Building a Safety Intelligence Unit from the Ground Up

“My dream is that we spend our time on the things that really matter to patient safety.” Few would disagree with Pilar Carrero, vice president for Global Safety at LEO Pharma, that developing safer and more effective medicines is paramount. Yet many pharmacovigilance professionals find their time is spent on meeting compliance, or activities that do not have the biggest impact on their core mission.

Safety teams are often tasked with managing data across a myriad of systems and sources. That’s because companies have traditionally relied on distinct systems to collect safety information across the lifecycle, resulting in data silos between adverse event intake, case processing, reporting and submissions, and signal analysis. As Carrero comments, “We spend so much of our time shuffling data between spreadsheets. Is this really the best use of our time — or a way to deliver the best service to our patients?”

Siloed case data negatively impacts the work of safety teams. They lose time on duplicated activities and struggle to use high-value data from other parts of the organization (e.g., clinical) because it sits across two or three databases, and even more when working with partners. A highly complex system landscape also entails business risk, as each IT upgrade disrupts activity while manual overhead and fragmented systems impact productivity of skilled resources.

Technology can help address some of these inefficiencies and drive down the cost of case processing. However, to fulfill its role as a strategic partner to the wider business, safety teams need access to a single source of truth for safety data. Only then can they come to the table with insights that could become a competitive advantage during commercialization, novel indications, or new drug development.

Shared vision for safety intelligence

As LEO Pharma’s safety team embarked on its transformation journey a few years ago, the team faced an immediate challenge to convince the wider business of its strategic value and shift perceptions that it was purely a compliance function. Carrero explains, “We were seen as a reactive unit: we see a signal, then react. We wanted to become a safety intelligence unit.”

It’s an ambition likely to be shared by many safety teams. Chief medical officers and safety officers are accountable for the end-to-end process and for timely and transparent communication of drug benefit-risk information. Distributed data ownership makes this highly challenging even at a basic level, as it is difficult to get a cumulative view of the benefit-risk analyses that are completed as the product moves through its lifecycle.

To contribute strategically, teams need access to clean data managed in one place. Early interventions then become possible, making it easier to stay on top of a drug’s safety profile and even informing its development pathway. Potential opportunities where safety could contribute include proactively sharing insights on potential side effects; learning from adverse event, real-world, and genomic data to support researchers as they address risks during protocol design; collaborating with medical affairs on key opinion leaders (KOL) outreach; and boosting support during the authorization and post-marketing phases.

Greater data transparency also improves accountability across different levels of the organization. As Carrero notes, “If everyone can see the same information without too much effort, we can create more accountability and spend less time cleaning up data.” LEO Pharma found even incremental changes, such as discouraging reliance on spreadsheets and SharePoint, can help people unlearn long-established behaviors.

Many companies implement regional or in-country safety teams (or work with local affiliates) to meet growing local demand. This leads to mounting overhead to track, manage, and aggregate safety information as central teams attempt to gain global visibility. Creating a harmonized data strategy across key markets can improve connectivity and ensure affiliates remain accountable and have greater data transparency to data originating in other regions.

Safety culture requires data fluency

Building a safety intelligence culture requires different teams to speak the same language. In safety terms, this means having the same data format and nomenclature across different teams. Collaboration becomes smoother and the data is more reliable when all relevant stakeholders — from local affiliates to regulators — are working in one system. “There must always be a clear answer to the question, ‘Who has the right data?’”, observes Carrero.

Global biopharma companies face a particular challenge maintaining efficiency in processes to which local affiliates need to contribute for example, global submissions or local case processing. Companies struggle with hundreds of standard operating procedures (SOPs) across the pharmacovigilance quality management system (QMS). Regulatory change can precipitate a global review and modification of processes that must be cascaded locally. Working from one end-to-end database makes it easier to map out the required processes and capability changes. It’s also the best way of ensuring the right people have access to the right data, at the right time.

Despite the buzz over artificial intelligence (AI) and machine learning (ML), there are simple, smart ways to lighten the burden. For example, LEO Pharma prioritized reducing manual labor around case processing and reconciliation. Working with partners in the same system, eliminated monthly data reconciliation with each affiliate. And, algorithm-based automation helped reduce time and resourcing on case processing while remaining compliant. Instead of introducing point solutions, the team is focused on a holistic approach so that the safety data follows a single process from intake to processing, review, and submission. Next, LEO’s safety team will explore avoiding reinventing the wheel by scaling their content reuse.

Launchpad for safety forecasting

While some safety teams may feel unsettled by the changing role of the case processor to higher-value work by freeing up time, there are tangible opportunities. Sharpening a product’s competitive edge could happen at any point during the development process. Perhaps during post-marketing, the safety team identifies that certain patient groups report fewer side effects than other cohorts. These insights could enable commercial teams to focus their efforts on patient groups that would benefit most from the product. They may even help secure a better price when negotiating with payers. Carrero reflects, “Suddenly, we’re doing our jobs for real.”

As Carrero’s team sets its sights on future possibilities, there are no limits to how ambitious pharmacovigilance can be. Forecasting and prediction are likely to be the next focus areas, where safety teams can contribute before the business invests a lot of money — and, more importantly, before anything goes wrong for a patient.

But any shift to proactive, predictive safety first requires access and visibility to a single source of content and data across the drug lifecycle. That foundational work starts today.

To learn more, hear Merck’s safety transformation journey.

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