During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication. As part of the United States' scientific and research preparedness enterprise, there is an imperative to go "beyond the last mile" of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6?7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction and Overview 2 Setting the Stage: Defining Terminologies and Sharing Stakeholder Perspectives 3 Data Needs, Data Sources, and Collection Methodologies for Stakeholder Decision Making 4 Considerations for Conducting Rapid Clinical Research on MCMs During a PHE 5 Inspiring Collective Action: Perspectives from Federal Stakeholders and Reflections from Individual Workshop Participants Appendix A: References Appendix B: Workshop Agenda Appendix C: Biographical Sketches of Workshop Speakers and Moderators

In October 2016, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Population Health Improvement hosted a workshop to explore sustainable financing structures that reflect a recognition of the health and non-health factors that shape the well-being of U.S. communities. The goals of the workshop were to learn from the long-term, sustainable financing strategies used in other sectors, to explore how those approaches could be applied to population health, and to consider structures that work across sectors. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Sustainable Financing Structures for Population Health: Historical Patterns and Insights for the Future 3 Case Example 1: Justice Reinvestment 4 Case Example 2: Clean Energy Financing 5 Realigning Resources for Population Health: Small Group Conversations 6 Reflections on the Workshop Appendix A: References Appendix B: Workshop Agenda Appendix C: Sustainable Financing Structures for Population Health: Historical Patterns and Insights for the Future: Commissioned Paper Appendix D: Speaker Biographical Sketches

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

In September 2015, the National Academies of Sciences, Engineering, and Medicine hosted a workshop to explore the basic and translational research needs for population health science, and to discuss specific research priorities and actions to foster population health improvement. The workshop was designed to provide frameworks for understanding population health research and its role in shaping and having an effect on population health, identify individual and institutional facilitators and challenges regarding the production, communication, and use of research for population health improvement, and identify key areas for future research critical to the advancement of population health improvement. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Setting the Context 3 Research in Practice: Opportunities and Challenges 4 Building a Population Health Research Agenda: Views from the Field 5 Population Health Research Priorities: Perspectives from Users of Research 6 Toward a Research Agenda for Population Health Appendix A: References Appendix B: Workshop Agenda Appendix C: Suggested Readings for Krieger Presentation (Chapter 2) Appendix D: Results from a University of Michigan Survey Regarding Priorities for Population Health Research Appendix E: Speaker Biographies

Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Overarching Considerations for Implementing Successful Genetics-Enabled Drug Development 3 Case Studies in Precision Drug Development 4 Integrating Genetics into the Drug Development Pathway for Complex Diseases 5 Finding Innovative Ways to Integrate Genetic Research into the Drug Development Process 6 Reflecting Back and Looking Forward: Key Themes and Potential Next Steps in Genetics-Enabled Drug Development Appendix A: References Appendix B: Statement of Task and Workshop Agenda Appendix C: Speaker Biographical Sketches Appendix D: Registered Attendees

Business Engagement in Building Healthy Communities is the summary of a workshop convened by the Institute of Medicine's Roundtable on Population Health Improvement in July 2014 to consider the role of business in improving population health beyond the usual worksite wellness and health promotion activities. The workshop followed previous roundtable discussions on the importance of applying a health lens to decision making in non-health sectors and the need for cross-sector collaborations to advance population health. Invited speakers included representatives from several businesses that have taken action to improve the health of their communities and representatives of business coalitions on health. The workshop was designed to discuss why engaging in population health improvement is good for business; explore how businesses can be effective key leaders in improving the health of communities; and discuss ways in which businesses can engage in population health improvement. This report is a record of the presentations and discussion of the event Table of Contents Front Matter 1 Introduction 2 Lessons from the Blue Zones 3 Why Should Businesses Engage in Population Health Improvement? 4 The Impact of Business on Population Health 5 Community/Population Health as an Intentional Business Strategy 6 Stimulating and Supporting Business Engagement in Health Improvement 7 Reflections on the Day Appendix A: References Appendix B: Workshop Agenda Appendix C: Biographical Sketches of Workshop Speakers

Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world's health since these diseases also know no boundaries and will easily cross borders. Sustaining public and private investment in the development of medical countermeasures (MCMs) before an emerging infectious disease becomes a public health emergency in the United States has been extremely challenging. Interest and momentum peak during a crisis and wane between events, and there is little interest in disease threats outside the United States until they impact people stateside. On March 26 and 27, 2015, the Institute of Medicine convened a workshop in Washington, DC to discuss how to achieve rapid and nimble MCM capability for new and emerging threats. Public- and private-sector stakeholders examined recent efforts to prepare for and respond to outbreaks of Ebola Virus Disease, pandemic influenza, and coronaviruses from policy, budget, and operational standpoints. Participants discussed the need for rapid access to MCM to ensure national security and considered strategies and business models that could enhance stakeholder interest and investment in sustainable response capabilities. This report summarizes the presentations and discussions from this workshop. Table of Contents Front Matter 1 Introduction 2 A Wake-Up Call: The 2014 Ebola Outbreak Response 3 Preparedness as an Issue of National Security 4 Rapid Development of Ebola Vaccines 5 Influenza Risk Assessment and Pandemic Preparedness 6 Developing MCMs for Coronaviruses 7 Sustainable Business Models to Ensure Rapid and Nimble Responses 8 Supporting MCM Development Across Threats and Funding Cycles A References B Acronyms and Abbreviations C Statement of Task D Agenda E Biosketches of Invited Speakers and Facilitators

