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Improving And Accelerating Therapeutic Development For Nervous System Disorders
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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 118 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309455162 Total Pages :95 pages Book Rating :4.3/5 (94 download)
Book Synopsis Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders by : National Academies of Sciences, Engineering, and Medicine
Download or read book Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-05-24 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Compared with other disease areas, central nervous system (CNS) disorders have had the highest failure rate for new compounds in advanced clinical trials. Most CNS drugs fail because of efficacy, and the core issue underlying these problems is a poor understanding of disease biology. Concern about the poor productivity in neuroscience drug development has gained intensity over the past decade, amplified by a retraction in investment from the pharmaceutical industry. This retreat by industry has been fueled by the high failure rate of compounds in advanced clinical trials for nervous system disorders. In response to the de-emphasis of CNS disorders in therapeutic development relative to other disease areas such as cancer, metabolism, and autoimmunity, the National Academies of Sciences, Engineering, and Medicine initiated a series of workshops in 2012 to address the challenges that have slowed drug development for nervous system disorders. Motivated by the notion that advances in genetics and other new technologies are beginning to bring forth new molecular targets and identify new biomarkers, the Academies hosted the third workshop in this series in September 2016. Participants discussed opportunities to accelerate early stages of drug development for nervous system disorders in the absence of animal models that reflect disease and predict efficacy. This publication summarizes the presentations and discussions from the workshop.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309473101 Total Pages :73 pages Book Rating :4.3/5 (94 download)
Book Synopsis Enabling Novel Treatments for Nervous System Disorders by Improving Methods for Traversing the Bloodâ¬"Brain Barrier by : National Academies of Sciences, Engineering, and Medicine
Download or read book Enabling Novel Treatments for Nervous System Disorders by Improving Methods for Traversing the Bloodâ¬"Brain Barrier written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-05-29 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite substantial advances in developing treatments for the serious illnesses that affect people worldwide, there remains a tremendous unmet need in the treatment of complex neurologic diseases, including neuropsychiatric and neurodegenerative disorders. Chief among the challenges that have hindered the development of therapeutics for central nervous system (CNS) disorders is the bloodâ€"brain barrier (BBB). The Forum on Neuroscience and Nervous System Disorders of the National Academies of Sciences, Engineering, and Medicine convened a workshop to explore the challenges associated with the BBB that have thus far stymied development of CNS drugs, examine new technologies that could address these challenges, and highlight potential opportunities for moving the field forward. This publication summarizes the presentations and discussions from the workshop.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309473071 Total Pages :73 pages Book Rating :4.3/5 (94 download)
Book Synopsis Enabling Novel Treatments for Nervous System Disorders by Improving Methods for Traversing the Bloodâ¬"Brain Barrier by : National Academies of Sciences, Engineering, and Medicine
Download or read book Enabling Novel Treatments for Nervous System Disorders by Improving Methods for Traversing the Bloodâ¬"Brain Barrier written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-06-29 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite substantial advances in developing treatments for the serious illnesses that affect people worldwide, there remains a tremendous unmet need in the treatment of complex neurologic diseases, including neuropsychiatric and neurodegenerative disorders. Chief among the challenges that have hindered the development of therapeutics for central nervous system (CNS) disorders is the bloodâ€"brain barrier (BBB). The Forum on Neuroscience and Nervous System Disorders of the National Academies of Sciences, Engineering, and Medicine convened a workshop to explore the challenges associated with the BBB that have thus far stymied development of CNS drugs, examine new technologies that could address these challenges, and highlight potential opportunities for moving the field forward. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders by : Institute of Medicine
Download or read book Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2015-10-22 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309495849 Total Pages :93 pages Book Rating :4.3/5 (94 download)
Book Synopsis Advancing Gene-Targeted Therapies for Central Nervous System Disorders by : National Academies of Sciences, Engineering, and Medicine
Download or read book Advancing Gene-Targeted Therapies for Central Nervous System Disorders written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-12-01 with total page 93 pages. Available in PDF, EPUB and Kindle. Book excerpt: On April 23 and 24, 2019 the Forum on Neuroscience and Nervous System Disorders convened a workshop titled "Advancing Gene-Targeted Therapies for Central Nervous System Disorders" in Washington, DC. This public workshop brought together experts and key stakeholders from academia, government, industry, philanthropic foundations, and disease/patient-focused nonprofit organizations to explore approaches for advancing the development of gene-targeted therapies for central nervous system (CNS) disorders, and implications of developing these therapies. Participants explored lessons learned from both successful and unsuccessful clinical development programs; new knowledge about the genetic underpinnings of brain disorders; the current status and future potential of gene-targeted therapies for CNS disorders; challenges and potential solutions for translating preclinical findings to approved therapies; and patient and caregiver perspectives. They also discussed what will be needed to develop these therapies for common disorders such as Alzheimer's and Parkinson's disease, as well as neuropsychiatric and neurodevelopmental disorders such as schizophrenia and autism. The workshop included approaches that target both DNA and RNA, as well as gene products using viral vectors, antisense oligonucleotides, and RNA interference. This publication summarizes the presentations and discussion of the workshop.
