In 2011 the Grand Challenges in Global Mental Health initiative identified priorities that have the potential to make a significant impact on the lives of people with mental, neurological, and substance use disorders. Reduction of the cost and improvement of the supply of effective medicines was highlighted as one of the top five challenges. For low- and middle-income countries, improving access to appropriate essential medicines can be a tremendous challenge and a critical barrier to scaling up quality care for mental, neurological, and substance use disorders. Reduction of cost and improvement of the supply of effective medicines has the potential to significantly impact the lives of patients with these disorders. Improving Access to Essential Medicines for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa is the summary of a workshop convened by the Institute of Medicine Neuroscience Forum in January 2014 in Addis Ababa, Ethiopia to discuss opportunities for achieving long-term affordable access to medicines for these disorders. This report examines challenges and opportunities for improving access to essential medicines in four critical areas: demand, selection, supply chains, and financing and pricing. The report also discusses successful activities that increase access to essential medicines both within Sub-Saharan Africa and in other developing countries, and considers the role of governments, nongovernmental organizations, and private groups in procurement of essential medicines for mental, neurological, and substance use disorders. Table of Contents Front Matter 1 Introduction and Overview 2 Challenge: Insufficient Demand 3 Challenge: Inappropriate Selection 4 Challenge: Ineffective Supply Chains 5 Challenge: High Pricing and Poor Financing 6 Perspectives on Next Steps Appendix A: Access to Essential Medicines: Program Examples Appendix B: References Appendix C: Workshop Agenda Appendix D: Registered Attendees

In 2010, more than 105,000 people were injured or killed in the United States as the result of a firearm-related incident. Recent, highly publicized, tragic mass shootings in Newtown, CT; Aurora, CO; Oak Creek, WI; and Tucson, AZ, have sharpened the American public's interest in protecting our children and communities from the harmful effects of firearm violence. While many Americans legally use firearms for a variety of activities, fatal and nonfatal firearm violence poses a serious threat to public safety and welfare. In January 2013, President Barack Obama issued 23 executive orders directing federal agencies to improve knowledge of the causes of firearm violence, what might help prevent it, and how to minimize its burden on public health. One of these orders directed the Centers for Disease Control and Prevention (CDC) to, along with other federal agencies, immediately begin identifying the most pressing problems in firearm violence research. The CDC and the CDC Foundation asked the IOM, in collaboration with the National Research Council, to convene a committee tasked with developing a potential research agenda that focuses on the causes of, possible interventions to, and strategies to minimize the burden of firearm-related violence. Priorities for Research to Reduce the Threat of Firearm-Related Violence focuses on the characteristics of firearm violence, risk and protective factors, interventions and strategies, the impact of gun safety technology, and the influence of video games and other media.

During natural disasters, disease pandemics, terrorist attacks, and other public health emergencies, the health system must be prepared to accommodate a surge in the number of individuals seeking medical help. For the health community, a primary concern is how to provide care to individuals during such high demand, when the health system's resources are exhausted and there are more patients than the system can accommodate. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop June 10-11, 2009, to assess the capability of and tools available to federal, state, and local governments to respond to a medical surge. In addition, participants discussed strategies for the public and private sectors to improve preparedness for such a surge. The workshop brought together leaders in the medical and public health preparedness fields, including policy makers from federal agencies and state and local public health departments; providers from the health care community; and health care and hospital administrators. This document summarizes the workshop. Table of Contents Front Matter Workshop Summary Appendix A: References Appendix B: Agenda Appendix C: Registered Attendees Appendix D: Surge Medical Response Capability: What Is It? How Do We Get It? How Do We Know When We Have It? Appendix E: Alternate Care Systems: Stratification of Care Appendix F: Creating Situational Awareness: A Systems Approach Appendix G: Vulnerable Populations in Disasters: Health Effects and Needs Appendix H: Fatalities Management Strategies Appendix I: Financing Surge Capacity and Preparedness

