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Principles of Translational Science in Medicine

Principles of Translational Science in Medicine Author Martin Wehling
ISBN-10 9780128007211
Release 2015-04-02
Pages 364
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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



Principles of Translational Science in Medicine

Principles of Translational Science in Medicine Author Martin Wehling
ISBN-10 0521888697
Release 2009-12-21
Pages 404
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Despite advancements in the cloning of the total human genome, biomedical innovations at the patient level are becoming rare events. However, translational medicine is a burgeoning science that shows the potential to reverse the trend. This textbook will comprise a state-of-the-art survey of translational medicine, with emphasis on its emerging scientific backbone, its strengths, and its weaknesses. It explores all aspects of preclinical and clinical issues that are relevant to the success of translational pharmaceutical or medical device or diagnostic innovations, including target risk assessment, biomarker evaluation, and predictivity grading for both efficacy and toxicity; early human trial designs that are adequate to guide stop or go decisions on the grounds of biomarker panels; and biostatistical methods to analyze multiple readout situations and quantify risk projections. The book provides guidance to design smart profiling strategies for new approaches aimed at cutting timelines and concentrating on the comparison of quality issues of early developmental processes for pharmaceutical and biotechnology research. By furthering the substantiation of translational medicine, creating awareness about its potential to promote innovations into clinical practice, and examining the terminology surrounding current biotechnologies, this book hopes to create a dialogue about translational science and what this will mean for patient care in the near future.



Clinical and Translational Science

Clinical and Translational Science Author David Robertson
ISBN-10 9780128021118
Release 2016-11-25
Pages 808
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Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs



Translational Medicine Tools And Techniques

Translational Medicine  Tools And Techniques Author Aamir Shahzad
ISBN-10 9780128034941
Release 2015-11-24
Pages 196
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Translational Medicine: Tools and Techniques provides a standardized path from basic research to the clinic and brings together various policy and practice issues to simplify the broad interdisciplinary field. With discussions from academic and industry leaders at international institutions who have successfully implemented translational medicine techniques and tools in various settings, readers will be guided through implementation strategies relevant to their own needs and institutions. The book also addresses regulatory processes in USA, EU, Japan and China. By providing details on omics sciences techniques, biomarkers, data mining and management approaches, case reports from industry, and tools to assess the value of different technologies and techniques, this book is the first to provide a user-friendly go-to guide for key opinion leaders (KOLs), industry administrators, faculty members, clinicians, researchers, and students interested in translational medicine. Includes detailed and standardized information about the techniques and tools used in translational medicine Provides specific industry case scenarios Explains how to use translational medicine tools and techniques to plan and improve infrastructures and capabilities while reducing cost and optimizing resources



Translational Medicine and Drug Discovery

Translational Medicine and Drug Discovery Author Bruce H. Littman
ISBN-10 9781139498722
Release 2011-01-31
Pages
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This book, edited by two innovative leaders in the field, focuses on the new discipline of translational medicine as it pertains to drug development within the pharmaceutical and biotechnology industry. Translational medicine seeks to translate biological and molecular knowledge of disease and how drugs work into innovative development strategies that reduce the cost and increase the speed of delivering new medicines for patients. This book outlines general strategies, biomarker development, imaging tools, translational human models and examples of their application to real drug development. The latest thinking is presented by researchers from many of the world's leading drug development companies, including Pfizer, Merck, Eli Lilly, Abbott and Novartis, as well as academic institutions and public-private partnerships that support translational research. This book is essential for anyone interested in translational medicine from a variety of backgrounds: university institutes, medical schools, pharmaceutical companies and drug development researchers and decision-makers.



Early Drug Development

Early Drug Development Author Mitchell N. Cayen
ISBN-10 1118035208
Release 2011-02-25
Pages 654
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The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.



Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Author John I. Gallin
ISBN-10 9780128499047
Release 2017-11-17
Pages 824
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Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting



Placebo and Pain

Placebo and Pain Author Luana Colloca
ISBN-10 9780123979315
Release 2013-08-28
Pages 312
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The placebo effect continues to fascinate scientists, scholars, and clinicians, resulting in an impressive amount of research, mainly in the field of pain. While recent experimental and clinical studies have unraveled salient aspects of the neurobiological substrates and clinical relevance of pain and placebo analgesia, an authoritative source remained lacking until now. By presenting and integrating a broad range of research, Placebo and Pain enhances readers’ knowledge about placebo and nocebo effects, reexamines the methodology of clinical trials, and improves the therapeutic approaches for patients suffering from pain. Review for Placebo and Pain: “This ambitious book is the first comprehensive and unified presentation of the placebo and nocebo phenomena in the area of pain. Written by the international leading experts in the field, the book provides an accurate up-to-date [work] on placebo and pain dealing with current perspectives and future challenging issues. --Ted Kaptchuk, Associate Professor of Medicine, Harvard Medical School Contains historical aspects of the placebo effect Discusses biological and psychological mechanisms of placebo analgesic responses Reviews implications of the placebo effect for clinical research and pain management Includes methodological and ethical aspects of the placebo effect



