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Drug Research and Development for Adults Across the Older Age Span

Author: National Academies of Sciences Engineering and Medicine

Publisher:

Published: 2021-10-22

Total Pages:

ISBN-13: 9780309685689

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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 underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population. On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

Book Synopsis Drug Research and Development for Adults Across the Older Age Span by : National Academies of Sciences Engineering and Medicine

Download or read book Drug Research and Development for Adults Across the Older Age Span written by National Academies of Sciences Engineering and Medicine and published by . This book was released on 2021-10-22 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population. On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2014-02-06

Total Pages: 107

ISBN-13: 0309292492

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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-01-27

Total Pages: 103

ISBN-13: 0309498511

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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.

Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Developing Drug Products in an Aging Society

Author: Sven Stegemann

Publisher: Springer

Published: 2016-10-20

Total Pages: 771

ISBN-13: 3319430998

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This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Book Synopsis Developing Drug Products in an Aging Society by : Sven Stegemann

Download or read book Developing Drug Products in an Aging Society written by Sven Stegemann and published by Springer. This book was released on 2016-10-20 with total page 771 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Safe and Effective Medicines for Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-10-13

Total Pages: 432

ISBN-13: 0309225493

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The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Modern Methods of Clinical Investigation

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1990-02-01

Total Pages: 241

ISBN-13: 0309042860

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The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Rare Diseases and Orphan Products

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-04-03

Total Pages: 442

ISBN-13: 0309158060

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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.

Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Social Isolation and Loneliness in Older Adults

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-05-14

Total Pages: 317

ISBN-13: 0309671035

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Social isolation and loneliness are serious yet underappreciated public health risks that affect a significant portion of the older adult population. Approximately one-quarter of community-dwelling Americans aged 65 and older are considered to be socially isolated, and a significant proportion of adults in the United States report feeling lonely. People who are 50 years of age or older are more likely to experience many of the risk factors that can cause or exacerbate social isolation or loneliness, such as living alone, the loss of family or friends, chronic illness, and sensory impairments. Over a life course, social isolation and loneliness may be episodic or chronic, depending upon an individual's circumstances and perceptions. A substantial body of evidence demonstrates that social isolation presents a major risk for premature mortality, comparable to other risk factors such as high blood pressure, smoking, or obesity. As older adults are particularly high-volume and high-frequency users of the health care system, there is an opportunity for health care professionals to identify, prevent, and mitigate the adverse health impacts of social isolation and loneliness in older adults. Social Isolation and Loneliness in Older Adults summarizes the evidence base and explores how social isolation and loneliness affect health and quality of life in adults aged 50 and older, particularly among low income, underserved, and vulnerable populations. This report makes recommendations specifically for clinical settings of health care to identify those who suffer the resultant negative health impacts of social isolation and loneliness and target interventions to improve their social conditions. Social Isolation and Loneliness in Older Adults considers clinical tools and methodologies, better education and training for the health care workforce, and dissemination and implementation that will be important for translating research into practice, especially as the evidence base for effective interventions continues to flourish.

Book Synopsis Social Isolation and Loneliness in Older Adults by : National Academies of Sciences, Engineering, and Medicine

Download or read book Social Isolation and Loneliness in Older Adults written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-05-14 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Social isolation and loneliness are serious yet underappreciated public health risks that affect a significant portion of the older adult population. Approximately one-quarter of community-dwelling Americans aged 65 and older are considered to be socially isolated, and a significant proportion of adults in the United States report feeling lonely. People who are 50 years of age or older are more likely to experience many of the risk factors that can cause or exacerbate social isolation or loneliness, such as living alone, the loss of family or friends, chronic illness, and sensory impairments. Over a life course, social isolation and loneliness may be episodic or chronic, depending upon an individual's circumstances and perceptions. A substantial body of evidence demonstrates that social isolation presents a major risk for premature mortality, comparable to other risk factors such as high blood pressure, smoking, or obesity. As older adults are particularly high-volume and high-frequency users of the health care system, there is an opportunity for health care professionals to identify, prevent, and mitigate the adverse health impacts of social isolation and loneliness in older adults. Social Isolation and Loneliness in Older Adults summarizes the evidence base and explores how social isolation and loneliness affect health and quality of life in adults aged 50 and older, particularly among low income, underserved, and vulnerable populations. This report makes recommendations specifically for clinical settings of health care to identify those who suffer the resultant negative health impacts of social isolation and loneliness and target interventions to improve their social conditions. Social Isolation and Loneliness in Older Adults considers clinical tools and methodologies, better education and training for the health care workforce, and dissemination and implementation that will be important for translating research into practice, especially as the evidence base for effective interventions continues to flourish.

