Pharmacovigilance, product safety, and differentiation in life sciences

If the life sciences industry has to raise its game in pharmacovigilance, it may as well make it pay—especially if new diligence turns up product safety as a potential market differentiator, says Cheryl Key, head of PV platform services at ProductLife Group.

To many pharma firms, the call to innovate means giving the go-ahead to ambitious new development projects or becoming more acquisitive. Yet it could be that a company’s commitment to safety and a company’s ability to demonstrate its superiority already offer an edge the company could be taking more advantage of—and pharmacovigilance is helping uncover that.

When enhanced safety is highlighted as a product strength, companies have a chance to harness that for competitive gain. Biogen’s nusinersen product recently succeeded in getting approval as a treatment for spinal muscular atrophy because the drug’s safety profile outperformed that of a previously approved product. Similarly, Amicus’s migalastat drug for Fabry disease has been approved based on being easier to tolerate and having fewer side effects than already approved and marketed IV treatments.

A company’s ability to exploit pharmacovigilance for strategic market advantage depends on its recognition by and integration with the wider business. And we’re already starting to see pharmacovigilance as a discipline that’s beginning to play an earlier and earlier role in influencing whether product or company acquisitions go ahead, so that companies don’t expose themselves to unnecessary risk by taking on products with inferior safety profiles.

Barriers have to come down between the pharmacovigilance team and R&D so that safety measurements can be fed back into development. Pharmacovigilance/medical safety must be an integral part of the clinical development plan, and leaders in the discipline will have to acquire additional skills to enable them to play full roles in clinical risk–benefit decision making.

The role of the qualified person for pharmacovigilance (QPPV) is already evolving, as meeting minimal safety requirements gives way to more-comprehensive quality assurance, thereby preparing a company for inspections, making sure systems work, and keeping the pharmacovigilance system master file up-to-date, for example. As some in the industry have already found, the shift in emphasis is beginning to attract a different type of person to the role of QPPV.

Finding staff with the full range of skills for the increased remit may not be easy, but if pharmacovigilance responsibility is seen to carry more status and cachet by making a welcome contribution to product development, portfolio decisions, and so forth, it may become a more-sought-after role, even though the added responsibilities would inevitably drive up salary demands.

Undoubtedly, outstanding issues remain to be worked through, but if there’s a real chance to exploit investments in safety and safety checks to competitive advantage as market differentiators and market approval enablers, this is an area well worth investing in strategically.

About the author

Cheryl Key, MBBS, MFPM, is head of practice PV platform services/principal medic at ProductLife Group, with final responsibility for all projects, programmes, and engagements in the platform, as well as for day-to-day management of the platform team.