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W 51: Predicting Future State and Business Drivers of Safety System Upgrades based on Safety Database Upgrade and Industry Trends





Poster Presenter

      Amanda Bowles

      • Specialist Leader
      • Deloitte Consulting
        United States

Objectives

The objective of this abstract is to identify and understand the significance of current business drivers and costs behind PV system upgrades and to critically think about how industry trends will impact these in the near future.

Method

The industry drivers study was conducted over the last 10 years, from Jan. 2005-Dec. 2015, through direct and indirect involvement in safety system business cases, assessments and upgrades for over 25 global large/medium/small pharmaceutical and biotechnology companies.

Results

During the years of study, quantitative data was collected on companies’ business case for upgrade; previous, new, and planned safety systems and versions; desired system functionality; and components and the costs in terms of both financial costs and resourcing demands on the organization associated with these elements. The data revealed the following drivers to upgrade safety systems: • Regulatory compliance including compliance with new regulations, regulatory reporting capabilities, and increasing resourcing demands required to meet changing regulations • Business requirements including business process harmonization, availability of custom extensions, need for analytics platforms, and system integrations • Technical requirements including reusable implementation assets, technical support and compatibility, and multitenancy • Business situations including business operating models, total cost of ownership, global single safety database, and resourcing needs The data revealed the following drivers of upgrade costs: • Current state of safety system(s) including the volume and complexity of existing systems and data • User base, including the extent of global reach and the volume and complexity of users • Implementation resources including the extent of the update, timeline, and the volume and complexity of integrations and customizations The data suggests the following industry trends • Changes in healthcare demographics, access, and treatment methods is increasing the volume and sources of safety data • Growing consumer needs and the need to improve adverse event case acquisition is causing a growth in system upgrade market size • Managing the increasingly complex balance between cost and regulatory pressures is causing a shift in the ownership and oversight of safety systems The analysis confirmed that commonalities exist across the PV industry related to the drivers to upgrade and drivers of cost.

Conclusion

The study concluded that industry trends are disrupting the current balance of safety system upgrade drivers and cost. As safety upgrade costs are growing disproportionally to drivers, upgrade approaches will shift as the incremental value of the upgrade decreases. Implications to the drivers of safety system upgrades include: •Regulatory reporting capabilities will increase in significance, as increasing emphasis on patient safety will require life sciences companies to acquire and perfect additional regulatory reporting capabilities beyond the traditional methods of capturing and managing safety data •Multitenancy will increase in significance because this functionality will be favored for its versatility and potential to reduce costs as well as for its potential to leverage information across organizations •Need for analytics platforms will increase in significance as life sciences organizations look to increase the value obtained from system upgrades and accommodate a higher volume of reported AEs/SAEs •Total cost of ownership will increase in significance because life sciences organizations will seek out more cost effective system implementation and maintenance options as upgrades become more expensive and less valuable Implications to the costs of safety system upgrades include: •Volume and complexity of existing databases will increase in significance as regulatory pressures rise •Volume of complexity of data will increase in significance as more adverse events are reported and new AE/SAE reporting technologies are leveraged •Extent of global reach will increase in significance as consolidation pushes the global boundaries of many life sciences companies •Volume and complexity of users will increase in significance with the shift to patient-centered care and the development of new technology for AE capture •Volume and complexity of customizations will increase in significance as governance and objectives within a life sciences’ organization change