Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

The “omics” era has given a new perspective to the findings on the origin and evolution of the process of translation. This book provides insight into the evolution of the translation process and machinery from a modern perspective. Written by leading experts in molecular biology, this text looks into the origins and evolution of the protein synthetic machinery.

Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies Details IPR issues of translation, especially for public-private-partnerships Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

Recent advances in genomic and omics analysis have triggered a revolution affecting nearly every field of medicine, including reproductive medicine, obstetrics, gynecology, andrology, and infertility treatment. Reproductomics: The –Omics Revolution and Its Impact on Human Reproductive Medicine demonstrates how various omics technologies are already aiding fertility specialists and clinicians in characterizing patients, counseling couples towards pregnancy success, informing embryo selection, and supporting many other positive outcomes. A diverse range of chapters from international experts examine the complex relationship between genomics, transcriptomics, proteomics, and metabolomics and their role in human reproduction, identifying molecular factors of clinical significance. With this book Editors Jaime Gosálvez and José A. Horcajadas have provided researchers and clinicians with a strong foundation for a new era of personalized reproductive medicine. Thoroughly discusses how genomics and other omics approaches aid clinicians in various areas of reproductive medicine Identifies specific genomic and molecular factors of translational value in treating infertility and analyzing patient data Features chapter contributions by leading international experts

The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.

Medical and Health Genomics provides concise and evidence-based technical and practical information on the applied and translational aspects of genome sciences and the technologies related to non-clinical medicine and public health. Coverage is based on evolving paradigms of genomic medicine—in particular, the relation to public and population health genomics now being rapidly incorporated in health management and administration, with further implications for clinical population and disease management. Provides extensive coverage of the emergent field of health genomics and its huge relevance to healthcare management Presents user-friendly language accompanied by explanatory diagrams, figures, and many references for further study Covers the applied, but non-clinical, sciences across disease discovery, genetic analysis, genetic screening, and prevention and management Details the impact of clinical genomics across a diverse array of public and community health issues, and within a variety of global healthcare systems

This book provides thorough coverage of high-throughput OMICs technologies for the monitoring of stem cells and regenerative medicine. Specific topics covered include the genomics, proteomics, and metabolomics aspects of regenerative medicine, metabolic profiling of mesenchymal stem cells, genome profiling of mesenchymal stem cells, OMICs monitoring of stem cell-derived exosomes, stem cell proteomics, lipidomics, OMICs profiling of cancer (stem) cells, and finally ethical considerations of OMICs-based investigations. Chapters are authored by world-renowned scientists who have valuable expertise in the field of OMICs and regenerative medicine. Genomics, Proteomics, and Metabolomics: Stem Cells Monitoring in Regenerative Medicine, part of Springer’s Stem Cell Biology and Regenerative Medicine series, is essential reading for researchers, clinicians, biologists, biochemists, and pharmaceutical experts conducting research in the fields of stem cell biology, molecular aspects of stem cell research, tissue engineering, regenerative medicine, cellular therapy, OMICs, bioinformatics, and ethics.