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On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

The strengths and abilities children develop from infancy through adolescence are crucial for their physical, emotional, and cognitive growth, which in turn help them to achieve success in school and to become responsible, economically self-sufficient, and healthy adults. Capable, responsible, and healthy adults are clearly the foundation of a well-functioning and prosperous society, yet America's future is not as secure as it could be because millions of American children live in families with incomes below the poverty line. A wealth of evidence suggests that a lack of adequate economic resources for families with children compromises these children's ability to grow and achieve adult success, hurting them and the broader society. A Roadmap to Reducing Child Poverty reviews the research on linkages between child poverty and child well-being, and analyzes the poverty-reducing effects of major assistance programs directed at children and families. This report also provides policy and program recommendations for reducing the number of children living in poverty in the United States by half within 10 years.

America's farms and farmers are integral to the U.S. economy and, more broadly, to the nation's social and cultural fabric. A healthy agricultural sector helps ensure a safe and reliable food supply, improves energy security, and contributes to employment and economic development, traditionally in small towns and rural areas where farming serves as a nexus for related sectors from farm machinery manufacturing to food processing. The agricultural sector also plays a role in the nation's overall economic growth by providing crucial raw inputs for the production of a wide range of goods and services, including many that generate substantial export value. If the agricultural sector is to be accurately understood and the policies that affect its functioning are to remain well informed, the statistical system's data collection programs must be periodically revisited to ensure they are keeping up with current realities. This report reviews current information and makes recommendations to the U.S. Department of Agriculture's (USDA's) National Agricultural Statistics Service (NASS) and Economic Research Service (ERS) to help identify effective methods for collecting data and reporting information about American agriculture, given increased complexity and other changes in farm business structure in recent decades.

"The National Defense Authorization Act for fiscal year 2017 contained a request for a National Academies of Sciences, Engineering, and Medicine review and assessment of science and technology development efforts within the Department of Energy's Office of Environmental Management (DOE-EM). This technical report is the result of the review and presents findings and recommendations"--Publisher's description.

"The U.S. military has a stockpile of approximately 400,000 tons of excess, obsolete, or unserviceable munitions. About 60,000 tons are added to the stockpile each year. Munitions include projectiles, bombs, rockets, landmines, and missiles. Open burning/open detonation (OB/OD) of these munitions has been a common disposal practice for decades, although it has decreased significantly since 2011. OB/OD is relatively quick, procedurally straightforward, and inexpensive. However, the downside of OB and OD is that they release contaminants from the operation directly into the environment. Over time, a number of technology alternatives to OB/OD have become available and more are in research and development. Alternative technologies generally involve some type of contained destruction of the energetic materials, including contained burning or contained detonation as well as contained methods that forego combustion or detonation. Alternatives for the Demilitarization of Conventional Munitions reviews the current conventional munitions demilitarization stockpile and analyzes existing and emerging disposal, treatment, and reuse technologies. This report identifies and evaluates any barriers to full-scale deployment of alternatives to OB/OD or non-closed loop incineration/combustion, and provides recommendations to overcome such barriers"--

New York City's water supply system is one of the oldest, largest, and most complex in the nation. It delivers more than 1.1 billion gallons of water each day from three upstate watersheds (Croton, Catskill, and Delaware) to meet the needs of more than eight million people in the City, one million people in Westchester, Putnam, Orange, and Ulster counties, and millions of commuters and tourists who visit the City throughout the year. The Catskill and Delaware portions, which make up about 90 percent of the supply, receive no filtration or treatment other than disinfection, except for rare instances of high turbidity when a coagulant is added to increase deposition of suspended solids. The remaining 10 percent of the supply comes from the Croton watershed and receives treatment via filtration. The drinking water supply is managed by the Bureau of Water Supply within the New York City Department of Environmental Protection (NYC DEP). To continue to avoid filtration of the Catskill/Delaware portion of the water supply, in 2007, NYC DEP reexamined its control of turbidity in the Catskill portion of the water supply, including both structural improvements to the system and operational changes. The Operations Support Tool (OST) was developed as part of these efforts. OST couples models of reservoir operations and water quality; it uses real-time data on streamflow, snow pack, water quality, reservoir levels, diversions, and releases; and it incorporates streamflow forecasts--all in order to predict future reservoir levels, water delivery to customers, and water quality within the system. These predictions inform the system operators, who then make decisions based on the most current data and forecasts. This report reviews the use of OST in current and future reservoir operations. It considers potential ways in which the City can more effectively use OST, makes recommendations for additional performance measures, and reviews the potential effects of climate change on the City's water supply to help identify and enhance understanding of areas of potential future concern with regard to the use of OST.

