The pharmaceutical industry is currently facing some key challenges, like an increase in drug development costs, a decrease in the number of drugs being approved and scrutiny from regulatory authorities. Patients themselves are also demanding more effective and safer drugs.
Pharmacogenomics says they can help to guide drug development and therapy by correlating gene expression with a drug's efficacy. Personalized medicine is the result of individualized pharmacotherapy, which allows the formulation of drugs that offer appropriate treatment to the right person as needed.
Recent reports of mishaps taking place due to improper drug metabolism, even when taken at optimal dose, have forced companies to consider individualized medicine more of a necessity than a mere research project, notes public relations company Frost Sullivan's Research Analyst Prabakar Sampath. Every year several hundreds of patients either do not benefit from the treatment they are provided or develop adverse reactions to it. These are compelling reasons enough to pursue personalised medicine as a future directive.
Critics of personalized medicine often suggest that interest in research for a given pharmacogenomics study would decrease because it would only serve a niche market. They contend that a personalized approach would reduce new patient trials for some therapies.
However, a reduction in initial sales will be compensated by greater compliance, leading to higher product use, says Frost Sullivan. They believe that the commercial feasibility of personalized medicine is not what is gained or lost by moving forward, but what is at stake by not moving forward.
The desire to meet patients' unmet medical needs, the necessity for product differentiation to gain market share and reimbursement in increasingly crowded markets in several therapeutic areas are forcing companies to invest in pharmacogenomics research, notes Sampath.
Already, genetic testing has been made easy with the increase in availability of reagents and pharmacogenetics services. Diagnostic laboratories are marketing pharmacogenomics services to physicians and in some cases, patients too.
The ideal application of pharmacogenomics would be to integrate it into clinical and nonclinical studies in order to provide value to pharmaceutical RD by supplementing the information from these studies, says Sampath. The goal is to provide safer and more efficient medicines, combined with diagnostics, in order to meet the needs of patients.
Pharmacogenomics provides a novel area for product differentiation, competitive advantage, and enhancement of RD productivity and the pharmaceutical industry must decide if it can apply in its R&D programs.
Recent initiatives, such as the formation of several pharmacogenomics-focused consortia, new regulatory guidance documents, the introduction of legislative bills and high-profile safety concerns continue to illustrate the prominent role pharmacogenomics will play in moving drug development and therapy from a population-based to an individualized paradigm.
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