Safety: Pharma’s New Pharmacopoeia

Investments in pharmacovigilance offer an opportunity to drive a new wave of product innovation by using superior safety as a differentiator

By Cheryl Key, Head of PV Platform Service, ProductLife Group

Life sciences, like most industries, are under growing pressure to innovate and find new competitive advantages. To many companies, that might mean embarking on costly new development projects or ambitious mergers to expand the portfolio. But what if a company’s investment and commitment to safety, together with its ability to demonstrate its superiority through growing attention to pharmacovigilance, meant that the company already had an advantage that’s ripe for exploitation?

Today, pharmacovigilance is consuming a lot of resources, touching more parts of the life sciences organization, and placing considerable demands on international operations — including overseas affiliates. Regulatory compliance can be a vast preoccupation, but companies could make more of those associated investments — and take advantage of the knowledge accrued — to both help their products and meet regulatory obligations.

PHARMACOVIGILANCE'S GROWING REACH
As organizations start to appreciate its wider potential, we are likely to see pharmacovigilance having a greater bearing on risk-benefit balancing and related strategic decisions that in the past have been driven predominantly by efficacy (but which now take into account the wider impact of a drug on patients). A drug’s tolerability, and patient perspectives of risk, should have an influence over how and where a product finds itself in the marketplace and in defining the criteria for its choice by prescribers and patients.

If pharma companies want to be able to exploit a product’s superior safety profile, there is some work to do to both measure and define this — both for the product itself and for its comparators and competitors. Barriers need to come down between the pharmacovigilance team and R&D. 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 themselves to play full roles in clinical risk-benefit decision making.

The need to think about pharmacovigilance and tolerability at an earlier stage rather than at the end of phase three, when putting the Marketing Authorization Application or New Drug Application together, becomes essential. Too often, safety information is seen only as something for meeting the obligations and elements of product information post-marketing, rather than as something that can shape clinical development.

The target product profile, which is a standard approach at most pharmaceutical companies, should include more specific criteria for safety and tolerability that are shaped by elements already seen in a product’s competitors. Equally, the development risk management plan can be a useful tool for combining at an early stage both the potential clinical safety risks for patients with factors that will affect compliance, adherence and, as a result, efficacy — such as formulation, how the medicine is delivered, and packaging.

BE BETTER, SAFER OR BOTH
When safety emerges as a particular product strength, companies have a chance to harness it for competitive gain. Biogen’s SPINRAZA (nusinersen), for example, recently passed muster as a treatment for spinal muscular atrophy because its safety profile was found to be better than that of a previously approved product. Amicus’ oral drug, migalastat, for treating Fabry disease was deemed easier to tolerate and to have fewer side effects than already approved and marketed IV treatments, thereby smoothing its approval by the European Commission in 2016.

For companies focused on “me-too” products, having a safety focus could be a strategically important approach. Unless a manufacturer is developing targeted, personalized medicine, they have two real opportunities to differentiate their goods: make their drugs better or safer (or both).

Pharmacovigilance is also likely to gain a seat earlier in merger/acquisition decisions by making sure the safety profile of the target product or company can stand up to scrutiny and that it justifies an approach.

In the post-marketing arena, the role of the qualified person for pharmacovigilance (QPPV) is already evolving. Here, the practice of meeting minimal safety requirements is giving way to more-comprehensive quality assurance. This involves preparing for inspections, making sure systems work and keeping the pharmacovigilance system master file up to date — as well as being able to anticipate risks and dealing with safety issues surrounding the product. These might include tolerability, medication errors, product complaints, manufacturing and packaging.

ROLES & RESPONSIBILITIES
Management of affiliates has become another priority for pharmacovigilance heads. In the past, these roles would have focused on operational activities — such as receiving adverse events, doing the translation, entering the data into the database and ensuring the events were reported to the authorities on time. But now it’s becoming more important to appoint people with pharmacovigilance and quality experience — people who can ensure compliance, who are up to speed with the regulations and understand how these affect everything.

Similarly, the shift in emphasis is beginning to attract a different type of person to the QPPV role. Finding the full range of skills may not be easy, but if being responsible for pharmacovigilance is seen to carry more status and cachet — by being taken into product development and portfolio decisions, for instance, it may become a more-sought-after role, even though the added responsibilities would inevitably drive up salary demands.

Globalization has a bearing here too. QPPV has thus far been predominantly a European remit; now, however, it is a requirement in more markets. This introduces questions around who that person is going to be. On one hand, few QPPVs would be willing to take responsibility in markets outside Europe, because of the legal liabilities. Yet the whole point is to have a single, definitive pharmacovigilance system, so it doesn’t make sense for a global company to have multiple QPPVs.

Until standards are agreed globally, companies will have to keep abreast of all of the international variations in requirements and aspirations — ideally aiming high in their efforts so they can satisfy the demands of most markets — and have to be seen to uphold their professed commitment to patient safety.

Undoubtedly, there are outstanding issues that need to be worked through, but if there is a real chance to exploit investments in safety and safety checks to competitive advantage, this is an area well worth reviewing strategically.

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