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Because of the recent advances in embryo modeling techniques, and
at the request of the Office of Science Policy in the Office of the
Director at the National Institutes of Health, the National
Academies of Sciences, Engineering, hosted a 1-day public workshop
that would explore the state of the science of mammalian embryo
model systems. The workshop, which took place on January 17, 2020,
featured a combination of presentations, panels, and general
discussions, during which panelists and participants offered a
broad range of perspectives. Participants considered whether embryo
model systems - especially those that use nonhuman primate cells -
can be used to predict the function of systems made with human
cells. Presentations provided an overview of the current state of
the science of in vitro development of human trophoblast. This
publication summarizes the presentation and discussion of the
workshop. Table of Contents Front Matter 1 Introduction and
Overview 2 Mammalian Embryo Research and Pluripotent Stem Cells 3
Examining the Development of Extraembryonic Lineages 4 Stem
CellBased Models of Human Embryos 5 Comparative Embryonic
Development Across Species 6 Exploring Opportunities and Challenges
with Mammalian Embryo Model Systems References Appendix A: Workshop
Agenda Appendix B: Speaker Biographical Sketches Appendix C:
Statement of Task Appendix D: Registered Attendees
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. Table of Contents Front Matter Summary 1 Introduction and
Study Context 2 The U.S. Organ Transplantation System and
Opportunities for Improvement 3 Foundations for a Trustworthy
Deceased Donor Organ Transplantation System 4 Confronting and
Eliminating Inequities in the Organ Transplantation System 5 Saving
More Lives and Enhancing Equity with Deceased Donor Organ
Allocation Policies 6 Improving Procurement, Acceptance, and Use of
Deceased Donor Organs 7 Measuring and Improving System Performance
Appendix A: Public Meeting Agendas Appendix B: IOM and National
Academies Solid Organ Transplantation Reports Appendix C:
Biographical Sketches of Committee Members and Staff
Consumer genomics, encompassing both direct-to-consumer
applications (i.e., genetic testing that is accessed by a consumer
directly from a commercial company apart from a health care
provider) and consumer-driven genetic testing (i.e., genetic
testing ordered by a health care provider in response to an
informed patient request), has evolved considerably over the past
decade, moving from more personal utility-focused applications
outside of traditional health care to interfacing with clinical
care in nontraditional ways. As consumer genomics has increasingly
intersected with clinical applications, discussions have arisen
around the need to demonstrate clinical and analytical validity and
clinical utility due to the potential for misinterpretation by
consumers. Clinical readiness and interest for this information
have presented educational and training challenges for providers.
At the same time, consumer genomics has emerged as a potentially
innovative mechanism for thinking about health literacy and
engaging participants in their health and health care. To explore
the current landscape of consumer genomics and the implications for
how genetic test information is used or may be used in research and
clinical care, the Roundtable on Genomics and Precision Health of
the National Academies of Sciences, Engineering, and Medicine
hosted a public workshop on October 29, 2019, in Washington, DC.
Discussions included such topics as the diversity of participant
populations, the impact of consumer genomics on health literacy and
engagement, knowledge gaps related to the use of consumer genomics
in clinical care, and regulatory and health policy issues such as
data privacy and security. A broad array of stakeholders took part
in the workshop, including genomics and consumer genomics experts,
epidemiologists, health disparities researchers, clinicians, users
of consumer genomics research applications, representatives from
patient advocacy groups, payers, bioethicists, regulators, and
policy makers. This publication summarizes the presentations and
discussion of the workshop. Table of Contents Front Matter 1
Introduction and Workshop Overview 2 Understanding Consumer
Genomics Use 3 Exploring the Role of Diversity and Health
Disparities in Consumer Genomics 4 Integration Within Scientific
and Medical Communities 5 Regulatory and Health Policy Issues 6 How
Can Consumer Genomics Be Better Integrated to Improve Health?
