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      Cover image for Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary
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      Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary

      Forum on Drug Discovery, Development, and Translation

      All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks…

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      Cover image for Challenges for the FDA: The Future of Drug Safety, Workshop Summary
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      Challenges for the FDA: The Future of Drug Safety, Workshop Summary

      Leslie Pray,Sally Robinson,Forum on Drug Discovery, Development, and Translation

      To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM’s Forum on Drug Discovery, Development, and Translation convened a 1-day…

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      Cover image for International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary
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      International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013…

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      Cover image for Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary
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      Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary

      Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance…

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      Cover image for Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary
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      Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a…

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      Cover image for Emerging Safety Science: Workshop Summary
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      Emerging Safety Science: Workshop Summary

      Sally Robinson,Robert Pool,Robert Giffin,Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      The average cost of developing a new approved drug is now estimated to be $1.3 billion. This title offers ways to select successful drug candidates earlier in development that could…

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      Cover image for Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
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      Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary

      Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years…

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      Cover image for Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary
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      Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary

      Yeonwoo Lebovitz,Rebecca English,Anne Claiborne,Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA’s science base must be strong enough to make certain that regulatory decisions are…

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      Cover image for Defining and Evaluating In-Home Drug Disposal Systems For Opioid Analgesics
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      Defining and Evaluating In-Home Drug Disposal Systems For Opioid Analgesics

      National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation

      The proper disposal of unused or expired prescription drugs, particularly controlled substances such as opioids, may help to prevent serious risk of nonmedical use or overdose. In June 2023, the…

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      Cover image for Addressing the Barriers to Pediatric Drug Development: Workshop Summary
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      Addressing the Barriers to Pediatric Drug Development: Workshop Summary

      Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. This book identifies barriers to the development and testing of…

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

      Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they…

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      Cover image for Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary
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      Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      There is growing recognition that the United States’ clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely…

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      Cover image for Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS: Challenges and Opportunities: Summary of a Joint Workshop by the Institute of Medicine and the Institute of Microbiology, Chinese Academy of Sciences
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      Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS: Challenges and Opportunities: Summary of a Joint Workshop by the Institute of Medicine and the Institute of Microbiology, Chinese Academy of Sciences

      Forum on Drug Discovery, Development, and Translation,Board on Health Sciences Policy,Institute of Medicine

      Multidrug-resistant tuberculosis (TB) is caused by bacteria resistant to isoniazid and rifampicin, the two most effective first-line anti-TB drugs, originally developed and introduced in the 1950 and 1960s. This book…

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      Cover image for Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary
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      Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a…

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      Cover image for Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary
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      Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary

      Theresa Wizeman,Sally Robinson,Robert Giffin,Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can…

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      Cover image for The Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa: Global and Local Challenges and Solutions: Workshop Summary
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      The Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa: Global and Local Challenges and Solutions: Workshop Summary

      Forum on Drug Discovery, Development, and Translation,Institute of Medicine,Academy of Science of South Africa

      Tuberculosis (TB) kills approximately 4,500 people worldwide every day. While most cases of TB can be treated with antibiotics, some strains have developed drug resistance that makes their treatment more…

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      Cover image for The New Profile of Drug-Resistant Tuberculosis in Russia: A Global and Local Perspective: Summary of a Joint Workshop
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      The New Profile of Drug-Resistant Tuberculosis in Russia: A Global and Local Perspective: Summary of a Joint Workshop

      Forum on Drug Discovery, Development, and Translation,Institute of Medicine,Russian Academy of Medical Sciences

      An estimated 2 billion people, one third of the global population, are infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis. Spread through the air, this infectious disease killed 1.7…

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      Cover image for Facing the Reality of Drug-Resistant Tuberculosis in India: Challenges and Potential Solutions: Summary of a Joint Workshop by the Institute of Medicine, the Indian National Science Academy, and the Indian Council of Medical Research
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      Facing the Reality of Drug-Resistant Tuberculosis in India: Challenges and Potential Solutions: Summary of a Joint Workshop by the Institute of Medicine, the Indian National Science Academy, and the Indian Council of Medical Research

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      An estimated 8.8 million people fell ill with tuberculosis (TB) in 2010 and 1.4 million died from the disease. Although antibiotics to treat TB were developed in the 1950s and…

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      Cover image for Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary
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      Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      Forum on drug discovery, development, and translation. –Cover.

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      Cover image for Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics
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      Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics

      National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, Board on Health Care Services, National Cancer Policy Forum

      The use of immune modulator therapeutics, a type of immunotherapy enhancing the body immune system response to cancer, was perceived as the beginning of a new era in cancer care…

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      Cover image for Adult Attention-Deficit/Hyperactivity Disorder
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      Adult Attention-Deficit/Hyperactivity Disorder

      National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, Forum on Drug Discovery, Development, and Translation

      Attention deficit/hyperactivity disorder (ADHD) diagnosis and treatment among adults has increased over the past decade in the U.S. and globally. Evidence suggests adults with ADHD may be more likely to…

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      Cover image for Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary
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      Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary

      Rebecca English,Yeonwoo Lebovitz,Robert Griffin,Forum on Drug Discovery, Development, and Translation,Institute of Medicine

      An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications…

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      Cover image for Large Simple Trials and Knowledge Generation in a Learning Health System: Workshop Summary
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      Large Simple Trials and Knowledge Generation in a Learning Health System: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Roundtable on Value and Science-Driven Health Care

      Presents the summary of a workshop convened by the Institute of Medicine’s Roundtable on Value & Science-Driven Health Care and the Forum on Drug Discovery, Development, and Translation.

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      Cover image for The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary
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      The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary

      Forum on Medical and Public Health Preparedness for Catastrophic Events,Forum on Drug Discovery, Development, and Translation

      During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public’s well-being…

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      Cover image for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary
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      Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary

      Forum on Drug Discovery, Development, and Translation,Forum on Medical and Public Health Preparedness for Catastrophic Events,Institute of Medicine

      Whether or not the United States has safe and effective medical countermeasures–such as vaccines, drugs, and diagnostic tools–available for use during a disaster can mean the difference between life and…

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      Cover image for Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders: Workshop Summary
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      Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders: Workshop Summary

      Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Forum on Neuroscience and Nervous System Disorders

      The Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders, in collaboration with the IOM Forum on Drug Discovery, Development, and Translation, convened a workshop on January 20-21…

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      Cover image for Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop
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      Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials…

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      Cover image for Inclusion of Pregnant and Lactating Persons in Clinical Trials
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      Inclusion of Pregnant and Lactating Persons in Clinical Trials

      National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation

      Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, due to…

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      Cover image for Preparing the Future Workforce in Drug Research and Development
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      Preparing the Future Workforce in Drug Research and Development

      National Academies of Sciences, Engineering, and Medicine, Policy and Global Affairs, Health and Medicine Division, U.S. Science and Innovation Policy, Board on Population Health and Public Health Practice, Board on Health Sciences Policy, Roundtable on Black Men and Black Women in Science, Engineering, and Medicine, Forum on Drug Discovery, Development, and Translation

      Despite advances over the past several decades, the clinical trials enterprise has struggled to meet the needs of an increasingly diverse U.S. population. To help address this issue, a 2023…

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      Cover image for Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop
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      Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world…

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      Cover image for Sharing Clinical Research Data: Workshop Summary
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      Sharing Clinical Research Data: Workshop Summary

      Forum on Drug Discovery, Development, and Translation,Forum on Neuroscience and Nervous System Disorders,National Cancer Policy Forum,Roundtable on Translating Genomic-Based Research on Health,Board on Health Sciences Policy

      Sharing Clinical Research Data: Workshop Summary

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      Cover image for Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings of a Workshop
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      Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of…

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      Cover image for Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary
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      Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary

      Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals

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      Cover image for Deriving Drug Discovery Value from Large-Scale Genetic Bioresources: Proceedings of a Workshop
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      Deriving Drug Discovery Value from Large-Scale Genetic Bioresources: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Roundtable on Genomics and Precision Health

      The process of discovering and developing a new drug or therapy is extremely costly and time consuming, and recently, it has been estimated that the creation of a new medicine…

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      Cover image for Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary
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      Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      The field of endeavors known as regulatory science has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and…

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      Cover image for Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series
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      Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation

      Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical…

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      Cover image for Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance
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      Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance

      National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Global Health, Forum on Microbial Threats, Forum on Medical and Public Health Preparedness for Disasters and Emergencies, Forum on Drug Discovery, Development, and Translation

      The use and misuse of antibiotics contributes to the rise in drug-resistant bacteria - a serious and worsening threat to human health. The development and use of rapid point-of-care diagnostics…

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      Cover image for The Role of Digital Health Technologies in Drug Development: Proceedings of a Workshop
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      The Role of Digital Health Technologies in Drug Development: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,Forum on Drug Discovery, Development, and Translation

      On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This…

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      Cover image for Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop
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      Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,Forum on Drug Discovery, Development, and Translation

      Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical…

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      Cover image for Direct-to-Consumer Genetic Testing: Summary of a Workshop
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      Direct-to-Consumer Genetic Testing: Summary of a Workshop

      Committee on Science, Technology, and Law,Forum on Drug Discovery, Development, and Translation,Roundtable on Translating Genomic-Based Research for Health,National Research Council,Institute of Medicine

      Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they…

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      Cover image for Shortening the Time Line for New Cancer Treatments
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      Shortening the Time Line for New Cancer Treatments

      Joseph P. Newhouse,Hellen Gelband

      Examines the steps involved in developing treatments for cancer. The recommendations in this book are offered to organisations such as the National Cancer Institute and the pharmaceutical and biotechnology industries…

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      Cover image for Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop
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      Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services,National Cancer Policy Forum

      There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly…

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      Cover image for Rapid Medical Countermeasure Response to Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary
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      Rapid Medical Countermeasure Response to Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary

      National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Global Health,Board on Health Sciences Policy,Forum on Microbial Threats

      Report of the Enabling Rapid Response and Sustained Capability with Medical Countermeasures to Mitigate Risk of Emerging Infectious Diseases: an Institute of Medicine Workshop which took place at the National…

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      Cover image for Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop
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      Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health

      The workshop participants examine the current state of clinical trial data sharing and reuse and consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage…

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      Cover image for Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop
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      Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop

      National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health

      Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible…

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