The National Academies of Sciences, Engineering, and Medicine's Forum on Regenerative Medicine (the forum) provides a convening mechanism for interested parties from academia, industry, government, patient and provider organizations, regulatory bodies, foundations, societies, associations, and others. The forum identifies existing and potential barriers to scientific and therapeutic advances; discusses opportunities to assist in facilitating more effective partnerships among key stakeholders; examines the impact that current policies have on the discovery, development, and translation of regenerative medicine therapies; considers the unique challenges of identifying, validating, and bringing regenerative medicine applications to market; and explores the ethical, legal, and social issues posed by advances in regenerative medicine.
During 2021, the forum members continued to focus on two broad areas through their two working groups: Regenerative Engineering and Gene Therapy and Systems Thinking. The members and staff also continued to explore challenges and discuss possible solutions in a number of other areas relevant to the development of regenerative medicines, including communication, workforce development, cost of and access to therapies, and regulatory and legislative affairs. This publication describes the activities of the forum during 2021.
9 pages
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ISBN Ebook: 0-309-68914-7
DOI:
https://doi.org/10.17226/26583
National Academies of Sciences, Engineering, and Medicine. 2022. Forum on Regenerative Medicine: 2021 Annual Report. Washington, DC: The National Academies Press.
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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.
96 pages
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ISBN Paperback: 0-309-27755-8
ISBN Ebook: 0-309-27756-6
DOI:
https://doi.org/10.17226/26468
National Academies of Sciences, Engineering, and Medicine. 2022. From Molecular Insights to Patient Stratification for Neurological and Psychiatric Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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The persistent trends in suicide necessitate action among mental health care providers and payers, researchers, and community leaders. Health care settings provide an important opportunity for suicide intervention and prevention, but they cannot yet fully manage suicide risk because of a lack of training, knowledge gaps, and reimbursement challenges. School, workplace, and community-based interventions can help reduce the incidence of suicidal behavior, as can better access to care and reduced access to lethal means of suicide.
To better understand the strategies to improve access to effective interventions to prevent suicide, the Forum on Mental Health and Substance Use Disorders at the National Academies of Sciences, Engineering, and Medicine hosted a two-part virtual public workshop, Strategies and Interventions to Reduce Suicide, on June 22, 2021, and July 28, 2021. The first webinar examined the scope of the public health problem, discussed implementation of effective approaches for suicide prevention care, and addressed known barriers to health care access. The second webinar focused on building 9-8-8, the new nationwide emergency number designated to the National Suicide Prevention Lifeline. Participants discussed current crisis systems, gaps, challenges, and needs for marginalized populations. This Proceedings of a Workshop summarizes the presentations and discussions that occurred during the workshops.
120 pages
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ISBN Paperback: 0-309-27773-6
ISBN Ebook: 0-309-27774-4
DOI:
https://doi.org/10.17226/26471
National Academies of Sciences, Engineering, and Medicine. 2022. Strategies and Interventions to Reduce Suicide: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Each year, the individuals and organizations in the U.S. organ donation, procurement, allocation, and distribution system work together to provide transplants to many thousands of people, but thousands more die before getting a transplant due to the ongoing shortage of deceased donor organs and inequitable access to transplant waiting lists.
Realizing the Promise of Equity in the Organ Transplantation System, a new consensus study report from the National Academies of Sciences, Engineering, and Medicine's Committee on A Fairer and More Equitable, Cost-Effective, and Transparent System of Donor Organ Procurement, Allocation, and Distribution, provides expert recommendations to improve fairness, equity, transparency, and cost-effectiveness in the donor organ system.
278 pages
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ISBN Paperback: 0-309-27072-3
ISBN Ebook: 0-309-27073-1
DOI:
https://doi.org/10.17226/26364
National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press.
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During 2021, the Roundtable on Genomics and Precision Health explored important topics including diversity, equity, inclusion, and justice in the genetics and genomics workforce; case studies of innovation in the genetics and genomics spaces that have led to creative ways to approach clinical care; and barriers and facilitators of the adoption of genomics-based tools in clinical care. As part of the strategic plan that was adopted in 2020, the work of the Roundtable is centered on four main areas: Innovation, Dialogue, Equity, and Adoption. This annual report summarizes the activities of the roundtable in 2021.
12 pages
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8.5 x 11
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ISBN Ebook: 0-309-68867-1
DOI:
https://doi.org/10.17226/26570
National Academies of Sciences, Engineering, and Medicine. 2022. Roundtable on Genomics and Precision Health: 2021 Annual Report. Washington, DC: The National Academies Press.
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Every community is affected by traumatic brain injury (TBI). Causes as diverse as falls, sports injuries, vehicle collisions, domestic violence, and military incidents can result in injuries across a spectrum of severity and age groups. Just as the many causes of TBI and the people who experience it are diverse, so too are the physiological, cognitive, and behavioral changes that can occur following injury. The overall TBI ecosystem is not limited to healthcare and research, but includes the related systems that administer and finance healthcare, accredit care facilities, and provide regulatory approval and oversight of products and therapies. TBI also intersects with the wide range of community organizations and institutions in which people return to learning, work, and play, including the education system, work environments, professional and amateur sports associations, the criminal justice system, and others.