References Appendix A: Workshop Agenda Appendix B: Speaker
Biographical Sketches Appendix C: Statement of Task Appendix D:
Registered Attendees
The emerging multidisciplinary field of regenerative engineering is
devoted to the repair, regeneration, and replacement of damaged
tissues or organs in the body. To accomplish this it uses a
combination of principles and technologies from disciplines such as
advanced materials science, developmental and stem cell biology,
immunology, physics, and clinical translation. The term
"regenerative engineering" reflects a new understanding of the use
of tissue engineering for regeneration and also the growing number
of research and product development efforts that incorporate
elements from a variety of fields. Because regenerative engineered
therapies rely on live cells and scaffolds, there are inherent
challenges in quality control arising from variability in source
and final products. Furthermore, each patient recipient, tissue
donor, and product application is unique, meaning that the field
faces complexities in the development of safe and effective new
products and therapies which are not faced by developers of more
conventional therapies. Understanding the many sources of
variability can help reduce this variability and ensure consistent
results. The Forum on Regenerative Medicine hosted a public
workshop on October 18, 2018, in Washington, DC, to explore the
various factors that must be taken into account in order to develop
successful regenerative engineering products. Invited speakers and
participants discussed factors and sources of variability in the
development and clinical application of regenerative engineering
products, characteristics of high-quality products, and how
different clinical needs, models, and contexts can inform the
development of a product to improve patient outcomes. This
publication summarizes the presentation and discussion of the
workshop. Table of Contents Front Matter 1 Introduction and
Overview 2 Sources of Variability Associated with Regenerative
Therapies: Lessons from Case Studies 3 Factors Contributing to
Patient Variability 4 Addressing Variability in Donor Tissues and
Cells 5 Addressing Variability and Meeting Quality Expectations in
the Manufacturing Setting 6 Exploring Variability and Its Impact on
Product Regulation and Outcomes 7 Potential Next Steps to Consider
for Addressing Variability References Appendix A: Workshop Agenda
Appendix B: Speaker Biographical Sketches Appendix C: Statement of
Task Appendix D: Registered Attendees
Genomic applications are being integrated into a broad range of
clinical and research activities at health care systems across the
United States. This trend can be attributed to a variety of
factors, including the declining cost of genome sequencing and the
potential for improving health outcomes and cutting the costs of
care. The goals of these genomics-based programs may be to identify
individuals with clinically actionable variants as a way of
preventing disease, providing diagnoses for patients with rare
diseases, and advancing research on genetic contributions to health
and disease. Of particular interest are genomics- based screening
programs, which will, in this publication, be clinical screening
programs that examine genes or variants in unselected populations
in order to identify individuals who are at an increased risk for a
particular health concern (e.g., diseases, adverse drug outcomes)
and who might benefit from clinical interventions. On November 1,
2017, the National Academies of Sciences, Engineering, and Medicine
hosted a public workshop to explore the challenges and
opportunities associated with integrating genomics-based screening
programs into health care systems. This workshop was developed as a
way to explore the challenges and opportunities associated with
integrating genomics-based programs in health care systems in the
areas of evidence collection, sustainability, data sharing,
infrastructure, and equity of access. This publication summarizes
the presentations and discussions from the workshop. Table of
Contents Front Matter 1 Introduction 2 Evidence Considerations for
Integrating Genomics-Based Programs into Health Care Systems 3
Financial Considerations for Implementing Genomics-Based Screening
Programs 4 Exploring Approaches to Optimize Data Sharing Among
Early Implementers of Genomics-Based Programs 5 Understanding
Participant Needs and Preferences and Improving Diversity and
Equity 6 Improving Health Through the Integration of Genomics-Based
Programs: Potential Next Steps References Appendix A: Workshop
Agenda Appendix B: Speaker Biographies Appendix C: Statement of
Task Appendix D: Registered Attendees
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. Table of Contents Front Matter 1
Introduction 2 Introduction to Systems Thinking Concepts 3
Exploring the Challenges of Critical Quality Attributes: The Role
of Systems Thinking 4 Challenges Associated with Data Collection,
Aggregation, and Sharing 5 Challenges and Opportunities Associated
with Systems-Level Analysis and Modeling 6 Addressing Regenerative
Medicine Manufacturing and Supply Chain Challenges with
Systems-Level Approaches 7 Exploring Issues of Workforce
Development Related to Systems Thinking References Appendix A:
Workshop Agenda Appendix B: Speaker Biographical Sketches Appendix
C: Statement of Task
On February 26, 2020, the Board on Health Sciences Policy of the
National Academies of Sciences, Engineering, and Medicine hosted a
1-day public workshop in Washington, DC, to examine current and
emerging bioethical issues that might arise in the context of
biomedical research and to consider research topics in bioethics
that could benefit from further attention. The scope of bioethical
issues in research is broad, but this workshop focused on issues
related to the development and use of digital technologies,
artificial intelligence, and machine learning in research and
clinical practice; issues emerging as nontraditional approaches to
health research become more widespread; the role of bioethics in
addressing racial and structural inequalities in health; and
enhancing the capacity and diversity of the bioethics workforce.
