Safety & Surveillance / Pharmacovigilance

Safety and Surveillance / Pharmacovigilance (PV) has been traditionally viewed as a business function charged with ensuring regulatory compliance with adverse event (AE) reporting requirements of regulatory authorities (e.g., FDA, EMA, etc.), in addition to its role during development. Viewed as a cost center, it is often constrained to operate within a tight budget and as a largely siloed function. As a result, safety and surveillance data and operations are often not well-integrated with other business functions or the larger enterprise. Exponent’s team of consultants has experience with helping large and small pharmaceutical and biotechnology companies address these challenges by applying innovative technologies and methods combined with deep industry experience and technical understanding. We help our clients develop a comprehensive understanding of all evolving conditions and business needs in order to determine the best new safety and surveillance / PV concepts of operation that will support all future needs of the larger enterprise.

The continued evolution of external and internal factors and trends has subjected the safety and surveillance / PV function to increasing amounts of pressure. Such factors include continued growth in AE reports, increasing product complexities, changing regulatory requirements, tools that don’t support automation, challenges in optimizing workflows, value proposition of new technologies, and changing demographics. In the past, the pressure to scale up processes to meet demands of growing AE case loads, for example, could be addressed by continued optimization of strategic and tactical operations (e.g., via outsourcing). However, a tipping point may soon be reached when further optimization is no longer possible and existing approaches will become insufficient.

As a result, new concepts of operations for safety and surveillance / PV will become necessary, both at strategic and tactical levels. This includes new governance principles, integrated data-driven decision making capabilities, updated business operations, and support of new IT and analytic technologies.

Trends and Opportunities Influencing PV Functions


  1. There has been an exponential growth in the number of AE case reports. According to the latest statistics published by the FDA, the number of reports entered into FAERS has doubled every 3.5 years. This trend has been consistent over the past three years.
  2. Product complexities increase, driven by trends towards more biologics and/or personalized drug products for which risk profiles are harder to obtain. This may result in a higher number of adverse events per dollar revenue or per patient treated.
  3. Socio-demographic shifts associated with increased Internet access, social media as a readily available discussion medium, and shifts in social-cultural values in emerging markets provide easier access to reporting and may lower reporting thresholds as well as underreporting rates, resulting in a corresponding increase in AE reports.
  4. The regulatory environment continues to evolve, with new rules for currently-regulated products as well as the introduction of regulations for entirely new product categories. Depending on the specific product portfolio of a company, this could result in a substantial increase in the reportable AE case load.
  5. With the rapid rise of “Big Data” and analytics, organizations are beginning to implement a major paradigm shift towards “data-driven decision making” in order to stay competitive. This requires integration of data from all business functions, including PV. Although the data collected as part of existing PV operations are potentially valuable for other purposes (e.g., pharmacoeconomic and outcomes research), integration is not well-supported by current PV systems.
  6. Current PV tools have been developed largely for operational support of a previously paper-based process. While existing tools allow for some operational efficiency gains, additional gains can only be realized after the introduction of a holistic Big Data Analytics strategy with corresponding automation of operations.
  7. Outsourcing has helped maintain cost while ensuring compliance. However, increased outsourcing may become a less-effective option to respond to future AE case load growth, since economies of scale will be harder to realize.

How Exponent Can Help 

Current PV concepts of operation (strategic and tactical) and tools have reached a point where further optimization is not easily achievable. However, evolving external and internal factors and trends continue to challenge PV functions by generating an exponentially growing demand. Because of the lack of functionality in currently marketed PV systems, there is an imminent need of a paradigm shift that will rebalance supply and demand with a new generation of operational concepts and tools designed to meet future needs.

Exponent, with its wide array of scientific, technical, and analytics experience and expertise, is prepared to support the detailed exploration of novel PV systems designed to address all factors and trends with influence on the PV function. Exponent can:


  • Develop prototypes and proof-of-concepts to assess feasibility of process automation using advanced analytic techniques, novel signal detection capabilities, and predictive/prescriptive models to improve forecast of demand and supply.
  • Support the development of architecture and design specifications, in the form of comprehensive sets of use cases, to integrate these prototypes into an existing production system, and/or to upgrade and embed the production system into a holistic Big Data Analytics strategy.

 


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