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| american gene technologies hiv cure trial will end: Oversight and Review of Clinical Gene Transfer Protocols Institute of Medicine, Board on Health Sciences Policy, Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee, 2014-03-27 Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes. |
| american gene technologies hiv cure trial will end: Denying AIDS Seth C. Kalichman, 2009-01-16 Paralleling the discovery of HIV and the rise of the AIDS pandemic, a flock of naysayers has dedicated itself to replacing genuine knowledge with destructive misinformation—and spreading from the fringe to the mainstream media and the think tank. Now from the editor of the journal AIDS and Behavior comes a bold exposé of the scientific and sociopolitical forces involved in this toxic evasion. Denying AIDS traces the origins of AIDS dissidents disclaimers during the earliest days of the epidemic and delves into the psychology and politics of the current denial movement in its various incarnations. Seth Kalichman focuses not on the “difficult” or doubting patient, but on organized, widespread forms of denial (including the idea that HIV itself is a myth and HIV treatments are poison) and the junk science, faulty logic, conspiracy theories, and larger forces of homophobia and racism that fuel them. The malignant results of AIDS denial can be seen in those individuals who refuse to be tested, ignore their diagnoses, or reject the treatments that could save their lives. Instead of ignoring these currents, asserts Kalichman, science has a duty to counter them. Among the topics covered: Why AIDS denialism endures, and why science must understand it. Pioneer virus HIV researcher Peter Duesberg’s role in AIDS denialism. Flawed immunological, virological, and pharmacological pseudoscience studies that are central to texts of denialism. The social conservative agenda and the politics of AIDS denial, from the courts to the White House. The impact of HIV misinformation on public health in South Africa. Fighting fiction with reality: anti-denialism and the scientific community. For anyone affected by, interested in, or working with researchers in HIV/AIDS, and public health professionals in general, the insight and vision of Denying AIDS will inspire outrage, discussion, and ultimately action. See http://denyingaids.blogspot.com/ for more information. |
| american gene technologies hiv cure trial will end: Exploring Novel Clinical Trial Designs for Gene-Based Therapies National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Regenerative Medicine, 2020-08-27 Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop. |
| american gene technologies hiv cure trial will end: Disease Control Priorities, Third Edition (Volume 6) King K. Holmes, Stefano Bertozzi, Barry R. Bloom, Prabhat Jha, 2017-11-06 Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings. |
| american gene technologies hiv cure trial will end: HIV-1 Latency Guido Silvestri, Mathias Lichterfeld, 2018-10-11 This volume summarizes recent advances in understanding the mechanisms of HIV-1 latency, in characterizing residual viral reservoirs, and in developing targeted interventions to reduce HIV-1 persistence during antiretroviral therapy. Specific chapters address the molecular mechanisms that govern and regulate HIV-1 transcription and latency; assays and technical approaches to quantify viral reservoirs in humans and animal models; the complex interchange between viral reservoirs and the host immune system; computational strategies to model viral reservoir dynamics; and the development of therapeutic approaches that target viral reservoir cells. With contributions from an interdisciplinary group of investigators that cover a broad spectrum of subjects, from molecular virology to proof-of-principle clinical trials, this book is a valuable resource for basic scientists, translational investigators, infectious-disease physicians, individuals living with HIV/AIDS and the general public. |
| american gene technologies hiv cure trial will end: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| american gene technologies hiv cure trial will end: The Role of NIH in Drug Development Innovation and Its Impact on Patient Access National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Health Care Services, 2020-01-27 To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop. |
| american gene technologies hiv cure trial will end: Communities in Action National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Committee on Community-Based Solutions to Promote Health Equity in the United States, 2017-04-27 In the United States, some populations suffer from far greater disparities in health than others. Those disparities are caused not only by fundamental differences in health status across segments of the population, but also because of inequities in factors that impact health status, so-called determinants of health. Only part of an individual's health status depends on his or her behavior and choice; community-wide problems like poverty, unemployment, poor education, inadequate housing, poor public transportation, interpersonal violence, and decaying neighborhoods also contribute to health inequities, as well as the historic and ongoing interplay of structures, policies, and norms that shape lives. When these factors are not optimal in a community, it does not mean they are intractable: such inequities can be mitigated by social policies that can shape health in powerful ways. Communities in Action: Pathways to Health Equity seeks to delineate the causes of and the solutions to health inequities in the United States. This report focuses on what communities can do to promote health equity, what actions are needed by the many and varied stakeholders that are part of communities or support them, as well as the root causes and structural barriers that need to be overcome. |
