Psychiatric illnesses - such as major depressive disorder, anxiety disorder, substance use disorder, and posttraumatic stress disorder (PTSD) - are widely prevalent and represent a substantial health burden worldwide. Yet, conventional medications for mental illnesses often fail to provide relief to patients' disruptive and disabling symptoms. Existing and emerging evidence that psychedelics (e.g., LSD and psilocybin) and entactogens (e.g., MDMA) may be useful as tools to alleviate mental illness has sparked a renaissance of interest by investigators, clinicians, drug developers, and patient advocates in recent years. While promising data on therapeutic efficacy has energized research and development, resolving the mechanisms of action will be important for optimizing the efficacy and safety of these medicines. Further, evaluating the effect of psychedelics and entactogens on mood and behavior comes with unique challenges still in need of resolution. These include unresolved questions relating to blinding, placebo and nocebo effects, and the impact of psychosocial contexts. In response to this renewed interest, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop on March 29-30, 2022. The workshop brought together a diverse group of stakeholders to explore the use of psychedelics and entactogens as treatments for psychiatric disorders. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop. Table of Contents Front Matter 1 Introduction and Background 2 History and Current Status of Psychedelics and Entactogens for the Treatment of Psychiatric Disorders 3 Mechanisms of Action and Key Research Gaps for Psychedelics and Entactogens 4 Advancing Clinical Development: Challenges and Opportunities 5 Anticipating Implementation to Guide Clinical Research and Development 6 Reflecting on the Road Ahead Appendix A: References Appendix B: Workshop Agenda

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 public?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 public?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. Table of Contents Front Matter 1 Introduction and Background 2 Exploring Challenges to Developing Treatments for Pain and Opioid Use Disorders 3 Exploring the State of the Science and Preclinical Models for Pain Therapeutic Development 4 Clinical Development of Non-Addictive Pain Medications 5 Therapeutic Development for Opioid Use Disorders and Overdose Prevention and Reversal 6 PublicPrivate Partnerships to Advance Pain and Opioid Use Disorders Research and Development Appendix A References Appendix B Workshop Agenda Appendix C Registered Attendees

Societies around the world are concerned about dementia and the other forms of cognitive impairment that affect many older adults. We now know that brain changes typically begin years before people show symptoms, which suggests a window of opportunity to prevent or delay the onset of these conditions. Emerging evidence that the prevalence of dementia is declining in high-income countries offers hope that public health interventions will be effective in preventing or delaying cognitive impairments. Until recently, the research and clinical communities have focused primarily on understanding and treating these conditions after they have developed. Thus, the evidence base on how to prevent or delay these conditions has been limited at best, despite the many claims of success made in popular media and advertising. Today, however, a growing body of prevention research is emerging. Preventing Cognitive Decline and Dementia: A Way Forward assesses the current state of knowledge on interventions to prevent cognitive decline and dementia, and informs future research in this area. This report provides recommendations of appropriate content for inclusion in public health messages from the National Institute on Aging. Table of Contents Front Matter Summary 1 Introduction 2 Communicating with the Public about Interventions to Prevent Cognitive Decline and Dementia 3 Methodological Improvements 4 Priorities for Future Research Appendix A: Agency for Healthcare Research and Quality (AHRQ) Systematic Review Appendix B: Public Meeting Agendas Appendix C: Biosketches of Committee Members

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. Table of Contents Front Matter 1 Introduction and Overview 2 Exploring the Current Landscape of Central Nervous System Gene-Targeted Therapies 3 Gene-Targeted Therapy Approaches for Central Nervous System Disorders: Opportunities and Challenges 4 Translating Gene-Targeted Therapies from Bench to Bedside 5 Meaningful Engagement of Patients and Families 6 Future Directions in the Development of Gene-Targeted Therapies Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

The cloud model of data sharing has led to a vast increase in the quantity and complexity of data and expanded access to these data, which has attracted many more researchers, enabled multi-national neuroscience collaborations, and facilitated the development of many new tools. Yet, the cloud model has also produced new challenges related to data storage, organization, and protection. Merely switching the technical infrastructure from local repositories to cloud repositories is not enough to optimize data use. To explore the burgeoning use of cloud computing in neuroscience, the National Academies Forum on Neuroscience and Nervous System Disorders hosted a workshop on September 24, 2019. A broad range of stakeholders involved in cloud-based neuroscience initiatives and research explored the use of cloud technology to advance neuroscience research and shared approaches to address current barriers. This publication summarizes the presentation and discussion of the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Harnessing Cloud-Based Technologies to Advance Neuroscience Research: Select Current Initiatives Part 1: Cloud-Based Technologies for Neuroscience Research: Challenges and Potential Solutions 3 Protecting Privacy in the Cloud 4 Managing Data and Promoting Interoperability in the Cloud 5 Assigning Credit, Determining Ownership, and Licensing Data in the Cloud 6 Governing, Funding, and Sustaining Cloud-Based Platforms Part 2: Different Types of Neuroscience Data: Challenges and Potential Opportunities 7 Clinical Trial and Research Data 8 Genetic Data 9 Neuroimaging Data 10 Real-World Data 11 Future Directions Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered In-Person Attendees

To examine the promise, concerns, and challenges related to neuroscience research using genetically modified nonhuman primates, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop on October 4, 2018, bringing together an international group of experts and stakeholders representing academia, industry, laboratory animal management, disease-focused foundations, and federal agencies. The workshop was designed to explore the current state and future promise of research using genetically modified nonhuman primate models of disease to understand the complex functions of the brain that control behavior, movement, and cognition in both health and disease states. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Genetically Modified Nonhuman Primate Models for Neuroscience Research: Rationale and Overview of Potential Opportunities and Challenges 3 State of the Science of Transgenic Nonhuman Primate Models for Nervous System Disorders 4 Translating Research from Nonhuman Primates to Humans 5 Bioethical Considerations for Transgenic Nonhuman Primate Models in Neuroscience Research 6 Understanding the Policy, Infrastructure, and Funding Needed to Advance Neuroscience Research Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

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. Table of Contents Front Matter 1 Introduction and Overview 2 Drug Development for Nervous System Disorders: Overview of Challenges and Potential Opportunities 3 Case Studies: Therapeutic Development for Parkinson's Disease and Schizophrenia in the Absence of Predictive Animal Models of Disease 4 New Modeling Approaches for Nervous System Disorders 5 Private-Sector Thresholds for Investment in Neuroscience Clinical Trials 6 Ethical Considerations 7 Regulatory Perspectives Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

Methadone is a Food and Drug Administration- (FDA-) approved medication for treating opioid use disorder (OUD), a chronic brain disease that affects more than 2.7 million people in the United States aged 12 and older. Despite its effectiveness in saving lives, many barriers impede access to, initiation of, and retention in methadone treatment for OUD. To address these barriers, on March 3 and 4, 2022, the National Academies of Sciences, Engineering, and Medicine hosted a workshop on "Methadone Treatment for Opioid Use Disorder: Examining Federal Regulations and Laws," at the request of the Office of National Drug Control Policy in the Executive Office of the President. This publication summarizes the presentation and discussion of the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Methadone Treatment: Personal Perspectives 3 The History of Methadone and Barriers to Access for Different Populations 4 Current Federal Priorities and Regulatory Flexibilities during the COVID-19 Pandemic 5 Improving Access to Quality Treatment in Opioid Treatment Programs through Regulatory Innovation 6 Improving Access to Quality Treatment in the Criminal Justice System and Other Institutional Settings 7 Expanding Access to Methadone through Regulatory Innovation: Envisioning Approaches Outside the Opioid Treatment Program System 8 Ensuring Equitable Access to Methadone by Removing Current Barriers and Providing Incentives 9 Frameworks to Guide the Assessment of Legal and Regulatory Challenges 10 Moving Forward: Potential Concrete Legal and Regulatory Actions Appendix A: References Appendix B: Workshop Agenda Appendix C: Commissioned Papers

