Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders

Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309373263
Category : Medical
Languages : en
Pages : 128

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Book Description
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, 2015, to explore policy changes that might increase private sector investment in research and development innovation that fills unmet medical needs for central nervous system (CNS) disorders. Workshop participants strategized about how to incentivize companies to fortify their CNS drug development programs, shrinking obstacles that currently deter ventures. Representatives from academia, government agencies, patient groups, and industry gathered to share information and viewpoints, and to brainstorm about budget-neutral policy changes that could help widen the pipeline toward drugs that address unmet needs for CNS disorders. This report summarizes the presentations and discussion of the workshop.

Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders

Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309373263
Category : Medical
Languages : en
Pages : 128

Get Book

Book Description
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, 2015, to explore policy changes that might increase private sector investment in research and development innovation that fills unmet medical needs for central nervous system (CNS) disorders. Workshop participants strategized about how to incentivize companies to fortify their CNS drug development programs, shrinking obstacles that currently deter ventures. Representatives from academia, government agencies, patient groups, and industry gathered to share information and viewpoints, and to brainstorm about budget-neutral policy changes that could help widen the pipeline toward drugs that address unmet needs for CNS disorders. This report summarizes the presentations and discussion of the workshop.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 118

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Book Description
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.

Biomarkers of Neuroinflammation

Biomarkers of Neuroinflammation PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309463653
Category : Medical
Languages : en
Pages : 89

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Book Description
Neuroinflammation is a burgeoning area of interest in academia and biopharma, with a broadly acknowledged role in many central nervous system (CNS) disorders. However, there is little agreement on the pathophysiological mechanisms that underlie the manifestations of neuroinflammation in the CNS compartment and how neuroinflammation operates as a driver and also as a consequence of disease in the brain. Moreover, another unclear area is how to translate increased understanding of the mechanisms that underlie neuroinflammation and its manifestations in the CNS to therapeutics. To address these gaps in understanding mechanisms and how to translate that understanding into therapeutics, the Forum on Neuroscience and Nervous System Disorders of the National Academies of Sciences, Engineering, and Medicine convened a workshop on March 20-21, 2017, bringing together key leaders in the field from industry, academia, and governmental agencies to explore the role and mechanisms of neuroinflammation in a variety of CNS diseases. The workshop also considered strategies to advance the identification and validation of biomarkers of neuroinflammation that could accelerate development of therapies, bringing much-needed treatments to patients with disorders ranging from neuroinflammatory diseases such as multiple sclerosis (MS) to neuropsychiatric disorders such as depression. This publication summarizes the presentations and discussions from the workshop.

The Fourth Industrial Revolution

The Fourth Industrial Revolution PDF Author: Klaus Schwab
Publisher: Currency
ISBN: 1524758868
Category : Business & Economics
Languages : en
Pages : 194

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Book Description
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.

Dying in America

Dying in America PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309303133
Category : Medical
Languages : en
Pages : 638

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Book Description
For patients and their loved ones, no care decisions are more profound than those made near the end of life. Unfortunately, the experience of dying in the United States is often characterized by fragmented care, inadequate treatment of distressing symptoms, frequent transitions among care settings, and enormous care responsibilities for families. According to this report, the current health care system of rendering more intensive services than are necessary and desired by patients, and the lack of coordination among programs increases risks to patients and creates avoidable burdens on them and their families. Dying in America is a study of the current state of health care for persons of all ages who are nearing the end of life. Death is not a strictly medical event. Ideally, health care for those nearing the end of life harmonizes with social, psychological, and spiritual support. All people with advanced illnesses who may be approaching the end of life are entitled to access to high-quality, compassionate, evidence-based care, consistent with their wishes. Dying in America evaluates strategies to integrate care into a person- and family-centered, team-based framework, and makes recommendations to create a system that coordinates care and supports and respects the choices of patients and their families. The findings and recommendations of this report will address the needs of patients and their families and assist policy makers, clinicians and their educational and credentialing bodies, leaders of health care delivery and financing organizations, researchers, public and private funders, religious and community leaders, advocates of better care, journalists, and the public to provide the best care possible for people nearing the end of life.

Relieving Pain in America

Relieving Pain in America PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030921484X
Category : Medical
Languages : en
Pages : 383

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Book Description
Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335

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Book Description
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

The Development of Medications for the Treatment of Opiate and Cocaine Addictions

The Development of Medications for the Treatment of Opiate and Cocaine Addictions PDF Author: Committee to Study Medication Development and Research at the National Institute on Drug Abuse
Publisher: National Academies Press
ISBN: 0309587913
Category : Medical
Languages : en
Pages : 271

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Book Description
Pharmacotherapy, as a means of treating drug addiction in combination with other treatment modalities, has received too little attention from the research community, the pharmaceutical industry, public health officials, and the federal government. Medications to combat drug addiction could have an enormous impact on the medical consequences and socioeconomic problems associated with drug abuse, both for drug-dependent individuals and for American society as a whole. This book examines the current environment for and obstacles to the development of anti-addiction medications, specifically those for treating opiate and cocaine addictions, and proposes incentives for the pharmaceutical industry that would help overcome those obstacles and accelerate the development of anti-addiction medications.

Investing in the Health and Well-Being of Young Adults

Investing in the Health and Well-Being of Young Adults PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309309980
Category : Medical
Languages : en
Pages : 502

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Book Description
Young adulthood - ages approximately 18 to 26 - is a critical period of development with long-lasting implications for a person's economic security, health and well-being. Young adults are key contributors to the nation's workforce and military services and, since many are parents, to the healthy development of the next generation. Although 'millennials' have received attention in the popular media in recent years, young adults are too rarely treated as a distinct population in policy, programs, and research. Instead, they are often grouped with adolescents or, more often, with all adults. Currently, the nation is experiencing economic restructuring, widening inequality, a rapidly rising ratio of older adults, and an increasingly diverse population. The possible transformative effects of these features make focus on young adults especially important. A systematic approach to understanding and responding to the unique circumstances and needs of today's young adults can help to pave the way to a more productive and equitable tomorrow for young adults in particular and our society at large. Investing in The Health and Well-Being of Young Adults describes what is meant by the term young adulthood, who young adults are, what they are doing, and what they need. This study recommends actions that nonprofit programs and federal, state, and local agencies can take to help young adults make a successful transition from adolescence to adulthood. According to this report, young adults should be considered as a separate group from adolescents and older adults. Investing in The Health and Well-Being of Young Adults makes the case that increased efforts to improve high school and college graduate rates and education and workforce development systems that are more closely tied to high-demand economic sectors will help this age group achieve greater opportunity and success. The report also discusses the health status of young adults and makes recommendations to develop evidence-based practices for young adults for medical and behavioral health, including preventions. What happens during the young adult years has profound implications for the rest of the life course, and the stability and progress of society at large depends on how any cohort of young adults fares as a whole. Investing in The Health and Well-Being of Young Adults will provide a roadmap to improving outcomes for this age group as they transition from adolescence to adulthood.

Patient Safety and Quality

Patient Safety and Quality PDF Author: Ronda Hughes
Publisher: Department of Health and Human Services
ISBN:
Category : Medical
Languages : en
Pages : 592

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Book Description
"Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/