| american gene technologies hiv cure trial will end: Blood Stem Cell Transplantation James O Armitage, John M Goldman, Josy Reiffers, 1998-01-01 Significant progress has been made in recent years in developing the use of peripheral blood as a source of stem cells for transplantation for patients with haematological and non-haematological malignancies. This book presents an overview of many of the scientific and technical advances that have been made, and discusses the clinical applications and results of transplants with blood-derived stem cells. |
| american gene technologies hiv cure trial will end: Assessing Genetic Risks Institute of Medicine, Committee on Assessing Genetic Risks, 1994-01-01 Raising hopes for disease treatment and prevention, but also the specter of discrimination and designer genes, genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings. |
| american gene technologies hiv cure trial will end: Regulatory Aspects of Gene Therapy and Cell Therapy Products Maria Cristina Galli, Mercedes Serabian, 2015-09-15 This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent must-know guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals. |
| american gene technologies hiv cure trial will end: House on Fire William H. Foege, Milbank Memorial Fund, 2011-06-06 “Bill Foege takes us inside the world's greatest public health triumph: the eradication of smallpox. It's a story of true determination, passion and courage. The story of smallpox should encourage all of us to continue the critical work of worldwide disease eradication.”--Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation “Bill Foege is one of the public health giants of our times. He was responsible for the design of the campaign that eradicated smallpox—the most important global health achievement in history and possibly the greatest feat in any field of international cooperation. His insights into the nature of this major event will undoubtedly help to meet the global health challenges of the 21st century.”—Julio Frenk, M.D, PhD, Dean, Harvard School of Public Health “The eradication of a disease has long been the holy grail of global health and Bill Foege found it: more than any other person, he was responsible for the eradication of smallpox from the face of the earth. This is a story told by a remarkably humble man, about the extraordinary coalition that he helped to build, and the most impressive global health accomplishment the world has ever seen.”—Mark Rosenberg, author of Real Collaboration: What It Takes for Global Health to Succeed “I am thrilled that Bill Foege, one of the great heroes of the smallpox eradication campaign, has written this important book. It tells a beautiful human story of an incredible public health triumph, and is full of lessons that could be applied to many of the global challenges we face today.”—Helene D. Gayle MD, President and CEO, CARE USA “Bill Foege’s House on Fire is the first-hand account of how a revised strategy to eradicate smallpox was tested, validated, and applied. Without the global adoption of this new surveillance strategy, the final deathblow to this longtime global menace might never have been dealt.”—Adetokunbo O. Lucas, MD, DSc, author of It Was The Best of Times: From Local to Global Health “Smallpox is the most devastating disease the world has known, as it destroyed lives and shaped history over the centuries. House on Fire provides a day-to-day account by my friend Dr. Bill Foege of the battle required to defeat this wily and diabolic virus.--President Jimmy Carter |
| american gene technologies hiv cure trial will end: Pain Management and the Opioid Epidemic National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, 2017-09-28 Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring. |
| american gene technologies hiv cure trial will end: HIV Vaccines and Cure Linqi Zhang, Sharon R. Lewin, 2018-07-20 This book provides a comprehensive review of the major barriers to HIV cure and vaccine. It covers the fundamental virology and immunology leading to HIV transmission, protection from infection and long term HIV persistence on antiretroviral therapy. In addition, strategies being tested to eliminate persistent HIV and the rational design of vaccines to induce protective immunity are covered. This book also discusses the challenges related to the design of clinical trials for testing the safety and efficacy of these innovative approaches. This book will provide a systematic overview and also discuss controversial issues for researchers in virology and immunology, as well as practicing physicians, and scientists in the pharmaceutical industry. |
| american gene technologies hiv cure trial will end: Strengthening Forensic Science in the United States National Research Council, Division on Engineering and Physical Sciences, Committee on Applied and Theoretical Statistics, Policy and Global Affairs, Committee on Science, Technology, and Law, Committee on Identifying the Needs of the Forensic Sciences Community, 2009-07-29 Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators. |
