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Genomic Biomarkers For Pharmaceutical Development

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Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Yihong Yao,Bahija Jallal,Koustubh Ranade
Publisher : Academic Press
Release : 2013-07-16
ISBN : 0123977940
Language : En, Es, Fr & De

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Book Description :

Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters written by international authorities in industry and academia, this work is a truly unique presentation of the thoughts and approaches that lead to the development of personalized medicine. Intended for all those involved in clinical translational research, this book is the ideal resource for scientists searching for the applications, strategies and successful approaches of translational science in pharmaceutical development. Provides case studies in applications of pharmacodynamic and predictive markers in drug development in oncology, autoimmunity, respiratory diseases and infectious diseases Shows how to identify potential new therapeutic targets in different diseases and provides examples of potential new disease indications for life cycle management of drugs Authored by leading international experts from industry and academia

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 0128063564
Language : En, Es, Fr & De

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Book Description :

This chapter presents the processes required for the translation of a biomarker discovery from the research laboratory into a validated diagnostic for clinical application. To fully investigate the topic of assay validation, a brief review of the current regulatory guidance will be discussed, and thereafter this is used as the framework for topics surrounding assay validation. The time-sensitive stages in the assay development process and agreement with clinical development timelines are critical to delivering a viable clinic-ready assay. Methods to best maneuver this are presented to help emphasize the necessary level of validation for use of an assay in a clinical setting. Each pertinent stage is then described, and key focus areas are highlighted. For certain stages of the development process, such as cut-point determination, multiple vs. single analyte, classifier training/testing, and precision determination, various statistical arguments are presented to illustrate common misconceptions or potential pitfalls.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Yuping Wang,Jurgen Borlak,Weida Tong
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 0128063556
Language : En, Es, Fr & De

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Book Description :

Although we have seen increased spending on drug research and development, the submission of new drug applications to the US Food and Drug Administration (FDA) has steadily decreased over the past 15 years. Meanwhile, toxicology is celebrating the ten-year anniversary of the introduction of toxicogenomics, a field that was anticipated to change our way of conducting toxicology with enhanced safety assessment. Despite the excitement, and a decade of further technical advancement, the anticipated benefits have been slow to reach the clinical bedside. The failure to translate toxicogenomics to drug development faster, illustrates the need for further innovations in its methodology as well as in its technology. This review introduces the concept of toxicogenomics, summarizes the prominent applications of this relatively young discipline in drug development, and provides a future perspective of advancement in this field.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Nicholas C. Dracopoli,Katie Streicher
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 0128063513
Language : En, Es, Fr & De

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Book Description :

The goal of personalized healthcare in the treatment of cancer is to reduce the attrition of novel oncology drugs and improve patient outcomes. The discovery and application of novel biomarkers is essential for the successful implementation of personalized healthcare for cancer patients. This chapter focuses on the types of biomarkers that can be utilized clinically to guide treatment decisions in multiple cancer indications, including pharmacodynamic, predictive, prognostic, resistance, and surrogate biomarkers. Furthermore, multiple distinct examples highlight how the successful implementation of these biomarkers into clinical practice has benefited particular subsets of patients. Although these successful examples represent important first steps in using simple biomarkers to predict patient response, significant challenges still exist in prospectively identifying or co-developing biomarkers as companion diagnostics. The roles next generation sequencing and innovative biomarker-driven clinical trial design may play in overcoming these challenges are discussed.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 0128063521
Language : En, Es, Fr & De

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Book Description :