Modern materials science builds on knowledge from physics, chemistry, biology, mathematics, computer and data science, and engineering sciences to enable us to understand, control, and expand the material world. Although it is anchored in inquiry-based fundamental science, materials research is strongly focused on discovering and producing reliable and economically viable materials, from super alloys to polymer composites, that are used in a vast array of products essential to today's societies and economies. Frontiers of Materials Research: A Decadal Survey is aimed at documenting the status and promising future directions of materials research in the United States in the context of similar efforts worldwide. This third decadal survey in materials research reviews the progress and achievements in materials research and changes in the materials research landscape over the last decade; research opportunities for investment for the period 2020-2030; impacts that materials research has had and is expected to have on emerging technologies, national needs, and science; and challenges the enterprise may face over the next decade. --

"In November 2017, the The Forum on Promoting Children's Cognitive, Affective, and Behavioral Health, in collaboration with the Roundtable on the Promotion of Health Equity, convened a workshop on promoting children's behavioral health equity. The workshop used a socio-ecological developmental model to explore health equity of children and families, including those with complex needs and chronic conditions. Particular attention was paid to challenges experienced by children and families in both rural and urban contexts, to include but not limited to poverty, individual and institutional racism, low-resourced communities, and hindered access to educational and health care services. Workshop participants also engaged in solution-oriented discussions of initiatives, policies, and programs that aim to improve social determinants of health, opportunities for behavioral health promotion, and access to quality services that address the behavioral health of all children and families. This publication summarizes the presentations and discussion of the event"--

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.

Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

Climate assessment activities are increasingly driven by subnational organizations--city, county, and state governments; utilities and private companies; and stakeholder groups and engaged publics--trying to better serve their constituents, customers, and members by understanding and preparing for how climate change will impact them locally. Whether the threats are drought and wildfires, storm surge and sea level rise, or heat waves and urban heat islands, the warming climate is affecting people and communities across the country. To explore the growing role of subnational climate assessments and action, the National Academies of Sciences, Engineering, and Medicine hosted the 2-day workshop on August 14-15, 2018. This publication summarizes the presentations and discussions from the workshop.

This workshop was preceded by two other workshops, "Examining Core Elements of International Research Collaboration", held on July 26-27, 2010, and "Culture Matters: An Approach to International Research Agreements", held on July 29-31, 2013.

"Nearly one-third of the United States is covered by forests, accounting for more than one million square miles, an area exceeded only in Canada, Brazil, and Russia. These forest ecosystems play vital roles in carbon storage, nutrient cycling, and air and water purification, as well as in supplying habitat for wildlife. Forests hold historical, cultural, and social significance for Americans and are sources of both food and fiber. Today, these valued resources are endangered as never before. Global commerce has hastened the introduction of nonnative, invasive tree pests and diseases, and those native to the country are becoming more virulent due to external drivers such as climate change. The loss of a tree species can have cascading adverse effects on the forest ecosystem and on the range of services it provides and the values it represents to human populations"--

