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July 31, 2009, Washington, DC
A new study funded by the National Pharmaceutical Council (NPC) shows that pharmacogenomics-the field of scientific research focused on learning how genetic profiles predict the body’s response to medicines-has the potential to lead to higher levels of research and development (R&D) investment and an increased pace of pharmaceutical innovation, offering substantial benefits for patients.
The study, “The Future Costs, Risks and Rewards of Drug Development: The Economics of Pharmacogenomics,” was written by Joseph Cook and Graeme Hunter of NERA Economic Consulting and John Vernon of the University of North Carolina at Chapel Hill, and published in the July issue of PharmacoEconomics. According to the study, pharmacogenomics can provide more focused and targeted information to researchers during the R&D process, potentially reducing the number of patients needed for clinical trials as well as the cost and time required to complete the trials. Products could reach the market faster, providing a longer period of time over which the innovator companies could recoup the investment costs of developing products.
“We may see pharmacogenomics pushing us in the right direction of more investment in pharmaceuticals,” said study author John Vernon. “The main features likely to drive this phenomenon are the ability of pharmacogenomics to drive adoption of drugs and lower costs of development and time to commercialization. Of course, we have yet to see how these factors are likely to play out, but pharmacogenomics has the makings of a powerful force for economic change and encouraging the financing of new drugs and treatments for patients.”
For example, better information about the patients who are more likely to respond to a medication could increase the rate of use of that medicine. Biological markers also could help to identify patients for whom a drug may pose a significant risk of harm. Knowing which patients are not appropriate candidates for a certain drug may help increase the likelihood that a product that might otherwise have been dropped from development could make it to market and become available to treat those patients who could benefit. Thus, as companies make decisions about products to develop, the potential for a product to generate a positive return on investment could well be affected by the improved information that pharmacogenomics can offer. As the study notes, this could have important implications for patients in the U.S. through the improved availability of new pharmaceutical and biological innovations.
The authors caution, however, that because this is such a new field of study, “there is considerable uncertainty as to how the area will evolve, both clinically and economically.” Although “the time horizon necessary for the science to develop and be adopted into clinical practice is not clear,” the study does “shed some light on possible outcomes and provides researchers with a better understanding of the economics of pharmacogenomics.”
“The ability to target medicines more specifically to patient groups is a significant change in the pharmaceutical landscape,” said Dan Leonard, NPC President. “This study shows how pharmacogenomics can positively affect innovation and lead to increased benefits for patients.”
NPC will continue to explore the issue of targeted, or personalized medicine, during an October 28 conference hosted in conjunction with the Personalized Medicine Coalition. Further information is available on NPC’s website, www.npcnow.org.
To download a copy of the pharmacogenomics study, go to https://articleworks.cadmus.com/doc
About the National Pharmaceutical Council
NPC’s overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization’s strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation’s major research-based biopharmaceutical companies. For more information, visit www.npcnow.org.