| american gene technologies hiv cure trial will end: The Immortal Life of Henrietta Lacks Rebecca Skloot, 2010-02-02 #1 NEW YORK TIMES BESTSELLER • “The story of modern medicine and bioethics—and, indeed, race relations—is refracted beautifully, and movingly.”—Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE • ONE OF THE “MOST INFLUENTIAL” (CNN), “DEFINING” (LITHUB), AND “BEST” (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE • ONE OF ESSENCE’S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS • WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • Entertainment Weekly • O: The Oprah Magazine • NPR • Financial Times • New York • Independent (U.K.) • Times (U.K.) • Publishers Weekly • Library Journal • Kirkus Reviews • Booklist • Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells—taken without her knowledge—became one of the most important tools in medicine: The first “immortal” human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb’s effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta’s family did not learn of her “immortality” until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family—past and present—is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family—especially Henrietta’s daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn’t her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences. |
| american gene technologies hiv cure trial will end: Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade World Intellectual Property Organization, 2013 This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies. |
| american gene technologies hiv cure trial will end: Public Health Research Methods Greg Guest, Emily E. Namey, 2015 Providing a comprehensive foundation for planning, executing, and monitoring public health research of all types, this book goes beyond traditional epidemiologic research designs to cover technology-based approaches emerging in the new public health landscape. |
| american gene technologies hiv cure trial will end: Human Genetics and Genomics Bruce R. Korf, Mira B. Irons, 2012-11-19 This fourth edition of the best-selling textbook, Human Genetics and Genomics, clearly explains the key principles needed by medical and health sciences students, from the basis of molecular genetics, to clinical applications used in the treatment of both rare and common conditions. A newly expanded Part 1, Basic Principles of Human Genetics, focuses on introducing the reader to key concepts such as Mendelian principles, DNA replication and gene expression. Part 2, Genetics and Genomics in Medical Practice, uses case scenarios to help you engage with current genetic practice. Now featuring full-color diagrams, Human Genetics and Genomics has been rigorously updated to reflect today’s genetics teaching, and includes updated discussion of genetic risk assessment, “single gene” disorders and therapeutics. Key learning features include: Clinical snapshots to help relate science to practice 'Hot topics' boxes that focus on the latest developments in testing, assessment and treatment 'Ethical issues' boxes to prompt further thought and discussion on the implications of genetic developments 'Sources of information' boxes to assist with the practicalities of clinical research and information provision Self-assessment review questions in each chapter Accompanied by the Wiley E-Text digital edition (included in the price of the book), Human Genetics and Genomics is also fully supported by a suite of online resources at www.korfgenetics.com, including: Factsheets on 100 genetic disorders, ideal for study and exam preparation Interactive Multiple Choice Questions (MCQs) with feedback on all answers Links to online resources for further study Figures from the book available as PowerPoint slides, ideal for teaching purposes The perfect companion to the genetics component of both problem-based learning and integrated medical courses, Human Genetics and Genomics presents the ideal balance between the bio-molecular basis of genetics and clinical cases, and provides an invaluable overview for anyone wishing to engage with this fast-moving discipline. |
| american gene technologies hiv cure trial will end: Good Participatory Practice , 2007 These Good Participatory Practice guidelines aim to provide systematic guidance on the roles and responsibilities of entities funding and conducting biomedical HIV prevention trials towards participants and their communities. Such entities include investigators, research staff, pharmaceutical industry sponsors, foundations, government-supported research networks, non-governmental research sponsors, and all others involved in designing, financing, and executing clinical trials research. |
| american gene technologies hiv cure trial will end: The Fourth Industrial Revolution Klaus Schwab, 2017-01-03 World-renowned economist Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, explains that we have an opportunity to shape the fourth industrial revolution, which will fundamentally alter how we live and work. Schwab argues that this revolution is different in scale, scope and complexity from any that have come before. Characterized by a range of new technologies that are fusing the physical, digital and biological worlds, the developments are affecting all disciplines, economies, industries and governments, and even challenging ideas about what it means to be human. Artificial intelligence is already all around us, from supercomputers, drones and virtual assistants to 3D printing, DNA sequencing, smart thermostats, wearable sensors and microchips smaller than a grain of sand. But this is just the beginning: nanomaterials 200 times stronger than steel and a million times thinner than a strand of hair and the first transplant of a 3D printed liver are already in development. Imagine “smart factories” in which global systems of manufacturing are coordinated virtually, or implantable mobile phones made of biosynthetic materials. The fourth industrial revolution, says Schwab, is more significant, and its ramifications more profound, than in any prior period of human history. He outlines the key technologies driving this revolution and discusses the major impacts expected on government, business, civil society and individuals. Schwab also offers bold ideas on how to harness these changes and shape a better future—one in which technology empowers people rather than replaces them; progress serves society rather than disrupts it; and in which innovators respect moral and ethical boundaries rather than cross them. We all have the opportunity to contribute to developing new frameworks that advance progress. |
