Companion Diagnostics (CDx) in Precision Medicine

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Author :
Publisher : CRC Press
ISBN 13 : 1000007219
Total Pages : 256 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Companion Diagnostics (CDx) in Precision Medicine by : Il-Jin Kim

Download or read book Companion Diagnostics (CDx) in Precision Medicine written by Il-Jin Kim and published by CRC Press. This book was released on 2019-03-06 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.

Companion Diagnostics (CDx) in Precision Medicine

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Publisher :
ISBN 13 : 9781000000382
Total Pages : pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Companion Diagnostics (CDx) in Precision Medicine by : Il-Jin Kim

Download or read book Companion Diagnostics (CDx) in Precision Medicine written by Il-Jin Kim and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.

Companion and Complementary Diagnostics

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Publisher : Academic Press
ISBN 13 : 0128135409
Total Pages : 508 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Companion and Complementary Diagnostics by : Jan Trøst Jørgensen

Download or read book Companion and Complementary Diagnostics written by Jan Trøst Jørgensen and published by Academic Press. This book was released on 2019-05-08 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. Covers all aspects, from biomarker discovery, to development and regulatory approval Explains the "how to" aspects of companion diagnostics Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

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Publisher : Academic Press
ISBN 13 : 0128161221
Total Pages : 294 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biomarkers, Diagnostics and Precision Medicine in the Drug Industry by : Abdel Halim

Download or read book Biomarkers, Diagnostics and Precision Medicine in the Drug Industry written by Abdel Halim and published by Academic Press. This book was released on 2019-06-08 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations

Handbook of Biomarkers and Precision Medicine

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Publisher : CRC Press
ISBN 13 : 0429574622
Total Pages : 1025 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Handbook of Biomarkers and Precision Medicine by : Claudio Carini

Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 1025 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Economic Dimensions of Personalized and Precision Medicine

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Publisher : University of Chicago Press
ISBN 13 : 022661123X
Total Pages : 361 pages
Book Rating : 4.2/5 (266 download)

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Book Synopsis Economic Dimensions of Personalized and Precision Medicine by : Ernst R. Berndt

Download or read book Economic Dimensions of Personalized and Precision Medicine written by Ernst R. Berndt and published by University of Chicago Press. This book was released on 2019-04-22 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement of PPM is a challenge in traditional clinical, reimbursement, and regulatory landscapes because it is costly to develop and introduces a wide range of scientific, clinical, ethical, and socioeconomic issues. PPM raises a multitude of economic issues, including how information on accurate diagnosis and treatment success will be disseminated and who will bear the cost; changes to physician training to incorporate genetics, probability and statistics, and economic considerations; questions about whether the benefits of PPM will be confined to developed countries or will diffuse to emerging economies with less developed health care systems; the effects of patient heterogeneity on cost-effectiveness analysis; and opportunities for PPM’s growth beyond treatment of acute illness, such as prevention and reversal of chronic conditions. This volume explores the intersection of the scientific, clinical, and economic factors affecting the development of PPM, including its effects on the drug pipeline, on reimbursement of PPM diagnostics and treatments, and on funding of the requisite underlying research; and it examines recent empirical applications of PPM.

Precision Medicine and Companion Diagnostic Devices

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Publisher : Chapman & Hall/CRC
ISBN 13 : 9781138033634
Total Pages : 250 pages
Book Rating : 4.0/5 (336 download)

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Book Synopsis Precision Medicine and Companion Diagnostic Devices by : Meijuan Li

Download or read book Precision Medicine and Companion Diagnostic Devices written by Meijuan Li and published by Chapman & Hall/CRC. This book was released on 2018-08 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: A key component of personalized medicine is companion diagnostics that measure biomarkers e.g. protein expression, gene amplification or specific mutations. This will be the first book that covers (1) companion diagnostic device measurement performance, (2) companion diagnostic device clinical performance, (3) companion diagnostic device bridging study, (4) follow-on companion diagnostic device, and (5) the impact of companion diagnostic device measurement performance on clinical validation of personalized medicine.

Advancing Healthcare Through Personalized Medicine

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Publisher : Springer Nature
ISBN 13 : 3030801004
Total Pages : 755 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Advancing Healthcare Through Personalized Medicine by : Priya Hays

Download or read book Advancing Healthcare Through Personalized Medicine written by Priya Hays and published by Springer Nature. This book was released on 2021-09-27 with total page 755 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a unique perspective on the biomedical and societal implications of personalized medicine and how it helps to mitigate the healthcare crisis and rein in ever-growing expenditure. It introduces the reader to the underlying concepts at the heart of personalized medicine. An innovative second edition, this book functions as an update to the successful first edition to include new, state-of-the-art information and advancements in the fast-paced field of personalized medicine. Chapters examine pharmacogenomics, targeted therapies, individualized diagnosis and treatment, and cancer immunotherapies. The book also features an essential discussion on how the advent of genomic technologies gives clinicians the capability to predict and diagnose disease more efficiently and offers a detailed up-to-date compilation of clinical trials in cancer leading to breakthrough therapies. The book also addresses the impact of Big Data on personalized medicine and the newfound applications of digital health and artificial intelligence. A work that advocates for a patient-centered approach, Advancing Healthcare Through Personalized Medicine, Second Edition is an invaluable text for clinicians, healthcare providers, and patients.

