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The Funding Of Biopharmaceutical Research And Development

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The Funding of Biopharmaceutical Research and Development

The Funding of Biopharmaceutical Research and Development Book
Author : David R Williams
Publisher : Elsevier
Release : 2013-10-31
ISBN : 1908818387
Language : En, Es, Fr & De

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Book Description :

The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public. Presents a comprehensive view of the funding issues of R&D in this market sector, adopting a theory-to-practice approach A comprehensive and analytical review of the biopharmaceutical R&D literature and practice An overview of the various and competing/complementary theories of the firm and valuation methods as they apply to biopharmaceutical R&D

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services
Publisher : National Academies Press
Release : 2020-01-27
ISBN : 0309498511
Language : En, Es, Fr & De

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Book Description :

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.

Research and Development in the Pharmaceutical Industry A CBO Study

Research and Development in the Pharmaceutical Industry  A CBO Study  Book
Author : Congressional Budget Office
Publisher : Lulu.com
Release : 2013-06-09
ISBN : 1304121445
Language : En, Es, Fr & De

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Book Description :

Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

The Oxford Handbook of the Economics of the Biopharmaceutical Industry Book
Author : Patricia M. Danzon,Sean Nicholson
Publisher : Oxford University Press
Release : 2012-04-12
ISBN : 0199909261
Language : En, Es, Fr & De

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Book Description :

The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.

Making Medicines Affordable

Making Medicines Affordable Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
Publisher : National Academies Press
Release : 2018-03-01
ISBN : 0309468086
Language : En, Es, Fr & De

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Book Description :

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.

Breakthrough Business Models

Breakthrough Business Models Book
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Robert Giffin,Sally Robinson,Theresa Wizemann
Publisher : National Academies Press
Release : 2009-02-17
ISBN : 0309178169
Language : En, Es, Fr & De

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Book Description :

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.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Release : 2011-04-03
ISBN : 0309158060
Language : En, Es, Fr & De

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Book Description :

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.

Health at a Glance 2019 OECD Indicators

Health at a Glance 2019 OECD Indicators Book
Author : OECD
Publisher : OECD Publishing
Release : 2019-11-07
ISBN : 9264807667
Language : En, Es, Fr & De

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Book Description :

Health at a Glance compares key indicators for population health and health system performance across OECD members, candidate and partner countries. It highlights how countries differ in terms of the health status and health-seeking behaviour of their citizens; access to and quality of health care; and the resources available for health. Analysis is based on the latest comparable data across 80 indicators, with data coming from official national statistics, unless otherwise stated.

The Funding of Biopharmaceutical Research and Development

The Funding of Biopharmaceutical Research and Development Book
Author : David R. Williams
Publisher : Woodhead Pub Limited
Release : 2013
ISBN : 9781907568947
Language : En, Es, Fr & De

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Book Description :

The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public. Presents a comprehensive view of the funding issues of R&D in this market sector, adopting a theory-to-practice approach A comprehensive and analytical review of the biopharmaceutical R&D literature and practice An overview of the various and competing/complementary theories of the firm and valuation methods as they apply to biopharmaceutical R&D

Strategies to Leverage Research Funding

Strategies to Leverage Research Funding Book
Author : Institute of Medicine,Board on Health Sciences Policy,Medical Follow-Up Agency,Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs
Publisher : National Academies Press
Release : 2004-11-27
ISBN : 0309092779
Language : En, Es, Fr & De

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Book Description :

Since 1992 the Department of Defense (DOD), through the U.S. Army Medical Research and Material Command, has received congressionally earmarked appropriations for programs of biomedical research on prostate, breast, and ovarian cancer; neurofibromatosis; tuberous sclerosis; and other health problems. Appropriations for these Congressionally Directed Medical Research Programs are used to support peer reviewed extramural research project, training, and infrastructure grants. Congress has become concerned about funding increases for these programs given current demands on the military budget. At the request of Congress, the Institute of Medicine (IOM) examined possibilities of augmenting program funding from alternative sources. The resulting IOM book, Strategies to Leverage Research Funding: Guiding DOD's Peer Reviewed Medical Research Programs, focuses on nonfederal and private sector contributions that could extend the appropriated funds without biasing the peer review project selection process.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders Book
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Release : 2014-02-06
ISBN : 0309292492
Language : En, Es, Fr & De

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Book Description :

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.