Spread, Scale, and Sustainability in Population Health is the summary of a workshop convened by the Institute of Medicine's Roundtable on Population Health Improvement in December 2014 to discuss the spread, scale, and sustainability of practices, models, and interventions for improving health in a variety of inter-organizational and geographical contexts. This report explores how users measure whether their strategies of spread and scale have been effective and discusses how to increase the focus on spread and scale in population health. Table of Contents Front Matter 1 Introduction 2 Spread and Scale 3 Approaches to Spread, Scale, and Evaluation of Impact 4 Learning About Spread and Scale from Other Sectors 5 Learning from the Spread and Scale of Tobacco Control: From Concept to Movement 6 Accelerating Spread and Scale in Population Health 7 Reflections on the Day Appendix A: References Appendix B: Workshop Agenda Appendix C: Background Questions and Panelist Responses Appendix D: Speaker and Moderator Biographies

Health systems and assets are a large part of the critical infrastructure of any community and are vital not only for the safety and well-being of its citizens, but also for the economic vitality, quality of life, and livelihood of the entire community. As part of its ongoing mission to foster dialogue among stakeholders and to confront the challenges inherent in ensuring the nation's health security, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events sponsored a town hall session at the 2012 Public Health Preparedness Summit. This event took place February 21-24 in Anaheim, California. In this session sponsored by the IOM, the focus of discussion was sustaining health care delivery beyond the initial response to a disaster and facilitating the full long-term recovery of the local health care delivery systems. Many elements required for recovery are also fundamental to the day-to-day operations of these systems. Investing in improved health care delivery systems, both financially and through collaborative capacity building, can enhance economic development and growth before a disaster, and also prove instrumental in sustaining services and recovering after a disaster. Post-Incident Recovery Considerations of the Health Care Service Delivery Infrastructure serves as a summary of the session and explains the value of regional capacity building; the importance of interagency, intergovernmental, and public-private collaboration; and the significant role that health care coalitions can play in ensuring resilient communities and national health security. Table of Contents Front Matter Workshop Summary Appendix A: Workshop Statement of Task Appendix B: Agenda Appendix C: Speaker Biographies

As information technology becomes an integral part of health care, it is important to collect and analyze data in a way that makes the information understandable and useful. Informatics tools-which help collect, organize, and analyze data-are essential to biomedical and health research and development. The field of cancer research is facing an overwhelming deluge of data, heightening the national urgency to find solutions to support and sustain the cancer informatics ecosystem. There is a particular need to integrate research and clinical data to facilitate personalized medicine approaches to cancer prevention and treatment-for example, tailoring treatment based on an individual patient's genetic makeup as well as that of the tumor-and to allow for more rapid learning from patient experiences. To further examine informatics needs and challenges for 21st century biomedical research, the IOM's National Cancer Policy Forum held a workshop February 27-28, 2012. The workshop was designed to raise awareness of the critical and urgent importance of the challenges, gaps and opportunities in informatics; to frame the issues surrounding the development of an integrated system of cancer informatics for acceleration of research; and to discuss solutions for transformation of the cancer informatics enterprise. Informatics Needs and Challenges in Cancer Research: Workshop Summary summarizes the workshop. Table of Contents Front Matter 1 Introduction 2 Overview of the Cancer Informatics Landscape 3 Informatics and Personalized Medicine 4 Informatics-Supported Cancer Research Endeavors 5 Potential Pathways and Models for Moving Forward 6 Proposal for a Coalition of All Stakeholders 7 Transforming Cancer Informatics: From Silos to Systems Acronyms Appendix A: Workshop Agenda Appendix B: Speaker, Moderator, and Panelist Biographies

Problems contacting emergency services and delayed assistance are not unusual when incidents occur in rural areas, and the consequences can be devastating, particularly with mass casualty incidents. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop to examine the current capabilities of emergency response systems and the future opportunities to improve mass casualty response in rural communities.

When a nation or region prepares for public health emergencies such as a pandemic influenza, a large-scale earthquake, or any major disaster scenario in which the health system may be destroyed or stressed to its limits, it is important to describe how standards of care would change due to shortages of critical resources. At the 17th World Congress on Disaster and Emergency Medicine, the IOM Forum on Medical and Public Health Preparedness sponsored a session that focused on the promise of and challenges to integrating crisis standards of care principles into international disaster response plans. Table of Contents Front Matter Workshop Summary Appendix A: References Appendix B: Agenda

Knowing one's genetic disposition to a variety of diseases, including common chronic diseases, can benefit both the individual and society at large. The IOM's Roundtable on Translating Genomic-Based Research for Health held a workshop on March 22, 2010, to bring together diverse perspectives on the value of genetic testing, and to discuss its use in clinical practice. Table of Contents Front Matter 1 Introduction 2 Tumor-Based Screening for Lynch Syndrome 3 Pharmacogenomic Testing to Guide Warfarin Dosing 4 Genomic Profiling 5 Closing Remarks References Appendix A: Workshop Agenda Appendix B: Speaker Biographical Sketches Appendix C: Lynch Syndrome Topic Brief Appendix D: Warfarin Topic Brief Appendix E: Genomic Profiling Topic Brief