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Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial ...
Biodefense in the Age of Synthetic Biology
Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.
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81.900000 USD

Biodefense in the Age of Synthetic Biology

by Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology, Board on Chemical Sciences and Technology, Board on Life Sciences, Division on Earth and Life Studies, National Academies of Sciences, Engineering, and Medicine
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Many developing countries are exploring whether biotechnology has a role in addressing national issues such as food security and environmental remediation, and are considering whether the putative benefits of the technology-for example, enabling greater agricultural productivity and stability in the food supply-outweigh concerns that the technology might pose a danger-to ...
Global Challenges and Directions for Agricultural Biotechnology: Workshop Report
Many developing countries are exploring whether biotechnology has a role in addressing national issues such as food security and environmental remediation, and are considering whether the putative benefits of the technology-for example, enabling greater agricultural productivity and stability in the food supply-outweigh concerns that the technology might pose a danger-to biodiversity, health, and local jobs. Some policy leaders worry that their governments are not prepared to take control of this evolving technology and that introducing it into society would be a risky act. Others have suggested that taking no action carries more risk, given the dire need to produce more food. This book reports on an international workshop held to address these issues. Global Challenges and Directions for Agricultural Biotechnology: Mapping the Course, organized by the National Research Council on October 24-25, 2004, in Washington, DC, focused on the potential applications of biotechnology and what developing countries might consider as they contemplate adopting biotechnology. Presenters at the workshop described applications of biotechnology that are already proving their utility in both developing and developed countries.
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14.23 USD

Global Challenges and Directions for Agricultural Biotechnology: Workshop Report

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Agriculture and Natural Resources, Steering Committee on Global Challenges and Directions for Agricultural Biotechnology: Mapping the Course
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Museums catalogue our knowledge of the Earth's biodiversity, and their collections represent many decades of work by experts. Access to DNA sequence information in archival specimens would greatly extend knowledge of the genetic relationships within our biosphere. However, molecular genetic analysis of museum specimens has been slowed by the usual ...
Path to Effective Recovering of DNA from Formalin-Fixed Biological Samples in Natural History Collections: Workshop Summary
Museums catalogue our knowledge of the Earth's biodiversity, and their collections represent many decades of work by experts. Access to DNA sequence information in archival specimens would greatly extend knowledge of the genetic relationships within our biosphere. However, molecular genetic analysis of museum specimens has been slowed by the usual practice of fixation and storage of samples in formalin. Formalin is an environmental toxin and induces genetic and chromosomal alterations to the samples. Few of the many attempts to obtain and sequence DNA from formalin-fixed specimens stored in aqueous formalin or ethanol have been successful. All of the protocols are slow, difficult, and often expensive, and few produce DNA fragments longer than 500 base pairs. Path to Effective Recovering of DNA from Formalin-Fixed Biological Samples in Natural History Collections examines past attempts on DNA recovery from formalin-preserved biological specimens and discusses the research needed to advance the development of similar but more efficient and cost-effective protocols.
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14.23 USD

Path to Effective Recovering of DNA from Formalin-Fixed Biological Samples in Natural History Collections: Workshop Summary

by Division on Earth and Life Studies, National Academy of Sciences, Board on Life Sciences, National Research Council
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During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State's Biosecurity Engagement Program sponsored the workshop, which was ...
Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop
During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State's Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories- equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories summarizes the workshop discussion, which included the following topics: Technological options to meet diagnostic, research, and other goals; Laboratory construction and commissioning; Operational maintenance to provide sustainable capabilities, safety, and security; and Measures for encouraging a culture of responsible conduct. Workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action.
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34.22 USD

Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop

by National Research Council, National Academy of Sciences, Policy and Global Affairs, Division on Earth and Life Studies, Committee on International Security and Arms Control, Board on Life Sciences, Committee on Anticipating Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories
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During the last decade, national and international scientific organizations have become increasingly engaged in considering how to respond to the biosecurity implications of developments in the life sciences and in assessing trends in science and technology (S&T) relevant to biological and chemical weapons nonproliferation. The latest example is an international ...
Life Sciences and Related Fields: Trends Relevant to the Biological Weapons Convention
During the last decade, national and international scientific organizations have become increasingly engaged in considering how to respond to the biosecurity implications of developments in the life sciences and in assessing trends in science and technology (S&T) relevant to biological and chemical weapons nonproliferation. The latest example is an international workshop, Trends in Science and Technology Relevant to the Biological Weapons Convention, held October 31 - November 3, 2010 at the Institute of Biophysics of the Chinese Academy of Sciences in Beijing. Life Sciences and Related Fields summarizes the workshop, plenary, and breakout discussion sessions held during this convention. Given the immense diversity of current research and development, the report is only able to provide an overview of the areas of science and technology the committee believes are potentially relevant to the future of the Biological and Toxic Weapons Convention (BWC), although there is an effort to identify areas that seemed particularly ripe for further exploration and analysis. The report offers findings and conclusions organized around three fundamental and frequently cited trends in S&T that affect the scope and operation of the convention: The rapid pace of change in the life sciences and related fields; The increasing diffusion of life sciences research capacity and its applications, both internationally and beyond traditional research institutions; and The extent to which additional scientific and technical disciplines beyond biology are increasingly involved in life sciences research. The report does not make recommendations about policy options to respond to the implications of the identified trends. The choice of such responses rests with the 164 States Parties to the Convention, who must take into account multiple factors beyond the project's focus on the state of the science.
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USD

Life Sciences and Related Fields: Trends Relevant to the Biological Weapons Convention

by National Research Council, International Union of Microbiological Sciences, International Union of Biochemistry and Molecular Biology, International Union of Microbiological Societies, IAP - The Global Network of Science Academies, Chinese Academy of Sciences, Division on Earth and Life Studies, Board on Life Sciences, Committee on Trends in Science and Technology Relevant to the Biological Weapons Convention: An International Workshop
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Human reproductive cloning is an assisted reproductive technology that would be carried out with the goal of creating a newborn genetically identical to another human being. It is currently the subject of much debate around the world, involving a variety of ethical, religious, societal, scientific, and medical issues. Scientific and ...
Scientific and Medical Aspects of Human Reproductive Cloning
Human reproductive cloning is an assisted reproductive technology that would be carried out with the goal of creating a newborn genetically identical to another human being. It is currently the subject of much debate around the world, involving a variety of ethical, religious, societal, scientific, and medical issues. Scientific and Medical Aspects of Human Reproductive Cloning considers the scientific and medical sides of this issue, plus ethical issues that pertain to human-subjects research. Based on experience with reproductive cloning in animals, the report concludes that human reproductive cloning would be dangerous for the woman, fetus, and newborn, and is likely to fail. The study panel did not address the issue of whether human reproductive cloning, even if it were found to be medically safe, would beaEURO or would not beaEURO acceptable to individuals or society.
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22.77 USD

Scientific and Medical Aspects of Human Reproductive Cloning

by Board on Life Sciences, Policy and Global Affairs, National Research Council, Committee on Science, Engineering and Public Policy
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Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases -- including the highly contagious foot-and-mouth disease (FMD), which affects cattle, ...
Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas
Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases -- including the highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals -- and diseases deadly to humans that can be transmitted between animals and people. Congress also asked the Research Council to review the validity and adequacy of the document. Until these studies are complete, Congress has withheld funds to build the NBAF. Upon review of the DHS assessment, the National Research Council found several major shortcomings. Based on the DHS risk assessment, there is nearly a 70 percent chance over the 50-year lifetime of the facility that a release of FMD could result in an infection outside the laboratory, impacting the economy by estimates of $9 billion to $50 billion. The present Research Council report says the risks and costs of a pathogen being accidently released from the facility could be significantly higher. The committee found that the SSRA has many legitimate conclusions, but it was concerned that the assessment does not fully account for how a Biosafety-Level 3 Agriculture and Biosafety-Level 4 Pathogen facility would operate or how pathogens might be accidently released. In particular, the SSRA does not include important operation risks and mitigation issues, such as the risk associated with the daily cleaning of large animal rooms. It also fails to address risks that would likely increase the chances of an FMD leak or of the disease's spread after a leak, including the NBAF's close proximity to the Kansas State University College of Veterinary Medicine clinics and KSU football stadium or personnel moving among KSU facilities.
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Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas

by National Research Council, Division on Earth and Life Studies, Board on Agriculture and Natural Resources, Board on Life Sciences, Committee on the Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio-and Agro-Defense Facility
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In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, ...
2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007, the Committee identified issues that warranted revision, and this book addresses those issues in a second set of amendments. Most importantly, this book addresses new scientific developments in reprogramming of somatic cells to pluripotency by adding a new section and revising other relevant sections of the Guidelines.
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14.23 USD

