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Book Innovation in Drug Research and Development for Prevalent Chronic Diseases

Download or read book Innovation in Drug Research and Development for Prevalent Chronic Diseases written by and published by . This book was released on 2021 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic disease. As a result, prevalent chronic diseases are producing immense health care costs as well as preventable suffering and death. On February 22, March 2, and March 8, 2021, the National Academies of Sciences, Engineering, and Medicine, convened a workshop to discuss barriers to innovation in this space and examine strategies and incentives to support equitable, person-centered drug R&D for prevalent chronic diseases.

Book Rare Diseases and Orphan Products

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

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 Improving and Accelerating Therapeutic Development for Nervous System Disorders

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 Breakthrough Business Models

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 2009-02-17
  • ISBN : 0309178169
  • Pages : 151 pages

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.

Book Accelerating the Development of New Drugs and Diagnostics

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.

Book Technological Innovation

Download or read book Technological Innovation written by Annetine C. Gelijns and published by National Academies. This book was released on 1989 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Modern Methods of Clinical Investigation

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.

Book Drug Research and Drug Development in the 21st Century

Download or read book Drug Research and Drug Development in the 21st Century written by H.P. Wolff and published by Springer. This book was released on 1989-07-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Distinguished scientists and members of the medical profession discuss the research and development of safe and suitable drugs for the long-term treatment of chronic diseases. The book provides an up-to-date survey on new insights and technologies - as well as ethical considerations - , since traditional means and methods of drug research and drug development may no longer suffice to meet the challenges of the next century.

Book Preparing the Future Workforce in Drug Research and Development

Download or read book Preparing the Future Workforce in Drug Research and Development written by National Academies of Sciences Engineering and Medicine and published by . This book was released on 2025-02-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite advances over the past several decades, the clinical trials enterprise has struggled to meet the needs of an increasingly diverse U.S. population. To help address this issue, a 2023 National Academies workshop sought to identify the expertise and disciplines needed to achieve the aspirations for a transformed clinical trials enterprise by 2030 and enable a workforce that can better support the evolving needs of drug R&D - one that is resilient, culturally aware, anti-racist, and interdisciplinary. The workshop, hosted by the Forum on Drug Discovery, Development, and Translation and Roundtable on Black Men and Black Women in Science, Engineering, and Medicine explored strategies to bolster workforce capacity and challenges and opportunities associated with supporting the next-generation drug R&D workforce.

Book Research and Development in the Pharmaceutical Industry  A CBO Study

Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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...

Book Medical Innovation in the Changing Healthcare Marketplace

Download or read book Medical Innovation in the Changing Healthcare Marketplace written by National Research Council and published by National Academies Press. This book was released on 2002-05-06 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: A wave of new health care innovation and growing demand for health care, coupled with uncertain productivity improvements, could severely challenge efforts to control future health care costs. A committee of the National Research Council and the Institute of Medicine organized a conference to examine key health care trends and their impact on medical innovation. The conference addressed the following question: In an environment of renewed concern about rising health care costs, where can public policy stimulate or remove disincentives to the development, adoption and diffusion of high-value innovation in diagnostics, therapeutics, and devices?

Book The Science of Medicines Exploring Drug Discovery and Development

Download or read book The Science of Medicines Exploring Drug Discovery and Development written by Derek Otto and published by . This book was released on 2023-12-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Importance of MedicinesIn today's fast-paced world, medicines play a vital role in maintaining and improving our overall health. From curing life-threatening diseases to alleviating common ailments, the significance of medicines cannot be overstated. This subchapter aims to highlight the importance of medicines in our lives and shed light on their role in the field of biomedical science and biotechnology. Medicines are a cornerstone of modern healthcare, enabling us to combat a vast array of illnesses and conditions. They are designed to target specific diseases and provide relief by either eliminating the root cause or managing symptoms. Without medicines, our ability to prevent, treat, and cure diseases would be severely limited. One of the key aspects of medicines is their role in drug discovery and development. Biomedical science and biotechnology rely heavily on the creation and advancement of new drugs to tackle emerging health challenges. Through rigorous research and testing, scientists can develop innovative medicines that address unmet medical needs, saving countless lives in the process. Medicines have revolutionized the treatment of chronic diseases, such as diabetes, hypertension, and asthma. They allow individuals to manage these conditions effectively, leading to improved quality of life and longevity. Additionally, medicines have played a crucial role in eradicating or controlling infectious diseases like smallpox, polio, and tuberculosis, transforming the landscape of public health. In the field of biotechnology, medicines have opened doors to groundbreaking therapies. Biologic drugs, derived from living organisms, have revolutionized the treatment of diseases like cancer, rheumatoid arthritis, and multiple sclerosis. These innovative medicines offer targeted treatments, minimizing side effects and maximizing efficacy. Furthermore, medicines have a significant impact on society as a whole. They not only alleviate human suffering but also contribute to economic development. By improving health outcomes, medicines enable individuals to live productive lives, contributing to the growth of communities and nations. Moreover, the pharmaceutical industry generates employment opportunities, drives research and innovation, and fosters collaborations across various scientific disciplines.

Book The Changing Economics of Medical Technology

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Book Global Health and the Future Role of the United States

Download or read book Global Health and the Future Role of the United States written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-05 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: While much progress has been made on achieving the Millenium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency â€" both within the U.S. government and across the global health field.

Book Clinical Pharmacology  Current Topics and Case Studies

Download or read book Clinical Pharmacology Current Topics and Case Studies written by Markus Müller and published by Springer Science & Business Media. This book was released on 2011-02-04 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.

Book Making Medicines Affordable

    Book Details:
  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release : 2018-03-01
  • ISBN : 0309468086
  • Pages : 235 pages

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.