| american gene technologies hiv cure trial will end: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| american gene technologies hiv cure trial will end: Human Germline Genome Modification and the Right to Science Andrea Boggio, Cesare P. R. Romano, Jessica Almqvist, 2022-06-30 The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally. |
| american gene technologies hiv cure trial will end: Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee on Guidelines for the Use of Animals in Neuroscience and Behavioral Research, 2003-08-22 Expanding on the National Research Council's Guide for the Care and Use of Laboratory Animals, this book deals specifically with mammals in neuroscience and behavioral research laboratories. It offers flexible guidelines for the care of these animals, and guidance on adapting these guidelines to various situations without hindering the research process. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research offers a more in-depth treatment of concerns specific to these disciplines than any previous guide on animal care and use. It treats on such important subjects as: The important role that the researcher and veterinarian play in developing animal protocols. Methods for assessing and ensuring an animal's well-being. General animal-care elements as they apply to neuroscience and behavioral research, and common animal welfare challenges this research can pose. The use of professional judgment and careful interpretation of regulations and guidelines to develop performance standards ensuring animal well-being and high-quality research. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research treats the development and evaluation of animal-use protocols as a decision-making process, not just a decision. To this end, it presents the most current, in-depth information about the best practices for animal care and use, as they pertain to the intricacies of neuroscience and behavioral research. |
| american gene technologies hiv cure trial will end: Global Health and the Future Role of the United States National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Global Health, Committee on Global Health and the Future of the United States, 2017-10-05 While much progress has been made on achieving the Millenium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency †both within the U.S. government and across the global health field. |
| american gene technologies hiv cure trial will end: Disease Control Priorities in Developing Countries Dean T. Jamison, Joel G. Breman, Anthony R. Measham, George Alleyne, Mariam Claeson, David B. Evans, Prabhat Jha, Anne Mills, Philip Musgrove, 2006-04-02 Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries. |
| american gene technologies hiv cure trial will end: The Changing Economics of Medical Technology Institute of Medicine, Committee on Technological Innovation in Medicine, 1991-02-01 Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€as well as the involvement of numerous government agenciesâ€affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public. |
| american gene technologies hiv cure trial will end: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| american gene technologies hiv cure trial will end: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Committee on Ensuring Patient Access to Affordable Drug Therapies, 2018-03-01 Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€and health care at largeâ€more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€coupled with the broader trends in overall health care costsâ€is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care. |
| american gene technologies hiv cure trial will end: Sexually Transmitted Infections National Academies of Sciences, Engineering, and Medicine, National Academies Of Sciences Engineeri, Health and Medicine Division, Board On Population Health And Public He, Board on Population Health and Public Health Practice, Committee on Prevention and Control of Sexually Transmitted Infections in the United States, 2021-12-24 One in five people in the United States had a sexually transmitted infection (STI) on any given day in 2018, totaling nearly 68 million estimated infections. STIs are often asymptomatic (especially in women) and are therefore often undiagnosed and unreported. Untreated STIs can have severe health consequences, including chronic pelvic pain, infertility, miscarriage or newborn death, and increased risk of HIV infection, genital and oral cancers, neurological and rheumatological effects. In light of this, the Centers for Disease Control and Prevention, through the National Association of County and City Health Officials, commissioned the National Academies of Sciences, Engineering, and Medicine to convene a committee to examine the prevention and control of sexually transmitted infections in the United States and provide recommendations for action. In 1997, the Institute of Medicine released a report, The Hidden Epidemic: Confronting Sexually Transmitted Diseases. Although significant scientific advances have been made since that time, many of the problems and barriers described in that report persist today; STIs remain an underfunded and comparatively neglected field of public health practice and research. The committee reviewed the current state of STIs in the United States, and the resulting report, Sexually Transmitted Infections: Advancing a Sexual Health Paradigm, provides advice on future public health programs, policy, and research. |