While significant progress has been seen in fields such as cardiovascular medicine and cancer in improving patient stratification and developing targeted drugs based on genetic findings, progress continues to lag for neuropsychiatric disorders. To address this issue, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop in October 2021. The workshop brought together government, philanthropic foundations, and disease-focused non--profit organizations to discuss new genetic and neuroscience technologies and explore how they can be used to elucidate disease mechanisms and to advance the development of biomarkers and targeted therapies for people with neurological and psychiatric disorders. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Leveraging New Genetic and Neuroscience Technologies to Advance Therapeutic Development: Opportunities and Challenges 3 Increasing Ancestral Diversity to Enable Precision Medicine for Neurological and Psychiatric Disorders 4 Leveraging New Methodologies to Interpret Genetic Data in Neurological and Psychiatric Disorders 5 Identifying and Validating Molecular Pathways Using New Technologies for Human Biology 6 Enabling Patient Stratification through Deep Phenotyping and Biomarker Discovery 7 Potential Next Steps: Shifting the Trajectory of Treatment Development for Neurological and Psychiatric Disorders Appendix A: References Appendix B: Workshop Agenda

Accumulating evidence gathered over the past three decades has demonstrated a biological basis for differences between men and women with respect to clinical features and treatment responses to several neuropsychiatric, neurodevelopmental, and neurodegenerative disorders. Dramatic sex differences have also been identified in the brain transcriptomes of individuals with multiple brain disorders, including depression, posttraumatic stress disorder, and autism. The brain transcriptome includes all of the messenger RNA as well as the non-protein-coding RNA molecules expressed in brain tissue and thus represents gene activity. To explore these sex-based transcriptomic differences further, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders hosted a workshop on September 23, 2020, titled Sex Differences in Brain Disorders: Emerging Transcriptomic Evidence and Implications for Therapeutic Development. The workshop brought together a broad spectrum of stakeholders to share cutting-edge emerging evidence, discuss challenges, and identify future opportunities and potential directions. This publication summarizes the presentation and discussion of the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Transcriptomic Evidence for Sex Differences in Stress- and Reward-Related Disorders 3 Transcriptomic Evidence for Sex Differences in Neurodevelopmental and Neurodegenerative Disorders 4 Moving Forward Appendix A: References Appendix B: Workshop Agenda

Millions of people are living with dementia in the United States and globally. To live well with dementia, people need care, services, and supports that reflect their values and preferences, build on their strengths and abilities, promote well-being, and address needs that evolve as cognitive impairment deepens. Persons living with dementia co-manage their care with or rely on the support of a wide range of care partners and caregivers, including spouses, other family members and friends, and direct care workers in homes or residential care settings. While dementia care has improved since the 1970s, many individuals still lack access to high-quality care and are not living as well as they might. Disadvantaged groups, especially racial and ethnic minorities, still face challenges in access to care, services, and supports, due to deep and persistent inequities. Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers: A Way Forward examines the complex body of evidence on dementia care and informs decision making about which interventions are ready to be broadly disseminated and implemented. It also offers a blueprint to guide future research using rigorous, cutting-edge methods that are inclusive, equitable, and yield critical information for real-world implementation, toward the ultimate goal of better supporting persons living with dementia and their care partners and caregivers in living as well as possible. Table of Contents Front Matter Summary 1 Introduction 2 Moving Toward Better Dementia Care, Services, and Supports 3 Complexity of Systems for Dementia Care, Services, and Supports 4 Making Decisions About Implementation 5 Assessing the Current State of Evidence 6 A Blueprint for Future Research Appendix A: Agency for Healthcare Research and Quality Systematic Review and Inclusion Criteria Appendix B: Public Meeting Agendas Appendix C: Biographical Sketches of Committee Members and Staff