Immunotherapy – A Novel Facet of Modern Therapeutics

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Publisher : Springer Nature
ISBN 13 : 9811590389
Total Pages : 267 pages
Book Rating : 4.8/5 (115 download)

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Book Synopsis Immunotherapy – A Novel Facet of Modern Therapeutics by : Sujata P. Sawarkar

Download or read book Immunotherapy – A Novel Facet of Modern Therapeutics written by Sujata P. Sawarkar and published by Springer Nature. This book was released on 2020-12-16 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates the significance and relevance of immunotherapy in modern-day therapeutics. Focusing on the application of immunotherapy in oncology, neurodegenerative and autoimmune diseases, it discusses the drug delivery systems, and pre-clinical and clinical methodologies for immunotherapy-based drugs. It also comprehensively reviews various aspects of immunotherapy, such as regulatory affairs, quality control, safety, and pharmacovigilance. Further, the book discusses the in vitro validation of therapeutic strategies prior to patient application and management of immunotherapy-related side effects and presents case studies demonstrating the design and development (pre-clinical to clinical) of immunotherapy for various diseases. It also describes various design considerations and the scale-up synthesis of immunotherapeutics and screening methods. Lastly, it explores the important aspect of cost-effectiveness and rational immunotherapy strategies.

HER2-Positive Breast Cancer

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Publisher : Elsevier Health Sciences
ISBN 13 : 0323581234
Total Pages : 264 pages
Book Rating : 4.3/5 (235 download)

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Book Synopsis HER2-Positive Breast Cancer by : Sara Hurvitz

Download or read book HER2-Positive Breast Cancer written by Sara Hurvitz and published by Elsevier Health Sciences. This book was released on 2018-07-26 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get a quick, expert overview of clinically-focused topics and guidelines that are relevant to testing for HER2, which contributes to approximately 25% of breast cancers today. This concise resource by Drs. Sara Hurvitz, and Kelly McCann consolidates today’s available information on this growing topic into one convenient resource, making it an ideal, easy-to-digest reference for practicing and trainee oncologists.

Clinical Molecular Diagnostics

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Publisher : Springer Nature
ISBN 13 : 9811610371
Total Pages : 889 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Clinical Molecular Diagnostics by : Shiyang Pan

Download or read book Clinical Molecular Diagnostics written by Shiyang Pan and published by Springer Nature. This book was released on 2021-07-08 with total page 889 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the discovery of molecular biomarkers, the development of laboratory testing techniques and their clinical applications, focusing on basic research to clinical practice. It introduces new and crucial knowledge and ethics of clinical molecular diagnosis. This book emphasizes the applications of clinical molecular diagnostic test on health management, especially from different diseased organs. It lets readers to understand and realize precision healthcare.

Advancing the Science of Cancer in Latinos

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Publisher : Springer Nature
ISBN 13 : 303029286X
Total Pages : 320 pages
Book Rating : 4.0/5 (32 download)

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Book Synopsis Advancing the Science of Cancer in Latinos by : Amelie G. Ramirez

Download or read book Advancing the Science of Cancer in Latinos written by Amelie G. Ramirez and published by Springer Nature. This book was released on 2019-11-21 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book gives an overview of the sessions, panel discussions, and outcomes of the Advancing the Science of Cancer in Latinos conference, held in February 2018 in San Antonio, Texas, USA, and hosted by the Mays Cancer Center and the Institute for Health Promotion Research at UT Health San Antonio. Latinos – the largest, youngest, and fastest-growing minority group in the United States – are expected to face a 142% rise in cancer cases in coming years. Although there has been substantial advancement in cancer prevention, screening, diagnosis, and treatment over the past few decades, addressing Latino cancer health disparities has not nearly kept pace with progress. The diverse and dynamic group of speakers and panelists brought together at the Advancing the Science of Cancer in Latinos conference provided in-depth insights as well as progress and actionable goals for Latino-focused basic science research, clinical best practices, community interventions, and what can be done by way of prevention, screening, diagnosis, and treatment of cancer in Latinos. These insights have been translated into the chapters included in this compendium; the chapters summarize the presentations and include current knowledge in the specific topic areas, identified gaps, and top priority areas for future cancer research in Latinos. Topics included among the chapters: Colorectal cancer disparities in Latinos: Genes vs. Environment Breast cancer risk and mortality in women of Latin American origin Differential cancer risk in Latinos: The role of diet Overcoming barriers for Latinos on cancer clinical trials Es tiempo: Engaging Latinas in cervical cancer research Emerging policies in U.S. health care Advancing the Science of Cancer in Latinos proves to be an indispensable resource offering key insights into actionable targets for basic science research, suggestions for clinical best practices and community interventions, and novel strategies and advocacy opportunities to reduce health disparities in Latino communities. It will find an engaged audience among researchers, academics, physicians and other healthcare professionals, patient advocates, students, and others with an interest in the broad field of Latino cancer.

