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In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further. At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years.

"High-quality primary care is the foundation of the health care system. It provides continuous, person-centered, relationship-based care that considers the needs and preferences of individuals, families, and communities. Without access to high-quality primary care, minor health problems can spiral into chronic disease, chronic disease management becomes difficult and uncoordinated, visits to emergency departments increase, preventive care lags, and health care spending soars to unsustainable levels. Unequal access to primary care remains a concern, and the COVID-19 pandemic amplified pervasive economic, mental health, and social health disparities that ubiquitous, high-quality primary care might have reduced. Primary care is the only health care component where an increased supply is associated with better population health and more equitable outcomes. For this reason, primary care is a common good, which makes the strength and quality of the country's primary care services a public concern. Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care puts forth an evidence-based plan with actionable objectives and recommendations for implementing high-quality primary care in the United States. The implementation plan of this report balances national needs for scalable solutions while allowing for adaptations to meet local needs." --

Immunization against disease is among the most successful global health efforts of the modern era, and substantial gains in vaccination coverage rates have been achieved worldwide. However, that progress has stagnated in recent years, leaving an estimated 20 million children worldwide either undervaccinated or completely unvaccinated. The determinants of vaccination uptake are complex, mutable, and context specific. A primary driver is vaccine hesitancy - defined as a "delay in acceptance or refusal of vaccines despite availability of vaccination services". The majority of vaccine-hesitant people fall somewhere on a spectrum from vaccine acceptance to vaccine denial. Vaccine uptake is also hampered by socioeconomic or structural barriers to access. On August 17-20, 2020, the Forum on Microbial Threats at the National Academies of Sciences, Engineering, and Medicine held a 4-day virtual workshop titled The Critical Public Health Value of Vaccines: Tackling Issues of Access and Hesitancy. The workshop focused on two main areas (vaccine access and vaccine confidence) and gave particular consideration to health systems, research opportunities, communication strategies, and policies that could be considered to address access, perception, attitudes, and behaviors toward vaccination. This publication summarizes the presentations and discussion of the workshop.

In response to a request from the National Oceanic and Atmospheric Administration - and with the support of the National Aeronautics and Space Administration and the National Science Foundation - the National Academies of Sciences, Engineering, and Medicine conducted a two-part virtual workshop, "Space Weather Operations and Research Infrastructure," on June 16-17 and September 9-11, 2020. The overall goals of the workshop were to review present space weather monitoring and forecasting capabilities, to consider future observational infrastructure and research needs, and to consider options toward the further development of an effective, resilient, and achievable national space weather program. This publication summarizes the presentation and discussion of the workshop.

"At the request of Congress, this report presents findings and recommendations related to governance of the U.S. government's monitoring, detection, and verification (MDV) enterprise and offers findings and recommendations related to technical MDV capabilities and research, development, test, and evaluation efforts, focused in particular on the nuclear fuel cycle, nuclear test explosions, and arms control." --

"Advance Care Planning(ACP)has long been a staple of caring for people with serious illness. Over its history, it has been defined in different ways. Clinicians, researchers, patients, and the public have developed a variety of perspectives about the many aspects of ACP, ranging from the definition to the timing, goals, outcomes, and value of ACP. To better understand the challenges and opportunities for ACP, acknowledge and highlight divergent viewpoints, and examine what is empirically known and not known about ACP and its outcomes, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Quality Care for People with Serious Illness hosted a virtual public workshop, Advance Care Planning: Challenges and Opportunities, on October 26 and November 2, 2020. The workshop explored the paradox of ACP, its evidence base, ways to think differently about ACP, and various approaches to making it more effective.This Proceedings of a Workshop summarizes the presentations and discussions from that workshop." --

"Federal laboratories play a unique role in the U.S. economy. Research and development conducted at these labs has contributed to the advancement or improvement of such key general-purpose technologies as nuclear energy, computers, the Internet, genomics, satellite navigation, the Global Positioning System, artificial intelligence, and virtual reality. Digital output from federal laboratories includes data, metadata, images, software, code, tools, databases, algorithms, and statistical models. Importantly, these digital products are nonrivalrous, meaning that unlike physical products, they can be copied at little or no cost and used by many without limit or additional cost. Advancing Commercialization of Digital Products from Federal Laboratories explores opportunities to add economic value to U.S. industry through enhanced utilization of intellectual property around digital products created at federal laboratories. This report examines the current state of commercialization of digital products developed at the federal labs and, to a limited extent, by extramural awardees, to help identify barriers to commercialization and technology transfer, taking into account differences between government-owned, contractor-operated (GOCO) and government-owned, government-operated (GOGO) federal labs." --

