Download or read book Clinical and Translational Science written by David Robertson and published by Academic Press. This book was released on 2016-11-25 with total page 812 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Principles of Translational Science in Medicine written by Martin Wehling and published by Academic Press. This book was released on 2015-04-02 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Download or read book Basic Science Methods for Clinical Researchers written by Morteza Jalali and published by Academic Press. This book was released on 2017-03-31 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Science Methods for Clinical Researchers addresses the specific challenges faced by clinicians without a conventional science background. The aim of the book is to introduce the reader to core experimental methods commonly used to answer questions in basic science research and to outline their relative strengths and limitations in generating conclusive data. This book will be a vital companion for clinicians undertaking laboratory-based science. It will support clinicians in the pursuit of their academic interests and in making an original contribution to their chosen field. In doing so, it will facilitate the development of tomorrow’s clinician scientists and future leaders in discovery science. Serves as a helpful guide for clinical researchers who lack a conventional science background Organized around research themes pertaining to key biological molecules, from genes, to proteins, cells, and model organisms Features protocols, techniques for troubleshooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Appendices provide resources for practical research methodology, including legal frameworks for using stem cells and animals in the laboratory, ethical considerations, and good laboratory practice (GLP)

Download or read book Broadly Engaged Team Science in Clinical and Translational Research written by Debra Lerner and published by Springer Nature. This book was released on 2022-02-27 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the large U.S. investment in health science, and the vast and growing body of peer-reviewed research findings it has produced, a compelling body of evidence suggests that research too often has been slow, inefficient, and fallen short of desired impacts on health. A key question is how research might be changed to be more innovative, less wasteful, and more responsive to unmet health needs. One emerging response within clinical and translational science is to advance an approach that attempts to close the gap between research scientists and key stakeholders; the individuals and groups responsible for or affected by health-related decisions. Broadly engaged team science promises to support this aim by transforming the gold standard, multi-disciplinary team science, to include key stakeholders in activities across the research spectrum. These new roles and responsibilities range from generating research questions to implementing research projects, to aiding in the translation of discoveries from the laboratory to the community. A transition to broadly engaged team science reflects the idea that inclusivity and a diversity of perspectives are necessary to achieving progress in addressing complex health issues while representing a new benchmark for ethical research practice. This is one of the first collections of papers describing how clinical and translational science researchers are defining and implementing new research practices, and the successes and challenges involved. This book represents a first and critical step towards organizing knowledge of broadly engaged team science and advancing the development of evidence-based practices. Written in an accessible style, this book is intended to highlight the breadth of broadly engaged team science within one community, motivate researchers and stakeholders to build inclusive teams, bring rigor to often informal stakeholder engagement research practices and encourage people to think more broadly about the development of scientific knowledge. It includes examples of multi-disciplinary, broadly engaged team science projects, the perspectives of academic leaders about the changes needed to encourage scientists to conduct broadly engaged team science, and a resource directory.

Download or read book Translational Research in Traumatic Brain Injury written by Daniel Laskowitz and published by CRC Press. This book was released on 2015-12-01 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traumatic brain injury (TBI) remains a significant source of death and permanent disability, contributing to nearly one-third of all injury related deaths in the United States and exacting a profound personal and economic toll. Despite the increased resources that have recently been brought to bear to improve our understanding of TBI, the development of new diagnostic and therapeutic approaches has been disappointingly slow. Translational Research in Traumatic Brain Injury attempts to integrate expertise from across specialties to address knowledge gaps in the field of TBI. Its chapters cover a wide scope of TBI research in five broad areas: Epidemiology Pathophysiology Diagnosis Current treatment strategies and sequelae Future therapies Specific topics discussed include the societal impact of TBI in both the civilian and military populations, neurobiology and molecular mechanisms of axonal and neuronal injury, biomarkers of traumatic brain injury and their relationship to pathology, neuroplasticity after TBI, neuroprotective and neurorestorative therapy, advanced neuroimaging of mild TBI, neurocognitive and psychiatric symptoms following mild TBI, sports-related TBI, epilepsy and PTSD following TBI, and more. The book integrates the perspectives of experts across disciplines to assist in the translation of new ideas to clinical practice and ultimately to improve the care of the brain injured patient.

