Traditionally seen as the department of bad news and marred by largely incomprehensible jargon to non-experts, pharmacovigilance (PV) has more recently morphed into a vital activity that spans a medicine’s entire lifecycle, starting as soon as it enters human trials. The overall objective is to ensure that safety signals are identified as early as possible to minimize the risk of serious safety issues causing harm to public health. Strict regulatory requirements and the increasing focus on collecting safety data outside of the rigid environment of clinical trials should continue fuelling demand for PV services, with specialized service providers particularly well positioned to benefit from the rising outsourcing trend.

Most data collected through surveillance
Most PV activities span an entire drug’s lifecycle, starting in Phase I development. The latter includes adverse event reporting and management, which essentially consists of the collection of vast amounts of safety data and subsequently its interpretation. While safety data forms a critical part of a drug’s regulatory dossier, most information from a PV process is obtained through surveillance rather than formal clinical testing, with the bulk collected once a drug is on the market. Clinical trials are commonly conducted in a homogeneous patient population based on stringent enrolment criteria. Hence, they often fail to capture events that only become apparent once a drug is used in a large population, including both rare events and those with a long latency period.

Strict regulatory requirements are the single most important driver
Demand for PV services has risen significantly in the last decade, due largely to several high-profile safety issues, which in a few cases have forced manufacturers to withdraw drugs from the market. As a consequence, health authorities worldwide have been enforcing stricter regulatory requirements through the passing of new legislation. Not only has this increased the level of drug safety reporting required by drug manufacturers, but it has also led to a substantial rise in post approval (Phase IV) studies, which are usually larger and of longer duration than pre-approval Phase III studies, as well as risk evaluation and mitigation strategies (REMS) and other risk management programs. This has translated to an increased burden for biopharma companies of all sizes and a concomitant shortage of skilled professionals, therefore fuelling demand for outsourced service providers.

Outsourcing is on the rise
Concerns around confidentiality, data security and potential liability arising from non-compliance with regulatory requirements were among the key reasons biopharma companies were traditionally reluctant to outsource pharmacovigilance activities to external service providers. Outsourcing was therefore mostly limited to the management of serious adverse events (SAE) and pharmacoepidemiology studies. However, most companies no longer have the choice but to outsource to specialized service providers, for a variety of reasons.

Reasons to outsource depend on the type of organization
Large pharma companies outsource mainly to shift fixed to variable costs, manage temporary peak demand, access unique capabilities and to streamline and automate their adverse management systems. At the other end of the spectrum are biotechs, who usually lack any form of safety department and therefore outsource most pharmacovigilance activities. Those companies that fall in between seek external help, for example, due to lack of appropriate infrastructure and personnel, as well as limited regional presence.

Specialized service providers compete on the global stage
The growing demand for external service providers has led to the emergence of a number of highly specialized companies focused on drug safety and pharmacovigilance who successfully compete with the two traditional groups of service providers: large global CROs and industry agnostic business process optimizers. We would expect M&A in this field to accelerate as emerging companies gain scale while larger players look to reach critical mass and acquire additional expertise.

Results Healthcare is holding a pharmacovigilance panel event on March 18, 2015. We anticipate a lively and interesting debate, fuelled by highly experienced panelists from diverse backgrounds. Please contact jhartley@resultsig.com for further details. 

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Brigitte de Lima
Results Healthcare

Brigitte de Lima, manager, Results Healthcare, joined the company in April 2013 from a long/short start-up investment fund focused on healthcare. She has nine years of experience in the healthcare sector, with particular expertise in biotechnology. Brigitte started her career as a healthcare analyst at Datamonitor. She then worked as an equity research analyst at Merrill Lynch and then Bank of America Merrill Lynch.