Leveraging Technology for a More Strategic Approach to Drug Safety

Safety leaders shared how they are enabling pharmacovigilance to become a strategic R&D business function at this year’s Veeva R&D and Quality Summit in Zurich, Switzerland.

Previous approaches were more focused on compliance, but with better data management, automation, and greater collaboration, drug safety can become more proactive and a key business differentiator.

“Pharmacovigilance needs a transformation,” said Pilar Carrero, vice president of global safety at LEO Pharma. Many companies are dealing with significant challenges from a fragmented landscape with data silos, multiple solutions that do not work well together, and inefficient processes. This is not sustainable, given growing caseloads and increasingly complex global regulations. “We spend most of our time shuffling data from Excel to Excel, and reconciling data with multiple systems, but is that the best use of our time? Is that the best service to patients?” Carrero asked.

Creating a Safety Intelligence Unit

Currently, companies are handling safety this way because “they don’t know what the possibilities are”, Carrero said. In her session, Carrero discussed LEO Pharma’s vision to create a ‘Safety Intelligence Unit’, in which safety would eventually evolve to become a strategic business advantage. “We have a lot more to offer to the organization than [compliance]”, she commented, noting that the following are all part of the plan:

• Returning the focus to patients and continuing to ensure that products are safe
• Becoming a strategic R&D partner, providing safety intelligence to other business areas, and shifting from reactive to proactive safety practices
• Enabling transformation by streamlining processes and developing a strong data foundation with a single source of truth and more thoughtful approaches to automation
• Prioritizing end-to-end harmonization, rethinking lean processes, and simplifying roles and responsibilities.

Regulatory and Inspection Trends

The industry’s adoption of more modern operating models such as digital and decentralized clinical trials accelerated during the COVID-19 pandemic. These new approaches may require changes in regulatory and legal guidance. In his session on regulatory and inspection trends, Olivier Goarnisson, counsel at Sidley Austin, LLP, emphasized the importance of assessing the impact of new approaches on patient rights, patient safety, and data integrity.

He also underscored the importance of using validated software to collect adverse event information. Currently, unvalidated systems are one of global regulators’ top inspection findings at pharma companies, he said. Selecting a safety system that vendors have pre-validated and for which sponsors can easily verify the validation status can minimize compliance risks.

Emphasizing Quality in Outsourcing

With increased outsourcing of pharmacovigilance activities, pharmacovigilance transformation must involve CROs, service providers, and other partners. Currently, more than 60% of all drug safety activities are outsourced,¹ which requires clear sponsor oversight and collaboration between sponsors and CROs.

As case volume increases, quality of work and access to data have become as important as efficiency, or even more so, many panelists in the outsourcing session agreed. Kieran O’Donnell, vice president of global drug safety at the CRO, Arriello, noted that clients are emphasizing quality over output quantity, since one case could make or break their product.

As this trend continues, performance metrics must be redefined. “We need to look beyond traditional operational KPI metrics, such as how many cases are being processed, and put practices in place to assess quality, because that is the foundation of everything that we do”, commented Antti Miikki, associate director of drug safety at the CRO, TFS HealthScience.

Real-time access to data and safety systems, for both sponsors and CROs, can provide transparency to improve work quality and trust. Having access to data ranging from top-level metrics to individual case data ensures alignment at all levels.

Big Picture Impact of Automation

Automation will be a key enabler in scaling case processing without sacrificing quality. There was a lot of interest in the ‘touchless case processing’ for EMA and MHRA highlighted in the Vault Safety Suite roadmap, which could also alleviate challenges the industry faces in retaining skilled talent. Other automation capabilities include auto-coding, auto-promoting, duplicate check, and validation, which streamline intake, case processing, and submissions.

Savings in data-entry time can be reallocated to value-added tasks and reduce the time required for case triaging, allowing serious and unexpected cases to be visible sooner and appropriate actions taken earlier.

With greater automation, the role of case processors will change, according to Martijn van de Leur, head of global pharmacovigilance at the CRO, Biomapas. He predicts a shift from the current practice of having junior staffers perform data entry, “In two years, we will be looking at a completely different profile. If 80-90% of case intake is automated, case processors will need to have a very deep understanding of the full scope of PV, including aggregate reports, signaling, and even PSMF. They will also need to understand what can happen if automation goes wrong. Making that link requires very senior people”, he said.

Becoming a Strategic R&D Partner

Pharmacovigilance teams are offering a glimpse of a future in which drug safety is considered a strategic function. They are building a strong foundation for transformation, strengthening core safety functions, and adapting to changing needs with digital evolution.

With valuable safety data and intelligence shared across functions, and technology and automation freeing up more resources, pharmacovigilance can focus more on patient well-being, rather than just compliance, and become a strategic R&D partner.

To learn more, join our next Summit.

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