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New-drug approvals have remained roughly constant since 1950, while the cost of drug development has soared. It seems likely that a more modular approach to drug discovery and development will evolve, deriving some features from the not-for-profit sector. For this to occur, we must address the deficit in human capital with expertise in both translational medicine and therapeutics and also in regulatory science; utilize regulatory reform to incentivize innovation and the expansion of the precompetitive space; and develop an informatics infrastructure that permits the global, secure, and compliant sharing of heterogeneous data across academic and industry sectors. These developments, likely prompted by the perception of crisis rather than opportunity, will require linked initiatives among academia, the pharmaceutical industry, the US National Institutes of Health, and the US Food and Drug Administration, along with a more adventurous role for venture capital. A failure to respond threatens the United States' lead in biomedical science and in the development and regulation of novel therapeutics. Mt Sinai J Med 77:327–332, 2010. © 2010 Mount Sinai School of Medicine [ABSTRACT FROM AUTHOR]

The inhibition of cyclooxygenase (COX)-2 confers a small but absolute risk of cardiovascular events on patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). This risk has been established by placebo-controlled trials of NSAIDs selective for COX-2; traditional NSAIDs seem to be heterogeneous with respect to cardiovascular risk. The American Heart Association (AHA) has proposed a ‘stepped-care’ approach to the use of NSAIDs in patients with cardiovascular disease, whereas the Food and Drug Administration (FDA) has failed to approve the COX-2-selective NSAID etoricoxib. In this article, these actions of the AHA and the FDA are interpreted in the light of current knowledge, prompting the formulation of scientific questions that might be addressed. [Copyright &y& Elsevier]

Despite the large investments made in drug discovery in the past decade, there is still a dearth of new drugs. This highlights the persistence of a model of drug development that has not adapted to changes in science, public perception of drug companies or the marketplace. A high profit margin in the United States has shielded drug development from the usual economic pressures that would ordinarily drive reform. The strategy of merger, pursued by many companies to compensate for the failure to develop new drugs, has, in most cases, compounded the problem, imposing geographic and cultural segregation on an already inefficient process. [ABSTRACT FROM AUTHOR]

The article discusses role of U.S. National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSAs) in fostering research on human phenotyping. It states that program was designed to encourage the integration of basic and clinical science, and mentions that recent CTSA funding opportunity announcement has reflected a budgetary and programmatic shift. It notes the need of maintaining flexibility around the nature of the collaborations under the program.

In this article the authors' discuss that efficient drug approval and monitoring must rely on sound regulatory science. It states that the U.S. Food and Drug Administration (FDA) has promised to advocate regulatory science which aims to transform its decision-making process to be more efficient, transparent and accountable. It states that however stakeholders, including patients, drug developers and the U.S. Congress, will have to rise to the challenge of coordinating their priorities.

The article focuses on the plan of the U.S. National Institutes of Health (NIH) to launch the National Center for Advancing Translational Sciences, an interdisciplinary center that deals with the translational medicine and therapeutics (TMAT). NIH director Francis Collins considers the move to create the center as an important innovation on an institutional scale. The NIH center intends to restructure the drug development process to make it more efficient and effective.

The rate of new drug approvals in the US has remained essentially constant since 1950, while the costs of drug development have soared. Many commentators question the sustainability of the current model of drug development, in which large pharmaceutical companies incur markedly escalating costs to deliver the same number of products to market. This Issue Brief summarizes the problem, describes ongoing governmental efforts to influence the process, and suggests changes in regulatory science and translational medicine that may promote more successful development of safe and effective therapeutics

Advances in human health require the efficient and rapid translation of scientific discoveries into effective clinical treatments; this process, in turn, depends on observational data gathered from patients, communities, and public health research that can be used to guide basic scientific investigation. Such bidirectional translational science, however, faces unprecedented challenges due to the rapid pace of scientific and technological development, as well as the difficulties of negotiating increasingly complex regulatory and commercial environments that overlap the research domain. Further, numerous barriers to translational science have emerged among the nation's academic research centers, including basic structural and cultural impediments to innovation and collaboration, shortages of trained investigators, and inadequate funding.To address these serious and systemic problems, in 2006 the National Institutes of Health created the Clinical and Translational Science Awards (CTSA) program, which aims to catalyze the transformation of biomedical research at a national level, speeding the discovery and development of therapies, fostering collaboration, engaging communities, and training succeeding generations of clinical and translational researchers. The authors report in detail on the planning process, begun in 2008, that was used to engage stakeholders and to identify, refine, and ultimately implement the CTSA program's overarching strategic goals. They also discuss the implications and likely impact of this strategic planning process as it is applied among the nation's academic health centers.