2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

by National Academies, Institute of Medicine, Division on Earth and Life Studies, National Research Council, Board on Health Sciences Policy, Board on Life Sciences, Human Embryonic Stem Cell Research Advisory Committee
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Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologya key issues that must be resolved ...
Animal Biotechnology: Science Based Concerns
Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologya key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsa the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.
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22.77 USD

Animal Biotechnology: Science Based Concerns

by National Academy of Sciences, Debra Davis, National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Agriculture and Natural Resources, Committee on Agricultural Biotechnology, Health, and the Environment, Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology
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Beginning in the early 1980s, new technologies, began to permit evaluation of the expression of individual genes. Recent technological advances have expanded those evaluations to permit the simultaneous detection of the expression of tens of thousands of genes and to support holistic evaluations of the entire genome. The application of ...
Validation of Toxicogenomic Technologies: A Workshop Summary
Beginning in the early 1980s, new technologies, began to permit evaluation of the expression of individual genes. Recent technological advances have expanded those evaluations to permit the simultaneous detection of the expression of tens of thousands of genes and to support holistic evaluations of the entire genome. The application of these technologies has enabled researchers to unravel complexities of cell biology and, in conjunction with toxicologic evaluations, the technologies are used to probe and gain insight into questions of toxicologic relevance. As a result, the use of the technologies has become increasingly important for scientists in academia, as well as for the regulatory and drug development process.
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14.23 USD

Validation of Toxicogenomic Technologies: A Workshop Summary

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Environmental Studies and Toxicology, Committee on Emerging Issues and Data on Environmental Contaminants, Committee on Validation of Toxicogenomic Technologies: A Focus on Chemical Classification Strategies
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The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve ...
Protecting the Frontline in Biodefense Research: The Special Immunizations Program
The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. Protecting the Frontline in Biodefense Research examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.
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USD

Protecting the Frontline in Biodefense Research: The Special Immunizations Program

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Committee on Special Immunizations Program for Laboratory Personnel Engaged in Research on Countermeasures for Select Agents
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Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to ...
Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values
Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. Because gene drive systems are designed to alter the environments we share in ways that will be hard to anticipate and impossible to completely roll back, questions about the ethics surrounding use of this research are complex and will require very careful exploration. Gene Drives on the Horizon outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process. This report offers principles for responsible practices of gene drive research and related applications for use by investigators, their institutions, the research funders, and regulators.
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82.950000 USD

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

by National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Life Sciences
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Safeguarding U.S. agriculture from foreign animal diseases and protecting our food system require cutting-edge research and diagnostic capabilities. The Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA) have embarked on an important mission to replace the aging Plum Island Animal Disease Center (PIADC) with a new ...
Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas
Safeguarding U.S. agriculture from foreign animal diseases and protecting our food system require cutting-edge research and diagnostic capabilities. The Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA) have embarked on an important mission to replace the aging Plum Island Animal Disease Center (PIADC) with a new facility, the National Bio- and Agro-Defense Facility (NBAF). When operational, this new facility would be the world's fourth biosafety level-4 laboratory capable of large animal research. It would serve as a critical world reference laboratory for identifying emerging and unknown disease threats, and would thus be a critical asset in securing the future health, wealth, and security of the nation. DHS selected Manhattan, Kansas, as the site for the new NBAF after an extensive site-selection process that involved an environmental impact statement. The Government Accountability Office (GAO) raised concerns about DHS's analysis of the potential spread of foot-and-mouth disease virus (FMDv), one of the most serious foreign animal disease threats. Congress directed DHS to conduct a site-specific risk assessment (SSRA) for the NBAF, instructed the National Research Council (NRC) to independently evaluate the SSRA, and prohibited obligation of NBAF construction funds until the NRC review was complete. Congress mandated that DHS revise its SSRA to address shortcomings of the 2010 SSRA, directed the NRC to evaluate the updated SSRA (uSSRA), and again prohibited obligation of construction funds until the completion of the second review. The scope for both of these SSRA reports addressed accidental release of pathogens from the NBAF in Manhattan, Kansas and excluded terrorist acts and malicious threats from its risk assessments. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas is the evaluation of the final uSSRA.
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27.56 USD

Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas

by National Research Council, Division on Earth and Life Studies, Board on Agriculture and Natural Resources, Board on Life Sciences, Committee on the Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas
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The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved ...
Industrialization of Biology: A Roadmap to Accelerate the Advanced Manufacturing of Chemicals
The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.
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63.000000 USD

Industrialization of Biology: A Roadmap to Accelerate the Advanced Manufacturing of Chemicals

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Chemical Sciences and Technology, Committee On Industrialization Of Biology
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Dramatic developments in understanding the fundamental underpinnings of life have provided exciting opportunities to make marine bioproducts an important part of the U.S. economy. Several marine based pharmaceuticals are under active commercial development, ecosystem health is high on the public's list of concerns, and aquaculture is providing an ever greater ...
Marine Biotechnology in the Twenty-First Century: Problems, Promise, and Products
Dramatic developments in understanding the fundamental underpinnings of life have provided exciting opportunities to make marine bioproducts an important part of the U.S. economy. Several marine based pharmaceuticals are under active commercial development, ecosystem health is high on the public's list of concerns, and aquaculture is providing an ever greater proportion of the seafood on our tables. Nevertheless, marine biotechnology has not yet caught the public's, or investor's, attention. Two workshops, held in October 1999 and November 2001 at the National Academies, were successful in highlighting new developments and opportunities in environmental and biomedical applications of marine biotechnology, and also in identifying factors that are impeding commercial exploitation of these products. This report includes a synthesis of the 2001 sessions addressing drug discovery and development, applications of genomics and proteomics to marine biotechnology, biomaterials and bioengineering, and public policy and essays contributed by the workshop speakers.
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21.85 USD

Marine Biotechnology in the Twenty-First Century: Problems, Promise, and Products

by National Academy of Sciences, National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Ocean Studies Board, Committee on Marine Biotechnology: Biomedical Applications of Marine Natural Products
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In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, ...
2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. This letter report is the committee's first set of amendments to the Guidelines and clarifies earlier recommendations and conclusions, including the criteria for determining which stem cell lines it is acceptable to use. Future deliberations of the committee will address items for which additional information gathering and more extensive debate and discussion will be necessary.
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14.23 USD

2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

by National Academy of Sciences, National Research Council, Institute of Medicine, Division on Earth and Life Studies, Board on Health Sciences Policy, Board on Life Sciences, Human Embryonic Stem Cell Research Advisory Committee
Paperback / softback
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Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem ...
Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research
Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits. To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. Stem Cell Therapies summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings.
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42.000000 USD
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A new focus on glycoscience, a field that explores the structures and functions of sugars, promises great advances in areas as diverse as medicine, energy generation, and materials science, this report finds. Glycans--also known as carbohydrates, saccharides, or simply as sugars--play central roles in many biological processes and have properties ...
Transforming Glycoscience: A Roadmap for the Future
A new focus on glycoscience, a field that explores the structures and functions of sugars, promises great advances in areas as diverse as medicine, energy generation, and materials science, this report finds. Glycans--also known as carbohydrates, saccharides, or simply as sugars--play central roles in many biological processes and have properties useful in an array of applications. However, glycans have received little attention from the research community due to a lack of tools to probe their often complex structures and properties. Transforming Glycoscience: A Roadmap for the Future presents a roadmap for transforming glycoscience from a field dominated by specialists to a widely studied and integrated discipline, which could lead to a more complete understanding of glycans and help solve key challenges in diverse fields.
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29.47 USD

