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Nonprofit Role In Medical ResearchNonprofit organizations can support alliances that typically would not be supported through public investments, such as with for-profit companies. They can bridge disciplines, institutions, and ideas when the opportunity arises and in record time. With financial incentives, they can change the culture and structure of research.Even though private contributions cannot match those of the federal government or industry, nonprofit disease research organizations play a special role. Because of their close relationships with the patient communities, their ability to move quickly to address emerging translational and clinical opportunities, and their capacity to leverage public investment, these organizations can catalyze and jump-start innovation. Moreover, they can serve as a reliable source of funds for novel, high-risk research that might not be able to compete successfully for public funds. Because they are closer to the patients and therefore closer to the problems needing solutions, innovative nonprofit funders have heightened awareness of the importance of translational and clinical research programs. Increasingly, they are forming a unified advocacy front on key public policy issues affecting the pace of research, such as privacy regulations, intellectual property challenges, and the resolution of ethical issues. Translational ResearchTranslational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment and prevention of human disease. It is, in short, research that matters focused on patients. It includes early "proof-of-principle" Phase I clinical studies, in which the therapy is introduced into humans - because you don't really know what you have until you try it on people. Translational research is the critical bridge between basic research and clinical research. Basic research is intended to get a better understanding of biological processes in general and does not necessarily address specific health outcomes. Clinical research is based primarily on the study of patients and is designed to answer questions relating to human disease, such as etiology, diagnosis, prevention, treatment, and outcomes.
The Valley of DeathThe "valley of death" is an ever-widening gap in funding and support for the kind of research that moves basic science down the path toward treatments. Our current publicly-funded academic research infrastructure, as guided by the policies and practices of NIH – the single largest sponsor of biomedical research in the world – has focused primarily on unlocking the underlying questions of biology, that is, basic research. This has been a critical approach, leading to many advances in our understanding of human and disease biology, but it is not sufficient to develop a therapy for a patient. The biopharmaceutical industry funds primarily clinical research – and as costs have grown and uncertainty increased, companies are in many cases investing later along the research continuum and becoming more conservative in their decisions about what to fund. The average cost to research and develop a successful drug is estimated to be more than $800 million, which includes the cost of thousands of failures. Translational and clinical research—which aim to apply fundamental knowledge to the human condition—are far more difficult and expensive to conduct than basic research because they often involve complex organisms (i.e., animal models, humans) living in multifaceted environments. Translational and clinical research are typically conducted under strict regulatory regimes, for example, for the protection of laboratory animals or human subjects, or to protect against conflicts of interest. thus, structural and intellectual barriers have made it difficult to quickly or easily translate basic research into clinical applications. | ||||||||||||||||||||
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