Pharmaceutical R D

Pharmaceutical R   D Book
Author : Anonim
Publisher : DIANE Publishing
Release : 1993-01-31
ISBN : 9780788104688
Language : En, Es, Fr & De

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Book Description :

Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology Book
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Release : 1991-02-01
ISBN : 030904491X
Language : En, Es, Fr & De

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Book Description :

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation Book
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Release : 1990-02-01
ISBN : 0309042860
Language : En, Es, Fr & De

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Book Description :

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.

The Business of Healthcare Innovation

The Business of Healthcare Innovation Book
Author : Lawton Robert Burns
Publisher : Cambridge University Press
Release : 2005-08-25
ISBN : 9781139445887
Language : En, Es, Fr & De

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Book Description :

The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.

Recovering from Success

Recovering from Success Book
Author : D. Hugh Whittaker,Robert E. Cole
Publisher : Oxford University Press
Release : 2006-08-17
ISBN : 0191538108
Language : En, Es, Fr & De

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Book Description :

How did Japan fall from challenger to US hegemonic leadership in the high tech industries in the 1980s, to stumbling giant by the turn of the century? What is it doing about it? This book examines the challenges faced by Japan's high tech companies through successful emulation of some of their key practices by foreign competitors and the emergence of new competitive models linked to open innovation and modular production. High tech companies were slow to respond, relying at first on formulae which had worked in the past, but in a new environment, some of these traditional strengths had now become sources of weakness. Stability and success, moreover, had decreased their appetite for risk. Early in the new century, however, there were signs of a more concerted response, which opened up past practices to scrutiny, and modification through selective learning and adaptation of the new models. The 'MOT' (management of technology) movement provided a vehicle for this change. It was linked, in turn, to efforts to change the national innovation system, giving universities a more central role, and encouraging spin-offs and startups. The book features contributions from Japanese and Western scholars and practitioners who have distinctive insights into the nature of these challenges and responses, with substantial introductory and concluding chapters. The result is a highly accessible account of innovation, technology, and change management in the world's second largest economy.

Re inventing Drug Development

Re inventing Drug Development Book
Author : Jeffrey S. Handen
Publisher : CRC Press
Release : 2014-10-28
ISBN : 1466579986
Language : En, Es, Fr & De

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Book Description :

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.

A Biotech Manager s Handbook

A Biotech Manager s Handbook Book
Author : M O'Neill,M M Hopkins
Publisher : Elsevier
Release : 2012-05-02
ISBN : 1908818158
Language : En, Es, Fr & De

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Book Description :

A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development

Alzheimer s Disease Drug Development

Alzheimer s Disease Drug Development Book
Author : Jeffrey L. Cummings,Jefferson W. Kinney,Howard Fillit
Publisher : Unknown
Release : 2021
ISBN : 9781108975759
Language : En, Es, Fr & De

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Book Description :

"Alzheimer's Disease Drug Development: A Research and Development Ecosystem captures the complexity of Alzheimer's disease (AD) drug develop and provides a comprehensive set of perspectives from the many stakeholders involved in discovering and developing new therapies for AD. There is no greater unmet therapeutic need for humanity than effective therapies for brain disorders. The suffering caused by these conditions and other neurodegenerative disorders is overwhelming and is burdened with substantial stigma. Therefore, I have devoted my professional life to changing the way brain disorders such as schizophrenia, depression, AD, among others are not only treated, but also viewed by society. From my time with the National Institutes of Health, Janssen and Johnson & Johnson where I serve as the Global Head of Science for Minds, my colleagues and I recognize there is still much to uncover about brain disorders due to the rich complexity of the brain and the challenges in accessing it. But that is not a reason to stop - especially as we enter the golden age of neuroscience, driven largely by scientific breakthroughs and accelerated regulatory pathways"--

Strengthening Forensic Science in the United States

Strengthening Forensic Science in the United States Book
Author : National Research Council,Division on Engineering and Physical Sciences,Committee on Applied and Theoretical Statistics,Policy and Global Affairs,Committee on Science, Technology, and Law,Committee on Identifying the Needs of the Forensic Sciences Community
Publisher : National Academies Press
Release : 2009-07-29
ISBN : 0309142393
Language : En, Es, Fr & De

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Book Description :

Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.