Mental, neurological, and substance use (MNS) disorders have a substantial impact on global health and well-being. Disorders such as depression, alcohol abuse, and schizophrenia constitute about 13 percent of the total burden of disease. Worldwide, MNS disorders are the leading cause of disability, and the 10th leading cause of death. Despite this high burden, there is a significant shortage of resources available to prevent, diagnose, and treat MNS disorders. Approximately four out of five people with serious MNS disorders living in low- and middle-income countries do not receive needed health services. This treatment gap is particularly high in Sub-Saharan Africa (SSA). Challenges to MNS care in SSA countries include a lack of trained mental health professionals, few mental health facilities, and low prioritization for MNS disorders in budget allocations. African countries, on average, have one psychiatrist for every 2 million people, whereas European countries have one psychiatrist per 12,000 people. Expanding on previous efforts to address the development and improvement of sustainable mental health systems in SSA, the Institute of Medicine convened this 2015 workshop series, bringing together key stakeholders to examine country-specific opportunities to improve the health care infrastructure in order to better prevent, diagnose, and treat MNS disorders. Providing Sustainable Mental and Neurological Health Care in Ghana and Kenya summarizes the presentations and discussions from these workshops. Table of Contents Front Matter 1 Introduction and Overview 2 Kenya 3 Ghana 4 Case Studies 5 Perspectives on Potential Next Steps Appendix A: References Appendix B: Workshop Agendas Appendix C: Registered Attendees Appendix D: Participant Biographies Appendix E: Providing Sustainable Mental Health Care in Kenya: A Demonstration Project Appendix F: Providing Sustainable Mental Health Care in Ghana: A Demonstration Project

From its very beginning, neuroscience has been fundamentally interdisciplinary. As a result of rapid technological advances and the advent of large collaborative projects, however, neuroscience is expanding well beyond traditional subdisciplines and intellectual boundaries to rely on expertise from many other fields, such as engineering, computer science, and applied mathematics. This raises important questions about to how to develop and train the next generation of neuroscientists to ensure innovation in research and technology in the neurosciences. In addition, the advent of new types of data and the growing importance of large datasets raise additional questions about how to train students in approaches to data analysis and sharing. These concerns dovetail with the need to teach improved scientific practices ranging from experimental design (e.g., powering of studies and appropriate blinding) to improved sophistication in statistics. Of equal importance is the increasing need not only for basic researchers and teams that will develop the next generation of tools, but also for investigators who are able to bridge the translational gap between basic and clinical neuroscience. Developing a 21st Century Neuroscience Workforce is the summary of a workshop convened by the Institute of Medicine's Forum on Neuroscience and Nervous System Disorders on October 28 and 29,2014, in Washington, DC, to explore future workforce needs and how these needs should inform training programs. Workshop participants considered what new subdisciplines and collaborations might be needed, including an examination of opportunities for cross-training of neuroscience research programs with other areas. In addition, current and new components of training programs were discussed to identify methods for enhancing data handling and analysis capabilities, increasing scientific accuracy, and improving research practices. This report highlights the presentation and discussion of the workshop. Table of Contents Front Matter 1 Introduction and Overview 2 Training Neuroscientists in Basic Research, Tool and Technology Development, and Big Data 3 Improving Training in Protocol Design, Experimental Rigor, and Quantitative Skills 4 Training in Transdisciplinary Research 5 Enhancing Training to Support Translational Research Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees Appendix D: Participant Biographies

During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.

Catastrophic disasters occurring in 2011 in the United States and worldwide-from the tornado in Joplin, Missouri, to the earthquake and tsunami in Japan, to the earthquake in New Zealand-have demonstrated that even prepared communities can be overwhelmed. In 2009, at the height of the influenza A (H1N1) pandemic, the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services, along with the Department of Veterans Affairs and the National Highway Traffic Safety Administration, asked the Institute of Medicine (IOM) to convene a committee of experts to develop national guidance for use by state and local public health officials and health-sector agencies and institutions in establishing and implementing standards of care that should apply in disaster situations-both naturally occurring and man-made-under conditions of scarce resources. Building on the work of phase one (which is described in IOM's 2009 letter report, Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations), the committee developed detailed templates enumerating the functions and tasks of the key stakeholder groups involved in crisis standards of care (CSC) planning, implementation, and public engagement-state and local governments, emergency medical services (EMS), hospitals and acute care facilities, and out-of-hospital and alternate care systems. Crisis Standards of Care provides a framework for a systems approach to the development and implementation of CSC plans, and addresses the legal issues and the ethical, palliative care, and mental health issues that agencies and organizations at each level of a disaster response should address. Please note: this report is not intended to be a detailed guide to emergency preparedness or disaster response. What is described in this report is an extrapolation of existing incident management practices and principles. Crisis Standards of Care is a seven-volume set: Volume 1 provides an overview; Volume 2 pertains to state and local governments; Volume 3 pertains to emergency medical services; Volume 4 pertains to hospitals and acute care facilities; Volume 5 pertains to out-of-hospital care and alternate care systems; Volume 6 contains a public engagement toolkit; and Volume 7 contains appendixes with additional resources. Table of Contents Front Matter Volume 1--Introduction and CSC Framework Volume 2--State and Local Government Volume 3--EMS Volume 4--Hospital Volume 5--Alternate Care Systems Volume 6--Public Engagement Volume 7--Appendixes

Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes. Table of Contents Front Matter Summary 1 Introduction 2 Gene Transfer Research: The Evolution of the Clinical Science 3 Oversight of Gene Transfer Research 4 Evolution of Oversight of Emerging Clinical Research Appendix A: Data Sources and Methods Appendix B: Historical and Policy Timelines for Recombinant DNA Technology Appendix C: Committee Biographies

Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system. Table of Contents Front Matter 1 Introduction and Overview 2 Evaluation of Current Animal Models 3 Translation from Animal Models to the Clinic: Case Examples from Neuroscience Research 4 Perspectives on Standardization 5 Perspectives on Corresponding Animal and Clinical Endpoints 6 Addressing the Translational Disconnect 7 Summary of Workshop Topics Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research. To consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences. This document summarizes the workshop. Table of Contents Front Matter 1 Introduction and Overview 2 The Evolving Regulatory Environment 3 Emerging Legal Trends Impacting Animal Research 4 Animals in Neuroscience Research 5 Advancing the 3Rs in Neuroscience Research 6 Public Engagement and Animal Research Regulations 7 Core Principles for the Care and Use of Animals in Research 8 Summary of Workshop Topics Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.

Problems contacting emergency services and delayed assistance are not unusual when incidents occur in rural areas, and the consequences can be devastating, particularly with mass casualty incidents. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop to examine the current capabilities of emergency response systems and the future opportunities to improve mass casualty response in rural communities.

Biological differences between the sexes influence not only individual health but also public health, biomedical research, and health care. The Institute of Medicine held a workshop March 8-9, 2010, to discuss sex differences and their implications for translational neuroscience research, which bridges the gap between scientific discovery and application. Table of Contents Front Matter 1 Introduction 2 Studying Sex Differences in Health and Disease 3 Studying Sex Differences in Translational Research: Examples from Four Major Disease Areas 4 Reporting Sex Differences in Research Publications 5 Sex Differences in Drug Development: Policy and Practice 6 Needs, Opportunities, and Next Steps Appendix A: References Appendix B: Registered Attendees Appendix C: Workshop Agenda

Millions of people in sub-Saharan Africa suffer from mental, neurological, and substance use (MNS) disorders, and most do not have the resources to obtain treatment. The Uganda National Academy of Sciences and the Institute of Medicine hosted a workshop to discuss the state of care for MNS disorders in sub-Saharan Africa. Table of Contents Front Matter Introduction 1 Background 2 Systems of Care for MNS in Sub-Saharan Africa 3 MNS Healthcare Policy 4 Needs, Opportunities, and Next Steps Appendix A: Putting into Context MNS Disorders in Sub-Saharan Africa Appendix B: References Appendix C: Agenda Appendix D: Registered Attendees Appendix E: Speaker Biographies

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. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)-a partnership among federal, state, and local governments; industry; and academia-is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health. Table of Contents Front Matter Workshop Summary Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Workshop Attendees Appendix D: Case Studies of HHS Chemical, Biological, Radiological, and Nuclear Medical Countermeasure Development Programs, Executive Summary Appendix E: Synthesis of Business Models and Economic and Market Incentives for Vaccines and Therapeutics

The influenza pandemic caused by the 2009 H1N1 virus underscores the immediate and critical need to prepare for a public health emergency in which thousands, tens of thousands, or even hundreds of thousands of people suddenly seek and require medical care in communities across the United States. "Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations" draws from a broad spectrum of expertise--including state and local public health, emergency medicine and response, primary care, nursing, palliative care, ethics, the law, behavioral health, and risk communication--to offer guidance toward establishing standards of care that should apply to disaster situations, both naturally occurring and man-made, under conditions in which resources are scarce. This book explores two case studies that illustrate the application of the guidance and principles laid out in the report. One scenario focuses on a gradual-onset pandemic flu. The other scenario focuses on an earthquake and the particular issues that would arise during a no-notice event. Outlining current concepts and offering guidance, this book will prove an asset to state and local public health officials, health care facilities, and professionals in the development of systematic and comprehensive policies and protocols for standards of care in disasters when resources are scarce. In addition, the extensive operations section of the book provides guidance to clinicians, health care institutions, and state and local public health officials for how crisis standards of care should be implemented in a disaster situation.

