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Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

Biomarkers, Diagnostics and Precision Medicine in the Drug Industry
  • Author : Abdel Halim
  • Publisher :Unknown
  • Release Date :2019-06-08
  • Total pages :294
  • ISBN : 9780128161227
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Summary : 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

Handbook of Biomarkers and Precision Medicine
  • Author : Claudio Carini,Mark Fidock,Alain van Gool
  • Publisher :Unknown
  • Release Date :2019-04-16
  • Total pages :631
  • ISBN : 9780429576737
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Summary : "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.

Predictive Biomarkers in Oncology

Predictive Biomarkers in Oncology
  • Author : Sunil Badve,George Louis Kumar
  • Publisher :Unknown
  • Release Date :2018-12-06
  • Total pages :642
  • ISBN : 9783319952284
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Summary : “Precision/personalized or stratified medicine” refers to the tailoring of medical treatment or drug administration to the individual characteristics of each patient treatment. It does not literally mean that a pharmaceutical company makes a drug for an individual patient for consumption and treatment but rather means the ability to stratify (or classify) individuals into sub-populations that differ in their responsiveness to a specific drug. A marker that provides information on the likely response to therapy, i.e., either in terms of tumor shrinkage or survival of the patient is termed “predictive biomarker”. Despite their promise in precision medicine and the explosion of knowledge in this area, there is not a single source on this subject that puts all this evidence together in a concise or richly illustrated and easy to understand manner. This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.

Precision Medicine

Precision Medicine
  • Author : Hans-Peter Deigner,Matthias Kohl
  • Publisher :Unknown
  • Release Date :2018-02-15
  • Total pages :374
  • ISBN : 9780128054338
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Summary : Precision Medicine: Tools and Quantitative Approaches discusses precision and personalized medicine, two relevant topics that are revolutionizing diagnostics and treatment, while also providing a shift toward prevention. The book covers the most relevant features and explanations underlying developments in the field. A timely review on prerequisites, causes and consequences is given. Unique to this book is a combined view on technical and data analysis aspects that is mandatory for obtaining and interpreting results. This book is a valuable source for researchers in medical and life sciences, physicians and students with an interest in this emerging field of precision medicine. Provides technological aspects in precision medicine with aspects of modern statistical and bioinformatics models and methods Brings timely reviews on status and chances in precision medicine and associated aspects of data analysis, statistics and data interpretation Encompasses easy access to relevant approaches, interactions and original literature

Information Resources in Toxicology

Information Resources in Toxicology
  • Author : Steve Gilbert,Asish Mohapatra,Sol Bobst,Antoinette Hayes,Sara T. Humes
  • Publisher :Unknown
  • Release Date :2020-05-16
  • Total pages :1054
  • ISBN : 9780128137253
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Summary : This new fifth edition of Information Resources in Toxicology offers a consolidated entry portal for the study, research, and practice of toxicology. Both volumes represents a unique, wide-ranging, curated, international, annotated bibliography, and directory of major resources in toxicology and allied fields such as environmental and occupational health, chemical safety, and risk assessment. The editors and authors are among the leaders of the profession sharing their cumulative wisdom in toxicology’s subdisciplines. This edition keeps pace with the digital world in directing and linking readers to relevant websites and other online tools. Due to the increasing size of the hardcopy publication, the current edition has been divided into two volumes to make it easier to handle and consult. Volume 1: Background, Resources, and Tools, arranged in 5 parts, begins with chapters on the science of toxicology, its history, and informatics framework in Part 1. Part 2 continues with chapters organized by more specific subject such as cancer, clinical toxicology, genetic toxicology, etc. The categorization of chapters by resource format, for example, journals and newsletters, technical reports, organizations constitutes Part 3. Part 4 further considers toxicology’s presence via the Internet, databases, and software tools. Among the miscellaneous topics in the concluding Part 5 are laws and regulations, professional education, grants and funding, and patents. Volume 2: The Global Arena offers contributed chapters focusing on the toxicology contributions of over 40 countries, followed by a glossary of toxicological terms and an appendix of popular quotations related to the field. The book, offered in both print and electronic formats, is carefully structured, indexed, and cross-referenced to enable users to easily find answers to their questions or serendipitously locate useful knowledge they were not originally aware they needed. Among the many timely topics receiving increased emphasis are disaster preparedness, nanotechnology, -omics, risk assessment, societal implications such as ethics and the precautionary principle, climate change, and children’s environmental health. Introductory chapters provide a backdrop to the science of toxicology, its history, the origin and status of toxicoinformatics, and starting points for identifying resources. Offers an extensive array of chapters organized by subject, each highlighting resources such as journals, databases,organizations, and review articles. Includes chapters with an emphasis on format such as government reports, general interest publications, blogs, and audiovisuals. Explores recent internet trends, web-based databases, and software tools in a section on the online environment. Concludes with a miscellany of special topics such as laws and regulations, chemical hazard communication resources, careers and professional education, K-12 resources, funding, poison control centers, and patents. Paired with Volume Two, which focuses on global resources, this set offers the most comprehensive compendium of print, digital, and organizational resources in the toxicological sciences with over 120 chapters contributions by experts and leaders in the field.

