Download or read book Translational Medicine in CNS Drug Development written by George G. Nomikos and published by Academic Press. This book was released on 2019-06-18 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans. Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders Includes chapters written by international experts from industry and academia

Download or read book Modern CNS Drug Discovery written by Rudy Schreiber and published by Springer Nature. This book was released on 2021-06-17 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook provides a comprehensive overview of the currently used concepts, approaches and technologies in the discovery and development of new treatments for the full spectrum of disorders of the central nervous system. It guides the reader through all essential steps, from finding an innovative idea, to the registration of a new drug. Divided into four sections, the book starts by presenting a broad perspective on current approaches in central nervous system (CNS) drug discovery. The second section addresses the generation of ideas for the identification of targets and novel treatment strategies; covers core functions in early discovery, and provides an example of a novel treatment paradigm: brain stimulation. The third section highlights strategies and technologies in translational CNS drug discovery. In an effort to bridge the gap between discovery and clinical development, it also covers brain imaging, EEG and cognitive testing approaches. The fourth section extensively discusses the clinical phase of drug development, covering the basics of early clinical testing for psychopharmacological drugs. The book’s final chapter addresses the registration for newly developed drugs. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments in drug discovery. Offering in-depth insights into the world of drug development, it represents essential reading for early researchers who want to prepare for a career in drug discovery in academia or industry.

Download or read book Imaging in CNS Drug Discovery and Development written by David Borsook and published by Springer Science & Business Media. This book was released on 2010-03-10 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development today needs to balance agility, speed, and risk in defining probability of success for molecules, mechanisms, and therapeutic concepts. New techniques such as fMRI promise to be part of a sequence that could transform drug development. Although numerous review articles exist that discuss the use of imaging in drug development, no one source is available that combines the various techniques and includes a discussion of disease mapping. Imaging in CNS Drug Discovery and Development, Implications for Disease and Therapy will serve to distill the most salient developments in the use of imaging in drug development and disease mapping. It will launch evolving concepts that integrate new imaging technologies and paradigms with molecular medicine and molecular profiling ("monics") as well as consider the ethical issues that arise as a result of disease or state diagnosis and the use of imaging in the public eye.

Download or read book Translational Neuroimaging written by Robert A. McArthur and published by Academic Press. This book was released on 2012-10-05 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Neuroimaging: Tools for CNS Drug Discovery, Development and Treatment combines the experience of academic, clinical and industrial neuroimagers in a unique collaborative approach to provide an integrated perspective of the use of small animal and human brain imaging in developing and validating translational models and biomarkers for the study and treatment of neuropsychiatric disorders. Translational Neuroimaging: Tools for CNS Drug Discovery, Development and Treatment examines the translational role of neuroimaging in model development from preclinical animal models, to human experimental medicine, and finally to clinical studies. The focus of this book is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This book covers methodical issues in human and animal neuroimaging translational research as well as detailed applied examples of the use of neuroimaging in neuropsychiatric disorders and the development of drugs for their treatment. Offering an accompanying website with illustrations and text available for further knowledge and presentations, Translational Neuroimaging: Tools for CNS Drug Discovery, Development and Treatment appeals to non-clinical and clinical neuroscientists working in and studying neuropsychiatric disorders and their treatment as well as providing the novice researcher or researcher outside of his/her expertise the opportunity to understand the background of translational research and the use of imaging in this field. Provides a background to translational research and the use of brain imaging in neuropsychiatric disorders Critical discussion of the potential and limitations of neuroimaging as a translational tool for identifying and validating biomarkers Identifies cross species neurosystems and common endpoints necessary to help accelerate CNS drug discovery and development for the treatment of neuropsychiatric disorders Features an accompanying website with additional images and text

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Download or read book Animal and Translational Models for CNS Drug Discovery Neurological Disorders written by Robert A. McArthur and published by Academic Press. This book was released on 2008-11-18 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer’s disease, Parkinson’s disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasis on what results mean to the overall drug discovery process Exploration of issues in clinical trial design and conductance in each therapeutic area

Download or read book Animal and Translational Models for CNS Drug Discovery 3 Vols Set written by Robert A. McArthur and published by . This book was released on 2008-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Animal and Translational Models for CNS Drug Discovery written by Robert A. McArthur and published by Academic Press. This book was released on 2008-11-27 with total page 1367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal and Translational Models for CNS Drug Discovery combines the experience of academic, clinical and pharmaceutical neuroscientists in a unique collaborative approach to provide a greater understanding of the relevance of animal models of neuropsychiatric disorders and their role as translational tools for the discovery of CNS drugs being developed for the treatment of these disorders. The focus of this three-volume series of essays is to present a consensual picture of the translational value of animal models from leading experts actively involved in the use of animal models for understanding fundamental neurobiology of CNS disorders and the application of this knowledge to CNS drug discovery, and clinical investigators involved in clinical trials, drug development and eventual registration of novel pharmaceuticals. Each volume of the Animal and Translational Models for CNS Drug Discovery series is dedicated to the development and use of animal models in key therapeutic areas in psychiatric, neurologic and reward deficit disorders. Each volume has introductory chapters expressing the view of the role and relevance of animal models for CNS drug discovery and development from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in relevant therapeutic areas and discusses the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. - Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasizes what results mean to the overall drug discovery process - Explores issues in clinical trial design and conductance in each therapeutic area - Each volume is available for purchase individually.