| american gene technologies hiv cure trial will end: Editing Humanity Kevin Davies, 2020-10-06 One of the world's leading experts on genetics unravels one of the most important breakthroughs in modern science and medicine. IIf our genes are, to a great extent, our destiny, then what would happen if mankind could engineer and alter the very essence of our DNA coding? Millions might be spared the devastating effects of hereditary disease or the challenges of disability, whether it was the pain of sickle-cell anemia to the ravages of Huntington’s disease. But this power to “play God” also raises major ethical questions and poses threats for potential misuse. For decades, these questions have lived exclusively in the realm of science fiction, but as Kevin Davies powerfully reveals in his new book, this is all about to change. Engrossing and page-turning, Editing Humanity takes readers inside the fascinating world of a new gene editing technology called CRISPR, a high-powered genetic toolkit that enables scientists to not only engineer but to edit the DNA of any organism down to the individual building blocks of the genetic code. Davies introduces readers to arguably the most profound scientific breakthrough of our time. He tracks the scientists on the front lines of its research to the patients whose powerful stories bring the narrative movingly to human scale. Though the birth of the “CRISPR babies” in China made international news, there is much more to the story of CRISPR than headlines seemingly ripped from science fiction. In Editing Humanity, Davies sheds light on the implications that this new technology can have on our everyday lives and in the lives of generations to come. |
| american gene technologies hiv cure trial will end: Mapping and Sequencing the Human Genome National Research Council, Division on Earth and Life Studies, Commission on Life Sciences, Committee on Mapping and Sequencing the Human Genome, 1988-01-01 There is growing enthusiasm in the scientific community about the prospect of mapping and sequencing the human genome, a monumental project that will have far-reaching consequences for medicine, biology, technology, and other fields. But how will such an effort be organized and funded? How will we develop the new technologies that are needed? What new legal, social, and ethical questions will be raised? Mapping and Sequencing the Human Genome is a blueprint for this proposed project. The authors offer a highly readable explanation of the technical aspects of genetic mapping and sequencing, and they recommend specific interim and long-range research goals, organizational strategies, and funding levels. They also outline some of the legal and social questions that might arise and urge their early consideration by policymakers. |
| american gene technologies hiv cure trial will end: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture. |
| american gene technologies hiv cure trial will end: Splicing Life United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982 |
| american gene technologies hiv cure trial will end: Hereditary Chorioretinal Disorders Gemmy Cheung, 2020-01-29 This volume of the retina atlas focuses on hereditary chorioretinal disorders. The topics covered include retinitis pigmentosa, Best disease, congenital X-linked retinoschisis, cone dystrophy, Stargardt’s disease, pattern dystrophy, North Carolina macular dystrophy, choroideremia, Mallattia Leventinese, Bietti’s crystalline dystrophy, and albinism. All clinical features are clearly illustrated with multimodal imaging techniques. The utility of some of the latest imaging tools such as OCT angiography, adaptive optics-scanning laser ophthalmoscopy, and microperimetery is discussed. Readers will gain valuable new insights into pathogenesis at the molecular level, which have been facilitated by recent genetic discoveries. The use of genetic testing and the latest advances in and challenges of gene therapy and cell-based therapy are also covered in detail. Hereditary Chorioretinal Disorders atlas is one of nine volumes in the series Retina Atlas. The series provides validated and comprehensive information on vitreoretinal diseases, covering imaging basics, retinal vascular diseases, macular disorders, ocular inflammatory and infectious disorders, retinal degeneration, the surgical retina, ocular oncology, pediatric retina and trauma. |
| american gene technologies hiv cure trial will end: An Introduction to Molecular Medicine and Gene Therapy Thomas F. Kresina, 2004-03-24 An Introduction to Molecular Medicine and Gene Therapy Edited by Thomas F. Kresina, Ph.D. Gene therapy, or the use of genetic manipulation for disease treatment, is derived from advances in genetics, molecular biology, clinical medicine, and human genomics. Molecular medicine, the application of molecular biological techniques to disease treatment and diagnosis, is derived from the development of human organ transplantation, pharmacotherapy, and elucidation of the human genome. An Introduction to Molecular Medicine and Gene Therapy provides a basis for interpreting new clinical and basic research findings in the areas of cloning, gene transfer, and targeting; the applications of genetic medicine to clinical conditions; ethics and governmental regulations; and the burgeoning fields of genomics, biotechnology, and bioinformatics. By dividing the material into three sections - an introduction to basic science, a review of clinical applications, and a discussion of the evolving issues related to gene therapy and molecular