Precision medicine is focused on the individual and will require the rapid and accurate identification and prioritization of causative factors of disease. To move forward and accelerate the delivery of the anticipated benefits of precision medicine, developing predictable, reproducible, and reliable animal models will be essential. In order to explore the topic of animal-based research and its relevance to precision medicine, the National Academies of Sciences, Engineering, and Medicine convened a 2-day workshop on October 5 and 6, 2017. The workshop was designed to focus on the development, implementation, and interpretation of model organisms to advance and accelerate the field of precision medicine. Participants examined the extent to which next-generation animal models, designed using patient data and phenotyping platforms targeted to reveal and inform disease mechanisms, will be essential to the successful implementation of precision medicine. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction to Precision Medicine and Animal Models 2 Existing Precision Medicine Initiatives 3 The Promise and Perils of Animal Models 4 Reproducibility and Predictivity 5 In Vitro Alternatives to Animal Models 6 Assessing Safety and Toxicology 7 Patient Perspectives 8 Reflections on the Workshop References Appendix A: Agenda Appendix B: Planning Committee Biographies Appendix C: Speaker Biographies

The surface of the human body and its mucous membranes are heavily colonized by microorganisms. Our understanding of the contributions that complex microbial communities make to health and disease is advancing rapidly. Most microbiome research to date has focused on the mouse as a model organism for delineating the mechanisms that shape the assembly and dynamic operations of microbial communities. However, the mouse is not a perfect surrogate for studying different aspects of the microbiome and how it responds to various environmental and host stimuli, and as a result, researchers have been conducting microbiome studies in other animals. To examine the different animal models researchers employ in microbiome studies and to better understand the strengths and weaknesses of each of these model organisms as they relate to human and nonhuman health and disease, the Roundtable on Science and Welfare in Laboratory Animal Use of the National Academies of Sciences, Engineering, and Medicine convened a workshop in December 2016. The workshop participants explored how to improve the depth and breadth of analysis of microbial communities using various model organisms, the challenges of standardization and biological variability that are inherent in gnotobiotic animal-based research, the predictability and translatability of preclinical studies to humans, and strategies for expanding the infrastructure and tools for conducting studies in these types of models. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 A Trans-Kingdom Perspective on Animal Models and Microbiome Research 3 Non-Rodent Models for Microbiome Research 4 Modeling Human Microbiota in Animal Systems 5 Experimental Reproducibility Using Gnotobiotic Animal Models 6 Establishing and Evolving Gnotobiotic Facilities 7 Reflections on the Workshop References Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Planning Committee Appendix C: Biographical Sketches of Workshop Speakers and Moderators Appendix D: Glossary

The marmoset, a type of small monkey native to South America, is a research model of increasing importance for biomedical research in the United States and globally. Marmosets offer a range of advantages as animal models in neuroscience, aging, infectious diseases, and other fields of study. They may be particularly useful for the development of new disease models using genetic engineering and assisted reproductive technologies. However, concerns have been voiced with respect to the development of new marmoset-based models of disease, ethical considerations for their use, the supply of marmosets available for research, and gaps in guidance for their care and management. To explore and address these concerns, the Roundtable on Science and Welfare in Laboratory Animal Use hosted a public workshop on October 22-23, 2018, in Washington, DC. The workshop focused on the availability of marmosets in the United States and abroad; animal welfare and ethical considerations stemming from the use of wildtype and genetically modified marmosets; and standards of housing and care, dietary needs, and feeding requirements for marmosets in captivity. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Context for the Use of Marmosets as Animal Models 3 Ethical Considerations 4 Current Research Applications 5 Marmoset Genomics and Genetic Diversity 6 Marmoset Supply and Availability 7 Marmoset Care and Management 8 Final Remarks Appendix A: Workshop Agenda Appendix B: Professional Biosketches

The obligation to treat animals used in research ethically and humanely extends beyond their lives in the laboratory to include their transportation from place to place. Yet transporting animals is a highly regulated and complex process that raises many difficult issues. To examine these issues, the Roundtable on Science and Welfare in Laboratory Animal Use held a workshop on September 3-4, 2014, in Washington, DC. More than 200 people participated in the workshop in person and online, including representatives of academic research institutions, pharmaceutical and consumer product companies, government agencies, research advocacy groups, professional associations, and the public. The workshop was designed to draw attention to the essential thoughtful journey planning behind each transport of laboratory animals. Table of Contents Front Matter 1 Introduction and Overview 2 Air Transportation 3 Land Transportation 4 The Health Status and Logistics of Laboratory Animals 5 Species-Specific Considerations 6 International, National, and State Regulatory Requirements 7 Perspectives on the Transportation of Laboratory Animals 8 Interactive Sessions 9 Key Points from the Workshop and a Look to the Future Appendix A: Workshop Agenda Appendix B: Committee and Speaker Biographies Appendix C: Transportation Checklist Appendix D: Statement of Task

In order to better understand the critical issues pertaining to the concept of performance standards for laboratory animal use, the Institute for Laboratory Animal Research Roundtable on Science and Welfare in Laboratory Animal Use held a public workshop on April 20-21, 2015. The purpose of the workshop was to promote the appropriate and responsible care of animals in research, to provide a balanced and civil forum for discussion and collaboration, and to help build transparency and trust among stakeholders. Participants addressed the challenges of defining, developing, implementing, assessing, and validating performance standards to ensure "optimal practices, management, and operations." This report summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Overview of Performance Standards for the Humane Care and Use of Laboratory Animals 3 Regulatory and Advisory Perspectives 4 End-User Perspectives 5 Detailed Steps in the Development and Implementation of Performance Standards 6 Reports from the Breakout Sessions 7 Sharing Acceptable Performance Standards 8 Reflections on the Workshop Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Workshop Speakers and Organizing Committee Members Appendix C: Statement of Task