Translational Systems Biology

Translational Systems Biology Author Yoram Vodovotz
ISBN-10 9780123978905
Release 2014-10-08
Pages 178
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Are we satisfied with the rate of drug development? Are we happy with the drugs that come to market? Are we getting our money’s worth in spending for basic biomedical research? In Translational Systems Biology, Drs. Yoram Vodovotz and Gary An address these questions by providing a foundational description the barriers facing biomedical research today and the immediate future, and how these barriers could be overcome through the adoption of a robust and scalable approach that will form the underpinning of biomedical research for the future. By using a combination of essays providing the intellectual basis of the Translational Dilemma and reports of examples in the study of inflammation, the content of Translational Systems Biology will remain relevant as technology and knowledge advances bring broad translational applicability to other diseases. Translational systems biology is an integrated, multi-scale, evidence-based approach that combines laboratory, clinical and computational methods with an explicit goal of developing effective means of control of biological processes for improving human health and rapid clinical application. This comprehensive approach to date has been utilized for in silico studies of sepsis, trauma, hemorrhage, and traumatic brain injury, acute liver failure, wound healing, and inflammation. Provides an explicit, reasoned, and systematic approach to dealing with the challenges of translational science across disciplines Establishes the case for including computational modeling at all stages of biomedical research and healthcare delivery, from early pre-clinical studies to long-term care, by clearly delineating efficiency and costs saving important to business investment Guides readers on how to communicate across domains and disciplines, particularly between biologists and computational researchers, to effectively develop multi- and trans-disciplinary research teams



Regenerative Engineering

Regenerative Engineering Author Yusuf Khan
ISBN-10 9781351647397
Release 2018-04-19
Pages 154
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This book focuses on both advances in materials science and in scaffold development techniques, paying close attention to state-of-the-art research. Each chapter will delve into specific materials categories (e.g. composite materials, bioactive ceramics, etc.) and how these materials are specifically designed for regenerative engineering applications. There will also be unique chapters on Biologically Derived Scaffolding along with 3-D Printing Technology for Regenerative Engineeering.



Basic Principles of Drug Discovery and Development

Basic Principles of Drug Discovery and Development Author Benjamin Blass
ISBN-10 9780124115255
Release 2015-04-24
Pages 580
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Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, providing comprehensive explanations of enabling technologies such as high throughput screening, structure based drug design, molecular modeling, pharmaceutical profiling, and translational medicine, all areas that have become critical steps in the successful development of marketable therapeutics. The text introduces the fundamental principles of drug discovery and development, also discussing important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles in pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. It is designed to enable new scientists to rapidly understand the key fundamentals of drug discovery, including pharmacokinetics, toxicology, and intellectual property." Provides a clear explanation of how the pharmaceutical industry works Explains the complete drug discovery process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual propertyIdeal for anyone interested in learning about the drug discovery process and those contemplating careers in the industry Explains the transition process from academia or other industries



Diseases of the Nervous System

Diseases of the Nervous System Author Harald Sontheimer
ISBN-10 9780128004036
Release 2015-03-06
Pages 520
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The study of the brain continues to expand at a rapid pace providing fascinating insights into the basic mechanisms underlying nervous system illnesses. New tools, ranging from genome sequencing to non-invasive imaging, and research fueled by public and private investment in biomedical research has been transformative in our understanding of nervous system diseases and has led to an explosion of published primary research articles. Diseases of the Nervous System summarizes the current state of basic and clinical knowledge for the most common neurological and neuropsychiatric conditions. In a systematic progression, each chapter covers either a single disease or a group of related disorders ranging from static insults to primary and secondary progressive neurodegenerative diseases, neurodevelopmental illnesses, illnesses resulting from nervous system infection and neuropsychiatric conditions. Chapters follow a common format and are stand-alone units, each covering disease history, clinical presentation, disease mechanisms and treatment protocols. Dr. Sontheimer also includes two chapters which discuss common concepts shared among the disorders and how new findings are being translated from the bench to the bedside. In a final chapter, he explains the most commonly used neuroscience jargon. The chapters address controversial issues in current day neuroscience research including translational research, drug discovery, ethical issues, and the promises of personalized medicine. This book provides an introduction for course adoption and an introductory tutorial for students, scholars, researchers and medical professionals interested in learning the state of the art concerning our understanding and treatment of diseases of the nervous system. 2016 PROSE Award winner of the Best Textbook Award in Biological & Life Sciences Provides a focused tutorial introduction to the core diseases of the nervous system Includes comprehensive introductions to Stroke, Epilepsy, Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease, ALS, Head and Spinal Cord Trauma, Multiple Sclerosis, Brain Tumors, Depression, Schizophrenia and many other diseases of the nervous system Covers more than 40 diseases from the foundational science to the best treatment protocols Includes discussions of translational research, drug discovery, personalized medicine, ethics, and neuroscience



