The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Facilitating Interdisciplinary Research examines current interdisciplinary research efforts and recommends ways to stimulate and support such research. Advances in science and engineering increasingly require the collaboration of scholars from various fields. This shift is driven by the need to address complex problems that cut across traditional disciplines, and the capacity of new technologies to both transform existing disciplines and generate new ones. At the same time, however, interdisciplinary research can be impeded by policies on hiring, promotion, tenure, proposal review, and resource allocation that favor traditional disciplines. This report identifies steps that researchers, teachers, students, institutions, funding organizations, and disciplinary societies can take to more effectively conduct, facilitate, and evaluate interdisciplinary research programs and projects. Throughout the report key concepts are illustrated with case studies and results of the committee's surveys of individual researchers and university provosts.
In a world where advanced knowledge is widespread and low-cost labor is readily available, U.S. advantages in the marketplace and in science and technology have begun to erode. A comprehensive and coordinated federal effort is urgently needed to bolster U.S. competitiveness and pre-eminence in these areas. This congressionally requested report by a pre-eminent committee makes four recommendations along with 20 implementation actions that federal policy-makers should take to create high-quality jobs and focus new science and technology efforts on meeting the nation's needs, especially in the area of clean, affordable energy: 1) Increase America's talent pool by vastly improving K-12 mathematics and science education; 2) Sustain and strengthen the nation's commitment to long-term basic research; 3) Develop, recruit, and retain top students, scientists, and engineers from both the U.S. and abroad; and 4) Ensure that the United States is the premier place in the world for innovation. Some actions will involve changing existing laws, while others will require financial support that would come from reallocating existing budgets or increasing them. Rising Above the Gathering Storm will be of great interest to federal and state government agencies, educators and schools, public decision makers, research sponsors, regulatory analysts, and scholars.
Calling the Shots examines the basic strategies that finance the national immunization system in the current health care climate. It is a comprehensive volume, rich with data and highlighted examples, that explores: The evolution of the system in light of changing U.S. demographics, development of new vaccines, and other factors. The effectiveness of public health and health insurance strategies, with special emphasis on the performance of the "Section 317" program. The condition of the infrastructure for control and prevention of infectious disease, surveillance of vaccines rates and safety, and efforts to sustain high coverage. Calling the Shots will be an indispensable resource to those responsible for maintaining our nation's vaccine vigilance.
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
America's research universities have undergone striking change in recent decades, as have many aspects of the society that surrounds them. This change has important implications for the heart of every university: the faculty. To sustain their high level of intellectual excellence and their success in preparing young people for the various roles they will play in society, universities need to be aware of how evolving conditions affect their ability to attract the most qualified people and to maximize their effectiveness as teachers and researchers. Gender roles, family life, the demographic makeup of the nation and the faculty, and the economic stability of higher education all have shifted dramatically over the past generation. In addition, strong current trends in technology, funding, and demographics suggest that change will continue and perhaps even accelerate in academe in the years to come. One central element of academic life has remained essentially unchanged for generations, however: the formal structure of the professorial career. Developed in the mid-nineteenth and early twentieth centuries to suit circumstances quite different from today's, and based on traditions going back even earlier, this customary career path is now a source of strain for both the individuals pursuing it and the institutions where they work. The Arc of the Academic Research Career is the summary of a workshop convened by The Committee on Science, Engineering, and Public Policy in September 2013 to examine major points of strain in academic research careers from the point of view of both the faculty members and the institutions. National experts from a variety of disciplines and institutions discussed practices and strategies already in use on various campuses and identified issues as yet not effectively addressed. This workshop summary addresses the challenges universities face, from nurturing the talent of future faculty members to managing their progress through all the stages of their careers to finding the best use of their skills as their work winds down.
Breakthroughs in biomedicine often lead to new life-giving treatments but may also raise troubling, even life-and-death, quandaries. Society's Choices discusses ways for people to handle today's bioethics issues in the context of America's unique history and cultureâ€"and from the perspectives of various interest groups. The book explores how Americans have grappled with specific aspects of bioethics through commission deliberations, programs by organizations, and other mechanisms and identifies criteria for evaluating the outcomes of these efforts. The committee offers recommendations on the role of government and professional societies, the function of commissions and institutional review boards, and bioethics in health professional education and research. The volume includes a series of 12 superb background papers on public moral discourse, mechanisms for handling social and ethical dilemmas, and other specific areas of controversy by well-known experts Ronald Bayer, Martin Benjamin, Dan W. Brock, Baruch A. Brody, H. Alta Charo, Lawrence Gostin, Bradford H. Gray, Kathi E. Hanna, Elizabeth Heitman, Thomas Nagel, Steven Shapin, and Charles M. Swezey.
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