Textbook of Personalized Medicine

Textbook of Personalized Medicine
  • Author : Kewal K. Jain
  • Publisher :Unknown
  • Release Date :2020-12-05
  • Total pages :744
  • ISBN : 9783030620806
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Summary : This book is for personalized medicine as a prescription of specific treatments and therapeutics best suited for an individual and considers genetic as well as environmental factors that influence responses to therapy. Best approaches are described for integration of all available technologies for optimizing the therapy of individual patients. This comprehensive third edition covers the latest advances in personalized medicine and several chapters are devoted to various specialties, particulary cancer which is the largest area of application. The book discusses the development of personalized medicine and various players in it such as companies, academic institutions, the government, and the public as the consumer of healthcare. Additionally, the roles of bioinformatics, electronic health records, and digital technologies for personalized medicine are discussed. Textbook of Personalized Medicine, 3rd Edition serves as a convenient source of information for students at many levels and in a wide range of fields, including physicians, scientists, and decision makers in the biopharmaceutical and healthcare industries.

Companion and Complementary Diagnostics

Companion and Complementary Diagnostics
  • Author : Jan Trøst Jørgensen
  • Publisher :Unknown
  • Release Date :2019-05-08
  • Total pages :508
  • ISBN : 9780128135402
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Summary : 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

Advancing the Science of Cancer in Latinos

Advancing the Science of Cancer in Latinos
  • Author : Amelie G. Ramirez,Edward J. Trapido
  • Publisher :Unknown
  • Release Date :2019-11-21
  • Total pages :329
  • ISBN : 9783030292867
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Summary : 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. EnvironmentBreast cancer risk and mortality in women of Latin American originDifferential cancer risk in Latinos: The role of dietOvercoming barriers for Latinos on cancer clinical trialsEs tiempo: Engaging Latinas in cervical cancer researchEmerging 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 Cancers and Non-Communicable Diseases

Precision Medicine in Cancers and Non-Communicable Diseases
  • Author : Debmalya Barh
  • Publisher :Unknown
  • Release Date :2018-09-03
  • Total pages :326
  • ISBN : 9781498775625
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Summary : The availability of human genome, large amount of data on individual genetic variations, environmental interactions, influence of lifestyle, and cutting-edge tools and technologies for big-data analysis have led to the era of clinical practice of "Precision Medicine". This book aims to provide a readily available resource on all the important developments achieved so far in the field of oncology. All recent developments have been explained along with epidemiology, technologies and approaches to manage the included diseases. Therefore, readers will get the up to date information on the next-generation approach in tackling all kinds of cancer. Key Features • Presents the latest trend of cancer management based on precision/predictive medicine approach • Reviews the latest and up to date literature in the field of Precision Medicine • Highlights the next generation approach in tackling malignant diseases • Discusses how a life-threatening disease like cancer can be managed with the help of Precision Medicine • Encapsulates a global prospective