medicine-this comprehensive manual describes the basic approaches to the broad range of actual and potential genetic-based therapies. In addition, An Introduction to Molecular Medicine and Gene Therapy: * Covers new frontiers in gene therapy, animal models, vectors, gene targeting, and ethical/legal considerations * Provides organ-based reviews of current studies in gene therapy for monogenetic, multifactoral or polygenic disorders, and infectious diseases * Includes bold-faced terms, key concepts, summaries, and lists of helpful references by subject in each chapter * Contains appendices on commercial implications and a review of the history of gene therapy This textbook offers a clear, concise writing style, drawing upon the expertise of the authors, all renowned researchers in their respective specialties of molecular medicine. Researchers in genetics and molecular medicine will all find An Introduction to Molecular Medicine and Gene Therapy to be an essential guide to the rapidly evolving field of gene therapy and its applications in molecular medicine. |
| american gene technologies hiv cure trial will end: Tri-council Policy Statement , 2014 This document is a joint policy of Canada's three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. This updated version replaces the TCPS 2 (2010) as the official human research ethics policy of these agencies. |
| american gene technologies hiv cure trial will end: Guidelines for Diagnosing and Managing Disseminated Histoplasmosis Among People Living with HIV Pan American Pan American Health Organization, 2020-06-18 Histoplasmosis is a disease caused by the fungus Histoplasma capsulatum. This disease is highly endemic in some regions of North America, Central America, and South America and is also reported in certain countries of Asia and Africa. It often affects people with impaired immunity, including people living with HIV, among whom the most frequent clinical presentation is disseminated histoplasmosis. The symptoms of disseminated histoplasmosis are non-specific and may be indistinguishable from those of other infectious diseases, especially disseminated tuberculosis (TB), thus complicating diagnosis and treatment. Histoplasmosis is one of the most frequent opportunistic infections caused by fungal pathogens among people living with HIV in the Americas and may be responsible for 5-15% of AIDS-related deaths every year in this Region. These guidelines aim to provide recommendations for the diagnosis, treatment, and management of disseminated histoplasmosis in persons living with HIV. Although the burden of disease is concentrated in the Americas, the recommendations presented within these guidelines are applicable globally. These guidelines were produced in accordance with the World Health Organization (WHO) handbook for guideline development. The Guideline Development Group elaborated the final recommendations based on a systematic review of scientific literature and critical evaluation of the evidence available using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. These guidelines are intended for health-care providers, HIV program managers, policy-makers, national treatment advisory boards, researchers, and other professionals involved in caring for people who either have or may be at risk of developing disseminated histoplasmosis. |
| american gene technologies hiv cure trial will end: Hacking the Code of Life Nessa Carey, 2019-03-07 'An excellent, brisk guide to what is likely to happen as opposed to the fantastically remote.' - Los Angeles Review of Books In 2018 the world woke up to gene editing with a storm of controversy over twin girls born in China with genetic changes deliberately introduced by scientists - changes they will pass on to their own offspring. Genetic modification (GM) has been with us for 45 years now, but the new system known as CRISPR or gene editing can manipulate the genes of almost any organism with a degree of precision, ease and speed that we could only dream of ten years ago. But is it ethical to change the genetic material of organisms in a way that might be passed on to future generations? If a person is suffering from a lethal genetic disease, is it unethical to deny them this option? Who controls the application of this technology, when it makes 'biohacking' - perhaps of one's own genome - a real possibility? Nessa Carey's book is a thrilling and timely snapshot of a cutting-edge technology that will radically alter our futures and the way we prevent disease. 'A focused snapshot of a brave new world.' - Nature 'A brisk, accessible primer on the fast-moving field, a clear-eyed look at a technology that is already driving major scientific advances - and raising complex ethical questions.' - Emily Anthes, Undark |
| american gene technologies hiv cure trial will end: Stem Cell Transplantation for Hematologic Malignancies Robert J. Soiffer, 2004 A comprehensive survey of the current state-of-the-art in hematopoietic stem cell transplantation for malignant disease. The authors focus on the indications and results of transplantation for acute leukemia, chronic myelogenous leukemia, lymphoma, multiple myeloma, and breast cancer. Special attention is given to transplant-related complications, including the pathophysiology and clinical consequences of acute and chronic GVHD, delayed immune reconstitution leading to infectious complications, and organ damage to the lung and liver. Additional chapters address the sources of stem cells and the effects of graft manipulation used to eliminate residual contaminating tumor cells in autologous transplantation, or to reduce the number of T lymphocytes causing GVHD in allogenic transplantation. |
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