Autoimmune diseases constitute a wide range of mostly complex and multifactorial disorders that are difficult to treat. Increasing insight in the pathogenesis of autoimmune diseases has led to development of targeted therapies aimed at regulating key components of the disease pathways. In particular, the advent of biologic therapeutics has led to significant advances in the treatment of autoimmune diseases. However, the multifactorial nature of the different clinical entities, reflected by the uniqueness of an individual’s genetic make-up and environmental factors, create a high degree of molecular and clinical heterogeneity within a clinically defined disease. Consequently, targeted therapies are not efficacious for all patients diagnosed with such a disease, and selection of therapies is still conducted on a trial-and-error basis. With the rapid advances in modern genomics and genetics technology, there has been some encouraging progress made in the last several years in developing genomic biomarkers as pharmacodynamics markers to evaluate target neutralization for dose selection in pivotal trials, and to identify and evaluate potential predictive markers for efficacy in targeted therapies. This chapter provides highlights and case studies in this field.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 0128063505
Language : En, Es, Fr & De

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Book Description :

Despite the large and ever-growing investment in pharmaceutical R&D, the number of innovative new medicines that meet significant unmet medical needs has been stagnant, if not declining. There are many potential reasons for this low return on pharmaceutical R&D investment, but one likely cause is the low probability of the success of clinical trials, particularly in early clinical development. Translational science, which we define as identifying the ‘right’ patient for the ‘right’ drug at the ‘right’ dose, promises to improve not only the odds of success of clinical development, but perhaps more importantly, to get the right drug to the right patient, thereby sparing those patients who may be less likely to benefit from a new therapeutic. We believe that this goal can be achieved by putting the patient first, i.e., by investing in understanding of disease heterogeneity at the molecular level, and then tailoring new therapeutics to subsets of patients. Using examples from the literature and our own experience, we describe current and emerging translational approaches that employ genomic and genetic methods in the areas of cancer, inflammation, and metabolic and infectious disease to this end. We use simple simulations to demonstrate how such translational strategies can significantly reduce the size of clinical trials or increase the likelihood of success of early phase trials. We end by discussing genomic approaches to understand adverse drug reactions.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Elizabeth Mambo,Anna E. Szafranska-Schwarzbach,Gary Latham,Alex Adai,Annette Schlageter,Bernard Andruss
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 0128063548
Language : En, Es, Fr & De

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Book Description :

The focus of this chapter is on the development of miRNA diagnostics and the process for miRNA biomarker development. We discuss pancreatic cancer as a model for the application of miRNA-based tests in different clinical biopsy specimen types. Asuragen’s miRInform® Pancreas test illustrates the development of a laboratory developed test (LDT) that was validated in compliance with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) regulations. We provide an overview of work on miRNA-based signatures which is focused on resolving clinical dilemmas in solid and cystic pancreatic lesions. We also review some of the promising miRNA candidates identified in biofluids from other cancer types. These studies highlight the emergence of miRNA-based diagnostic tools which have the potential to impact the clinical management of cancer by guiding early diagnosis, aiding in the assessment of patients’ prognosis, and enabling the identification of novel, more effective therapeutic targets.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development Book
Author : Joseph R. Arron,Jeffrey M. Harris
Publisher : Elsevier Inc. Chapters
Release : 2013-07-16
ISBN : 012806353X
Language : En, Es, Fr & De

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Book Description :

Asthma is a heterogeneous disorder on molecular, cellular, physiological, and clinical levels, but there is a lack of consensus on how discrete subtypes of asthma should be defined. Gene expression profiling of bronchial samples from asthma patients and healthy controls has enabled the definition of molecular subtypes of asthma which correspond to distinct pathophysiological features. Genomic data from bronchial samples has been used to identify non-invasive biomarkers such as serum periostin, fractional exhaled nitric oxide (FeNO), and blood eosinophil counts which correspond to these molecular subtypes. These biomarkers have been used in recent proof-of-concept clinical trials of investigational biologic therapies directed at the type 2 cytokines interleukin (IL) 5 and 13 to stratify patients according to the activity of the targeted pathways, enabling the enrichment of subsets of patients most likely to show clinical benefit from those interventions. However, translating these biomarkers into companion diagnostic tests subject to regulatory approval will be a complex process, and intriguing initial findings must be verified prospectively in pivotal clinical trials.

