Genomic Biomarkers for Pharmaceutical Development Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Yihong Yao
  • Publisher : Unknown
  • Release Date : 2013-08-14
  • Genre: Medical
  • Pages : 190
  • ISBN 10 : 0123973368

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Yihong Yao
  • Publisher : Academic Press
  • Release Date : 2013-07-16
  • Genre: Science
  • Pages : 208
  • ISBN 10 : 9780123977946

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Yuping Wang
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063552

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Nicholas C. Dracopoli
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063514

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Philip Brohawn
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063569

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Joseph R. Arron
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063538

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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.

Genomic Biomarkers for Pharmaceutical Development Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Koustubh Ranade
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063507

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Elizabeth Mambo
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063545

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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 Book

Genomic Biomarkers for Pharmaceutical Development


  • Author : Cornelis L. Verweij
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-07-16
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128063521

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Genomic Biomarkers for Pharmaceutical Development Excerpt :

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.

Biomarkers in Drug Discovery and Development Book

Biomarkers in Drug Discovery and Development


  • Author : Ramin Rahbari
  • Publisher : John Wiley & Sons
  • Release Date : 2020-03-24
  • Genre: Medical
  • Pages : 620
  • ISBN 10 : 9781119187509

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Biomarkers in Drug Discovery and Development Excerpt :

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 Book

Genomics in Drug Discovery and Development


  • Author : Dimitri Semizarov
  • Publisher : John Wiley & Sons
  • Release Date : 2008-11-03
  • Genre: Medical
  • Pages : 480
  • ISBN 10 : 9780470409763

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Genomics in Drug Discovery and Development Excerpt :

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.

Biomarkers in Drug Development Book

Biomarkers in Drug Development


  • Author : Michael R. Bleavins
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Genre: Medical
  • Pages : 663
  • ISBN 10 : 9781118210420

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Biomarkers in Drug Development Excerpt :

Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Role of Biomarkers in Medicine Book

Role of Biomarkers in Medicine


  • Author : Mu Wang
  • Publisher : BoD – Books on Demand
  • Release Date : 2016-08-17
  • Genre: Medical
  • Pages : 262
  • ISBN 10 : 9789535125051

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Role of Biomarkers in Medicine Excerpt :

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 as clinical tools and as surrogate endpoints in clinical research. This book highlights the current state of biomarkers and will aid scientists and clinicians to develop better and more specific biomarkers for disease management.

Handbook of Biomarkers and Precision Medicine Book

Handbook of Biomarkers and Precision Medicine


  • Author : Claudio Carini
  • Publisher : CRC Press
  • Release Date : 2019-04-16
  • Genre: Mathematics
  • Pages : 1025
  • ISBN 10 : 9780429574627

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Handbook of Biomarkers and Precision Medicine Excerpt :

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

Predictive Approaches in Drug Discovery and Development Book

Predictive Approaches in Drug Discovery and Development


  • Author : J. Andrew Williams
  • Publisher : John Wiley & Sons
  • Release Date : 2012-04-10
  • Genre: Medical
  • Pages : 407
  • ISBN 10 : 9780470170830

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Predictive Approaches in Drug Discovery and Development Excerpt :

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.