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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.
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.
Emerging Cognitive Neuroscience and Related Technologies, from the National Research Council, identifies and explores several specific research areas that have implications for U.S. national security, and should therefore be monitored consistently by the intelligence community. These areas include: neurophysiological advances in detecting and measuring indicators of psychological states and intentions of individuals the development of drugs or technologies that can alter human physical or cognitive abilities advances in real-time brain imaging breakthroughs in high-performance computing and neuronal modeling that could allow researchers to develop systems which mimic functions of the human brain, particularly the ability to organize disparate forms of data. As these fields continue to grow, it will be imperative that the intelligence community be able to identify scientific advances relevant to national security when they occur. To do so will require adequate funding, intelligence analysts with advanced training in science and technology, and increased collaboration with the scientific community, particularly academia. A key tool for the intelligence community, this book will also be a useful resource for the health industry, the military, and others with a vested interest in technologies such as brain imaging and cognitive or physical enhancers.
Presents a thorough examination of the unifying principles from the subcellular to the systems and clinical levels; Identifies common themes among molecular biology, genetics, physiology, pathology, biomarkers, behavior, and treatment strategies that are shared between neurodegenerative diseases; Enables better care of patients and help build collaboration across researchers in multiple specializations that could help advance future insights and facilitate novel therapies and enhancing basic scientific understanding of these diseases to a new generation.
Neural Engineering, 2nd Edition, contains reviews and discussions of contemporary and relevant topics by leading investigators in the field. It is intended to serve as a textbook at the graduate and advanced undergraduate level in a bioengineering curriculum. This principles and applications approach to neural engineering is essential reading for all academics, biomedical engineers, neuroscientists, neurophysiologists, and industry professionals wishing to take advantage of the latest and greatest in this emerging field.
Traumatic brain injury (TBI) remains a significant source of death and permanent disability, contributing to nearly one-third of all injury related deaths in the United States and exacting a profound personal and economic toll. Despite the increased resources that have recently been brought to bear to improve our understanding of TBI, the developme
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Mental, neurological, and substance use disorders are common, highly disabling, and associated with significant premature mortality. The impact of these disorders on the social and economic well-being of individuals, families, and societies is large, growing, and underestimated. Despite this burden, these disorders have been systematically neglected, particularly in low- and middle-income countries, with pitifully small contributions to scaling up cost-effective prevention and treatment strategies. Systematically compiling the substantial existing knowledge to address this inequity is the central goal of this volume. This evidence-base can help policy makers in resource-constrained settings as they prioritize programs and interventions to address these disorders.