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Genomic Biomarkers For Pharmaceutical Development
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Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Yihong Yao
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Yihong Yao and published by Academic Press. This book was released on 2013-07-16 with total page 203 pages. Available in PDF, EPUB and Kindle. Book 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
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Yuping Wang
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Yuping Wang and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Koustubh Ranade
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Koustubh Ranade and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genomics in Drug Discovery and Development by : Dimitri Semizarov
Download or read book Genomics in Drug Discovery and Development written by Dimitri Semizarov and published by John Wiley & Sons. This book was released on 2008-11-03 with total page 496 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Biomarkers in Drug Discovery and Development by : Ramin Rahbari
Download or read book Biomarkers in Drug Discovery and Development written by Ramin Rahbari and published by John Wiley & Sons. This book was released on 2020-02-28 with total page 624 pages. Available in PDF, EPUB and Kindle. Book 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)
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Philip Brohawn
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Philip Brohawn and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Nicholas C. Dracopoli
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Nicholas C. Dracopoli and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Cornelis L. Verweij
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Cornelis L. Verweij and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Elizabeth Mambo
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Elizabeth Mambo and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genomic Biomarkers for Pharmaceutical Development by : Joseph R. Arron
Download or read book Genomic Biomarkers for Pharmaceutical Development written by Joseph R. Arron and published by Elsevier Inc. Chapters. This book was released on 2013-07-16 with total page 208 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Predictive Approaches in Drug Discovery and Development by : J. Andrew Williams
Download or read book Predictive Approaches in Drug Discovery and Development written by J. Andrew Williams and published by John Wiley & Sons. This book was released on 2012-04-10 with total page 420 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Biomarkers in Drug Development by : Michael R. Bleavins
Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by Wiley. This book was released on 2010-03-18 with total page 688 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Biomarkers in Clinical Drug Development by : John Bloom
Download or read book Biomarkers in Clinical Drug Development written by John Bloom and published by CRC Press. This book was released on 2003-05-20 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.
Book Synopsis The Path from Biomarker Discovery to Regulatory Qualification by : Federico Goodsaid
Download or read book The Path from Biomarker Discovery to Regulatory Qualification written by Federico Goodsaid and published by Academic Press. This book was released on 2013-07-16 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development by : Institute of Medicine
Download or read book Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development written by Institute of Medicine and published by National Academies Press. This book was released on 2011-03-17 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the many basic research discoveries in genetics, relatively few gene-based treatments, drugs, or preventative measures have been developed. One way to bridge this gap may be for industry, academia, and government to develop partnerships that share resources while distributing risk. However, intellectual property protections and other barriers can inhibit collaborative efforts. The Institute of Medicine held a workshop on July 22, 2010, to explore these issues and develop solutions.
Book Synopsis Handbook of Biomarkers and Precision Medicine by : Claudio Carini
Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 631 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis Genome-Based Therapeutics by : Institute of Medicine
Download or read book Genome-Based Therapeutics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-12-21 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: The number of new drug approvals has remained reasonably steady for the past 50 years at around 20 to 30 per year, while at the same time the total spending on health-related research and development has tripled since 1990. There are many suspected causes for this trend, including increases in regulatory barriers, the rising costs of scientific inquiry, a decrease in research and development efficiency, the downstream effects of patient expirations on investment, and the lack of production models that have successfully incorporated new technology. Regardless, this trajectory is not economically sustainable for the businesses involved, and, in response, many companies are turning toward collaborative models of drug development, whether with other industrial firms, academia, or government. Introducing greater efficiency and knowledge into these new models and aligning incentives among participants may help to reverse the trends highlighted above, while producing more effective drugs in the process. Genome-Based Therapeutics explains that new technologies have the potential to open up avenues of development and to identify new drug targets to pursue. Specifically, improved validation of gene-disease associations through genomics research has the potential to revolutionize drug production and lower development costs. Genetic information has helped developers by increasing their understanding of the mechanisms of disease as well as individual patients' reactions to their medications. There is a need to identify the success factors for the various models that are being developed, whether they are industry-led, academia-led, or collaborations between the two. Genome-Based Therapeutics summarizes a workshop that was held on March 21, 2012, titled New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process. At this workshop the goal was to examine the general approaches being used to apply successes achieved so far, and the challenges ahead.