Preparing the Future Workforce in Drug Research and Development

Author: National Academies of Sciences Engineering and Medicine

Publisher:

Published: 2025-02-16

Total Pages: 0

ISBN-13: 9780309718561

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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 National Academies workshop sought to identify the expertise and disciplines needed to achieve the aspirations for a transformed clinical trials enterprise by 2030 and enable a workforce that can better support the evolving needs of drug R&D - one that is resilient, culturally aware, anti-racist, and interdisciplinary. The workshop, hosted by the Forum on Drug Discovery, Development, and Translation and Roundtable on Black Men and Black Women in Science, Engineering, and Medicine explored strategies to bolster workforce capacity and challenges and opportunities associated with supporting the next-generation drug R&D workforce.

Book Synopsis Preparing the Future Workforce in Drug Research and Development by : National Academies of Sciences Engineering and Medicine

Download or read book Preparing the Future Workforce in Drug Research and Development written by National Academies of Sciences Engineering and Medicine and published by . This book was released on 2025-02-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 National Academies workshop sought to identify the expertise and disciplines needed to achieve the aspirations for a transformed clinical trials enterprise by 2030 and enable a workforce that can better support the evolving needs of drug R&D - one that is resilient, culturally aware, anti-racist, and interdisciplinary. The workshop, hosted by the Forum on Drug Discovery, Development, and Translation and Roundtable on Black Men and Black Women in Science, Engineering, and Medicine explored strategies to bolster workforce capacity and challenges and opportunities associated with supporting the next-generation drug R&D workforce.

U.S. Health in International Perspective

Author: National Research Council

Publisher: National Academies Press

Published: 2013-04-12

Total Pages: 421

ISBN-13: 0309264146

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The United States is among the wealthiest nations in the world, but it is far from the healthiest. Although life expectancy and survival rates in the United States have improved dramatically over the past century, Americans live shorter lives and experience more injuries and illnesses than people in other high-income countries. The U.S. health disadvantage cannot be attributed solely to the adverse health status of racial or ethnic minorities or poor people: even highly advantaged Americans are in worse health than their counterparts in other, "peer" countries. In light of the new and growing evidence about the U.S. health disadvantage, the National Institutes of Health asked the National Research Council (NRC) and the Institute of Medicine (IOM) to convene a panel of experts to study the issue. The Panel on Understanding Cross-National Health Differences Among High-Income Countries examined whether the U.S. health disadvantage exists across the life span, considered potential explanations, and assessed the larger implications of the findings. U.S. Health in International Perspective presents detailed evidence on the issue, explores the possible explanations for the shorter and less healthy lives of Americans than those of people in comparable countries, and recommends actions by both government and nongovernment agencies and organizations to address the U.S. health disadvantage.

Book Synopsis U.S. Health in International Perspective by : National Research Council

Download or read book U.S. Health in International Perspective written by National Research Council and published by National Academies Press. This book was released on 2013-04-12 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States is among the wealthiest nations in the world, but it is far from the healthiest. Although life expectancy and survival rates in the United States have improved dramatically over the past century, Americans live shorter lives and experience more injuries and illnesses than people in other high-income countries. The U.S. health disadvantage cannot be attributed solely to the adverse health status of racial or ethnic minorities or poor people: even highly advantaged Americans are in worse health than their counterparts in other, "peer" countries. In light of the new and growing evidence about the U.S. health disadvantage, the National Institutes of Health asked the National Research Council (NRC) and the Institute of Medicine (IOM) to convene a panel of experts to study the issue. The Panel on Understanding Cross-National Health Differences Among High-Income Countries examined whether the U.S. health disadvantage exists across the life span, considered potential explanations, and assessed the larger implications of the findings. U.S. Health in International Perspective presents detailed evidence on the issue, explores the possible explanations for the shorter and less healthy lives of Americans than those of people in comparable countries, and recommends actions by both government and nongovernment agencies and organizations to address the U.S. health disadvantage.