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Companion Diagnostics (CDx) in Precision Medicine

Companion Diagnostics (CDx) in Precision Medicine
Author: Il-Jin Kim
Publisher: CRC Press
Total Pages: 256
Release: 2019-03-06
Genre: Computers
ISBN: 1000007219

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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

Companion Diagnostics (CDx) in Precision Medicine
Author: Il-Jin Kim
Publisher:
Total Pages:
Release: 2019
Genre: COMPUTERS
ISBN: 9781000000382

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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

Companion and Complementary Diagnostics
Author: Jan Trøst Jørgensen
Publisher: Academic Press
Total Pages: 508
Release: 2019-05-08
Genre: Medical
ISBN: 0128135409

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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

Biomarkers, Diagnostics and Precision Medicine in the Drug Industry
Author: Abdel Halim
Publisher: Academic Press
Total Pages: 294
Release: 2019-06-08
Genre: Medical
ISBN: 0128161221

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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


Precision Medicine and Companion Diagnostic Devices

Precision Medicine and Companion Diagnostic Devices
Author: Meijuan Li
Publisher: Chapman & Hall/CRC
Total Pages: 250
Release: 2018-08
Genre:
ISBN: 9781138033634

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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.


Economic Dimensions of Personalized and Precision Medicine

Economic Dimensions of Personalized and Precision Medicine
Author: Ernst R. Berndt
Publisher: University of Chicago Press
Total Pages: 361
Release: 2019-04-22
Genre: Business & Economics
ISBN: 022661123X

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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.


Immunotherapy – A Novel Facet of Modern Therapeutics

Immunotherapy – A Novel Facet of Modern Therapeutics
Author: Sujata P. Sawarkar
Publisher: Springer Nature
Total Pages: 267
Release: 2020-12-16
Genre: Medical
ISBN: 9811590389

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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

HER2-Positive Breast Cancer
Author: Sara Hurvitz
Publisher: Elsevier Health Sciences
Total Pages: 264
Release: 2018-07-26
Genre: Medical
ISBN: 0323581234

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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.


Advancing Healthcare Through Personalized Medicine

Advancing Healthcare Through Personalized Medicine
Author: Priya Hays
Publisher: Springer Nature
Total Pages: 755
Release: 2021-09-27
Genre: Medical
ISBN: 3030801004

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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.


Clinical Molecular Diagnostics

Clinical Molecular Diagnostics
Author: Shiyang Pan
Publisher: Springer Nature
Total Pages: 889
Release: 2021-07-08
Genre: Medical
ISBN: 9811610371

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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.