Pain is a leading cause of disability globally. The dramatic increase in opioid prescriptions within the past decade in the United States has contributed to the opioid epidemic the country currently faces, magnifying the need for longer term solutions to treat pain. The substantial burden of pain and the ongoing opioid crisis have attracted increased attention in medical and public policy communities, resulting in a revolution in thinking about how pain is managed. This new thinking acknowledges the complexity and biopsychosocial nature of the pain experience and the need for multifaceted pain management approaches with both pharmacological and nonpharmacological therapies. The magnitude and urgency of the twin problems of chronic pain and opioid addiction, combined with the changing landscape of pain management, prompted the National Academies of Sciences, Engineering, and Medicine to convene a workshop on December 4?5, 2018, in Washington, DC. The workshop brought together a diverse group of stakeholders to discuss the current status of nonpharmacological approaches to pain management, gaps, and future directions. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Workshop Context: Lived Experience, Provider Perspectives, and Current Patterns of Usage 3 Effectiveness, Safety, and Cost-Effectiveness of Nonpharmacological and Nonsurgical Therapies for Chronic Pain 4 Emerging Models of Care 5 Major Current Research Initiatives and Priorities 6 Education and Training of Health Professionals in Pain Management 7 Policies to Address Barriers to the Use of Evidence-Based Nonpharmacological Approaches to Pain Management 8 Future Directions Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

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

Technological advances in noninvasive neuroimaging, neurophysiology, genome sequencing, and other methods together with rapid progress in computational and statistical methods and data storage have facilitated large-scale collection of human genomic, cognitive, behavioral, and brain-based data. The rapid development of neurotechnologies and associated databases has been mirrored by an increase in attempts to introduce neuroscience and behavioral genetic evidence into legal proceedings. In March 2018, the National Academies of Science, Engineering and Medicine organized a workshop in order to explore the current uses of neuroscience and bring stakeholders from neuroscience and legal societies together in both the United Kingdom and the United States. Participants worked together to advance an understanding of neurotechnologies that could impact the legal system and the state of readiness to consider these technologies and where appropriate, to integrate them into the legal system. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Use of Neurotechnologies and Neuroscience in Legal Settings: Case Studies 3 Looking into the Future: Novel Uses of Emerging Neurotechnologies with Potential Legal Applications 4 Developing a Framework for Use of Evidence from Emerging Neurotechnologies 5 Moving Forward: Potential Next Steps Appendix A References Appendix B Workshop Agenda Appendix C Registered Attendees

Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potential?and perhaps essential?ways to enhance clinical outcomes for patients with psychiatric and neurological disorders. In order to examine the general principles underlying multimodal therapies and to explore challenges, potential barriers, and opportunities for their development, the National Academies of Sciences, Engineering, and Medicine convened a workshop in June 2016. Participants explored scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and potential opportunities to enhance clinical outcomes for individuals with nervous system disorders. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Multimodal Therapy: Overview of Principles, Barriers, and Opportunities 3 Exploring the State of the Science 4 Regulatory and Reimbursement Considerations 5 Trial Designs to Establish Efficacy and Safety in Multimodal Therapies 6 Developing Multimodal Therapies: Practical Considerations Relating to Industry 7 Role of Research Funders in Multimodal Therapy Development Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Participants

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. Table of Contents Front Matter 1 Introduction 2 Neuroscience Clinical Trials: An Overview of Challenges and Potential Opportunities 3 Clinical Trial Design 4 Transforming Clinical Trials with Technology 5 The Regulatory Landscape: International Opportunities and Challenges 6 Ethical Considerations 7 Improving the Evidence Base for Real-World Use Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