Stem Cells

Stem Cells Author Ariff Bongso
ISBN-10 9789814289382
Release 2011
Pages 688
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Stem cell biology has drawn tremendous interest in recent years as it promises cures for a variety of incurable diseases. This book deals with the basic and clinical aspects of stem cell research and involves work on the full spectrum of stem cells isolated today. It also covers the conversion of stem cell types into a variety of useful tissues which may be used in the future for transplantation therapy. It is thus aimed at undergraduates, postgraduates, scientists, embryologists, doctors, tissue engineers and anyone who wishes to gain some insight into stem cell biology. This book is important as it is comprehensive and covers all aspects of stem cell biology, from basic research to clinical applications. It will have 33 chapters written by renowned stem cell scientists worldwide. It will be up-to-date and all the chapters include self-explanatory figures, color photographs, graphics and tables. It will be easy to read and give the reader a complete understanding and state of the art of the exciting science and its applications.



Heart Failure in the Child and Young Adult

Heart Failure in the Child and Young Adult Author John L Jefferies
ISBN-10 9780128026137
Release 2017-12-15
Pages 824
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Heart Failure in the Child and Young Adult: From Bench to Bedside combines multiple etiologies for pediatric heart failure, including congenital heart disease, cardiomyopathies, infectious diseases and metabolic abnormalities. This comprehensive resource combines research from multiple contributors with current guidelines to bridge the knowledge gap for the recognition and management of heart failure in children. Coverage begins with the basic science of heart failure, then progresses through diagnosis, management, treatment and surgery, finally concluding with advanced special topics, including genetics, self-management and nanomedicine. Provides coverage of the basic science of heart failure, its epidemiology and economic aspects, outpatient and inpatient management, and advanced therapies, including mechanical circulatory support and heart transplantation Combines cutting-edge research with current guidelines from the field Includes online access to a downloadable slide set for each chapter and clinical imaging and procedural cases



Gene Therapy of the Central Nervous System

Gene Therapy of the Central Nervous System Author Matthew J. During
ISBN-10 0123976324
Release 2006
Pages 355
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Few areas of biomedical research provide greater opportunities for radically new therapies for devastating diseases that have evaded treatment so far than gene therapy. This is particularly true for the brain and nervous system, where gene transfer has become a key technology for basic research and has recently been translated to human therapy in several landmark clinical trials. Gene Therapy of the Central Nervous System: From Bench to Bedside represents the first definitive volume on this subject. Edited by two pioneers of neurological gene therapy, this volume contains contributions by leaders who helped create this field and are expanding the promise of gene therapy for the future of basic and clinical neuroscience. Drawing upon this extensive collective experience, this book provides clear and informative reviews on a variety of subjects of interest to anyone exploring or using gene therapy for neurobiological applications in research and clinical praxis. * Presents gene transfer technologies with particular emphases upon novel vehicles, immunological issues and the role of gene therapy in stem cells * Discusses preclinical areas that are likely to translate into clinical studies in the near future, including epilepsy, pain and amyotrophic lateral sclerosis * Includes "insider" information on technological and regulatory issues which can often limit effective translation of even the most promising idea into clinical use



Principles of Molecular Cardiology

Principles of Molecular Cardiology Author Marschall S. Runge
ISBN-10 9781592598786
Release 2007-11-14
Pages 617
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An easy-to-read survey of all the latest developments in molecular cardiologic research and therapy. The authors explain in a readable style the complex process of the heart's development, the molecular basis of cardiovascular diseases, and the translation of these research advances to actual clinical treatments. The expert information provided here serves as an invaluable building block for novel treatments of cardiovascular diseases and includes a comprehensive discussion of cardiac function and dysfunction, coronary artery disease, cardiac arrhythmias, vascular diseases, and risk factors for cardiovascular disease. These state-of-the-art approaches to molecular cardiologic research include critical discussion of such topics as the molecular events that regulate angiogenesis and the potential for angiogenic therapy, emerging therapies for arrhythmias, and a description of the molecular biology of aging and its impact on the cardiovascular system.



The Social Construction of Technological Systems

The Social Construction of Technological Systems Author Wiebe E. Bijker
ISBN-10 9780262300872
Release 2012-05-18
Pages 472
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This pioneering book, first published in 1987, launched the new field of social studies of technology. It introduced a method of inquiry--social construction of technology, or SCOT--that became a key part of the wider discipline of science and technology studies. The book helped the MIT Press shape its STS list and inspired the Inside Technology series. The thirteen essays in the book tell stories about such varied technologies as thirteenth-century galleys, eighteenth-century cooking stoves, and twentieth-century missile systems. Taken together, they affirm the fruitfulness of an approach to the study of technology that gives equal weight to technical, social, economic, and political questions, and they demonstrate the illuminating effects of the integration of empirics and theory. The approaches in this volume--collectively called SCOT (after the volume's title) have since broadened their scope, and twenty-five years after the publication of this book, it is difficult to think of a technology that has not been studied from a SCOT perspective and impossible to think of a technology that cannot be studied that way.