Pharmaceutical Executive Europe - November/December 2007 - (Page 37) Pharmaceutical Executive Europe Nov/Dec 2007 Risk management 37 Pharmacovigilance as a competitive advantage Another important aspect of expanding the pharmacovigilance paradigm is to view safety as an asset for the company, rather than as a cost or a liability. A successful, proactive risk management strategy enhances the value of a pharmaceutical company by supporting all of its key goals: ● Bringing safe and effective products to market; ● Keeping marketed products on the market; ● Reducing patient risk; ● Increasing shareholder value; and, ● Boosting employee morale. While there are significant costs associated with investments in improved safety performance, the potential benefits are even larger. If a company’s expenditures for pharmacovigilance prevent just one product from reaching the market only to be withdrawn, or keep just one product from entering — and then failing — Phase III trials, then they will have paid for themselves and provided a handsome return. More importantly, if those investments prevent a single fatal adverse event, their value is incalculable. The competitive advantages of pharmacovigilance are not confined to large, research-based pharmaceutical companies. For the thousands of smaller pharmaceutical and biotechnology companies that do not have products either on the market or in late-stage clinical trials, establishing strong safety and risk management standards tailored to the company’s stage of development and business goals can still pay substantial dividends. If the goal of a smaller company is to develop products through the preclinical period and then license or sell them to a larger company, establishing strong safety programmes targeted at preclinical development will make its products more desirable for potential buyers. In this era of rampant product litigation, widespread public scepticism about the pharmaceutical industry, and greater regulatory emphasis on risk mitigation, the most important benefit of investments in safety performance for any bio/pharmaceutical company may be an enhanced reputation for being concerned about the safety of its products and the patients who use them. Companies must focus on better education for physicians and patients about appropriate product use, a reduction in the incidence of adverse events, elimination of product withdrawals, and other safety improvements. A company with a proactive approach to risk management will reap not only competitive benefits, but also the benefits that come with enhancing its reputation among patients, regulators, lawmakers, physicians, insurers, and the many other important stakeholders that ultimately determine the success of a company in the healthcare field. So, like the investor with a balanced financial portfolio, a pharmaceutical company that invests in pharmacovigilance to help it more accurately balance risk and safety has the greatest chance of increasing the value of its assets and maximising returns over the long term, making pharmacovigilance an investment in success for the bio/pharmaceutical industry. ■ References 1. Thomas J. Moore, Michael R. Cohen, Curt D. Furberg, “Serious Adverse Drug Events Reported to the Food and Drug Administration,1998–2005,” Arch Intern Med 2007 167: 1752–1759. 2. CMR International, 2006, as cited in the PhRMA 2007 R&D report, The Pursuit of High Performance Through Research and Development, prepared by Accenture. 3. CDER Standard NDA/BLA Approval Rates; www.fda.gov/cder/rdmt/app_rate_standard_ndabla_fy.pdf 4. Kola and Landis, “Can the Pharmaceutical Industry Reduce Attrition Rates?” Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008, 212–213. About the Author Gadi Saarony is corporate vice president and worldwide head, PAREXEL Consulting. Prior to his current role, Mr Saarony led the GxP Strategic Compliance and Operational Performance Excellence practice worldwide. Before joining PAREXEL in 2003, Mr Saarony was an associate director, strategy, with Ernst & Young, LLP. He graduated from Rider University (New Jersey, US) with a degree in Economics and a Masters degree in International Business (MBA) from The American Graduate School of International Business (Thunderbird). http://www.fda.gov/cder/rdmt/app_rate_standard_ndabla_fy.pdf
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