Download or read book Drug Repositioning written by Joel Dudley and published by CRC Press. This book was released on 2017-07-14 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nervous system diseases represent a major health concern worldwide. Although important financial and professional investment, their etiology and pathophysiology still remain mostly elusive. Moreover, the clinical need of disease-modifying therapies is still unmet. In the last decades, traditional R&D has failed in identifying new effective therapies in many medical areas and drug repositioning has recently emerged as a promising alternative strategy to de novo drug discovery to improve and accelerate therapeutic development. For the first time, Drug Repositioning: Approaches and Applications for Neurotherapeutics reviews history and advances in drug repositioning, with a special focus on therapeutics for nervous system diseases. International experts from Academia, Industry and Non-profit organisations will provide different views on drug repositioning advantages, challenges and specific applications, which will be covered for nervous system diseases including Alzheimer's, Parkinson's, Huntington's diseases, Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy, ischemic stroke, and psychiatric disorders. This book provides a balanced overview and synthesis of drug repositioning concept, methods and applications for neurotherapeutics. It represents a valuable resource for students, scientists and clinicians working in academic settings, industry and government agencies within the fields of neuroscience, pharmacology, neurology, pharmaceutical sciences, drug discovery and development.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309442559 Total Pages :111 pages Book Rating :4.3/5 (94 download)
Book Synopsis Neuroscience Trials of the Future by : National Academies of Sciences, Engineering, and Medicine
Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-12-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309473993 Total Pages :107 pages Book Rating :4.3/5 (94 download)
Book Synopsis Advancing Therapeutic Development for Pain and Opioid Use Disorders Through Public-Private Partnerships by : National Academies of Sciences, Engineering, and Medicine
Download or read book Advancing Therapeutic Development for Pain and Opioid Use Disorders Through Public-Private Partnerships written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-06-22 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronic pain is one of the most prevalent, costly, and disabling health conditions in the United States. Estimates show that more than 11 percent of the American population suffer from chronic pain, yet the federal pain research investment has been minimal. In parallel with a gradual increased recognition of the problems of treating chronic pain, the opioid epidemic has emerged as a growing public health emergency. The intersection of these two crises lies in the fact that an unintended consequence of treating pain has been an increasing number of opioid prescriptions and diversion of drugs for illicit purposes. In May 2017, the National Institutes of Health (NIH), and the National Institute on Drug Abuse announced a publicâ€"private partnership to develop solutions to the opioid crisis and cut in half the time it takes to develop non-addictive analgesics. To advance the planning of NIH's anticipated publicâ€"private partnerships, the National Academies' Forum on Neuroscience and Nervous Systems Disorders hosted a public workshop that brought together a diverse group of stakeholders from academia, federal agencies, advocacy organizations and companies developing therapeutics for pain and opioid use disorders. Participants discussed potential strategies to accelerate development of non-addictive pain medications and treatments for opioid use disorders. This publication summarizes the presentations and discussions from the workshop.