This publication summarizes the presentations and discussions from
the workshop. Table of Contents Front Matter 1 Introduction 2
Ethically Leveraging Digital Technology for Health 3 Ethical
Questions Concerning Nontraditional Approaches for Data Collection
and Use 4 Understanding the Impact of Inequality on Health,
Disease, and Who Participates in Research 5 Bioethics Research
Workforce 6 Reflecting on the Workshop and Looking to the Future
References Appendix A: Workshop Agenda Appendix B: Speaker
Biographical Sketches Appendix C: Statement of Task Appendix D:
Registered Attendees
Recognizing the potential design complexities and ethical issues
associated with clinical trials for gene therapies, the Forum on
Regenerative Medicine of the National Academies of Sciences,
Engineering, and Medicine held a 1-day workshop in Washington, DC,
on November 13, 2019. Speakers at the workshop discussed patient
recruitment and selection for gene-based clinical trials, explored
how the safety of new therapies is assessed, reviewed the
challenges involving dose escalation, and spoke about ethical
issues such as informed consent and the role of clinicians in
recommending trials as options to their patients. The workshop also
included discussions of topics related to gene therapies in the
context of other available and potentially curative treatments,
such as bone marrow transplantation for hemoglobinopathies. This
publication summarizes the presentation and discussion of the
workshop. Table of Contents Front Matter 1 Introduction and
Overview 2 Developing First-in-Human Gene Therapy Clinical Trials 3
Understanding the Complexities of Patient Selection, Enrollment,
and the Consent Process 4 Developing Endpoints for Gene Therapy
Clinical Trials 5 Integrating Gene-Based Therapies into Clinical
Practice: Exploring Long-Term Clinical Follow-Up of Patients 6
Reflections on the Workshop and Potential Opportunities for Next
Steps References Appendix A: Workshop Agenda Appendix B: Speaker
Biographical Sketches Appendix C: Statement of Task Appendix D:
Registered Attendees
On June 26, 2017, the Forum on Regenerative Medicine hosted a
public workshop in Washington, DC, titled Navigating the
Manufacturing Process and Ensuring the Quality of Regenerative
Medicine Therapies in order to examine and discuss the challenges,
opportunities, and best practices associated with defining and
measuring the quality of cell and tissue products and raw materials
in the research and manufacturing of regenerative medicine
therapies. The goal of the workshop was to learn from existing
examples of the manufacturing of early-generation regenerative
medicine products and to address how progress could be made in
identifying and measuring critical quality attributes. The workshop
also addressed the challenges of designing and adhering to
standards as a way of helping those who are working to scale up
processes and techniques from a research laboratory to the
manufacturing environment. This publication summarizes the
presentations and discussions from the workshop. Table of Contents
Front Matter 1 Introduction 2 Transitioning from Discovery and
Development to Manufacturing 3 Identifying and Measuring Critical
Quality Attributes 4 Designing Technologies to Meet the
Manufacturing Needs of New Regenerative Medicine Therapies 5
Considerations for Improving and Regulating Regenerative Medicine
Products 6 Potential Next Steps for Supporting the Development,
Manufacture, and Regulation of Regenerative Medicine Therapies
References Appendix A: Workshop Agenda Appendix B: Speaker
Biographical Sketches Appendix C: Statement of Task Appendix D:
Registered Attendees
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