Progress and Challenges in Precision Medicine

Progress and Challenges in Precision Medicine
  • Author : Mukesh Verma,Debmalya Barh
  • Publisher :Unknown
  • Release Date :2016-12-22
  • Total pages :344
  • ISBN : 9780128095027
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Summary : Progress and Challenges in Precision Medicine presents an insightful overview to the myriad factors of personalized and precision medicine. The availability of the human genome, large amounts of data on individual genetic variations, environmental interactions, influence of lifestyle, and cutting-edge tools and technologies for big-data analysis have led to the age of personalized and precision medicine. Bringing together a global range of experts on precision medicine, this book collects previously scattered information into one concise volume which covers the most important developments so far in precision medicine and also suggests the most likely avenues for future development. The book includes clinical information, informatics, public policy implications, and information on case studies. It is a useful reference and background work for students, researchers, and clinicians working in the biomedical and medical fields, as well as policymakers in the health sciences. Provides an overview of the growing field of precision medicine Contains chapters from geographically diverse experts in their field Explores important aspects of precision medicine, including applications, ethics, and development

Companion Diagnostics (CDx) in Precision Medicine

Companion Diagnostics (CDx) in Precision Medicine
  • Author : Il-Jin Kim
  • Publisher :Unknown
  • Release Date :2019-03-06
  • Total pages :256
  • ISBN : 9781000007213
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Summary : 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.

Progress and Challenges in Precision Medicine

Progress and Challenges in Precision Medicine
  • Author : Mukesh Verma,Debmalya Barh
  • Publisher :Unknown
  • Release Date :2016-12-22
  • Total pages :344
  • ISBN : 9780128095027
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Summary : Progress and Challenges in Precision Medicine presents an insightful overview to the myriad factors of personalized and precision medicine. The availability of the human genome, large amounts of data on individual genetic variations, environmental interactions, influence of lifestyle, and cutting-edge tools and technologies for big-data analysis have led to the age of personalized and precision medicine. Bringing together a global range of experts on precision medicine, this book collects previously scattered information into one concise volume which covers the most important developments so far in precision medicine and also suggests the most likely avenues for future development. The book includes clinical information, informatics, public policy implications, and information on case studies. It is a useful reference and background work for students, researchers, and clinicians working in the biomedical and medical fields, as well as policymakers in the health sciences. Provides an overview of the growing field of precision medicine Contains chapters from geographically diverse experts in their field Explores important aspects of precision medicine, including applications, ethics, and development

Pharmacoepigenetics

Pharmacoepigenetics
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2019-06-04
  • Total pages :983
  • ISBN : 9780128139400
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Summary : Pharmacoepigenetics, Volume Eleven provides a comprehensive volume on the role of epigenetics and epigenomics in drug discovery and development, providing a detailed, but accessible, view of the field, from basic principles, to applications in disease therapeutics. Leading international researchers from across academia, clinical settings and the pharmaceutical industry discuss the influence of epigenetics and epigenomics in human pathology, epigenetic biomarkers for disease prediction, diagnosis, and treatment, current epigenetic drugs, and the application of epigenetic procedures in drug development. Throughout the book, chapter authors offer a balanced and objective discussion of the future of pharmacoepigenetics and its crucial contribution to the growth of precision and personalized medicine. Fully examines the influence of epigenetics and epigenomics in human pathology, epigenetic biomarkers for disease prediction, diagnosis, treatment, current epigenetic drugs and the application of epigenetic procedures in drug development Features chapter contributions from leading international researchers in academia, clinical settings and the pharmaceutical industry Instructs researchers, students and clinicians on how to better interpret and employ pharmacoepigenetics in drug development, efficiency and safety Provides a balanced and objective discussion of the future of pharmacoepigenetics and its crucial role in precision medicine

Economic Dimensions of Personalized and Precision Medicine

Economic Dimensions of Personalized and Precision Medicine
  • Author : Ernst R. Berndt
  • Publisher :Unknown
  • Release Date :2019-04-22
  • Total pages :392
  • ISBN : 9780226611068
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Summary : 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.