Traumatic Brain Injury: A Roadmap for Accelerating Progress examines the current landscape of basic, translational, and clinical TBI research and identifies gaps and opportunities to accelerate research progress and improve care with a focus on the biological, psychological, sociological, and ecological impacts. This report calls not merely for improvement, but for a transformation of attitudes, understanding, investments, and care systems for TBI.
244 pages
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ISBN Paperback: 0-309-49043-X
ISBN Ebook: 0-309-49044-8
DOI:
https://doi.org/10.17226/25394
National Academies of Sciences, Engineering, and Medicine. 2022. Traumatic Brain Injury: A Roadmap for Accelerating Progress. Washington, DC: The National Academies Press.
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The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands.
Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.
138 pages
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ISBN Paperback: 0-309-26928-8
ISBN Ebook: 0-309-26929-6
DOI:
https://doi.org/10.17226/26349
National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Individuals in the United States and Americans abroad are exposed to inhalation hazards from a variety of sources, and these hazards can have both short- and long-term adverse effects on health. For example, exposure to wildfire smoke, which contains particulate matter and toxic chemicals, can lead to respiratory problems, increased risk for heart attacks, and other adverse health outcomes. Individuals also may be exposed to airborne infectious agents through aerosol or droplet transmission, and as demonstrated by the COVID-19 pandemic, the individual and public health consequences of these exposures can be severe. Storms, floods, and hurricanes can increase exposure to moisture-driven hazards, such as mold, and to accidental releases from production facilities or transport vehicles that may result in chemical exposures.
The current regulatory system is focused primarily on ensuring access to respiratory protection in occupational settings characterized by well-defined hazards and employer-employee relationships. With this narrow regulatory focus, the respiratory protection needs of the public and many workers are not being met. As climate change increases the incidence and severity of wildfires, hurricanes, floods, infectious disease outbreaks, and other phenomena that impact air quality and human health, it is imperative that the United States ensure that the respiratory protection needs of the public and all workers are met. Recognizing the urgent need to address the gaps in the nation's ability to meet the respiratory protection needs of the public and workers without workplace respiratory protection programs, this report makes recommendations for a framework of responsibilities and authorities that would provide a unified and authoritative source of information and effective oversight for the development, approval, and use of respiratory protection.
572 pages
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ISBN Paperback: 0-309-27137-1
ISBN Ebook: 0-309-27141-X
DOI:
https://doi.org/10.17226/26372
National Academies of Sciences, Engineering, and Medicine. 2022. Frameworks for Protecting Workers and the Public from Inhalation Hazards. Washington, DC: The National Academies Press.
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In 2021, the National Academies' Forum on Drug Discovery, Development, and Translation (the forum) hosted a four-part public workshop, Envisioning a Transformed Clinical Trials Enterprise: Establishing an Agenda for 2030, to set goals for the clinical trial enterprise in the year 2030 and chart a path toward those goals. The forum also completed a three-part public workshop, Innovation in Drug Research and Development for Prevalent Chronic Diseases, which brought together stakeholders to address barriers to spurring innovation for drug research and development for highly prevalent chronic diseases. Together with the National Cancer Policy Forum and the Forum on Aging, Disability, and Independence, the forum convened a three-day public workshop to identify opportunities to improve the evidence base on the effectiveness and safety of cancer therapies in adults across the older age span. For more information, please visit the forum webpage.
28 pages
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ISBN Ebook: 0-309-68851-5
DOI:
https://doi.org/10.17226/26561
National Academies of Sciences, Engineering, and Medicine. 2022. Forum on Drug Discovery, Development, and Translation: 2021 Annual Review. Washington, DC: The National Academies Press.
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Approximately five percent of Medicare beneficiaries (2.2 million Americans) are living with serious illness, as are many other non-Medicare eligible individuals. This number is expected to grow rapidly as the population ages and the prevalence of progressive illness increases. In many communities, particularly urban and rural underserved communities, primary care clinicians are the main workforce caring for people with serious illness, which underscores the need to integrate high quality serious illness care into primary care delivery.
To better understand the challenges and opportunities for integrating serious illness care into primary care settings, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Quality Care for People with Serious Illness hosted a virtual workshop on June 10 and 17, 2021. The workshop, titled Integrating Serious Illness Care into Primary Care Delivery, explored the shared principles of primary and serious illness care, the interdisciplinary teams that power both disciplines, the policy issues that can act as barriers to or incentives for integration, and best practices for integrating primary care and serious illness care. This Proceedings of a Workshop summarizes the presentations and discussions that occurred during the workshop.
