Joe Rymsza, vice president, pharmacovigilance and regulatory technology solutions at Iqvia, told us, the backdrop for the launch “is that now is a really exciting although incredibly challenging time for drug safety/pharmacovigilance organizations, as achieving and sustaining compliance is becoming increasingly difficult for them due to a whole variety of factors.”
According to Rymsza, adverse event volumes are increasing by over 20% year-over-year across the industry, due to new product launches, expansion into new markets, M&A, as well as a requirement to monitor social media for potential adverse events and adverse drug reactions.
Subsequently, companies are challenged to retool their aging technology stacks, which Rymsza said are increasingly expensive to update and maintain and keep current with changing regulations.
Among these regulations includes most recently, E2B(R3), which cost the industry more than $1.5bn, and IDMP which Rymsza noted is coming down the pike – and likely will drive this number north of $15bn over the next five years in terms of compliance.
“So what Iqvia’s safety platform is all about is really helping companies invert the pyramid,” he explained. “Today they spend north of 70% of their operational budget to meet regulatory requirements and only are able to spend 20-30% of their budget on operational activities that allow them to meaningfully improve the safety profile as well as to feedback the insights that they are able to garner through PV [pharmacovigilance] back into their discovery and R&D processes.”
The platform is designed to reduce the cost and complexity of the complete pharmacovigilance process, ranging from adverse event identification and case processing as well as to simplify regulatory reporting and to provide organizations with the ability to do real-time signal detection.
Built from the ground up as a cloud-based solution on the Salesforce architecture, the platform will leverage advanced technology, such as optical character recognition, natural language processing (NLP), as well as propriety artificial intelligence (AI) and machine larding algorithms. This will enable companies to process potential cases, identify issues, prioritize risk, and help determine required actions, said Rymsza.
“As a result of that, we're going to give our customers the ability to do advanced analytics on really massive quantities of information,” he added. Ultimately, Rymsza said this will turn pharmacovigilance into an offering not just about meeting regulatory requirements, but one that can add value back to the business.