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PP01-17: Establishing a Strategic Intelligence Capability within Pharmacovigilance

Poster Presenter

      Anjali Shah

      • Executive Director, Business Capabilities and Innovation, WWPS
      • Bristol-Myers Squibb Company
        United States


To enable strategic decision making through a scalable market and organizational intelligence capability within a pharmacovigilance (PV) context.


A pilot study to evaluate partnership among a Corporate Knowledge function and PV function. Publicly available information such as literature databases and market research were used to create a consistent and accessible body of knowledge for stakeholder consumption.


Stakeholder interviews among senior PV leadership and cross-functional stakeholders were used to understand key knowledge gaps for driving organizational strategy and decisions. These knowledge gaps were identified as: a) new capabilities to support data collection, collation, and evaluation; b) advances in healthcare including personalized treatment and digital health; c) measurement of impact and value; d) HCP and patient engagements. Findings from these interviews were further contextualized to create 10 open knowledge questions (OKQs; see below) to guide our intelligence strategy. Working collaboratively with a Corporate knowledge group, we defined the process for information acquisition; synthesized and documented relevant knowledge based on PV subject matter expertise; established a knowledge repository for on-demand access of data and evidence; and developed an intelligence report for stakeholder communication. This information is being used to develop aligned awareness and support decisions surrounding our PV innovation roadmap. For example, an evaluation of literature on the technology related OKQs has substantiated unmet needs within and external to our organization, as well as provided relevant insight to support proof of concept design, strategic partnerships, publication planning and development, and technology implementation. Selected Open Knowledge Questions -What are new technologies and methods in data collection/collation, evaluation, decision, communication? -What/how to upskill professionals given digitization? -What is the impact of pharmacogenomics data in drug safety evaluation? -What is the impact of digital health/wearables on PV/safety monitoring? -How is value/impact measured within PV/patient safety across the healthcare ecosystem? -How can the impact of innovation be measured? -What are the factors that drive under-reporting in safety? -What is the role of PV in supporting healthcare decision makers today and in future?


In PV, business decisions are largely guided by the regulations; however, the pace of regulation is slower than that of innovation which is occurring with scientific discoveries, data proliferation, automation and digitization. Furthermore, growing pressure in the PV domain has resulted in our industry actively seeking new ways to collect, collate, evaluate and communicate safety data and knowledge to improve patient safety and create value beyond regulatory expectation. We have previously presented our blueprint for progressive innovation, which has led to research and development of new technologies, processes and capabilities in PV [1, 2]. This experience has demonstrated the importance of knowledge on emerging business needs, healthcare and digital trends, as well as new innovations in people, process, and technology in guiding our innovation strategy and making evidence-based business decisions. However, this knowledge was limited to a subset of the organization and not explicit. Furthermore, the traditional core capabilities within a PV setting [2] do not include evaluation of market intelligence outside of a regulatory context. This pilot study identified knowledge gaps within our organization and defined an approach to make knowledge explicit to inform our innovation strategy. This study also provides preliminary evidence of a scalable and extensible intelligence capability which can be applied not only more broadly across the PV value chain, but in other functional domains as well. References: 1.Beauchamp S, et al. Creation of an Innovation Function in Pharmacovigilance [oral presentation]. Presented at 19th Annual ISOP Meeting; Bogota, Columbia. Oct 26-29, 2019. 2.Danysz K, et al. Artificial Intelligence and the Future of the Drug Safety Professional. Drug Safety 2019: 42(4): 491-497. 3.King E. Core Competencies for Drug Safety/Pharmacovigilance Professionals.2011.