"A virtual workshop titled Integrating Systems and Sectors Toward Obesity Solutions, held April 6, 2020 (Part I), and June 30, 2020 (Part II), was convened by the Roundtable on Obesity Solutions, Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine. The workshop introduced the concept of complex systems and the field of systems science, and explored systems science approaches to obesity solutions. Speakers provided an overview of systems science theories, approaches, and applications, highlighting examples from within and outside the obesity field. Presentations and discussions examined complex systems in society that have the potential to shape public health and well-being, and considered opportunities for systems change as they relate to obesity solutions. Specifically, the workshop explored factors that can influence obesity - such as (in)equity, relationships, connections, networks, capacity, power dynamics, social determinants, and political will - and how these factors can impact communications and cross-sector collaboration to address obesity. This publication summarizes the presentations and discussion of the workshop." --

"The U.S. Social Security Administration (SSA) administers programs that provide disability benefits. Once SSA establishes the presence of a severe impairment, it determines whether the impairment meets the criteria in the Listing of Impairments (Listings) that qualify a candidate for disability benefits. The current Listings that address hearing loss treated with cochlear implantation contain criteria that evaluate hearing ability through a speech recognition test called the Hearing in Noise Test (HINT). Since its development in 1994, the HINT has been widely used to measure cochlear implant candidacy and postoperative outcomes. However, the test characteristics, the state of cochlear implant technology, and the environment that made the HINT a common choice of assessment in 1994 are different in 2021. The HINT has several limitations in its characteristics and deviation from its intended use. At the request of SSA, the National Academies of Sciences, Engineering, and Medicine convened a consensus study committee to identify and recommend generalized testing procedures and criteria for evaluating the level of functional hearing ability needed to make a disability determination in adults and children after cochlear implantation. The committee's report, Evaluating Hearing Loss for Individuals with Cochlear Implants, details and supports its findings, conclusions, and recommendations based on published evidence and professional judgment." --

"Each year, tens of millions of individuals in the U.S. suffer from neurological and psychiatric disorders including neurodegenerative diseases such as Alzheimer's Disease and Parkinson's Disease, and psychiatric disorders such as autism spectrum disorder, depression and schizophrenia. Treatments for these diseases are often completely lacking or only partially effective, due in large part to the difficulty of conducting brain research and the complexity of the brain itself. Researchers in recent years have developed new models to better represent and study the human brain. The three models considered in this report, all of which generate and use pluripotent stem cells from healthy individuals and patients, are human neural organoids, human neural transplants, and human-animal neural chimeras. The Emerging Field of Human Neural Organoids, Transplants, and Chimeras: Science, Ethics, and Governance reviews the status of research, considers its benefits and risks, discusses associated ethical issues, and considers governance mechanisms for this type of research." --

"Over the past several decades, fertility rates have fallen substantially in low- and middle-income countries, and efforts to limit fertility, primarily through the implementation of family planning programs, have become increasingly widespread. Although there is a substantial scholarly literature on the determinants of contraceptive use and other measures to limit fertility and on the resulting differentials in fertility, relatively little is known about the role played by women's empowerment as both a determinant and a consequence of fertility decline. In addition, there continues to be little consensus about the link between fertility decline and broader societal impacts, including economic development. The National Academies of Sciences, Engineering, and Medicine convened a workshop, "Family Planning, Women's Empowerment, and Population and Societal Impacts," in September 2020. This event brought together experts and stakeholders to discuss conceptual, methodological, and policy issues regarding the relationships among family planning, women's empowerment, fertility decline, and population and societal impacts. The discussion was intended to inform research and policy focused on the issues of women's roles and empowerment and on longstanding questions surrounding the determinants and consequences of fertility reduction behavior. This publication summarizes the presentations and discussion of the workshop." --

"Government statistics are widely used to inform decisions by policymakers, program administrators, businesses and other organizations as well as households and the general public. Principles and Practices for a Federal Statistical Agency, Seventh Edition will assist statistical agencies and units, as well as other agencies engaged in statistical activities, to carry out their responsibilities to provide accurate, timely, relevant, and objective information for public and policy use. This report will also inform legislative and executive branch decision makers, data users, and others about the characteristics of statistical agencies that enable them to serve the public good." --

