Pharmacogenomic Study Feasibility Assessment and Pharmaceutical Business Decision-Making

With the relatively short history of pharmacogenomics being applied in the context of the pharmaceutical industry, many questions and concerns (some legitimate, some not so legitimate) arise regarding the appropriate implementation of this technology to deliver the greatest value. Questions on how to make a decision about whether to embark on a given pharmacogenomic study, concerns around generating potentially uninterpretable results in a regulated environment, and uncertainty regarding the true business value and implications of this research are not uncommon. This chapter offers recommendations for a systematic approach to assessing the feasibility and the added value of pharmacogenomic studies in clinical trials. Specifically, the Multi-Attribute Decision Analysis (MADA) approach is described and tailored to the application of pharmacogenomics in industry. Particular attention is given to one attribute of the MADA, namely Commercial Value and Risk . A sensitivity analysis for assessing this attribute is presented by highlighting the potential impact of pharmacogenomic biomarkers on basic forecast factors. Since feasibility assessments must be tailored on a case by case basis, it is not realistic to offer a specific set of instructions that will apply to every possible situation. A number of examples are used to draw attention to some of the key points to consider. The overall intent is to help improve the probability of success of pharmacogenomics in the industry and to highlight the importance of education and cooperation among experts from a range of divergent functional areas.