balicer’s talk, Real-World, Data-Driven Drug Safety Evaluation, presented a case study involving teething gels, highlighting how better insight lead from real-world inputs. (Dr. Balicer is a Director with the Clalit Research Institute and a member of the Advisory Board at Data2Life.) The bottom line is that while everyone agrees it will play a more important role in the relatively near future, no one is quite sure exactly how it will play out. To a large extent, the uncertainty results from the lack of clear guidance from the FDA, EMA, and other regulatory bodies – which is understandable given the fast-moving and ever-changing nature of social media developments. The consensus is that the FDA is waiting to see the results of the Web RADR project run by the EMA before issuing guidance. (Background on the Web RADR project is available here and here.) Most people we talked to thought such guidance would come in late 2016 or early 2017. Pharmaceutical firms of all sizes believe the value of social media is in its ability to streamline and improve key PV processes though quicker and more robust signal detection, verification and management. Social media data can also be used to enhance and augment existing other data assets, like internal adverse event reporting systems. Across the industry, there are a range of postures regarding the opportunities. Some of the bigger pharmas are very anxious to adopt new tools and experiment with social monitoring labs, while others are taking more of a conservative, “wait-and-see” approach. For small to mid-sized organizations (including biotechs and research firms), the focus is on finding more efficient and cost-effective PV tools as options to the large-scale, full-featured and high-cost PV platforms on the market today. A common theme that could be heard during presentations and in the hallways between sessions: how can we make our PV people and teams more productive with new technologies and data streams. (A similar question is popular in discussions of optimizing clinical trial design and focusing research teams.) There was also a lot of discussion about interoperability of systems and integration of data sources. Beyond social streams, DIA participants want to see the integration of data from electronic health records, their own internal and regulatory adverse event reporting systems, claims databases, sales and prescription reporting. In other words, the value of multi-sourced data and cross-referencing in PV have become clear. Thus, many firms are taking a more holistic view of PV, and seeking a more integrated and interoperable approach. Again, everyone is waiting on further guidance from regulatory bodies, but the trends are pointing in the direction of more transparency and more information sharing.