Download or read book Translational Regenerative Medicine written by Anthony Atala and published by Academic Press. This book was released on 2014-12-01 with total page 607 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine

Download or read book The CTSA Program at NIH written by Institute of Medicine and published by National Academies Press. This book was released on 2013-10-09 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.

Download or read book Translational Pain Research written by Lawrence Kruger and published by CRC Press. This book was released on 2009-11-24 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the Most Rapidly Advancing Fields in Modern Neuroscience The success of molecular biology and the new tools derived from molecular genetics have revolutionized pain research and its translation to therapeutic effectiveness. Bringing together recent advances in modern neuroscience regarding genetic studies in mice and humans and the practical

Download or read book Translational Medicine What Why and How written by Barbara Alving and published by Karger Medical and Scientific Publishers. This book was released on 2012-12-01 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first to provide an aerial view, as well as detailed information, on 'how' activities in translational medicine are under development in countries such as the USA, China, the UK, and Taiwan. Institutions in each country are training investigators to work as sophisticated interdisciplinary teams. Investigators from 11 US academic health centers explain how they are incentivizing collaborations through pilot project programs, forming partnerships with business schools to promote efficient management of basic and clinical research, creating ethical, high- value public-private (industry) partnerships, improving efficiency with utilization of informatics, and engaging the community in research. The essential role of evaluation is explained in a clear and concise manner. The readers will also learn about the role of private funding in Taiwan and the vision of the government in China in developing multiple translational research centers. The UK is developing methodical approaches to patient needs across their lifespans; ongoing innovation is encouraged through incubator programs. With the emphasis on open innovation and sharing, the concepts and practice of translational medicine are spreading rapidly on an international scale.

Download or read book Translational Medicine Tools And Techniques written by Aamir Shahzad and published by Academic Press. This book was released on 2015-11-24 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Translational Immunology written by Seng-Lai Tan and published by Academic Press. This book was released on 2015-11-18 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Immunology: Mechanisms and Pharmacologic Approaches highlights and summarizes the most important advances in human immunology, clinical translations, new tools to analyze therapeutic targets, and new pharmacological approaches for autoimmunity, inflammatory disorders, and cancer. The book is an essential resource for those seeking to understand the potential translational applications of burgeoning studies in human immunology, helping readers make sense of the existing and emerging scientific advances. The book grounds fundamental science in the translational realm, providing insights from world renowned researchers at the top of their game in their respective fields, in both industry and academic settings. Readers will gain an understanding of the rationale and mechanisms underlying current and emerging pharmacologic approaches for interventional immunology, the gaps therein, and new ideas for better and safer therapeutic approaches, and physicians will glean information about pharmacological limitations in altering disease progression and complications. This reference on the translational realization of the burgeoning findings in immunology provides a go-to reference for experienced professional clinicians, researchers, industry scientists, and those seeking more information on the field. Delivers comprehensive coverage of seminal human immunology discoveries and the resulting impact on therapeutic strategies Presents potential novel targets and approaches for clinical applications in organ specific and systemic autoimmunity, transplant rejection, cancer, and vaccine development Discusses lessons learned from successful and failed clinical trials with specific interventions, including pharmacological issues and limitations, and complications due to immunosuppression Provides information on new strategies and outstanding issues that should be addressed in future research

Download or read book Principles of Translational Science in Medicine written by Martin Wehling and published by Academic Press. This book was released on 2021-07-15 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Translational Science in Medicine: From Bench to Bedside, Third 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 number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields. Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization

Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Download or read book Advancing the Nation s Health Needs written by National Research Council and published by National Academies Press. This book was released on 2005-08-13 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report is the twelfth assessment of the National Institutes of Health National Research Service Awards program. The research training needs of the country in basic biomedical, clinical, and behavioral and social sciences are considered. Also included are the training needs of oral health, nursing, and health services research. The report has been broadly constructed to take into account the rapidly evolving national and international health care needs. The past and present are analyzed, and predictions with regard to future needs are presented.

Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.