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Re Inventing Drug Development
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Book Synopsis Modern CNS Drug Discovery by : Rudy Schreiber
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.
Book Synopsis Re-inventing Drug Development by : Jeffrey S. Handen
Download or read book Re-inventing Drug Development written by Jeffrey S. Handen and published by CRC Press. This book was released on 2014-10-28 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection, and pipelines have been unable to fill the gap. This book explores the evolving definition of innovation in therapeutic product development and begins to examine its effects on the life sciences R&D industry. Historically, scientific innovation alone was sufficient to maintain ROI and deliver on unmet medical needs. However, with many forces now conspiring to increase pressures on the commoditization of drug development, industry support for truly novel, often high-risk development has eroded. This calls for a drastic redefinition of what "innovation" is. While innovation in the pharmaceutical R&D industry has historically been applied to major advances in therapy and unmet medical needs, we now need to see innovation increasingly defined in terms of financial, marketing (e.g. branded generics and emerging markets), pharmacoeconomic, and operational innovation. In this book, contributors drawn from the executive ranks of clinical development practitioners and stakeholders—from biopharmaceutical companies, clinical research organizations, academia, the financial community, and the patient perspective—have all come together to provide their expertise and visions. Their goal is to start a dialogue about ways to radically improve therapeutics development and get more and better medicines to the patients who need them, as fast as possible, in the most cost-efficient manner.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
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.
Book Synopsis Reinventing Patient Recruitment by : Joan F. Bachenheimer
Download or read book Reinventing Patient Recruitment written by Joan F. Bachenheimer and published by Gower Publishing, Ltd.. This book was released on 2007 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.
Book Synopsis Platform Trial Designs in Drug Development by : Zoran Antonijevic
Download or read book Platform Trial Designs in Drug Development written by Zoran Antonijevic and published by CRC Press. This book was released on 2018-12-07 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Book Synopsis Reinventing Drug & Medical Device Regulations, April 1995 by :
Download or read book Reinventing Drug & Medical Device Regulations, April 1995 written by and published by . This book was released on 1995 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Use of Drugs in Food Animals by : National Research Council
Download or read book The Use of Drugs in Food Animals written by National Research Council and published by National Academies Press. This book was released on 1999-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Book Synopsis Reinventing Hoodia by : Laura A. Foster
Download or read book Reinventing Hoodia written by Laura A. Foster and published by University of Washington Press. This book was released on 2017-09-18 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: Native to the Kalahari Desert, Hoodia gordonii is a succulent plant known by generations of Indigenous San peoples to have a variety of uses: to reduce hunger, increase energy, and ease breastfeeding. In the global North, it is known as a natural appetite suppressant, a former star of the booming diet industry. In Reinventing Hoodia, Laura Foster explores how the plant was reinvented through patent ownership, pharmaceutical research, the self-determination efforts of Indigenous San peoples, contractual benefit sharing, commercial development as an herbal supplement, and bioprospecting legislation. Using a feminist decolonial technoscience approach, Foster argues that although patent law is inherently racialized, gendered, and Western, it offered opportunities for Indigenous San peoples, South African scientists, and Hoodia growers to make unequal claims for belonging within the shifting politics of South Africa. This radical interdisciplinary and intersectional account of the multiple materialities of Hoodia illuminates the co-constituted connections between law, science, and the marketplace, while demonstrating how these domains value certain forms of knowledge and matter differently.
Book Synopsis Reinventing Regulation of Drugs and Medical Devices by : Bill Clinton
Download or read book Reinventing Regulation of Drugs and Medical Devices written by Bill Clinton and published by . This book was released on 1995 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Reinventing American Health Care by : Ezekiel Emanuel
Download or read book Reinventing American Health Care written by Ezekiel Emanuel and published by Public Affairs. This book was released on 2014-03-04 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive story of American health care today—its causes, consequences, and confusions In March 2010, the Affordable Care Act was signed into law. It was the most extensive reform of America’s health care system since at least the creation of Medicare in 1965, and maybe ever. The ACA was controversial and highly political, and the law faced legal challenges reaching all the way to the Supreme Court; it even precipitated a government shutdown. It was a signature piece of legislation for President Obama’s first term, and also a ball and chain for his second. Ezekiel J. Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania who also served as a special adviser to the White House on health care reform, has written a brilliant diagnostic explanation of why health care in America has become such a divisive social issue, how money and medicine have their own—quite distinct—American story, and why reform has bedeviled presidents of the left and right for more than one hundred years. Emanuel also explains exactly how the ACA reforms are reshaping the health care system now. He forecasts the future, identifying six mega trends in health that will determine the market for health care to 2020 and beyond. His predictions are bold, provocative, and uniquely well-informed. Health care—one of America’s largest employment sectors, with an economy the size of the GDP of France—has never had a more comprehensive or authoritative interpreter.
Book Synopsis Reinventing Management by : Julian Birkinshaw
Download or read book Reinventing Management written by Julian Birkinshaw and published by John Wiley & Sons. This book was released on 2012-04-25 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: The economic crisis was not just caused by a failure of regulation or economic policy; it was a story of the failure of management in a fundamental sense—a deeply flawed approach to management that encouraged bankers to pursue opportunities without regard for their long-term consequences, and to put their own interests ahead of those of their employers and their shareholders. The revised edition of this best-selling book shows convincingly that many of today’s major economic problems in the west can be traced to a failure of management. In this updated edition the author draws our attention to new examples of failed management, from Rupert Murdoch’s News Corp, and the disaster at BP, to the ongoing problems in financial services companies such as UBS and RBS. Throughout the book the references and statistics have been updated, to make this a current, highly relevant analysis of the problems besetting modern business and how managers need to tackle them.
Book Synopsis Reinventing Project Management by : Aaron J. Shenhar
Download or read book Reinventing Project Management written by Aaron J. Shenhar and published by Harvard Business Review Press. This book was released on 2007-08-13 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Projects are the engines that drive innovation from idea to commercialization. In fact, the number of projects in most organizations today is expanding while operations is shrinking. Yet, since many companies still focus on operational excellence and efficiency, most projects fail--largely because conventional project management concepts cannot adapt to a dynamic business environment. Moreover, top managers neglect their company's project activity, and line managers treat all their projects alike--as part of operations. Based on an unprecedented study of more than 600 projects in a variety of businesses and organizations around the globe, "Reinventing Project Management" provides a new and highly adaptive model for planning and managing projects to achieve superior business results.
Book Synopsis Artificial Intelligence in Drug Discovery by : Nathan Brown
Download or read book Artificial Intelligence in Drug Discovery written by Nathan Brown and published by Royal Society of Chemistry. This book was released on 2020-11-04 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following significant advances in deep learning and related areas interest in artificial intelligence (AI) has rapidly grown. In particular, the application of AI in drug discovery provides an opportunity to tackle challenges that previously have been difficult to solve, such as predicting properties, designing molecules and optimising synthetic routes. Artificial Intelligence in Drug Discovery aims to introduce the reader to AI and machine learning tools and techniques, and to outline specific challenges including designing new molecular structures, synthesis planning and simulation. Providing a wealth of information from leading experts in the field this book is ideal for students, postgraduates and established researchers in both industry and academia.
