Gender-Specific Medicine's Imminent Coming of Age

Gender-specific medicine is a new discipline. It has made significant progress over the last couple of decades, which has the potential to transform not only medicine but also the pharmaceutical industry and global healthcare. This article explores some of the most important ethical and legal aspects associated with implementing the principles of gender-specific medicine. This will require that the biopharmaceutical industry focuses on biological sex differences that play an important role in human disease and will mandate changes in global healthcare systems as well. Since drug discovery and development is a very complex, expensive, and time-consuming process that involves not only the biopharmaceutical industry but also entrepreneurs, regulatory bodies, federal funding agencies, private investors, advocacy groups, and nongovernmental/philanthropic organizations, this commentary analyzes how gender-specific research can move from the laboratory bench to the patient's bedside. We will also explore the disease areas most suitable for investigation to begin this translational process. We will discuss the ethical considerations involved in the genetic manipulation of human embryos. Finally, we summarize the driving forces for the full incorporation of gender-specific medicine into clinical practice.