"One in five people in the United States had a sexually transmitted infection (STI) on any given day in 2018, totaling nearly 68 million estimated infections. STIs are often asymptomatic (especially in women) and are therefore often undiagnosed and unreported. Untreated STIs can have severe health consequences, including chronic pelvic pain, infertility, miscarriage or newborn death, and increased risk of HIV infection, genital and oral cancers, neurological and rheumatological effects. In light of this, the Centers for Disease Control and Prevention, through the National Association of County and City Health Officials, commissioned the National Academies of Sciences, Engineering, and Medicine to convene a committee to examine the prevention and control of sexually transmitted infections in the United States and provide recommendations for action. In 1997, the Institute of Medicine released a report, The Hidden Epidemic: Confronting Sexually Transmitted Diseases. Although significant scientific advances have been made since that time, many of the problems and barriers described in that report persist today; STIs remain an underfunded and comparatively neglected field of public health practice and research. The committee reviewed the current state of STIs in the United States, and the resulting report, Sexually Transmitted Infections: Advancing a Sexual Health Paradigm, provides advice on future public health programs, policy, and research." --

Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a regenerative medicine product and the manufacturing process often involves measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable. The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened experts across disciplines for a 2-day virtual public workshop to explore systems thinking approaches and how they may be applied to support the identification of relevant quality attributes that can help in the optimization of manufacturing and streamline regulatory processes for regenerative medicine. A broad array of stakeholders, including data scientists, physical scientists, industry researchers, regulatory officials, clinicians, and patient representatives, discussed new advances in data acquisition, data analysis and theoretical frameworks, and how systems approaches can be applied to the development of regenerative medicine products that can address the unmet needs of patients. This publication summarizes the presentation and discussion of the workshop.

Climate change is creating impacts that are widespread and severe for individuals, communities, economies, and ecosystems around the world. While efforts to reduce emissions and adapt to climate impacts are the first line of defense, researchers are exploring other options to reduce warming. Solar geoengineering strategies are designed to cool Earth either by adding small reflective particles to the upper atmosphere, by increasing reflective cloud cover in the lower atmosphere, or by thinning high-altitude clouds that can absorb heat. While such strategies have the potential to reduce global temperatures, they could also introduce an array of unknown or negative consequences. This report concludes that a strategic investment in research is needed to enhance policymakers' understanding of climate response options. The United States should develop a transdisciplinary research program, in collaboration with other nations, to advance understanding of solar geoengineering's technical feasibility and effectiveness, possible impacts on society and the environment, and social dimensions such as public perceptions, political and economic dynamics, and ethical and equity considerations. The program should operate under robust research governance that includes such elements as a research code of conduct, a public registry for research, permitting systems for outdoor experiments, guidance on intellectual property, and inclusive public and stakeholder engagement processes.

The spring of 2020 marked a change in how almost everyone conducted their personal and professional lives, both within science, technology, engineering, mathematics, and medicine (STEMM) and beyond. The COVID-19 pandemic disrupted global scientific conferences and individual laboratories and required people to find space in their homes from which to work. It blurred the boundaries between work and non-work, infusing ambiguity into everyday activities. While adaptations that allowed people to connect became more common, the evidence available at the end of 2020 suggests that the disruptions caused by the COVID-19 pandemic endangered the engagement, experience, and retention of women in academic STEMM, and may roll back some of the achievement gains made by women in the academy to date. The Impact of COVID-19 on the Careers of Women in Academic Sciences, Engineering, and Medicine identifies, names, and documents how the COVID-19 pandemic disrupted the careers of women in academic STEMM during the initial 9-month period since March 2020 and considers how these disruptions - both positive and negative - might shape future progress for women. This publication builds on the 2020 report Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine to develop a comprehensive understanding of the nuanced ways these disruptions have manifested. The Impact of COVID-19 on the Careers of Women in Academic Sciences, Engineering, and Medicine will inform the academic community as it emerges from the pandemic to mitigate any long-term negative consequences for the continued advancement of women in the academic STEMM workforce and build on the adaptations and opportunities that have emerged.

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.

Space Nuclear Propulsion for Human Mars Exploration identifies primary technical and programmatic challenges, merits, and risks for developing and demonstrating space nuclear propulsion technologies of interest to future exploration missions. This report presents key milestones and a top-level development and demonstration roadmap for performance nuclear thermal propulsion and nuclear electric propulsion systems and identifies missions that could be enabled by successful development of each technology.

