Pharmacovigilance in the ‘New Pharma’
If each pharmaceutical company installs, maintains, upgrades and supports its own pharmacovigilance system there is a huge amount of work and cost involved. With each new (possibly annual) software release implemented, a company must exert an expensive, time-consuming and energy-sapping validation effort. As such, many companies avoid upgrading their software until it is has become so out-of-date and out-of-support that the upgrade is unavoidable. The upgrade effort, including data migration and validation activities, then becomes even more exhausting. Such an in-house approach to the provision of pharmacovigilance systems means that each biopharmaceutical company is replicating the work of every other biopharmaceutical company simply to produce the mandatory regulatory reports and basic signal detection.
With the considerable cost and effort involved, how is it that the management of clinical data, laboratory data, records and documents can be outsourced by pharmaceutical companies, yet safety data management cannot? Even discovery can be outsourced. A decade or so ago the concept of outsourcing clinical data management was unheard of. Now it is not uncommon to observe this being effected by small, mid-sized and large pharma. Safety data management is still predominately in-sourced. One major pharmacovigilance software vendor has at least four service offerings for pharma that include:
1. selling the software and pharma installs and runs it; 2. selling the software and the vendor will install and run it; 3. providing pharma access to the software, which is hosted by the vendor (software as a service [SaaS]); and
4. providing pharma with a full-service, outsourced pharmacovigilance capability (business process outsourcing).
Such a collection of service offerings would imply that at least some pharmaceutical companies are seeing the value of migrating from the familiar in-house provision of pharmacovigilance systems (option 1) to increasingly cost-effective ways of delivering a pharmacovigilance service (options 2 through 4).
Pharma has and continues to shed people and facilities and deploys business processes in its attempt to become more efficient. It is looking to focus its energy on key therapeutic areas and the core competencies that will support and deliver products to the market. So why is pharmacovigilance considered so special? Can in-house systems really demonstrate a better cost/quality return on investment than an outsourced SaaS ‘best of breed’ system? Can in-house pharmacovigilance departments demonstrate improved return on investment in terms of cost versus quality than an outsourced CSO? Outsourced service providers can exploit economies of scale, provide support by first-class personnel and deliver a premier service at a fraction of the internal cost.
Clearly the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulations and guidelines do not demand that each company has its own pharmacovigilance system. So what drives this special approach to pharmacovigilance? There are a number of controversial, albeit pertinent, questions that need to be considered here.
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Are the pharmacovigilance vendors and associated consultants maximising their own profitability by encouraging pharma to
DRUG DEVELOPMENT maintain in-house systems under the guise of avoiding risk? •
Are the pharmacovigilance departments of pharmaceutical companies trying to protect their status quo and the comfort and security of their jobs within the industry?
• Does senior management understand that risk management is just another activity – exploiting skills across the value chain – and not simply the name of a department?
Which Pharmacovigilance System to Use? Recently, Phase Forward offered their EmpiraTrace (ClinTrace) system, Argus had Relsys, Oracle had AERS and ARIS Global produced the eponymous ARISg system. In March 2009, Oracle purchased Argus and in April 2010 announced its intention to acquire Phase Forward. In just over a year, the major companies in the pharmacovigilance software business have been reduced from four to two.
What does this consolidation mean to pharma? One effect might be to minimise the tendency of pharmacovigilance software companies to modify their software to suit the whims of their individual clients. Pharma companies are prone to displaying hubris about their business processes; each thinking its processes are better than its competitors. Few appreciate the fact that the regulatory environment, legal environment, the public, the systems and therefore the different ways of operation are pretty much identical.
If pharmacovigilance organisations were required to re-engineer their processes to fit industry best practice – supported by industry best-configured software – that in itself would contribute significantly to efficiency. One of the major software vendors remarked that it was preferable to focus its product development attention on a few CSOs rather than a multiplicity of pharma companies. It was easier for the software vendor to determine from these CSOs what the major industry trends were that their software needed to follow and support.
The major pharmacovigilance software vendors should provide the statistical tools and visualisation software required for signal detection. ARIS Global offers agSignals, Oracle can offer its Argus Perceptive and Phase Forward (Oracle) has its Empirica Signal product. Qscan provides at least four competing products. However, many pharmas still insist on developing in-house algorithms, with some some adding Spotfire’s DecisionSite as a visualisation tool.
Follow the Data
In the world of pharmacovigilance and signal detection, there are: •
• • •
the FDA’s Adverse Event Reporting System database containing ~4 million records;
the Vaccines Adverse Events Reporting System (VAERS) with ~300,000 records;
the EMA’s EVDAS (EudraVigilance Data Analysis System) with ~570,000 records; and
The WHO’s Vigibase with ~4.7 million records.
Title IX of the Food and Drug Administration Amendments Act, passed into US law in September 2007, mandates that the FDA must have access to 100 million patient records by 1 July 2012 for proactive safety analysis and detection. Clearly the pharmaceutical industry-centric data sources listed above will not provide sufficient record numbers. For this reason the FDA launched its Sentinel Initiative, which will enable the FDA to access existing healthcare data to find such signals
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