Biomarker Analysis in Clinical Trials with R

Biomarker Analysis in Clinical Trials with R
  • Author : Nusrat Rabbee
  • Publisher :Unknown
  • Release Date :2020-03-11
  • Total pages :204
  • ISBN : 9780429766800
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Summary : The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc. Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers. Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.

Molecular Diagnostics

Molecular Diagnostics
  • Author : Jan Trost Jorgensen,Henrik Winther
  • Publisher :Unknown
  • Release Date :2019-05-08
  • Total pages :352
  • ISBN : 9789814241458
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Summary : This unique book provides a thorough overview of developing molecular cancer diagnostic assays, which are the prerequisites for optimal solutions within personalized cancer medicine. The book takes the reader through definitions of the pharmacodiagnostic concept, historical perspectives of the early steps into molecular cancer diagnostics linked to therapy, the basis of different diagnostic molecular techniques, ongoing research, drug-diagnostic co-development, assay validation, clinical trial methodology, regulatory issues around pharmacodiagnostics and future aspects within personalized cancer medicine.

Biomarker Tests for Molecularly Targeted Therapies

Biomarker Tests for Molecularly Targeted Therapies
  • Author : National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Health Care Services,Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies
  • Publisher :Unknown
  • Release Date :2016-07-30
  • Total pages :292
  • ISBN : 9780309381345
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Summary : Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic basis of disease, health care providers increasingly have access to advanced technologies that may identify molecular variations specific to an individual patient, which subsequently can be targeted for treatment. Known as biomarker tests for molecularly targeted therapies, these complex tests have the potential to enable the selection of the most beneficial treatment (and also to identify treatments that may be harmful or ineffective) for the molecular underpinnings of an individual patient's disease. Such tests are key to unlocking the promise of precision medicine. Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice. Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making. Biomarker Tests of Molecularly Targeted Therapies examines opportunities for and challenges to the use of biomarker tests to select optimal therapy and offers recommendations to accelerate progress in this field. This report explores regulatory issues, reimbursement issues, and clinical practice issues related to the clinical development and use of biomarker tests for targeting therapies to patients. Properly validated, appropriately implemented biomarker tests hold the potential to enhance patient care and improve outcomes, and therefore addressing the challenges facing such tests is critical.

Toward Precision Medicine

Toward Precision Medicine
  • Author : National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Committee on A Framework for Developing a New Taxonomy of Disease
  • Publisher :Unknown
  • Release Date :2012-01-16
  • Total pages :142
  • ISBN : 9780309222228
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Summary : Motivated by the explosion of molecular data on humans-particularly data associated with individual patients-and the sense that there are large, as-yet-untapped opportunities to use this data to improve health outcomes, Toward Precision Medicine explores the feasibility and need for "a new taxonomy of human disease based on molecular biology" and develops a potential framework for creating one. The book says that a new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment. The "new taxonomy" that emerges would define diseases by their underlying molecular causes and other factors in addition to their traditional physical signs and symptoms. The book adds that the new data network could also improve biomedical research by enabling scientists to access patients' information during treatment while still protecting their rights. This would allow the marriage of molecular research and clinical data at the point of care, as opposed to research information continuing to reside primarily in academia. Toward Precision Medicine notes that moving toward individualized medicine requires that researchers and health care providers have access to very large sets of health- and disease-related data linked to individual patients. These data are also critical for developing the information commons, the knowledge network of disease, and ultimately the new taxonomy.

