Safe mode

From today’s laborious compliance activity destined for heavy streamlining, to a proactive champion of patient priorities, a liberated pharmacovigilance function could play a much more strategically important role in drug development – and it must, says Lucinda Smith of ArisGlobal.

At the beginning of the decade, the role of drug safety attracted unprecedented mainstream attention. That was as the pandemic took hold, and as pioneering COVID-19 vaccines entered the market – and a raft of diverse treatments was applied – in the hope of virus containment and mass-scale symptom relief.

Suddenly, whole generations gained a first-hand appreciation of side-effects at scale – and of the fundamental assumption that the products they take are safe.

They now truly understood the importance of being able to quickly and efficiently capture accurate data, spot trends, draw robust conclusions about emerging safety issues, and act on them promptly, and expected companies to do this.

Yet, the pharma industry missed its opportunity to more permanently reframe pharmacovigilance (PV) and its scope for wider contribution to the drug development cycle, an oversight that has persisted until now.

Over the last couple of decades, drug safety’s primary remit – ensuring optimal outcomes for patients – has become diluted amid the rising demands of regulators.
As workloads have soared, the function has assumed ‘cost centre’ status, and become a target for significant streamlining – to enable the absorption of increasing workloads (e.g. around adverse event – AE – case processing) without adding costs.

Across the wider drug development ecosystem, meanwhile, Safety has (unfairly) found itself with a reputation as an inhibitor to new drug delivery – a conservative function always seeking additional assurances. In the process something important has been lost. That is the extended value represented by Safety, by virtue of its unique vantage point and rich patient/product insights.

As products and therapies become more targeted and personalised, and expensive to develop, one of the challenges is to ensure that they are made available to as many applicable patients as possible. Earlier, more timely involvement from Safety would enable more prompt identification and management of safety issues, at a point where valuable interventions can be made.

That could include ‘killing’ unviable products at an earlier stage. All of this reduces the risk to patients and to the company, and maximises the reach and beneficial outcomes of the approved product.

Today, Safety teams’ time is almost entirely consumed with the routine burden of manually processing AEs, authoring aggregate reports and analysing false signals. As a result, those professionals’ potential for strategic redeployment remains limited.

It is why, in the light of soaring workloads, processes must be modernised using advanced technology. Artificial intelligence (AI), especially generative AI (GenAI) technology, can now readily streamline activities such as capturing AE information straight into a database. That’s as long as teams trust the output sufficiently.

Implementing appropriate governance and oversight, and adapting quality assurance measures, can help here, maximising GenAI’s scope for resource liberation.

At the same time, Safety teams must now use their voice in internal decision-making – advocating both for patient outcomes and for maximum market success.

The more that internal groups grow to see Safety as an ally (anticipating AEs, honing a product’s drug safety profile, smoothing the path to market) the greater the scope to manage risk effectively. This could be through more products succeeding, or via reduced financial exposure (if a product can be killed earlier).

A national study in Italy published late last year into the need for PV’s reinvention highlighted the need for greater strategic alignment between the Safety function with business objectives and stakeholder focus – including those around patient-centricity and biotech innovation.

The optimal transition is likely to be two-way, whereby Safety teams embrace opportunities to better manage their time and use their voice in more influential ways, while adjacent internal functions become more open and receptive to the rounder value that Safety could bring to product advancement.

Given the immense pressure to accelerate drug development and delivery cycles now, pharma companies must give new emphasis to managing the Safety data that is collected at each stage. This is not about capturing more of it for its own sake, but rather identifying the optimal combination of data to support a rounded understanding of the safety profile.

To achieve this, there needs to be earlier collaboration and a development of trust between the respective groups, so that everyone is pulling in the same direction.

With many products now going to market with much less clinical data than previously – particularly in a context of unmet medical needs – careful planning and close collaboration with local markets is essential. This is to ensure that on-market data is collected, assessed and fed back quickly and effectively.

An additional driver of change could come from companies’ expansion into medical device development, establishing a greenfield scenario for modern Safety/PV.

Where existing processes and ways of working in PV have become complex over time, approaches to Safety for medical devices can be built from the ground up in a more connected, streamlined and digital-first way. Any resulting best practices could then be adapted and applied to longer-held pharma PV practices.

Either way, the time for substantial change has come, even if this begins with relatively modest and incremental improvements to processes – such as first harnessing GenAI to enable automatic AE data extraction in Individual Case Safety Report (ICSR) work. Being able to show what’s possible will help inspire – and justify – next steps.

Certainly, the more that advanced technologies are called on to alleviate pressure and accelerate routine process delivery, the easier it will be for the Safety function to move up the value chain and play a more proactive and strategic role at the core of product advancement.