Genomic Biomarkers for Pharmaceutical Development

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

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  • Author : Yihong Yao
  • Publisher : Academic Press
  • Pages : 208 pages
  • ISBN : 0123977940
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Yihong Yao,Bahija Jallal,Koustubh Ranade
  • Publisher : Academic Press
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Elizabeth Mambo,Anna E. Szafranska-Schwarzbach,Gary Latham,Alex Adai,Annette Schlageter,Bernard Andruss
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Joseph R. Arron,Jeffrey M. Harris
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Yuping Wang,Jurgen Borlak,Weida Tong
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Biomarkers in Drug Development

Biomarkers in Drug Development
  • Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOKBiomarkers in Drug Development

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

The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
  • Author : Federico Goodsaid,William B. Mattes
  • Publisher : Academic Press
  • Release : 16 July 2013
GET THIS BOOKThe Path from Biomarker Discovery to Regulatory Qualification

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—

Genomics in Drug Discovery and Development

Genomics in Drug Discovery and Development
  • Author : Dimitri Semizarov,Eric Blomme
  • Publisher : John Wiley & Sons
  • Release : 03 November 2008
GET THIS BOOKGenomics in Drug Discovery and Development

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

Role of Biomarkers in Medicine

Role of Biomarkers in Medicine
  • Author : Mu Wang,Frank Witzmann
  • Publisher : BoD – Books on Demand
  • Release : 17 August 2016
GET THIS BOOKRole of Biomarkers in Medicine

The use of biomarkers in basic and clinical research has become routine in many areas of medicine. They are accepted as molecular signatures that have been well characterized and repeatedly shown to be capable of predicting relevant disease states or clinical outcomes. In Role of Biomarkers in Medicine, expert researchers in their individual field have reviewed many biomarkers or potential biomarkers in various types of diseases. The topics address numerous aspects of medicine, demonstrating the current conceptual status of biomarkers

Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release : 20 August 2009
GET THIS BOOKAccelerating the Development of Biomarkers for Drug Safety

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for

Biomarkers in Toxicology

Biomarkers in Toxicology
  • Author : Ramesh C. Gupta
  • Publisher : Academic Press
  • Release : 13 February 2019
GET THIS BOOKBiomarkers in Toxicology

Biomarkers in Toxicology, Second Edition, is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This revised and completely updated edition includes both vertebrate and non-vertebrate species models for toxicological testing and the development of biomarkers. Divided into several key sections, this reference volume contains new chapters devoted to topics in microplastics, neuroimmunotoxicity and nutraceuticals, along with a look at the latest cutting-edge technologies used to detect

Genomic and Personalized Medicine

Genomic and Personalized Medicine
  • Author : Anonim
  • Publisher : Academic Press
  • Release : 30 October 2012
GET THIS BOOKGenomic and Personalized Medicine

Genomic and Personalized Medicine, Second Edition — winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — is a major discussion of the structure, history, and applications of the field, as it emerges from the campus and lab into clinical action. As with the first edition, leading experts review the development of the new science, the current opportunities for genome-based analysis in healthcare, and the potential of genomic medicine in future healthcare. The inclusion of the latest information on diagnostic

Precision Medicine

Precision Medicine
  • Author : Hans-Peter Deigner,Matthias Kohl
  • Publisher : Academic Press
  • Release : 15 February 2018
GET THIS BOOKPrecision Medicine

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

Development and Application of Biomarkers

Development and Application of Biomarkers
  • Author : Roger L. Lundblad
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKDevelopment and Application of Biomarkers

First introduced to biomedical research in 1980, the term biomarker has taken on a life of its own in recent years and has come to mean a number of things. In biomedical science, biomarker has evolved to most commonly mean a characteristic that can be used either as a diagnostic or a prognostic, but most significantly as a screening indicator for pathologies that tend to be somewhat silent prior to overt clinical display. Applying scientific rigor, as well as a disciplined