On March 3-4, 2008, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted a workshop titled "Medical Countermeasures Dispensing." The overall objective was to discuss a range of solutions to rapidly provide medical countermeasures to protect large numbers of people prior to or during a public health emergency, such as a bioterrorist attack or infectious disease outbreak. The United States is currently unprepared to confront the range of threats it is facing, such as an intentional anthrax release, severe acute respiratory syndrome (SARS), or pandemic influenza, and it must plan aggressively to counteract the threat of these and other future public health emergencies. Countermeasure dispensing must harness all types of imaginative partnerships between public and private institutions, working together in ways tailored to meet individual community needs. This workshop summary highlights the presentations and subsequent discussion that occurred at the workshop. Table of Contents Front Matter Workshop Summary Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Workshop Attendees Appendix D: Organizations Represented Appendix E: Biographical Sketches of Invited Speakers, Panelists, Workshop Planning Committee, Forum Members, and Staff

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.

One of the largest treatment gaps for mental, neurological, and substance use (MNS) disorders in the world can be seen in Sub-Saharan Africa (SSA). According to the World Health Organization (WHO), about 80% of people with serious MNS disorders living in low- and middle-income countries do not receive needed health services. A critical barrier to bridge this treatment gap is the ability to provide adequate human resources for the delivery of essential interventions for MNS disorders. An international workshop was convened in 2009, by the .S. Institute of Medicine (IOM) Forum on Neuroscience and Nervous Systems Disorders and the Uganda National Academy of Sciences (UNAS) Forum on Health and Nutrition, to bring together stakeholders from across SSA and to foster discussions about improving care for people suffering from MNS disorders and what steps, with potential for the greatest impact, might be considered to bridge the treatment gap. Due to the broad interest to further examine the treatment gap, the IOM forum organized a second workshop in Kampala, Uganda on September 4 and 5, 2012. The workshop\'s purpose was to discuss candidate core competencies that providers might need to help ensure the effective delivery of services for MNS disorders. The workshop focused specifically on depression, psychosis, epilepsy, and alcohol use disorders. Strengthening Human Resources Through Development of Candidate Core Competencies for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary outlines the presentations and discussions by expert panelists and participants of the plenary sessions of the workshop. This summary includes an overview of challenges faced by MNS providers in the SSA, perspectives on the next steps, the 2009 workshop, and more. Table of Contents Front Matter Strengthening Human Resources Through Development of Candidate Core Competencies for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary Appendix A: Summary of Candidate Core Competencies Appendix B: Candidate Core Competencies Appendix C: Provider Definitions and Relationship Roles Appendix D: References Appendix E: Workshop Agenda Appendix F: Working Groups Appendix G: Attendees

Influenza pandemics overwhelm health care systems with thousands or hundreds of thousands of sick patients, as well as those worried they may be sick. In order to ensure a successful response to the patient swell caused by a pandemic, robust planning is essential to prepare for challenges public health officials may face. This includes the need to quickly distribute and dispense antiviral medications that can reduce the severity and duration of disease to large numbers of people. In response to a request from the Centers for Disease Control, the Institute of Medicine's Forum on Medical and Public Health Preparedness for Catastrophic Events held a series of workshops that explored the public's perception of how to facilitate access to antiviral medications and treatment during an influenza pandemic. To help inform potential strategies still in the development stages at the CDC, workshops were held in Fort Benton, Montana; Chattanooga, Tennessee; and Los Angeles, California during February and March 2012 to consider the usefulness of several alternative strategies of delivering antiviral medication to the public. Participants considered how the normal systems for prescribing and dispensing antiviral medications could be adjusted to ensure that the public has quick, safe, and equitable access to both potentially life-saving drugs and information about the pandemic and treatment options. This document summarizes the workshops. Table of Contents Front Matter Introduction and Workshop Series Summary Appendix: Recruitment Flyer

When a nation or region prepares for public health emergencies such as a pandemic influenza, a large-scale earthquake, or any major disaster scenario in which the health system may be destroyed or stressed to its limits, it is important to describe how standards of care would change due to shortages of critical resources. At the 17th World Congress on Disaster and Emergency Medicine, the IOM Forum on Medical and Public Health Preparedness sponsored a session that focused on the promise of and challenges to integrating crisis standards of care principles into international disaster response plans. Table of Contents Front Matter Workshop Summary Appendix A: References Appendix B: Agenda