Download or read book NEUROTHERAPEUTICS IN THE ERA OF TRANSLATIONAL MEDICINE written by RICHARD A. SMITH and published by Elsevier. This book was released on 2021 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Animal and Translational Models for CNS Drug Discovery Psychiatric Disorders written by Robert A. McArthur and published by Academic Press. This book was released on 2008-11-17 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Psychiatric Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for psychiatric disorders such as anxiety, obsessive-compulsive disorder, depression, schizophrenia, bipolar disorder, ADHD, and autistic spectrum disorder. Psychiatric Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the first volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, and is also available for purchase individually. Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasizes what results mean to the overall drug discovery process Explores issues in clinical trial design and conductance in each therapeutic area Psychiatric Disorders is available for purchase individually.

Download or read book Translating Molecules into Medicines written by Shobha N. Bhattachar and published by Springer. This book was released on 2017-04-21 with total page 461 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field. The authors of each chapter address the paradox between the molecular understanding of diseases, drug discovery, and drug development. Laying out the detailed trends from various fields, different chapters are dedicated to target engagement, toxicological safety assessments, and the compelling relationship of optimizing early clinical studies with design strategies. The book also highlights the importance of balancing the three pillars: sufficient efficacy, acceptable safety and appropriate pharmacokinetics, all of which are crucial to successful efforts in discovery and development. With discussions regarding the combined approaches of molecular research, personalized medicine, pre-clinical and clinical development, as well as targeted therapies—this compendium is a flexible fit, perfect for professionals in the pharmaceutical industry and related academic fields.

Download or read book Critical Pathways to Success in CNS Drug Development written by Neal R. Cutler and published by John Wiley & Sons. This book was released on 2010-01-22 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering the latest advances in CNS drug development, this bookwill guide all those involved in pre-clinical to early clinicaltrials. The authors describe how recent innovations can acceleratethe development of novel CNS compounds, improve early detection ofefficacy and toxicity signals, and increase the safety oflater-stage clinical trials. The current crisis in the drug development industry iscritically reviewed, as well as the steps needed to correct theproblems, including new government-backed regulations andindustry-based innovations designed to accelerate CNS drugdevelopment in the future. Animal-based models of major CNS disorders are described indetail, and the ability of the latest in vitro and computer-basedmodels to simulate CNS disease states and predict drug efficacy andside-effects are examined. Particular attention is given tothe growing use of biomarkers and how they can be used effectivelyin early human trials as signals of potential drug efficacy, aswell as the increasingly important role of imaging studies to guidedose selection. Cognitive assessments that can be useful indicatorsof effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drugtrials for over 20 years, and based on a wealth of drug developmentand clinical trial experience, Critical Pathways to Success inCNS Drug Developmentis full of practical advice forsuccessfully designing and executing CNS drug trials, avoidingpotential pitfalls, and complying with government regulations

Download or read book Translational Medicine written by James Mittra and published by CRC Press. This book was released on 2016-04-19 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book brings together a range of academic, industry and practitioner perspectives on translational medicine (TM). It enhances conceptual and practical understanding of the emergence and progress of the field and its potential impact on basic research, therapeutic development, and institutional infrastructure. In recognition of the various impli

Download or read book Peptide Drug Discovery and Development written by Miguel Castanho and published by John Wiley & Sons. This book was released on 2011-10-24 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "bench to bedside" translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.

Download or read book Breakthrough Business Models written by Institute of Medicine and published by National Academies Press. This book was released on 2009-02-17 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.

Download or read book Accelerating the Development of New Drugs and Diagnostics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-23 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfully developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cures Acceleration Network (CAN)-a part of the National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH)-has the potential to catalyze widespread changes in NCATS, NIH, and the drug development ecosystem in general. On June 4-5, 2012, the IOM Forum on Drug Discovery, Development, and Translation held, at the request of NCATS, a workshop-bringing together members of federal government agencies, the private sector, academia, and advocacy groups-to explore options and opportunities in the implementation of CAN. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary summarizes the workshop.

Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery