Miriam Davis – författare

Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.

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.

The Food and Drug Administration (FDA) now requires that all clinical trials for drugs that affect the central nervous system—including psychiatric drugs—are assessed for whether that drug might cause suicidal ideation or behavior. The Institute of Medicine''s (IOM) Forum on Neuroscience and Nervous System Disorders hosted a meeting on June 26, 2009, to discuss the FDA''s new policy and how to analyze best whether suicidal thoughts predict actual suicidal behavior in the near future.

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.

Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.

Multiple Sclerosis: Current Status and Strategies for the Future identifies promising areas of multiple sclerosis (MS) research based on a strategic analysis of the current state of knowledge. The report was written by the Institute of Medicine (IOM) Committee on MS Research Strategies, and on April 2001, the Committee held a workshop to advance research recommended by the report. The specific goals of the workshop were to disseminate information about the report, foster collaboration, and serve as a launch pad for implementation of the report''s recommendations.Summary of a Workshop on Research in Multiple Sclerosis, April5-6,2001 presents the reports from each breakout group and summarizes the plenary session discussion. This workshop summary contains particular viewpoints attributed to individual participants or to groups of participants (including breakout groups), but does not contain statements about what "the workshop" or "all its participants" concluded.

The Food and Drug Administration (FDA) now requires that all clinical trials for drugs that affect the central nervous system—including psychiatric drugs—are assessed for whether that drug might cause suicidal ideation or behavior. The Institute of Medicine''s (IOM) Forum on Neuroscience and Nervous System Disorders hosted a meeting on June 26, 2009, to discuss the FDA''s new policy and how to analyze best whether suicidal thoughts predict actual suicidal behavior in the near future.

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.

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.

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.

Our nation faces the distinct possibility of a catastrophic terrorist attack using an improvised nuclear device (IND), according to international and U.S. intelligence. Detonation of an IND in a major U.S. city would result in tens of thousands to hundreds of thousands of victims and would overwhelm public health, emergency response, and health care systems, not to mention creating unprecedented social and economic challenges. While preparing for an IND may seem futile at first glance, thousands of lives can be saved by informed planning and decision making prior to and following an attack.

In 2009, the Institute of Medicine published the proceedings of a workshop assessing the health and medical preparedness for responding to an IND detonation. Since that time, multiple federal and other publications have added layers of detail to this conceptual framework, resulting in a significant body of literature and guidance. However, there has been only limited planning effort at the local level as much of the federal guidance has not been translated into action for states, cities and counties. According to an informal survey of community preparedness by the National Association of City and County Health Officials (NACCHO), planning for a radiation incident ranked lowest in priority among other hazards by 2,800 local health departments.

The focus of Nationwide Response Issues After an Improvised Nuclear Device Attack: Medical and Public Health Considerations for Neighboring Jurisdictions: Workshop Summary is on key response requirements faced by public health and health care systems in response to an IND detonation, especially those planning needs of outlying state and local jurisdictions from the detonation site. The specific meeting objectives were as follows:

- Understand the differences between types of radiation incidents and implications of an IND attack on outlying communities.

-Highlight current planning efforts at the federal, state, and local level as well as challenges to the implementation of operational plans.

-Examine gaps in planning efforts and possible challenges and solutions.

-Identify considerations for public health reception centers: how public health and health care interface with functions and staffing and how radiological assessments and triage be handled.

-Discuss the possibilities and benefits of integration of disaster transport systems.

-Explore roles of regional health care coalitions in coordination of health care response.

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.

When disaster strikes, it rarely impacts just one jurisdiction. Many catastrophic disaster plans include support from neighboring jurisdictions that likely will not be available in a regional disaster. Bringing multiple stakeholders together from sectors that do not routinely work with each other can augment a response to a disaster, but can also be extremely difficult because of the multi-disciplinary communication and coordination needed to ensure effective medical and public health response. As many communities within a region will have similar vulnerabilities, a logical step in planning is to establish responsibilities and capacities, and be able to work toward common goals to address all-hazards when the entire region is affected. To explore these considerations, the Institute of Medicine''s Forum on Medical and Public Health Preparedness for Catastrophic Events organized a series of three regional workshops in 2014 to explore opportunities to strengthen the regional coordination required in response to a large scale multijurisdictional disaster. The purpose of each regional workshop was to discuss ways to strengthen coordination among multiple jurisdictions in various regions to ensure fair and equitable treatment of communities from all impacted areas. Regional Disaster Response Coordination to Support Health Outcomes summarizes the presentation and discussion of these workshops.

Multiple Sclerosis: Current Status and Strategies for the Future identifies promising areas of multiple sclerosis (MS) research based on a strategic analysis of the current state of knowledge. The report was written by the Institute of Medicine (IOM) Committee on MS Research Strategies, and on April 2001, the Committee held a workshop to advance research recommended by the report. The specific goals of the workshop were to disseminate information about the report, foster collaboration, and serve as a launch pad for implementation of the report''s recommendations.Summary of a Workshop on Research in Multiple Sclerosis, April5-6,2001 presents the reports from each breakout group and summarizes the plenary session discussion. This workshop summary contains particular viewpoints attributed to individual participants or to groups of participants (including breakout groups), but does not contain statements about what "the workshop" or "all its participants" concluded.