Scientific advances during the last decade now indicate that Alzheimer's disease is a continuous, progressive cognitive disease, most likely beginning many years before dementia is apparent. To discuss the next steps in validating new diagnostic guidelines for Alzheimer's disease, the IOM Forum on Neuroscience and Nervous System Disorders hosted a public workshop session at the Alzheimer's Association International Conference. Table of Contents Front Matter Alzheimer's Diagnostic Guideline Validation: Exploration of Next Steps: Workshop Summary Appendix A: References Appendix B: Workshop Agenda Appendix C: Speaker Biographies

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 death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations. Table of Contents Front Matter 1 Introduction 2 MCM Enterprise and Stakeholder Perspectives 3 Cutting-Edge Efforts to Advance MCM Regulatory Science 4 MCM Regulatory Science Needs for At-Risk Populations 5 Crosscutting Themes and Future Directions 6 Closing Remarks References Appendix A: Workshop Agenda Appendix B: Participant Biographies

Glutamate is the most pervasive neurotransmitter in the central nervous system (CNS). Despite this fact, no validated biological markers, or biomarkers, currently exist for measuring glutamate pathology in CNS disorders or injuries. Glutamate dysfunction has been associated with an extensive range of nervous system diseases and disorders. Problems with how the neurotransmitter glutamate functions in the brain have been linked to a wide variety of disorders, including schizophrenia, Alzheimer's, substance abuse, and traumatic brain injury. These conditions are widespread, affecting a large portion of the United States population, and remain difficult to treat. Efforts to understand, treat, and prevent glutamate-related disorders can be aided by the identification of valid biomarkers. The Institute of Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop on June 21-22, 2010, to explore ways to accelerate the development, validation, and implementation of such biomarkers. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary investigates promising current and emerging technologies, and outlines strategies to procure resources and tools to advance drug development for associated nervous system disorders. Moreover, this report highlights presentations by expert panelists, and the open panel discussions that occurred during the workshop.

Clinical practice related to sleep problems and sleep disorders has been expanding rapidly in the last few years, but scientific research is not keeping pace. Sleep apnea, insomnia, and restless legs syndrome are three examples of very common disorders for which we have little biological information. This new book cuts across a variety of medical disciplines such as neurology, pulmonology, pediatrics, internal medicine, psychiatry, psychology, otolaryngology, and nursing, as well as other medical practices with an interest in the management of sleep pathology. This area of research is not limited to very young and old patients?sleep disorders reach across all ages and ethnicities. Sleep Disorders and Sleep Deprivation presents a structured analysis that explores the following: Improving awareness among the general public and health care professionals. Increasing investment in interdisciplinary somnology and sleep medicine research training and mentoring activities. Validating and developing new and existing technologies for diagnosis and treatment. This book will be of interest to those looking to learn more about the enormous public health burden of sleep disorders and sleep deprivation and the strikingly limited capacity of the health care enterprise to identify and treat the majority of individuals suffering from sleep problems. Table of Contents Front Matter Summary 1 Introduction 2 Sleep Physiology 3 Extent and Health Consequences of Chronic Sleep Loss and Sleep Disorders 4 Functional and Economic Impact of Sleep Loss and Sleep-Related Disorders 5 Improving Awareness, Diagnosis, and Treatment of Sleep Disorders 6 Ensuring Adequate Diagnosis and Treatment: Access, Capacity, and Technology Development 7 Opportunities to Improve Career Development in Somnology 8 Bolstering Somnology and Sleep Disorders Research Programs 9 Building Sleep Programs in Academic Health Centers Appendix A Study Process Appendix B Acronyms Appendix C Glossary of Major Terms Appendix D Congressional Language Establishing the National Center On Sleep Disorders Research Appendix E Sleep Disorders Research Advisory Board Membership Appendix F National Institutes of Health Sleep-Related Initiatives: 1994-2004 Appendix G National Institutes of Health Support of Sleep-Related R01 Grants Appendix H Summary of NIH Support of Sleep-Related Career Development Awards Appendix I Summary of NIH Support of Sleep-Related R13, R25, P, F, T, and U Grants Appendix J Summary of Investment in Sleep-Related Projects at The Top 30 NIH-Funded Institutions Appendix K Biographical Sketches of Committee Members and Staff Index