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


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.




Public-private Partnerships in Biomedical Research and Health Innovation for Alzheimer's Disease and Other Dementias


Book Description

Abstract: The Organisation for Economic Co-operation and Development (OECD), through its Working Party on Biotechnology, undertook a project on "Healthy Ageing and Biomedical Innovation for Dementia and Alzheimer's disease". The project was conducted under Output Result 2.1 of the WPB Programme of Work and Budget 2013-14 and aimed to identify good practices to strengthen effective co-operation at a global level for the governance of biomedical technologies and health innovation in Alzheimer's disease and other dementias. This report is in line with recommendations of the G8 Summit Declaration to strengthen collaboration for innovation and cross-sector partnerships focused on social impact investment, new care and prevention models, and academia/ industry partnerships. It had been informed by a literature review and information on public-private partnership case studies provided by members of the Working Party on Biotechnology




Assessing the Impact of Applications of Digital Health Records on Alzheimer's Disease Research


Book Description

Health information technology is providing patients, clinicians, and researchers with access to data that will enable novel approaches to science and medicine. Digital health records (DHRs) are capable of being shared across different health care settings for the examination of possible trends and long-term changes in a patient's disease progression or status as well as the effectiveness of the health care delivery system. While prevalence of paper records remains high, there has been a rapid trend toward the digitalization of medical and health records in many countries. DHRs are widely viewed as essential for improving health, reducing medical errors, and lowering costs. However, given that these databases have the potential to house the complete medical and health information of individuals, the potential misuse, de-identification or breaching of this data may have serious implications. On July 20, 2015, the Institute of Medicine's Forum on Neuroscience and Nervous System Disorders held a public session at the 2015 Alzheimer's Association International Conference to assess the impact of DHRs on Alzheimer's disease (AD) research. An estimated 46.8 million people worldwide are currently living with dementia, and the prevalence is expected to double every year for the next 20 years. Given the few therapies currently available to treat the symptoms of AD, compared to other central nervous system disorders, participants explored how DHRs may be used to help improve clinical trial design and methodology for AD research. This report summarizes the presentations and discussions from this workshop.




Emerging Trends in Biomedicine and Health Technology Innovation


Book Description

The economic and social impact of chronic brain disorders (CBD) such as Alzheimer's disease (AD) and other neurodegenerative diseases will become the number one public-health problem worldwide, directly affecting 100 million people by 2050. On-going demographic trends, namely ageing populations worldwide, are leading to the unprecedented expansion of consumer demand for healthcare services. Healthcare systems worldwide soon will confront a serious crisis as a result of significant growth of the healthcare market, in a climate of shrinking resources.




Alzheimer's Disease Drug Development


Book Description

Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.




Public-Private Partnerships as Drivers of Innovation in Healthcare, 2nd Edition


Book Description

Multi-stakeholder collaborations involving partners from public and private sectors are essential to address global health challenges and to move precision medicine forward. This eBook assembles a collection of papers which either illustrate recent achievements or discuss new perspectives offered by public-private partnerships in healthcare. Publisher’s note: In this 2nd edition, the following article has been added: Laverty H and Meulien P (2019) The Innovative Medicines Initiative −10 Years of Public-Private Collaboration. Front. Med. 6:275. doi: 10.3389/fmed.2019.00275




Research and Development in the Pharmaceutical Industry (A CBO Study)


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...




Reducing the Impact of Dementia in America


Book Description

As the largest generation in U.S. history - the population born in the two decades immediately following World War II - enters the age of risk for cognitive impairment, growing numbers of people will experience dementia (including Alzheimer's disease and related dementias). By one estimate, nearly 14 million people in the United States will be living with dementia by 2060. Like other hardships, the experience of living with dementia can bring unexpected moments of intimacy, growth, and compassion, but these diseases also affect people's capacity to work and carry out other activities and alter their relationships with loved ones, friends, and coworkers. Those who live with and care for individuals experiencing these diseases face challenges that include physical and emotional stress, difficult changes and losses in their relationships with life partners, loss of income, and interrupted connections to other activities and friends. From a societal perspective, these diseases place substantial demands on communities and on the institutions and government entities that support people living with dementia and their families, including the health care system, the providers of direct care, and others. Nevertheless, research in the social and behavioral sciences points to possibilities for preventing or slowing the development of dementia and for substantially reducing its social and economic impacts. At the request of the National Institute on Aging of the U.S. Department of Health and Human Services, Reducing the Impact of Dementia in America assesses the contributions of research in the social and behavioral sciences and identifies a research agenda for the coming decade. This report offers a blueprint for the next decade of behavioral and social science research to reduce the negative impact of dementia for America's diverse population. Reducing the Impact of Dementia in America calls for research that addresses the causes and solutions for disparities in both developing dementia and receiving adequate treatment and support. It calls for research that sets goals meaningful not just for scientists but for people living with dementia and those who support them as well. By 2030, an estimated 8.5 million Americans will have Alzheimer's disease and many more will have other forms of dementia. Through identifying priorities social and behavioral science research and recommending ways in which they can be pursued in a coordinated fashion, Reducing the Impact of Dementia in America will help produce research that improves the lives of all those affected by dementia.




Public-Private Partnerships for Sustainable Development


Book Description

Voluntary sustainability standards (VSS) and other private governance instruments (e.g., Fair Trade, Forest Stewardship Council, Fair Wear Foundation, GLOBALGAP) are increasingly regulating global production processes and economic activities. VSS verify the compliance of products or production processes with sustainability standards. The importance of voluntary sustainability standards is now widely recognized. After being operational for more than two decades, they have established themselves as private governance instruments. This recognition is also exemplified by their integration in public regulatory approaches. Governments and international organizations are partnering with voluntary sustainability standards to pursue sustainable development policies. We witness the integration of VSS in the regulatory approaches of local and national governments in countries around the world, the integration of VSS in trade policies, the emergence of public–private initiatives to govern global supply chains, and the inclusion of private initiatives in experimentalist governance regimes. This Special Issue seeks to bring together research on the interface between private and public governance. We welcome contributions which analyze specific case studies on the emergence and development of these private–public interactions, the design of public–private governance, the effectiveness of these governance arrangements, and critical perspectives on the possibilities and limitations of such public–private forms of governance. We welcome multi-disciplinary perspectives including contributions from economics, political science, law, sociology, geography, and anthropology. Papers selected for this Special Issue are subject to a peer review procedure with the aim of rapid and wide dissemination of research results, developments, and applications.