Humans have devised machines to replace computation by individuals since ancient times: The abacus predated the written Hindu–Arabic numeral system by centuries. We owe a quantum leap in the development of machines to help problem solve to the British mathematician Charles Babbage who built what he called the Difference Engine in the mid-19th century. But the Turing formula created in 1936 is the foundation for the modern computer; it produced printed symbols on paper tape that listed a series of logical instructions. Three decades later, Olivetti manufactured the first mass-marketed desktop computer (1964), and by 1981, IBM had developed the first personal computer. Computing machines have become more and more powerful, culminating recently in Google’s claim that it had achieved quantum supremacy in developing a system that can complete a task in 200 seconds that it would take the most powerful type of classical computer available 10 000 years to achieve. In short, we are in a period of human history in which we are creating more and more powerful and complex machines potentially capable of duplicating human intelligence and indeed surpassing/expanding its power. We are solidly in the age of artificial intelligence (AI). Increasing interest in the development of AI and its application to human health at all levels makes a roundtable discussion by experts a valuable project for publication in our journal, Gender and the Genome , the official journal of the Foundation for Gender-Specific Medicine and the International Society of Gender Medicine.

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.

The high price of medicines, the ongoing productivity crisis at the biopharmaceutical industry level, and the current world's health-care crisis, underline the need for more efficient approaches to bring drugs to the market. In this chapter, the "Core Model"—a novel organizational paradigm for research and development—is described to demonstrate the powerful potential of effective translational science and academia/industry–public/private collaboration in discovering and developing new drugs. The implementation of the Core Model, in a systematic manner, and the creation of relevant public policy initiatives fostering translational science and more academia–industry collaborations, could have a tremendous positive impact in solving some of the most important pharmaceutical and health-care problems worldwide.

The world is going through a health care crisis—that is, a financial crisis in which countries cannot successfully meet the twenty-first century person's access to medicine due to the rising cost of health care services and, more importantly, of pharmaceuticals. This was not the case a few decades ago, especially in the wealthier nations. Not surprisingly, people all over the world have expressed great dissatisfaction and concern about this situation, which is generally perceived as unsustainable in the near future. This health care crisis is worsened by rising age-dependency ratios and aging populations in these countries; and it then competes with the pension crisis for the money and political will that are needed to solve these problems. Though a health care crisis is more evident in the developing world and the United States—the country with the worst health care system in the industrialized world, as embarrassedly evidenced during the 2008 US presidential campaign and also by statistical measures—it is also affecting Europe, which, in opposition to the United States, has a long tradition of institutionalized social welfare. In many European countries, national health systems were developed to create social safety nets for all citizens. In fact, health care costs in Europe have continued to rise in recent years, and to keep costs low, in addition to pharmaceutical price controls, a variety of payment and reimbursement systems (i.e., copayments, reference pricing, differential pricing, and others) have been created.

The high price of many innovative drugs, which is in part due to the considerable expense and risk involved in drug development, underlines the need for more efficient approaches to bring drugs to the market, with more effective translational research in particular identified as an important part of such strategies. Here, the development of the cancer drug bortezomib (Velcade; Millennium Pharmaceuticals) by a biotechnology company - Myogenics/ProScript - started by academics from Harvard University is discussed to dissect the key academia-industry/public sector-private sector interactions that made the development of this drug a success despite many barriers. A model to explain how and why bortezomib was approved in record time is presented, and areas for public-policy initiatives to improve translational research in general are highlighted.