Author :Institute of Medicine (U.S.). Forum on Neuroscience and Nervous System Disorders Publisher : ISBN 13 :9780309376181 Total Pages :0 pages Book Rating :4.3/5 (761 download)
Book Synopsis Non-invasive Neuromodulation of the Central Nervous System : Opportunities and Challenges : Workshop Summary by : Institute of Medicine (U.S.). Forum on Neuroscience and Nervous System Disorders
Download or read book Non-invasive Neuromodulation of the Central Nervous System : Opportunities and Challenges : Workshop Summary written by Institute of Medicine (U.S.). Forum on Neuroscience and Nervous System Disorders and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on advances in biotechnology and neuroscience, non-invasive neuromodulation devices are poised to gain clinical importance in the coming years and to be of increasing interest to patients, clinicians, health systems, payers, and industry. Evidence suggests that both therapeutic and non-therapeutic applications of non-invasive neuromodulation will continue to expand in coming years, particularly for indications where treatments are currently insufficient, such as drug-resistant depression. Given the growing interest in non-invasive neuromodulation technologies, the Institute of Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop, inviting a range of stakeholders - including developers of devices and new technologies, researchers, clinicians, ethicists, regulators, and payers - to explore the opportunities, challenges, and ethical questions surrounding the development, regulation, and reimbursement of these devices for the treatment of nervous system disorders as well as for non-therapeutic uses, including cognitive and functional enhancement. This report highlights the presentation and discussion of the workshop.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309457971 Total Pages :145 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Drug Development Paradigm in Oncology by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309455138 Total Pages :95 pages Book Rating :4.3/5 (94 download)
Book Synopsis Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders by : National Academies of Sciences, Engineering, and Medicine
Download or read book Therapeutic Development in the Absence of Predictive Animal Models of Nervous System Disorders written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-06-24 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Compared with other disease areas, central nervous system (CNS) disorders have had the highest failure rate for new compounds in advanced clinical trials. Most CNS drugs fail because of efficacy, and the core issue underlying these problems is a poor understanding of disease biology. Concern about the poor productivity in neuroscience drug development has gained intensity over the past decade, amplified by a retraction in investment from the pharmaceutical industry. This retreat by industry has been fueled by the high failure rate of compounds in advanced clinical trials for nervous system disorders. In response to the de-emphasis of CNS disorders in therapeutic development relative to other disease areas such as cancer, metabolism, and autoimmunity, the National Academies of Sciences, Engineering, and Medicine initiated a series of workshops in 2012 to address the challenges that have slowed drug development for nervous system disorders. Motivated by the notion that advances in genetics and other new technologies are beginning to bring forth new molecular targets and identify new biomarkers, the Academies hosted the third workshop in this series in September 2016. Participants discussed opportunities to accelerate early stages of drug development for nervous system disorders in the absence of animal models that reflect disease and predict efficacy. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis fMRI Neurofeedback by : Michelle Hampson
Download or read book fMRI Neurofeedback written by Michelle Hampson and published by Academic Press. This book was released on 2021-10-09 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: fMRI Neurofeedback provides a perspective on how the field of functional magnetic resonance imaging (fMRI) neurofeedback has evolved, an introduction to state-of-the-art methods used for fMRI neurofeedback, a review of published neuroscientific and clinical applications, and a discussion of relevant ethical considerations. It gives a view of the ongoing research challenges throughout and provides guidance for researchers new to the field on the practical implementation and design of fMRI neurofeedback protocols. This book is designed to be accessible to all scientists and clinicians interested in conducting fMRI neurofeedback research, addressing the variety of different knowledge gaps that readers may have given their varied backgrounds and avoiding field-specific jargon. The book, therefore, will be suitable for engineers, computer scientists, neuroscientists, psychologists, and physicians working in fMRI neurofeedback. Provides a reference on fMRI neurofeedback covering history, methods, mechanisms, clinical applications, and basic research, as well as ethical considerations Offers contributions from international experts—leading research groups are represented, including from Europe, Japan, Israel, and the United States Includes coverage of data analytic methods, study design, neuroscience mechanisms, and clinical considerations Presents a perspective on future translational development
Book Synopsis Alzheimer's Disease Drug Development by : Jeffrey Cummings
Download or read book Alzheimer's Disease Drug Development written by Jeffrey Cummings and published by Cambridge University Press. This book was released on 2022-03-31 with total page 575 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.
Book Synopsis Peripheral Nerve Regeneration by : Giovanna Gambarotta
Download or read book Peripheral Nerve Regeneration written by Giovanna Gambarotta and published by Frontiers Media SA. This book was released on 2019-12-24 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Alcohol and the Nervous System by : Edith V. Sullivan
Download or read book Alcohol and the Nervous System written by Edith V. Sullivan and published by Elsevier. This book was released on 2014-10-08 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: Alcohol is the most widely used drug in the world, yet alcoholism remains a serious addiction affecting nearly 20 million Americans. Our current understanding of alcohol's effect on brain structure and related functional damage is being revolutionized by genetic research, basic neuroscience, brain imaging science, and systematic study of cognitive, sensory, and motor abilities. Volume 125 of the Handbook of Clinical Neurology is a comprehensive, in-depth treatise of studies on alcohol and the brain covering the basic understanding of alcohol's effect on the central nervous system, the diagnosis and treatment of alcoholism, and prospect for recovery. The chapters within will be of interest to clinical neurologists, neuropsychologists, and researchers in all facets and levels of the neuroscience of alcohol and alcoholism. The first focused reference specifically on alcohol and the brain Details our current understanding of how alcohol impacts the central nervous system Covers clinical and social impact of alcohol abuse disorders and the biomedical consequences of alcohol abuse Includes section on neuroimaging of neurochemical markers and brain function
