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Pharmacovigilance as a discipline should not be confined to regulatory compliance. Leading life sciences companies are using it to shape a number of strategic priorities, from M&A decisions to product innovation.

Compliance activities consume so much budget and so many resources that it is in companies’ best interests that they be able to exploit those investments to greater strategic advantage. It is the same with pharmacovigilance, whose reach as a discipline is fast extending beyond its immediate purpose.

If safety is a huge and growing concern for regulators and consumers—nowadays reflected in increased audits and inspections—doesn’t it make sense that safety should also become a source of product selection, differentiation, and R&D focus? Certainly, pharmacovigilance is touching more and more parts of life sciences organizations—as well as their international operations including affiliates—by spanning multiple functions.

At today’s life sciences organizations, the breaking down of silos and the establishment of greater collaboration between pharmacovigilance operations and quality operations is more and more a priority, and it’s becoming evident that responsibility for the monitoring of safety and associated systems has to be shared by an increasingly diverse range of stakeholders.

Greater Role in Due Diligence

Pharmacovigilance also has a bearing on risk–benefit balancing and related decisions, as fuller discussions take into account a drug’s wider impact—not just its immediate effect—on patients, its cost, and how effective it is relative to what else is on the market.

Companies are now more and more bringing in safety experts earlier in their M&A decisions so they can better assess the safety credentials of target products and their companies—in a recognition that poor choices could cost their business more than they would stand to gain in new sales. In time and as a result, we’re likely to see pharmacovigilance having a more formal and more prominent seat in the due diligence process.

When safety is seen as a strength, increased market potential could result. For example, Biogen recently had its first product approved for an orphan indication (nusinersen as a treatment for spinal muscular atrophy) because the drug’s safety profile was superior to that of the product that had been approved earlier. That approval gave nusinersen a superior risk–benefit profile.

Amicus, meanwhile, has been granted approval for an oral drug—Galafold—for treating Fabry disease. The product turns out to be easier to tolerate and to have fewer side effects compared with already approved and marketed IV treatments.

Integral Part of Clinical Development

Safety is becoming an interesting area for differentiation, then, when all other factors are equal. That in turn requires that pharmacovigilance and medical safety become integral parts of the clinical development plan, with implications for reach, integration, and management systems—and for pharmacovigilance skills.

Leaders in the discipline now have to equip themselves with the relevant business skills so that they become able to play full roles in clinical risk–benefit decision making. And to support the evolution of a pharmacovigilance department with an integral role in R&D, they’ll also have to develop higher-level visions and strategic overviews.

The role of the qualified person for pharmacovigilance (QPPV) is already evolving because quality assurance is becoming the chief concern, as opposed to merely meeting minimal safety requirements. The role is now much more devoted to readiness for inspections, making sure systems work, and keeping the pharmacovigilance system master file up-to-date. As some in the industry have already found, the shift in emphasis is beginning to attract a different type of person to the role.

Closely Watching Europe

The European Medicines Agency’s relatively well-evolved good-pharmacovigilance-practice guidelines are being closely watched by other regional markets, which might adopt many of the same principles in time—albeit with their own individual emphases. So, until standards are agreed to globally, companies will have to keep abreast of all of the international variations in requirements and aspirations—ideally, aiming high in their efforts—to satisfy the demands of most markets and to be seen to uphold their professed commitments to patient safety.

Asking one sole person, originally with a Europe-specific remit, to take on other territories is a tall order because of the additional liabilities, yet having multiple QPPVs doesn’t lend itself to a centralized process and system for managing all of those requirements.

The management of affiliates is a further consideration. In the past, in the hiring of a safety person in an emerging market, such a role focused on operational activities such as receiving adverse-event data, doing translations, inputting data, and ensuring events got reported to the authorities in a timely fashion. Now, by contrast, pharmacovigilance and quality experience is considered more important—in terms of having people who can ensure compliance and who know about regulations and how they affect everything a company does.

Clearly, outstanding issues remain to be worked through, but our expectations are that pharmacovigilance as a field will continue to expand in reach and importance and that life sciences organizations should be looking to profit from that expansion as much as they can—by encouraging and promoting pharmacovigilance’s growing influence and making sure the business can capitalize on it in all the right places.

About the Author: Adam Sherlock is Chief Executive Officer of ProductLife Group, which provides pharmacovigilance services, helping life sciences organizations manage information and stay compliant across the product life cycle.

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