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ISBN Paperback: 0-309-27433-8
ISBN Ebook: 0-309-27434-6
DOI:
https://doi.org/10.17226/26411
National Academies of Sciences, Engineering, and Medicine. 2022. Integrating Serious Illness Care into Primary Care Delivery: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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In 2020, as part of its strategic planning initiative, the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine decided to explore four action-oriented focus areas for its activities over the coming three to five years: driving innovation, shaping the policy dialogue, spurring the adoption of tools and approaches, and achieving equity. The roundtable began its exploration of the fourth thematic area - achieving equity in genomics and precision health - by holding a public workshop on October 5, 2021.
The workshop, Improving Diversity of the Genomics Workforce, examined the current state of diversity of the genetics and genomics workforce; the structural and social factors associated with the lack of workforce diversity; the impact of diversity in the workforce on access to genetic services and patient outcomes; and possible actions that could lead to a more diverse, equitable, and inclusive genomics workforce. This Proceedings of a Workshop-in Brief highlights the presentations and discussions that occurred during the workshop.
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ISBN Ebook: 0-309-27817-1
DOI:
https://doi.org/10.17226/26478
National Academies of Sciences, Engineering, and Medicine. 2022. Improving Diversity of the Genomics Workforce: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.
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There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population.
On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.
142 pages
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ISBN Paperback: 0-309-68568-0
ISBN Ebook: 0-309-68569-9
DOI:
https://doi.org/10.17226/25998
National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response.
Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.
138 pages
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ISBN Paperback: 0-309-27148-7
ISBN Ebook: 0-309-27149-5
DOI:
https://doi.org/10.17226/26373
National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press.
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Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic disease. As a result, prevalent chronic diseases are producing immense health care costs as well as preventable suffering and death. On February 22, March 2, and March 8, 2021, the National Academies of Sciences, Engineering, and Medicine, convened a workshop to discuss barriers to innovation in this space and examine strategies and incentives to support equitable, person-centered drug R&D for prevalent chronic diseases.
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ISBN Paperback: 0-309-09214-0
ISBN Ebook: 0-309-09229-9
DOI:
https://doi.org/10.17226/26291
National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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This special edition Ten-Year Review takes a look back at some of the most influential work of the National Academies' Forum on Drug Discovery, Development, and Translation over the past decade. In November 2011, amid growing concerns about the future of the U.S. clinical trials enterprise and its competitiveness on the global stage, the forum convened a public workshop for stakeholders to lay out a vision for a transformed clinical trials enterprise in the United States by 2020. This workshop laid the foundation for a variety of forum activities focused on the following thematic priorities:
For more information, please visit the Forum's webpage.
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ISBN Ebook: 0-309-27440-0
DOI:
https://doi.org/10.17226/26412
National Academies of Sciences, Engineering, and Medicine. 2021. Forum on Drug Discovery, Development, and Translation: 10 Year Review: 2011-2020. Washington, DC: The National Academies Press.
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Mood disorders - including depression and bipolar disorder - are common, disabling, and potentially lethal disorders, characterized by a shortened lifespan from comorbid medical illness and rising suicide rates. Medications for these conditions have been shown to be insufficiently effective in the majority of people who take them, and there remains a tremendous unmet medical need. Recent advances towards understanding the mechanisms of action for psychiatric medicines have led to the identification of potential novel molecular targets and agents for treating mood disorders. While these promising avenues for further investigation have re-energized scientific research in this area, many open questions remain. In response to this interest, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop in March 2021, Novel Molecular Targets for Mood Disorders and Psychosis.
The goal of this workshop was to explore the landscape of novel pharmacologic treatments for psychiatric disorders, review the challenges and opportunities that have been highlighted by the development of recently approved drugs, and reflect on how to apply those lessons learned towards current and future efforts to identify and validate additional novel molecular targets. With a grounding in the personal experiences of patients living with depression and schizophrenia, workshop participants discussed the scientific, clinical, technological, regulatory, and ethical considerations of this topic. Examples of drug classes discussed in the workshop include antagonists for NMDA (N-methyl-D-aspartate) receptors and GABA (gamma-aminobutyric acid) receptors, as well as modulators for muscarinic and serotonergic receptors. This publication summarizes the presentations and discussions from the workshop.
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ISBN Paperback: 0-309-68590-7
ISBN Ebook: 0-309-68591-5
DOI:
https://doi.org/10.17226/26218
National Academies of Sciences, Engineering, and Medicine. 2021. Novel Molecular Targets for Mood Disorders and Psychosis: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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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.
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ISBN Paperback: 0-309-44737-2
ISBN Ebook: 0-309-44745-3
DOI:
https://doi.org/10.17226/26119
National Academies of Sciences, Engineering, and Medicine. 2021. The Challenges and Opportunities of Advance Care Planning: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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20 pages
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ISBN Ebook: 0-309-09411-9
DOI:
https://doi.org/10.17226/26327
National Academies of Sciences, Engineering, and Medicine. 2021. Forum on Medical and Public Health Preparedness for Disasters and Emergencies: 2020 Annual Report. Washington, DC: The National Academies Press.
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