Up to now, drug safety has been viewed primarily as a matter for compliance and risk management. Not quite a necessary evil, nor is pharmacovigilance the positive contributor to drug development success and to optimal outcomes for patients that it could and should be. That needs to change, according to Lucinda Smith, chief safety product officer at ArisGlobal.
ArisGlobal
From original drug developers to contract manufacturers, the producers of human medicines have both a regulatory mandate as well as a duty of care to patients to ensure that their products are safe. From the drug developer’s perspective, that safety remit also includes ensuring the optimal beneficial impact for the highest number of patients. This expectation is intrinsic to claims around patient centricity, while a product’s commercial success will also be inextricably linked to honed population targeting and reach.
Up to now, however, drug safety’s primary remit - to deliver the best possible outcomes for the maximum number of patients, with minimal risk of harm - has been overshadowed by the function’s primary association, with compliance. This situation has been exacerbated over the last two decades, with the steady rise in regulator expectations around safety monitoring and reporting. As associated pharmacovigilance (PV) workloads have risen, the Safety function has been tarred with the “cost centre” brush and become a focus for streamlining. Any process transformation has been around absorbing increasing workloads (e.g. around adverse event - AE - case processing) without adding costs.
For adjacent functions, meanwhile, Safety has been seen as an inhibitor to new drug delivery - a function that is always seeking additional assurances; always conservative. Along the way, something important has been lost. That is the extended value represented by Safety, by virtue of its insights, and through its expertise. This additional value is needed now more than ever, as products and therapies become more targeted and personalized, and costlier as well as riskier to develop and bring to market.
Inserting Safety earlier into the drug development cycle
Including the expertise and insights of Safety teams much earlier in the drug development cycle offers manufacturers the opportunity to identify and manage safety issues much more proactively and pre-emptively, with a boost to internal efficiency. Those insights could help hone trial design, as well as a product’s scope. Early Safety insights could also help ‘kill’ unviable products sooner, before sunk costs spiral. All of this reduces the risk to patients and to the company, while maximising the reach and beneficial outcomes of the approved product.
The need to strategically reposition Safety is compounded by the unsustainability of current PV processes and resource use. As long as the time and skills of Safety teams are tied up in the day-to-day burden of manual AE processing, authoring aggregate reports, and analysing false signals, their scope to distil important insights for drug development will be curtailed.
It is why processes must be modernised1, harnessing the available technology. 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 innovation2.
Initiating the shift
Technology is proving a significant enabler in reframing PV’s contribution to drug development, by taking much of the strain of routine, resource-intensive work. Artificial intelligence (AI), in particular Generative AI (GenAI) technology, can now readily streamline activities such as capturing AE information straight into a database, for example.
Once Safety teams’ time has been freed up, the next priority must be to allow them earlier input, and a louder voice, in the drug development cycle. The more that other internal groups can come to see Safety as an ally (the way to get their products to market), the better the outcomes for everyone.
This starts with reemphasising the value of Safety’s input, and fostering greater collaboration between adjacent functions. This does not equate to collecting more data for its own sake, but rather identifying the optimal combination of data to support a rounded understanding of the safety profile.
Many products now go to market with far less clinical data now than in the past - especially in areas of unmet medical need. Closer collaboration with local markets will help ensure that on-market data is collected and assessed quickly and effectively, and insights fed back into product advancement.
Change is never easy, but it must be embraced. Establishing incremental improvements in productivity, efficiency and quality, and learning from them, is a good way to promote progress - even if this starts simply, e.g. deploying GenAI for automatic AE data extraction in Individual Case Safety Report (ICSR) work.
The more that advanced technologies can take care of more of routine, high-volume work, the easier it will be for Safety to speak up for patients in drug development, and become a more active contributor to biopharma innovation.