Cancer Biomarkers

Cancer Biomarkers
  • Author : Debmalya Barh,Angelo Carpi,Mukesh Verma,Mehmet Gunduz
  • Publisher :Unknown
  • Release Date :2014-01-30
  • Total pages :951
  • ISBN : 9781466584280
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Summary : Gleaning information from more than 100 experts in the field of cancer diagnosis, prognosis, and therapy worldwide, Cancer Biomarkers: Non-Invasive Early Diagnosis and Prognosis determines the significance of clinical validation approaches for several markers. This book examines the use of noninvasive or minimally invasive molecular cancer markers that are under development or currently in use. It deals with a majority of commonly prevalent cancers and can help anyone working in the health-care industry to recommend or develop early diagnostics, at-risk tests, and prognostic biomarkers for various cancers. It explores the practice of determining biomarkers by their characteristics and relative methodologies, and presents the most recent data as well as a number of current and upcoming early diagnostic noninvasive molecular markers for many common cancers. It also considers the sensitivity and specificity of markers, biomarker market, test providers, and patent information. Approximately 30-35 Cancer Specific Noninvasive Molecular Diagnostic Markers in a Single Volume The book details the general and technical aspects of noninvasive cancer markers. It covers imaging, cutting-edge molecular technologies for biomarker development, and noninvasive or minimally invasive sources of molecular markers, as well as quality control and ethical issues in cancer biomarker discovery. It also provides a detailed account of brain, head and neck, and oral cancer markers, and provides information on a number of gastrointestinal cancers, lung cancer, and mesothelioma markers. Emphasizes the Importance of Volatile Markers in Early Cancer Diagnosis Presents noninvasive early molecular markers in urological cancers Describes gynecological and endocrine cancer markers Details noninvasive markers of breast, ovarian, cervical, and thyroid cancers Addresses hematological malignancies Contains information on noninvasive molecular markers in myelodysplastic syndromes, acute myeloid leukemia, Hodgkin’s lymphoma, and multiple myeloma Provides comprehensive information on diagnostic and prognostic biomarkers in cutaneous melanoma This text considers molecular technologies for biomarker development, noninvasive or minimally invasive sources of molecular markers, and quality control and ethical issues in cancer biomarker discovery.

Biomarkers in Drug Development

Biomarkers in Drug Development
  • Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
  • Publisher :Unknown
  • Release Date :2011-09-20
  • Total pages :784
  • ISBN : 9781118210420
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Summary : Discover how biomarkers can boost the success rate of drugdevelopment efforts As pharmaceutical companies struggle to improve the success rateand cost-effectiveness of the drug development process, biomarkershave emerged as a valuable tool. This book synthesizes and reviewsthe latest efforts to identify, develop, and integrate biomarkersas a key strategy in translational medicine and the drugdevelopment process. Filled with case studies, the bookdemonstrates how biomarkers can improve drug development timelines,lower costs, facilitate better compound selection, reducelate-stage attrition, and open the door to personalizedmedicine. Biomarkers in Drug Development is divided into eightparts: Part One offers an overview of biomarkers and their role in drugdevelopment. Part Two highlights important technologies to help researchersidentify new biomarkers. Part Three examines the characterization and validation processfor both drugs and diagnostics, and provides practical advice onappropriate statistical methods to ensure that biomarkers fulfilltheir intended purpose. Parts Four through Six examine the application of biomarkers indiscovery, preclinical safety assessment, clinical trials, andtranslational medicine. Part Seven focuses on lessons learned and the practical aspectsof implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including dataintegration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or moreleading experts, including scientists from biotechnology andpharmaceutical firms, academia, and the U.S. Food and DrugAdministration. Their contributions offer pharmaceutical andclinical researchers the most up-to-date understanding of thestrategies used for and applications of biomarkers in drugdevelopment.

Precision Medicine in Oncology

Precision Medicine in Oncology
  • Author : Bulent Aydogan,James A. Radosevich
  • Publisher :Unknown
  • Release Date :2020-08-11
  • Total pages :288
  • ISBN : 9781119432494
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Summary : 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.