"A growing body of research indicates that social determinants of health have a significant impact on health care utilization and outcomes. Researchers and policymakers in the United States have spent decades exploring and discussing approaches to integrating health care and social services. While no nation has a truly integrated system, many other industrialized nations invest more heavily in social services than the United States, and are more effective in integrating these services with health care. Integrating health care and social services, such as accessible housing, meals and nutrition services, transportation, and caregiver training, is particularly important for those facing serious illness who typically encounter multiple chronic conditions, pain and other symptoms, functional dependency, frailty, and significant family caregiver needs. In an effort to better understand and facilitate discussions about the challenges and opportunities related to integrating health care and social services for people with serious illness, the National Academies of Sciences, Engineering, and Medicine held a full-day public workshop on July 19, 2018 in Washington, DC. The workshop featured a broad range of experts and stakeholders including researchers, policy analysts, patient and family caregiving advocates, and representatives of federal agencies. This publication summarizes the presentations and discussions from the workshop"--Publisher's description.

Obesity and overweight pose significant challenges to the armed forces in the United States, affecting service members (including active duty, guard, and reserve components), veterans, retirees, and their families and communities. The consequences of obesity and overweight in the armed forces influence various aspects of its operations that are critical to national security. On May 7, 2018, the National Academies of Sciences, Engineering, and Medicine, held a workshop titled "Understanding and Overcoming the Challenge of Obesity and Overweight in the Armed Forces." Speakers examined how obesity and overweight are measured in the armed forces and how they affect recruitment, retention, resilience, and readiness; discussed service-specific issues related to these problems and highlighted innovative strategies to address them through improved nutrition, physical activity, and stress management; and offered perspectives from outside of the armed forces on approaches to prevent and treat obesity. They also discussed the challenges and opportunities related to overcoming the concerns posed by obesity and overweight in the armed forces, military families, and their communities, including potential cross-sector opportunities. This publication summarizes the presentations and discussions from the workshop.

"Suicide prevention initiatives are part of much broader systems connected to activities such as the diagnosis of mental illness, the recognition of clinical risk, improving access to care, and coordinating with a broad range of outside agencies and entities around both prevention and public health efforts. Yet suicide is also an intensely personal issue that continues to be surrounded by stigma. On September 11-12, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop in Washington, DC, to discuss preventing suicide among people with serious mental illness. The workshop was designed to illustrate and discuss what is known, what is currently being done, and what needs to be done to identify and reduce suicide risk. Improving Care to Prevent Suicide Among People with Serious Mental Illness summarizes presentations and discussions of the workshop"--Publisher's description

Fusion offers the prospect of virtually unlimited energy. The United States and many nations around the world have made enormous progress toward achieving fusion energy. With ITER scheduled to go online within a decade and demonstrate controlled fusion ten years later, now is the right time for the United States to develop plans to benefit from its investment in burning plasma research and take steps to develop fusion electricity for the nation's future energy needs. At the request of the Department of Energy, the National Academies of Sciences, Engineering, and Medicine organized a committee to develop a strategic plan for U.S. fusion research. The final report's two main recommendations are: (1) The United States should remain an ITER partner as the most cost-effective way to gain experience with a burning plasma at the scale of a power plant. (2) The United States should start a national program of accompanying research and technology leading to the construction of a compact pilot plant that produces electricity from fusion at the lowest possible capital cost.

There are over 20 million young people of color in the United States whose representation in STEM education pathways and in the STEM workforce is still far below their numbers in the general population. Their participation could help re-establish the United States' preeminence in STEM innovation and productivity, while also increasing the number of well-educated STEM workers. There are nearly 700 minority-serving institutions (MSIs) that provide pathways to STEM educational success and workforce readiness for millions of students of color--and do so in a mission-driven and intentional manner. They vary substantially in their origins, missions, student demographics, and levels of institutional selectivity. But in general, their service to the nation provides a gateway to higher education and the workforce, particularly for underrepresented students of color and those from low-income and first-generation to college backgrounds. The challenge for the nation is how to capitalize on the unique strengths and attributes of these institutions and to equip them with the resources, exceptional faculty talent, and vital infrastructure needed to educate and train an increasingly critical portion of current and future generations of scientists, engineers, and health professionals. Minority Serving Institutions examines the nation's MSIs and identifies promising programs and effective strategies that have the highest potential return on investment for the nation by increasing the quantity and quality MSI STEM graduates. This study also provides critical information and perspective about the importance of MSIs to other stakeholders in the nation's system of higher education and the organizations that support them.

