Pharmaceutical Executive Europe - November/December 2007 - (Page 32) 32 Risk management Nov/Dec 2007 Pharmaceutical Executive Europe T he prevailing wisdom for investors who want to maximise the value of their financial assets is to evaluate the risks of various investment choices, then create a portfolio with a balance of safety and risk that provides competitive returns while protecting asset value. Prudent investors study the risks and potential returns before they invest to ensure that their investments are appropriate to their situation, and then monitor the returns to maintain the balance of risk and safety over time. Those who fail to do so risk losing everything. For a pharmaceutical company, products in development and on the market are its most valuable assets. The best way to protect those assets is thoroughly to understand the safety and risk of every product from the earliest stages of development. Some risk is good and necessary, in order that R&D not be stifled, but companies must determine the level of risk they are willing to tolerate. Armed with that information, a pharmaceutical company can maintain a ‘balanced’ product portfolio with a mixture of risk profiles that maximises returns for the company’s stakeholders without jeopardising the value of the assets or — in the worst case — the future of the company itself. In the financial world, ‘due diligence’ is the term that describes the research and evaluation of risk. For the bio/pharmaceutical industry, the accepted term ‘pharmacovigilance’ encompasses all of the processes a company utilises to evaluate drug safety and manage risk. Just as individual investors need resources such as research reports, financial software, or a trusted advisor to support their investment decisions, bio/pharmaceutical companies must invest in people, processes, governance, and technology to support an effective, proactive pharmacovigilance system that helps them balance their portfolios for risk and performance. The need for increased investment Significant improvements to the bio/pharmaceutical industry’s postmarketing surveillance and compliance programmes have been made in recent years. As important as post-marketing programmes are for patient safety, however, they are only one part of a comprehensive pharmacovigilance system. Because these monitoring and compliance activities take place after a product has been developed and launched, they do not protect pharmaceutical Due Pharmacovigilance Gadi Saarony explains how increased investment in pharmacovigilance can maximise your portfolio value.
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