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              Books by Anne B. Claiborne

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              Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary

              Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; English, Rebecca A.

              • RRP: $65.00
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              Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is gr...owing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.
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              ISBN 9780309219297
              Released NZ 15 Dec 2011
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              Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary

              Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; Olson, Steve

              • RRP: $48.99
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              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, a...nd 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--
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              ISBN 9780309222143
              Released NZ 15 Dec 2012
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              Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary

              Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Medical and Public Health Preparedness for Catastrophic Events; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.

              • RRP: $72.00
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              Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the sc...ientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing regulatory science for medical countermeasure development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing regulatory science for medical countermeasure development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations --Publisher's description.
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              ISBN 9780309214902
              Released NZ 15 Jul 2011
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              Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary

              Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; Guenther, Rita S.

              • RRP: $71.00
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              Forum on drug discovery, development, and translation. --Cover.

              ISBN 9780309265959
              Released NZ 15 Feb 2013
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              Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary

              Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary (Trade Paperback / Paperback)

              By Institute of Medicine; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.; Olson, Steve

              • RRP: $63.00
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              Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfu...lly developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cures Acceleration Network (CAN)-a part of the National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH)-has the potential to catalyze widespread changes in NCATS, NIH, and the drug development ecosystem in general. On June 4-5, 2012, the IOM Forum on Drug Discovery, Development, and Translation held, at the request of NCATS, a workshop-bringing together members of federal government agencies, the private sector, academia, and advocacy groups-to explore options and opportunities in the implementation of CAN. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary summarizes the workshop.
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              ISBN 9780309261166
              Released NZ 15 Oct 2012
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              Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary
               

              Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary (Trade Paperback / Paperback)

              By National Academies of Sciences, Engineering, and Medicine; Institute of Medicine; on Health Sciences Policy, Board; Edited by Claiborne, Anne B.; Mancher, Michelle A.

              • RRP: $141.50
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              The Workshop on Research and Development of Medical Products is one of the four workstream activities of the Global Health Risk Framework Initiative ... The workshop was co-hosted by the Institute of Medicine (IOM) and the University of Hong Kong, in Hong Kong, on August 19-21, 2...015 --Page 2-3.
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              ISBN 9780309380997
              Released NZ 6 May 2016
              Publisher National Academies Press
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              Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary
               

              Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary (Trade Paperback / Paperback)

              By National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; on Health Sciences Policy, Board; Forum on Drug Discovery, Development, and Translation; Edited by Claiborne, Anne B.

              • RRP: $125.99
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              The field of endeavors known as a regulatory sciencea has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implemen...tation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the disciplinea s success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
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              ISBN 9780309438841
              Released NZ 11 Jul 2016
              Publisher National Academies Press
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