"In 2014 the National Science Foundation (NSF) provided support to the National Academies of Sciences, Engineering, and Medicine for a series of Forums on Open Science in response to a government-wide directive to support increased public access to the results of research funded by the federal government. However, the breadth of the work resulting from the series precluded a focus on any specific topic or discussion about how to improve public access. Thus, the main goal of the Workshop on Transparency and Reproducibility in Federal Statistics was to develop some understanding of what principles and practices are, or would be, supportive of making federal statistics more understandable and reviewable, both by agency staff and the public. This publication summarizes the presentations and discussions from the workshop"--Publisher's description.

"The United States possesses a treasure-trove of extraterrestrial samples that were returned to Earth via space missions over the past four decades. Analyses of these previously returned samples have led to major breakthroughs in the understanding of the age, composition, and origin of the solar system. Having the instrumentation, facilities and qualified personnel to undertake analyses of returned samples, especially from missions that take up to a decade or longer from launch to return, is thus of paramount importance if the National Aeronautics and Space Administration (NASA) is to capitalize fully on the investment made in these missions, and to achieve the full scientific impact afforded by these extraordinary samples. Planetary science may be entering a new golden era of extraterrestrial sample return; now is the time to assess how prepared the scientific community is to take advantage of these opportunities. Strategic Investments in Instrumentation and Facilities for Extraterrestrial Sample Curation and Analysis assesses the current capabilities within the planetary science community for sample return analyses and curation, and what capabilities are currently missing that will be needed for future sample return missions. This report evaluates whether current laboratory support infrastructure and NASA's investment strategy is adequate to meet these analytical challenges and advises how the community can keep abreast of evolving and new techniques in order to stay at the forefront of extraterrestrial sample analysis"--Publisher's description.

"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"--

"Coral reef declines have been recorded for all major tropical ocean basins since the 1980s, averaging approximately 30-50% reductions in reef cover globally. These losses are a result of numerous problems, including habitat destruction, pollution, overfishing, disease, and climate change. Greenhouse gas emissions and the associated increases in ocean temperature and carbon dioxide (CO2) concentrations have been implicated in increased reports of coral bleaching, disease outbreaks, and ocean acidification (OA). For the hundreds of millions of people who depend on reefs for food or livelihoods, the thousands of communities that depend on reefs for wave protection, the people whose cultural practices are tied to reef resources, and the many economies that depend on reefs for fisheries or tourism, the health and maintenance of this major global ecosystem is crucial. A growing body of research on coral physiology, ecology, molecular biology, and responses to stress has revealed potential tools to increase coral resilience. Some of this knowledge is poised to provide practical interventions in the short-term, whereas other discoveries are poised to facilitate research that may later open the doors to additional interventions. A Research Review of Interventions to Increase the Persistence and Resilience of Coral Reefs reviews the state of science on genetic, ecological, and environmental interventions meant to enhance the persistence and resilience of coral reefs. The complex nature of corals and their associated microbiome lends itself to a wide range of possible approaches. This first report provides a summary of currently available information on the range of interventions present in the scientific literature and provides a basis for the forthcoming final report"--Publisher's description.

"Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances--whether the particular issue under debate is the development of ethical principles for human genome editing, how to establish regulatory systems for the safe conduct of field trials of gene drive-modified organisms, or many others. However there are continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop."--Publisher's description.

For the United States, the 1991 Persian Gulf War was a brief and successful military operation with few injuries and deaths. However, soon after returning from duty, a large number of veterans began reporting health problems they believed were associated with their service in the Gulf. At the request of Congress, the National Academies of Sciences, Engineering, and Medicine has been conducting an ongoing review of the evidence to determine veterans' long-term health problems and potential causes. Some of the health effects identified by past reports include post-traumatic stress disorders, other mental health disorders, Gulf War illness, respiratory effects, and self-reported sexual dysfunction. Veterans' concerns regarding the impacts of deployment-related exposures on their health have grown to include potential adverse effects on the health of their children and grandchildren. These concerns now increasingly involve female veterans, as more women join the military and are deployed to war zones and areas that pose potential hazards. Gulf War and Health: Volume 11 evaluates the scientific and medical literature on reproductive and developmental effects and health outcomes associated with Gulf War and Post-9/11 exposures, and designates research areas requiring further scientific study on potential health effects in the descendants of veterans of any era.