Major depressive disorder (MDD) is recognized worldwide as a major cause of disability, morbidity, and mortality. According to the World Health Organization, unipolar depressive disorders affect more than 150 million people around the world and represent the leading cause of years lost due to disability among both men and women. In the United States alone, nearly 8 percent of persons over the age of 12 report current depression. MDD has long been defined primarily as a mood disorder. However,more recently people have begun to recognize effects on cognition as a major contributor to the disablement that accompanies depression and to consider this an underrecognized treatment target for depression. To explore how best to enable the discovery, development, and translation of treatments for cognitive dysfunction in depression, including a focus on the regulatory path forward, the Institute of Medicine's Forum on Neuroscience and Nervous Disorders convened key stakeholders at a workshop in February 2015. This report summarizes the presentations from expert speakers and discussions among workshop participants. Table of Contents Front Matter 1 Introduction and Overview 2 The Burden of Cognitive Dysfunction in Depression 3 State of the Science: Treatment Development 4 Challenges and Potential Solutions to Enable Development of Successful Treatments 5 Regulatory Issues 6 Lessons Learned from the Schizophrenia Field Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

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. Table of Contents Front Matter 1 Introduction 2 Overview of Gaps, Challenges, and Potential Opportunities 3 The Science and Technology of Non-Invasive Neuromodulation 4 Therapeutic Uses of Non-Invasive Neuromodulation 5 Using Non-Invasive Neuromodulation for Diagnosis and Research 6 Enhancement of Brain Function and Performance 7 Ethical, Legal, and Social Issues 8 Regulatory Issues 9 Reimbursement Issues 10 The Business Environment Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

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

The critical importance of using mobile technology is clear to anyone in the health professions, particularly those who treat people with central nervous system (CNS) disorders. To explore current developments and opportunities for using mobile technology to advance research and treatment of CNS disorders, the National Academies' Forum on Neuroscience and Nervous System Disorders hosted a workshop in June 5?6, 2018. This publication summarizes the presentations and discussions at the workshop. Table of Contents Front Matter 1 Introduction and Background 2 Exploring Opportunities Afforded by Mobile Technology 3 Transforming Digital Data into Insight: Collection, Analysis, Standardization, and Validation 4 Regulatory Considerations and Pathways 5 Integrating Mobile Technology into Clinical Practice 6 Designing Mobile Technologies for Research and Clinical Practice That Reflect Patient Attitudes and Preferences 7 Moving Forward by Building Partnerships Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees

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.

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

Neurodegeneration: Exploring Commonalities Across Diseases is the summary of a workshop hosted by the Institute of Medicine\'s (IOM\'s) Forum on Neuroscience and Nervous System Disorders in Spring 2012 to explore commonalities across neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS), and frontotemporal dementia (FTD). Participants from academia; pharmaceutical and biotechnology industries; government agencies such as the National Institutes of Health and the U.S. Department of Veterans Affairs (VA); patient advocacy groups; and private foundations presented and identified potential opportunities for collaboration across the respective research and development communities. This report identifies and discusses commonalities related to genetic and cellular mechanisms, identifies areas of fundamental science needed to facilitate therapeutics development, and explores areas of potential collaboration among the respective research communities. Neurodegenerative diseases, such as Alzheimer\'s disease, Parkinson\'s disease, ALS, and FTD, are becoming increasingly prevalent in the United States due to an aging population. Implications are grave for quality of life and health care costs. Research on neurodegenerative diseases has expanded greatly over the past four decades. Nevertheless, fundamental questions remain about the biology of these diseases, and further insights into the mechanisms of these diseases would help to inform the development of effective means to prevent and to efficiently treat them. Recent findings have revealed certain commonalities in genetic and cellular mechanisms across neurodegenerative diseases. These findings suggest that it might be valuable - at least in some cases - to change the traditional way of studying these diseases by no longer seeing each as an independent entity, but rather as clinical variants of common cellular and molecular biological defects. This approach could help enhance basic scientific understanding of neurodegenerative disease, and could help with the development of biomarkers and new therapeutics. Table of Contents Front Matter 1 Introduction 2 Rationale for Exploring Commonalities Across Neurodegenerative Diseases 3 Protein Aggregation 4 Transmissibility 5 Mitochondrial Pathology 6 Errors in RNA 7 Closing Remarks Appendix A: References Appendix B: Statement of Task Appendix C: Workshop Agenda Appendix D: Registered Attendees

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.