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Sex is presently recognized as an important biological vari- able. FDA and NIH policies have sensitized researchers to the importance of sex differences stimulating a gradual increase of women enrollment in clinical studies over the last decade. There is now substantial evidence of sex differences in disease prevalence, disease presentation and response to treatment. It is obvious from these findings that simply including women to fulfill regulatory standards will not suffice for causal iden- tification of response differences. With the emergence of personalized medicine, a mechanistic understanding of sex differences that incorporates cutting edge research and eva- luation tools such as genomics, biomarkers and bioinfor- matics is fundamental to progress in medicine. This paper focuses on sex as one essential variable in understanding differences in response to therapies. It should be noted that other variables (e.g. age, race) contribute to variability in response, making the evaluation of therapies a complicated process.
The rising cost of medical product development and the increased rate of attrition are impediments to health care product development. It is crucial to explore and adopt more efficient ways to evaluate safety and efficacy of medical products. Despite large investments in clinical trials, several questions related to varied responses in subpopulations remain unanswered. Although inclusion of adequate num- bers of women and men, as well as other demographic groups, allows for a better understanding of subpopulation differences, it concurrently drives up the cost of and time for product development. Pharmacogenomic and biomarker guided drug, device and biologic development have paved a new path towards personalized medicine using mechanistic rather than empirical approaches.