Transforming Glycoscience: A Roadmap for the Future

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Chemical Sciences and Technology, Committee on Assessing the Importance and Impact of Glycomics and Glycosciences
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Traditionally, the natural sciences have been divided into two branches: the biological sciences and the physical sciences. Today, an increasing number of scientists are addressing problems lying at the intersection of the two. These problems are most often biological in nature, but examining them through the lens of the physical ...
Research at the Intersection of the Physical and Life Sciences
Traditionally, the natural sciences have been divided into two branches: the biological sciences and the physical sciences. Today, an increasing number of scientists are addressing problems lying at the intersection of the two. These problems are most often biological in nature, but examining them through the lens of the physical sciences can yield exciting results and opportunities. For example, one area producing effective cross-discipline research opportunities centers on the dynamics of systems. Equilibrium, multistability, and stochastic behavior--concepts familiar to physicists and chemists--are now being used to tackle issues associated with living systems such as adaptation, feedback, and emergent behavior. Research at the Intersection of the Physical and Life Sciences discusses how some of the most important scientific and societal challenges can be addressed, at least in part, by collaborative research that lies at the intersection of traditional disciplines, including biology, chemistry, and physics. This book describes how some of the mysteries of the biological world are being addressed using tools and techniques developed in the physical sciences, and identifies five areas of potentially transformative research. Work in these areas would have significant impact in both research and society at large by expanding our understanding of the physical world and by revealing new opportunities for advancing public health, technology, and stewardship of the environment. This book recommends several ways to accelerate such cross-discipline research. Many of these recommendations are directed toward those administering the faculties and resources of our great research institutions--and the stewards of our research funders, making this book an excellent resource for academic and research institutions, scientists, universities, and federal and private funding agencies.
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20.92 USD

Research at the Intersection of the Physical and Life Sciences

by National Research Council, Division on Earth and Life Studies, Division on Engineering and Physical Sciences, Board on Chemical Sciences and Technology, Board on Life Sciences, Board on Physics and Astronomy, Committee on Forefronts of Science at the Interface of Physical and Life Sciences
Paperback / softback
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Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologya key issues that must be resolved ...
Animal Biotechnology: Science Based Concerns
Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologya key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsa the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.
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Animal Biotechnology: Science Based Concerns

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Agriculture and Natural Resources, Committee on Agricultural Biotechnology, Health, and the Environment, Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology
Hardback
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Although its importance is not always recognized, theory is an integral part of all biological research. Biologists' theoretical and conceptual frameworks inform every step of their research, affecting what experiments they do, what techniques and technologies they develop and use, and how they interpret their data. By examining how theory ...
The Role of Theory in Advancing 21st-Century Biology: Catalyzing Transformative Research
Although its importance is not always recognized, theory is an integral part of all biological research. Biologists' theoretical and conceptual frameworks inform every step of their research, affecting what experiments they do, what techniques and technologies they develop and use, and how they interpret their data. By examining how theory can help biologists answer questions like What are the engineering principles of life? or How do cells really work? the report shows how theory synthesizes biological knowledge from the molecular level to the level of whole ecosystems. The book concludes that theory is already an inextricable thread running throughout the practice of biology; but that explicitly giving theory equal status with other components of biological research could help catalyze transformative research that will lead to creative, dynamic, and innovative advances in our understanding of life.
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The Role of Theory in Advancing 21st-Century Biology: Catalyzing Transformative Research

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Committee on Defining and Advancing the Conceptual Basis of Biological Sciences in the 21st Century
Hardback
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Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, ...
Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects
Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them. The book offers a framework to guide federal agencies in selecting the route of safety assessment. It identifies and recommends several pre- and post-market approaches to guide the assessment of unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps.
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Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Agriculture and Natural Resources, Institute of Medicine, Food and Nutrition Board, Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health
Hardback
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Synthetic biology -- unlike any research discipline that precedes it -- has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Ultimately, synthetic biologists hope to design and build engineered biological systems with capabilities that do ...
Positioning Synthetic Biology to Meet the Challenges of the 21st Century: Summary Report of a Six Academies Symposium Series
Synthetic biology -- unlike any research discipline that precedes it -- has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Ultimately, synthetic biologists hope to design and build engineered biological systems with capabilities that do not exist in natural systems -- capabilities that may ultimately be used for applications in manufacturing, food production, and global health. Importantly, synthetic biology represents an area of science and engineering that raises technical, ethical, regulatory, security, biosafety, intellectual property, and other issues that will be resolved differently in different parts of the world. As a better understanding of the global synthetic biology landscape could lead to tremendous benefits, six academies -- the United Kingdom's Royal Society and Royal Academy of Engineering, the United States' National Academy of Sciences and National Academy of Engineering, and the Chinese Academy of Science and Chinese Academy of Engineering -- organized a series of international symposia on the scientific, technical, and policy issues associated with synthetic biology. Positioning Synthetic Biology to Meet the Challenges of the 21st Century summarizes the symposia proceedings.
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Positioning Synthetic Biology to Meet the Challenges of the 21st Century: Summary Report of a Six Academies Symposium Series

