Drug Safety Pharmacovigilance in the ‘New Pharma’ Ron Fitzmartin1 and John Wise2 1. Managing Partner, Decision Analytics, LLC, Woodbridge, Connecticut; 2. Executive Director, Pistoia Alliance, Milton Keynes
Abstract
The traditional monolithic biopharmaceutical company is being replaced by the ‘New Pharma’ – Pharma 2.0 – the Fully Integrated Pharmaceutical NETwork (FIPNET) – an ecosystem of agile partners working collaboratively to deliver benefit to patients and value to financial stakeholders. Many important but nonetheless commodity operational services are being outsourced. Should pharmacovigilance be one of them? Some argue that ‘pharmacovigilance is too important to be outsourced’ yet the regulations constraining biopharmaceutical companies are the same for all, as are the legal and societal constraints. Furthermore, as pharmacovigilance software vendors consolidate (there will soon be just two) pharmacovigilance software functionality will almost all be the same too. The New Pharma must become focused on the advanced analytics of pharmacovigilance and signal detection, rather than dissipating its energies on the ‘handle turning’ of adverse drug event collection and regulatory reporting. Whether this is best achieved in-house or out-of-house is now an important decision for New Pharma.
Keywords
Pharmaceutical industry, pharmacovigilance, signal detection, advanced analytics, risk management, software vendor, software as a service (SaaS), outsourcing, contract safety organisation (CSO), business process outsourcing (BPO)
Disclosure: The authors have no conflicts of interest to declare. Received: 19 June 2010 Accepted: 17 November 2010 Citation: Drug Development, 2010;5:12–4 Correspondence: Ron Fitzmartin, Decision Analytics, LLC, 238 Peck Hill Road, Woodbridge, CT, US. E:
ronfitzmartin@msn.com
Pharmacovigilance is Important But is it a Core Function? The ‘New Pharma’ – Pharma 2.0 – the Fully Integrated Pharmaceutical NETwork (FIPNET) – is old pharma’s response to global society’s demands for a revolution in drug development. It is materialising as an integrated, networked and collaborative ecosystem of agile partners delivering benefits to patients and financial stakeholders.1
With such a
paradigm, should the pharmacovigilance function be a core component of this New Pharma or just another of its important, but nonetheless commodity-based, operational services?
It is an essential activity for a biopharmaceutical company to perform for the regulatory agencies mandate that serious adverse events be reported to them in an International Conference on Harmonisation-standardised format within clearly specified timelines. In times gone by, that was the end of the matter. Now with significantly increased public, and hence regulator, focus on drug safety and risk mitigation, signal detection is an additional important activity to be undertaken by the pharmacovigilance function.
The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug- related problems.2
According to the WHO, a signal can be defined as reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously.2
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biopharmaceutical companies with the capability to better understand the safety profiles of therapies they bring to the market.
A number of questions in terms of efficiency have arisen in recent years. One of these is: does each pharmaceutical company need to collect, manage, analyse and report on all this data itself? Cannot such transactional and indeed analytical work sensibly and more cost-effectively be outsourced to a third party, specialist, contract safety organisation (CSO)?
To Outsource, Insource or Both?
A study of pharmacovigilance deployments has shown that substantial cost-savings of 30–40% can be made by outsourcing pharmacovigilance.3
Indeed, some pharmaceutical companies are
pursuing such an approach, at least in part. One need only refer to the CSO directory published by the Drug Information Association. Until a few years ago there were only a few CSOs listed; now there are many references to such companies
Signal detection provides
Despite this growth in choice and capacity of externally provided pharmacovigilance services, many pharmaceutical companies assert that ‘pharmacovigilance is much too important to be outsourced’. Others will outsource the spontaneous reporting of adverse events associated with their well-established, low-risk products to CSOs. However, they will retain the pharmacovigilance activities in support of their higher-risk compounds or drugs in development.
© TOUCH BRIEFINGS 2010
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