Biomarkers in Drug Discovery and Development

Biomarkers in Drug Discovery and Development Book
Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
Publisher : John Wiley & Sons
Release : 2020-03-17
ISBN : 1119187508
Language : En, Es, Fr & De

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Book Description :

This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. • Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine • Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory • Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring • Includes case studies of biomarkers that have helped and hindered decision making • Reviews of the first edition: “If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and “…provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation.” (ChemMedChem)

Genomics in Drug Discovery and Development

Genomics in Drug Discovery and Development Book
Author : Dimitri Semizarov,Eric Blomme
Publisher : John Wiley & Sons
Release : 2008-11-03
ISBN : 0470409762
Language : En, Es, Fr & De

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Book Description :

Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine Book
Author : Claudio Carini,Mark Fidock,Alain van Gool
Publisher : CRC Press
Release : 2019-04-16
ISBN : 0429576730
Language : En, Es, Fr & De

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Book Description :

"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.

The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification Book
Author : Federico Goodsaid,William B. Mattes
Publisher : Academic Press
Release : 2013-07-16
ISBN : 0123944082
Language : En, Es, Fr & De

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Book Description :

The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities.

Surrogate Endpoints in Medicine

Surrogate Endpoints in Medicine Book
Author : John A. Wagner
Publisher : IOS Press
Release : 2002-05
ISBN : 9781586032470
Language : En, Es, Fr & De

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Book Description :

A review of the use of surrogate endpoints and biomarkers in drug development, validation and qualification of biomarkers, pharmacogenic biomarkers, and novel approaches to biomarker discovery. It also discusses specific biomarkers including QTc prolongation and biomarkers of early stage cancer.

Statistical Methods in Biomarker and Early Clinical Development

Statistical Methods in Biomarker and Early Clinical Development Book
Author : Liang Fang,Cheng Su
Publisher : Springer Nature
Release : 2020-02-24
ISBN : 3030315037
Language : En, Es, Fr & De

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Book Description :

This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.

Genomic and Personalized Medicine

Genomic and Personalized Medicine Book
Author : Anonim
Publisher : Academic Press
Release : 2008-11-11
ISBN : 9780080919034
Language : En, Es, Fr & De

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Book Description :

This two-volume set — winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — provides an in-depth look at one of the most promising avenues for advances in the diagnosis, prevention and treatment of human disease. The inclusion of the latest information on diagnostic testing, population screening, predicting disease susceptibility, pharmacogenomics and more presents this book as an essential tool for both students and specialists across many biological and medical disciplines, including human genetics and genomics, oncology, neuroscience, cardiology, infectious disease, molecular medicine, and biomedical science, as well as health policy disciplines focusing on ethical, legal, regulatory and economic aspects of genomics and medicine. Volume One Includes: Principles, Methodology and Translational Approaches, takes readers on the journey from principles of human genomics to technology, informatic and computational platforms for genomic medicine, as well as strategies for translating genomic discoveries into advances in personalized clinical care. Volume Two Includes: Genome Discoveries and Clinical Applications presents the latest developments in disease-based genomic and personalized medicine. With chapters dedicated to cardiovascular disease, oncology, inflammatory disease, metabolic disease, neuropsychiatric disease, and infectious disease, this work provides the most comprehensive guide to the principles and practice of genomic and personalized medicine. Highly Commended 2013 BMA Medical Book Award for Medicine Contributions from leaders in the field provide unparalleled insight into current technologies and applications in clinical medicine. Full colour throughout enhances the utility of this work as the only available comprehensive reference for genomic and personalized medicine. Discusses scientific foundations and practical applications of new discoveries, as well as ethical, legal/regulatory, and social issues related to the practice of genomic medicine.

