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

Produk Detail:

  • 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 : 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

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 : 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 : Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
  • Author : Nicholas C. Dracopoli,Katie Streicher
  • Publisher : Elsevier Inc. Chapters
  • Release : 16 July 2013
GET THIS BOOKGenomic Biomarkers for Pharmaceutical Development

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

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 : 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

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

Biomarkers in Drug Discovery and Development

Biomarkers in Drug Discovery and Development
  • Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
  • Publisher : John Wiley & Sons
  • Release : 17 March 2020
GET THIS BOOKBiomarkers in Drug Discovery and Development

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

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—

Surrogate Endpoints in Medicine

Surrogate Endpoints in Medicine
  • Author : John A. Wagner
  • Publisher : IOS Press
  • Release : 01 May 2002
GET THIS BOOKSurrogate Endpoints in Medicine

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.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release : 06 February 2014
GET THIS BOOKImproving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective

Toxicologic Biomarkers

Toxicologic Biomarkers
  • Author : Anthony P. DeCaprio
  • Publisher : CRC Press
  • Release : 18 April 2006
GET THIS BOOKToxicologic Biomarkers

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