Precision Medicine in Oncology

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Publisher : John Wiley & Sons
ISBN 13 : 1119432448
Total Pages : 288 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Precision Medicine in Oncology by : Bulent Aydogan

Download or read book Precision Medicine in Oncology written by Bulent Aydogan and published by John Wiley & Sons. This book was released on 2020-11-02 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: A FRESH EXAMINATION OF PRECISION MEDICINE'S INCREASINGLY PROMINENT ROLE IN THE FIELD OF ONCOLOGY Precision medicine takes into account each patient's specific characteristics and requirements to arrive at treatment plans that are optimized towards the best possible outcome. As the field of oncology continues to advance, this tailored approach is becoming more and more prevalent, channelling data on genomics, proteomics, metabolomics and other areas into new and innovative methods of practice. Precision Medicine in Oncology draws together the essential research driving the field forward, providing oncology clinicians and trainees alike with an illuminating overview of the technology and thinking behind the breakthroughs currently being made. Topics covered include: Biologically-guided radiation therapy Informatics for precision medicine Molecular imaging Biomarkers for treatment assessment Big data Nanoplatforms Casting a spotlight on this emerging knowledge base and its impact upon the management of tumors, Precision Medicine in Oncology opens up new possibilities and ways of working – not only for oncologists, but also for molecular biologists, radiologists, medical geneticists, and others.

The Drug Development Paradigm in Oncology

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Publisher : National Academies Press
ISBN 13 : 0309457971
Total Pages : 145 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Drug Development Paradigm in Oncology by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Oral Cancer

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Publisher : BoD – Books on Demand
ISBN 13 : 1789846706
Total Pages : 137 pages
Book Rating : 4.7/5 (898 download)

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Book Synopsis Oral Cancer by : Gokul Sridharan

Download or read book Oral Cancer written by Gokul Sridharan and published by BoD – Books on Demand. This book was released on 2022-01-07 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral cancer is a common disease with a high incidence of morbidity and mortality. Despite technological advancements in diagnosis and treatment, the five-year survival rate is low. Researchers worldwide are attempting to identify new and novel methods for early diagnosis and better treatment of oral cancer to improve survival rate and quality of life post recovery. This book examines current concepts in oral cancer and emphasizes future perspectives for diagnosis and treatment of disease for better clinical outcomes and patient care.

SEER Summary Staging Manual 2000

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Publisher :
ISBN 13 : 9780756714406
Total Pages : 293 pages
Book Rating : 4.7/5 (144 download)

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Book Synopsis SEER Summary Staging Manual 2000 by : National Cancer Institute (U.S.). Cancer Statistics Branch

Download or read book SEER Summary Staging Manual 2000 written by National Cancer Institute (U.S.). Cancer Statistics Branch and published by . This book was released on 2001-10 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the Surveill., Epidem., & End Results (SEER) Prog. based at the Nat. Cancer Inst. Intended as a coding manual beginning with cases diagnosed from Jan. 1, 2001 rather than a staging guide. Each anatomic site in the Topography Sect. of the Internat. Class. of Disease for Oncology -- 3rd Ed. (ICD-0-3) has a corresponding summary staging scheme. Certain specific histologic types also have specific staging schemes. In some cases, sites which previously had separate guides (such as the segments of the colon) have a single staging scheme (colon), whereas some sites which previously had a single guide (e.g., larynx) have separate schemes for each sub-site of the larynx.

MoneyBall Medicine

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Publisher : Taylor & Francis
ISBN 13 : 1351984330
Total Pages : 591 pages
Book Rating : 4.3/5 (519 download)

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Book Synopsis MoneyBall Medicine by : Harry Glorikian

Download or read book MoneyBall Medicine written by Harry Glorikian and published by Taylor & Francis. This book was released on 2017-11-20 with total page 591 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can a smartwatch help patients with diabetes manage their disease? Why can’t patients find out prices for surgeries and other procedures before they happen? How can researchers speed up the decade-long process of drug development? How will "Precision Medicine" impact patient care outside of cancer? What can doctors, hospitals, and health systems do to ensure they are maximizing high-value care? How can healthcare entrepreneurs find success in this data-driven market? A revolution is transforming the $10 trillion healthcare landscape, promising greater transparency, improved efficiency, and new ways of delivering care. This new landscape presents tremendous opportunity for those who are ready to embrace the data-driven reality. Having the right data and knowing how to use it will be the key to success in the healthcare market in the future. We are already starting to see the impacts in drug development, precision medicine, and how patients with rare diseases are diagnosed and treated. Startups are launched every week to fill an unmet need and address the current problems in the healthcare system. Digital devices and artificial intelligence are helping doctors do their jobs faster and with more accuracy. MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market, which includes interviews with dozens of healthcare leaders, describes the business challenges and opportunities arising for those working in one of the most vibrant sectors of the world’s economy. Doctors, hospital administrators, health information technology directors, and entrepreneurs need to adapt to the changes effecting healthcare today in order to succeed in the new, cost-conscious and value-based environment of the future. The authors map out many of the changes taking place, describe how they are impacting everyone from patients to researchers to insurers, and outline some predictions for the healthcare industry in the years to come.