The Drug Development Paradigm In Oncology
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The Drug Development Paradigm In Oncology
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-03-12
The Drug Development Paradigm In Oncology written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-12 with Medical categories.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
The Drug Development Paradigm In Oncology
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-02-12
The Drug Development Paradigm In Oncology written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-02-12 with Medical categories.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Novel Designs Of Early Phase Trials For Cancer Therapeutics
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Author : Shivaani Kummar
language : en
Publisher: Academic Press
Release Date : 2018-05-26
Novel Designs Of Early Phase Trials For Cancer Therapeutics written by Shivaani Kummar and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-26 with Medical categories.
Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials.
Early Drug Development
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Author : Mitchell N. Cayen
language : en
Publisher: John Wiley & Sons
Release Date : 2011-02-25
Early Drug Development written by Mitchell N. Cayen and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-25 with Medical categories.
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Companion And Complementary Diagnostics
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Author : Jan Trøst Jørgensen
language : en
Publisher: Academic Press
Release Date : 2019-05-08
Companion And Complementary Diagnostics written by Jan Trøst Jørgensen and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-08 with Medical categories.
Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic
Statistical Methods In Drug Combination Studies
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Author : Wei Zhao
language : en
Publisher: CRC Press
Release Date : 2014-12-19
Statistical Methods In Drug Combination Studies written by Wei Zhao and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-19 with Mathematics categories.
The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve
Phase I Oncology Drug Development
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Author : Timothy A. Yap
language : en
Publisher: Springer Nature
Release Date : 2020-09-16
Phase I Oncology Drug Development written by Timothy A. Yap and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-09-16 with Medical categories.
This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.
A National Cancer Clinical Trials System For The 21st Century
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-07-08
A National Cancer Clinical Trials System For The 21st Century written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-08 with Medical categories.
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Handbook Of Brain Tumor Chemotherapy Molecular Therapeutics And Immunotherapy
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Author : Herbert B. Newton
language : en
Publisher: Academic Press
Release Date : 2018-03-28
Handbook Of Brain Tumor Chemotherapy Molecular Therapeutics And Immunotherapy written by Herbert B. Newton and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
Handbook of Brain Tumor Chemotherapy, Molecular Therapeutics, and Immunotherapy, Second Edition, provides a comprehensive overview of the molecular methodologies in the neuro-oncology field. There have been profound changes in the landscape of approaches to brain tumor therapy since the first edition—mainly in the areas of molecular biology and molecular therapeutics, as well as in the maturation of immunotherapy approaches (e.g., vaccines). This updated edition has a new, primary focus on multidisciplinary molecular methods, and is broadened to include the latest cutting-edge molecular biology, therapeutics, immunobiology and immunotherapy approaches. As the first comprehensive book to address the molecular research into these concepts, users will find it to be an invaluable resource on the topics discussed. - Provides the most up-to-date information regarding conventional forms of cytotoxic chemotherapy, as well as the basic science and clinical application of molecular therapeutics for the treatment of brain tumors - Broadly appeals to anyone interested in neuro-oncology and the treatment of brain tumors - Features updated chapters on molecular biology, molecular therapeutics, maturation of immunotherapy approaches, and a focus on multidisciplinary molecular methods - Includes a new section on the basic science of immunology, as well as thorough updates on the use of vaccine technology and immunotherapy for the treatment of brain tumors
Drug Diagnostics Co Development In Oncology
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Author : Jan Trøst Jørgensen
language : en
Publisher: Frontiers E-books
Release Date : 2014-11-07
Drug Diagnostics Co Development In Oncology written by Jan Trøst Jørgensen and has been published by Frontiers E-books this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-07 with Developmental pharmacology categories.
The idea of combining drugs and diagnostics in oncology is not new. When the selective estrogen receptor modulator tamoxifen was developed in the 1970’s for the treatment of breast cancer a positive correlation between receptor status and treatment outcome was found. As a result of this research, it was suggested to use the estrogen-receptor assay as a diagnostic test for selection of patients for tamoxifen treatment. Despite this suggestion was put forward nearly 40 years ago the adaptation of the drug-diagnostic co-development model has been relatively slow and it is only within the last decade that it has gained more widespread acceptance. The parallel development of the monoclonal antibody trastuzumab (Herceptin®, Roche/Genentech) and the immunohistochemistry assay for HER2 protein overexpression (HercepTest™, Dako) seems to have served as an inspiration to a number of stakeholders such as pharma and diagnostic companies, regulatory agencies, and academia. In recent years we have seen an increasing number of oncology drug development projects that have taken advantage of the drug-diagnostic co-development model, as outline below. Most of the new targeted anti-cancer drugs that have been introduced in recent years, such as BRAF-, ALK-, EGFR- and HER2-inhibitors, are more or less all a product of the drugdiagnostic co-development model. These drugs have shown remarkable high response rates in selected groups of patients within cancer diseases with great unmet medical needs. This Research Topic on Drug-Diagnostic Co-Development in Oncology aims to provide you with an insight into some of the diverse activities that constitute this new research area.