"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." --

To explore various aspects of faculty development, the Global Forum on Innovation in Health Professional Education of the National Academies of Sciences, Engineering, and Medicine held a virtual workshop in August 2020 titled Health Professions Faculty for the Future. At the workshop, presenters provided examples of how educators are using effective teaching strategies and of practices in health professional education. This publication summarizes the presentation and discussion of the workshop.

The world is transforming its energy system from one dominated by fossil fuel combustion to one with net-zero emissions of carbon dioxide (CO2), the primary anthropogenic greenhouse gas. This energy transition is critical to mitigating climate change, protecting human health, and revitalizing the U.S. economy. To help policymakers, businesses, communities, and the public better understand what a net-zero transition would mean for the United States, the National Academies of Sciences, Engineering and Medicine convened a committee of experts to investigate how the U.S. could best decarbonize its transportation, electricity, buildings, and industrial sectors. This report, Accelerating Decarbonization of the United States Energy System, identifies key technological and socio-economic goals that must be achieved to put the United States on the path to reach net-zero carbon emissions by 2050. The report presents a policy blueprint outlining critical near-term actions for the first decade (2021-2030) of this 30-year effort, including ways to support communities that will be most impacted by the transition.

Cancer is the second leading cause of death among adults in the United States after heart disease. However, improvements in cancer treatment and earlier detection are leading to growing numbers of cancer survivors. As the number of cancer survivors grows, there is increased interest in how cancer and its treatments may affect a person's ability to work, whether the person has maintained employment throughout the treatment or is returning to work at a previous, current, or new place of employment. Cancer-related impairments and resulting functional limitations may or may not lead to disability as defined by the U.S. Social Security Administration (SSA), however, adults surviving cancer who are unable to work because of cancer-related impairments and functional limitations may apply for disability benefits from SSA. At the request of SSA, Diagnosing and Treating Adult Cancers and Associated Impairments provides background information on breast cancer, lung cancer, and selected other cancers to assist SSA in its review of the listing of impairments for disability assessments. This report addresses several specific topics, including determining the latest standards of care as well as new technologies for understanding disease processes, treatment modalities, and the effect of cancer on a person's health and functioning, in order to inform SSA's evaluation of disability claims for adults with cancer.

The U.S. Department of Energy (DOE) and its predecessor agencies have conducted activities to develop atomic energy for civilian and defense purposes since the initiation of the World War II Manhattan Project in 1942. These activities took place at large federal land reservations of hundreds of square miles involving industrial-scale operations, but also at many smaller federal and non-federal sites such as uranium mines, materials processing and manufacturing facilities. The nuclear weapons and energy production activities at these facilities produced large quantities of radioactive and hazardous wastes and resulted in widespread groundwater and soil contamination at these sites. DOE initiated a concerted effort to clean up these sites beginning in the 1980s. Many of these sites have been remediated and are in long-term caretaker status, closed or repurposed for other uses. Review of the Effectiveness and Efficiency of Defense Environmental Cleanup Activities of the Department of Energy's Office of Environmental Management: First Report provides background information on the sites currently assigned to the DOE's Office of Environmental Management that are undergoing cleanup; discusses current practices for management and oversight of the cleanups; offers findings and recommendations on such practices and how progress is measured against them; and considers the contracts under which the cleanups proceed and how these have been and can be structured to include incentives for improved cost and schedule performance.

Student wellbeing is foundational to academic success. One recent survey of postsecondary educators found that nearly 80 percent believed emotional wellbeing is a "very" or "extremely" important factor in student success. Studies have found the dropout rates for students with a diagnosed mental health problem range from 43 percent to as high as 86 percent. While dealing with stress is a normal part of life, for some students, stress can adversely affect their physical, emotional, and psychological health, particularly given that adolescence and early adulthood are when most mental illnesses are first manifested. In addition to students who may develop mental health challenges during their time in postsecondary education, many students arrive on campus with a mental health problem or having experienced significant trauma in their lives, which can also negatively affect physical, emotional, and psychological wellbeing. The nation's institutions of higher education are seeing increasing levels of mental illness, substance use and other forms of emotional distress among their students. Some of the problematic trends have been ongoing for decades. Some have been exacerbated by the COVID-19 pandemic and resulting economic consequences. Some are the result of long-festering systemic racism in almost every sphere of American life that are becoming more widely acknowledged throughout society and must, at last, be addressed. Mental Health, Substance Use, and Wellbeing in Higher Education lays out a variety of possible strategies and approaches to meet increasing demand for mental health and substance use services, based on the available evidence on the nature of the issues and what works in various situations. The recommendations of this report will support the delivery of mental health and wellness services by the nation's institutions of higher education.