by National Research Council, National Academy of Engineering, Division on Earth and Life Studies, Board on Life Sciences, Policy and Global Affairs, Committee on Science, Technology, and Law
Hardback
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The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve ...
Protecting the Frontline in Biodefense Research: The Special Immunizations Program
The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. Protecting the Frontline in Biodefense Research examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Committee on Special Immunizations Program for Laboratory Personnel Engaged in Research on Countermeasures for Select Agents
Hardback
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Museums catalogue our knowledge of the Earth's biodiversity, and their collections represent many decades of work by experts. Access to DNA sequence information in archival specimens would greatly extend knowledge of the genetic relationships within our biosphere. However, molecular genetic analysis of museum specimens has been slowed by the usual ...
Path to Effective Recovering of DNA from Formalin-Fixed Biological Samples in Natural History Collections: Workshop Summary
Museums catalogue our knowledge of the Earth's biodiversity, and their collections represent many decades of work by experts. Access to DNA sequence information in archival specimens would greatly extend knowledge of the genetic relationships within our biosphere. However, molecular genetic analysis of museum specimens has been slowed by the usual practice of fixation and storage of samples in formalin. Formalin is an environmental toxin and induces genetic and chromosomal alterations to the samples. Few of the many attempts to obtain and sequence DNA from formalin-fixed specimens stored in aqueous formalin or ethanol have been successful. All of the protocols are slow, difficult, and often expensive, and few produce DNA fragments longer than 500 base pairs. Path to Effective Recovering of DNA from Formalin-Fixed Biological Samples in Natural History Collections examines past attempts on DNA recovery from formalin-preserved biological specimens and discusses the research needed to advance the development of similar but more efficient and cost-effective protocols.
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Path to Effective Recovering of DNA from Formalin-Fixed Biological Samples in Natural History Collections: Workshop Summary

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences
Hardback
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Beginning in the early 1980s, new technologies, began to permit evaluation of the expression of individual genes. Recent technological advances have expanded those evaluations to permit the simultaneous detection of the expression of tens of thousands of genes and to support holistic evaluations of the entire genome. The application of ...
Validation of Toxicogenomic Technologies: A Workshop Summary
Beginning in the early 1980s, new technologies, began to permit evaluation of the expression of individual genes. Recent technological advances have expanded those evaluations to permit the simultaneous detection of the expression of tens of thousands of genes and to support holistic evaluations of the entire genome. The application of these technologies has enabled researchers to unravel complexities of cell biology and, in conjunction with toxicologic evaluations, the technologies are used to probe and gain insight into questions of toxicologic relevance. As a result, the use of the technologies has become increasingly important for scientists in academia, as well as for the regulatory and drug development process.
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Validation of Toxicogenomic Technologies: A Workshop Summary

by National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Board on Environmental Studies and Toxicology, Committee on Emerging Issues and Data on Environmental Contaminants, Committee on Validation of Toxicogenomic Technologies: A Focus on Chemical Classification Strategies
Hardback
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Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5aEURO 10 years? What scientific capabilities, tools, ...
Preparing for Future Products of Biotechnology
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5aEURO 10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
77.700000 USD

Preparing for Future Products of Biotechnology

by Board on Life Sciences, Board on Agriculture and Natural Resources, Board on Chemical Sciences and Technology, Division on Earth and Life Sciences, National Academies of Sciences, Engineering, and Medicine
Paperback / softback
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