Disposal of Surplus Plutonium at the Waste Isolation Pilot Plant: Interim Report evaluates the general viability of the U.S. Department of Energy's National Nuclear Security Administration's (DOE-NNSA's) conceptual plans for disposing of 34 metric tons (MT) of surplus plutonium in the Waste Isolation Pilot Plant (WIPP), a deep geologic repository near Carlsbad, New Mexico. This report evaluates DOE-NNSA's plans to ship, receive, and emplace surplus plutonium in WIPP and its understanding of the impacts of these plans on WIPP and WIPP-bound waste streams. This report, the first of two to be issued during this study, provides a preliminary assessment of the general viability of DOE-NNSA's conceptual plans, focusing on some of the barriers to their implementation.

"On June 13-14, 2018, the National Academies of Sciences, Engineering, and Medicine convened a multistakeholder workshop to examine the transitions affecting global health and innovative global health solutions. The goal of bringing these two topics together was to collectively explore models for innovative partnerships and private-sector engagement with the potential to support countries in transition. This publication summarizes the presentations and discussions from the workshop"--

"Genomic medicine is defined as the routine use of genomic information about an individual as part of his or her clinical care as well as the health outcomes and policy implications of that clinical use. It is one approach that has the potential to improve the quality of health care by allowing practitioners to tailor prevention, diagnostic, and treatment strategies to individual patients. In recent years, research breakthroughs, technological advances, and the decreasing cost of DNA sequencing have led to the wider adoption of genomic medicine. However, as with the introduction of new technologies into health care, there are concerns that genetic and genomic testing and services will not reach all segments of the population both now and in the near future, and there remains a gap in knowledge regarding potential health care disparities in genomic medicine and precision health approaches. On June 27, 2018, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop to examine the gaps in knowledge related to access to genomic medicine and to discuss health care disparities and possible approaches to overcoming the disparate use of genomic medicine among populations. Workshop participants discussed research on access to genetics and genomics services in medically underserved areas, model programs of care for diverse patient populations, and current challenges and possible best practices for alleviating health care disparities as they relate to genomics-based approaches. This publication summarizes the presentations and discussions from the workshop"--

In 1943, as part of the Manhattan Project, the Hanford Nuclear Reservation was established with the mission to produce plutonium for nuclear weapons. During 45 years of operations, the Hanford Site produced about 67 metric tonnes of plutonium--approximately two-thirds of the nation's stockpile. Production processes generated radioactive and other hazardous wastes and resulted in airborne, surface, subsurface, and groundwater contamination. Presently, 177 underground tanks contain collectively about 210 million liters (about 56 million gallons) of waste. The chemically complex and diverse waste is difficult to manage and dispose of safely. Section 3134 of the National Defense Authorization Act for Fiscal Year 2017 calls for a Federally Funded Research and Development Center (FFRDC) to conduct an analysis of approaches for treating the portion of low-activity waste (LAW) at the Hanford Nuclear Reservation intended for supplemental treatment. The second of four, this report reviews the results of the assessments, including the formulation and presentation of conclusions and the characterization and treatment of uncertainties.

An Assessment of Four Divisions of the Physical Measurement Laboratory at the National Institute of Standards and Technology: Fiscal Year 2018 assesses the scientific and technical work performed by four divisions of the National Institute of Standards and Technology (NIST) Physical Measurement Laboratory. This publication reviews technical reports and technical program descriptions prepared by NIST staff and summarizes the findings of the authoring panel.

"A consensus study report of The National Academy of Sciences, Engineering, Medicine."