Toxicologic Biomarkers

Toxicologic Biomarkers Book
Author : Anthony P. DeCaprio
Publisher : CRC Press
Release : 2006-04-18
ISBN : 0824723511
Language : En, Es, Fr & De

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Book Description :

Responding to the explosion of advances in the use of biomarkers to efficiently, rapidly, and economically evaluate the health effects of chemical entities, this authoritative reference provides a detailed overview of the theory, development, and practical application of biomarkers in the toxicological, environmental, forensic, and pharmaceutical sciences. Compiling the most recent studies on the generation and utilization of biomarkers for toxicant exposure, environmental and human health risk assessment, occupational safety, drug development, and the detection of biological and chemical warfare agents, this guide supplies numerous examples, figures, tables, and comprehensive reference listings within each chapter to provide the reader with an in-depth understanding of the subject.

Predictive Approaches in Drug Discovery and Development

Predictive Approaches in Drug Discovery and Development Book
Author : J. Andrew Williams,Richard Lalonde,Jeffrey R. Koup,David D. Christ
Publisher : John Wiley & Sons
Release : 2012-04-10
ISBN : 0470170832
Language : En, Es, Fr & De

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Book Description :

Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

Cancer Genomics

Cancer Genomics Book
Author : Janet E. Dancey
Publisher : Elsevier Inc. Chapters
Release : 2013-11-21
ISBN : 0128061049
Language : En, Es, Fr & De

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Book Description :

Many hope that the promise that “omics” science holds for medicine will be realized through the development of better biomarkers for patient management. However, the development of omic technologies magnifies the issues and challenges of performing high quality biomarker studies. The complexity of these technologies and of the resulting high-dimensional data require rigorous technical, statistical, bioinformatics, laboratory, and clinical procedures to develop, evaluate and validate these tests. A number of considerations are key to the design and successful execution of genomic biomarker studies. These include the assessment of (1) the complexity and heterogeneity of cancer samples, (2) the quality and quantity of tumor specimens, (3) the potential bias inherent in the assays, (4) the availability of appropriatecontrols or standards, (5) technical validation of assays and bioinformatics analysis, and (6) the validity of the final interpretation of results. In this chapter, we review these key considerations required to design and conduct biomarker studies that will yield results that can confidently inform future clinical research and clinical practice.

Genomic medicine

Genomic medicine Book
Author : Great Britain: Parliament: House of Lords: Science and Technology Committee
Publisher : The Stationery Office
Release : 2009-07-07
ISBN : 9780108444500
Language : En, Es, Fr & De

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Book Description :

Volume 1 Report also available (ISBN 9780108444517). Genomic medicine has developed from the sequencing of the human genome

Genomic and Personalized Medicine

Genomic and Personalized Medicine Book
Author : Geoffrey S. Ginsburg,Huntington F. Willard
Publisher : Academic Press
Release : 2012-11-15
ISBN : 0123822270
Language : En, Es, Fr & De

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Book Description :

This two-volume set provides an in-depth look at one of the most promising avenues for advances in the diagnosis, prevention and treatment of human disease. The inclusion of the latest information on diagnostic testing, population screening, predicting disease susceptibility, pharmacogenomics and more presents this book as an essential tool for both students and specialists across many biological and medical disciplines, including human genetics and genomics, oncology, neuroscience, cardiology, infectious disease, molecular medicine, and biomedical science, as well as health policy disciplines focusing on ethical, legal, regulatory and economic aspects of genomics and medicine. Volume One Includes: Principles, Methodology and Translational Approaches, takes readers on the journey from principles of human genomics to technology, informatic and computational platforms for genomic medicine, as well as strategies for translating genomic discoveries into advances in personalized clinical care. Volume Two Includes: Genome Discoveries and Clinical Applications presents the latest developments in disease-based genomic and personalized medicine. With chapters dedicated to cardiovascular disease, oncology, inflammatory disease, metabolic disease, neuropsychiatric disease, and infectious disease, this work provides the most comprehensive guide to the principles and practice of genomic and personalized medicine. * Contributions from leaders in the field provide unparalleled insight into current technologies and applications in clinical medicine. * Full colour throughout enhances the utility of this work as the only available comprehensive reference for genomic and personalized medicine. * Discusses scientific foundations and practical applications of new discoveries, as well as ethical, legal/regulatory, and social issues related to the practice of genomic medicine.