New Drug Development Science Business Regulatory Intellectual Property Issues Cited As Hampering Drug Development Efforts

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New Drug Development

Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781976430459
Total Pages : 52 pages
Book Rating : 4.4/5 (34 download)

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Book Synopsis New Drug Development by : United States Government Accountability Office

Download or read book New Drug Development written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-09-15 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is complex and costly, requiring the testing of numerous chemical compounds for their potential to treat disease. Before a new drug can be marketed in the United States, a new drug application (NDA), which includes scientific and clinical data, must be approved by the Food and Drug Administration (FDA). Recent scientific advances have raised expectations that an increasing number of new and innovative drugs would soon be developed to more effectively prevent, treat, and cure serious illnesses. However, industry analysts and the FDA have reported that new drug development, and in particular, development of new molecular entities (NMEs)-potentially innovative drugs containing ingredients that have never been marketed in the United States-has become stagnant. GAO was asked to provide information on (1) trends in the pharmaceutical industry's reported research and development expenses as well as trends in the number of NDAs submitted to, and approved by, FDA; and (2) experts' views on factors accounting for these trends and their suggestions for expediting and enhancing drug development. GAO analyzed data

New Drug Development: Science, Business, Regulatory, & Intellectual Property Issues Cited as Hampering Drug Development Efforts

Author : United States Government Accountability Office
Publisher : DIANE Publishing
ISBN 13 : 9781422310076
Total Pages : 54 pages
Book Rating : 4.3/5 (1 download)

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Book Synopsis New Drug Development: Science, Business, Regulatory, & Intellectual Property Issues Cited as Hampering Drug Development Efforts by : United States Government Accountability Office

Download or read book New Drug Development: Science, Business, Regulatory, & Intellectual Property Issues Cited as Hampering Drug Development Efforts written by United States Government Accountability Office and published by DIANE Publishing. This book was released on 2006 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:

New Drug Development

Author : United States. Government Accountability Office
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (2 download)

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Book Synopsis New Drug Development by : United States. Government Accountability Office

Download or read book New Drug Development written by United States. Government Accountability Office and published by . This book was released on 2006 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Trials Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470466359
Total Pages : 1247 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Clinical Trials Handbook by : Shayne Cox Gad

Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

Patenting of Pharmaceuticals and Development in Sub-Saharan Africa

Author : POKU ADUSEI
Publisher : Springer Science & Business Media
ISBN 13 : 3642325149
Total Pages : 312 pages
Book Rating : 4.6/5 (423 download)

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Book Synopsis Patenting of Pharmaceuticals and Development in Sub-Saharan Africa by : POKU ADUSEI

Download or read book Patenting of Pharmaceuticals and Development in Sub-Saharan Africa written by POKU ADUSEI and published by Springer Science & Business Media. This book was released on 2012-10-25 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter “SSA” or “Africa”). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime’s inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

Compound Solutions

Author : Susan Craddock
Publisher : U of Minnesota Press
ISBN 13 : 1452953783
Total Pages : 226 pages
Book Rating : 4.4/5 (529 download)

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Book Synopsis Compound Solutions by : Susan Craddock

Download or read book Compound Solutions written by Susan Craddock and published by U of Minnesota Press. This book was released on 2017-02-21 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: Claiming 1.5 million lives in 2015, tuberculosis is the world’s most deadly infectious disease. Because of the population it overwhelmingly affects, however, pharmaceutical companies are uninterested in developing better drugs for the disease. Compound Solutions examines Product Development Partnerships (PDPs), which arose early in the twenty-first century to develop new drugs and vaccines for infectious diseases in low-income countries. Here, for the first time, is a sustained examination of PDPs: the work they do, the partnerships they form, their mission, and their underlying philosophy of addressing global health needs—with implications that extend well beyond tuberculosis. Focusing on two PDPs for tuberculosis—the Global Alliance for TB Drug Development (TB Alliance) and Aeras (a nonprofit focused on vaccine development)—Susan Craddock argues that PDPs do much more than product development. As innovative sites of humanitarian pharmaceutical production, they are contravening mainstream pharmaceutical production by tying drug and vaccine research to global health needs rather than shareholder demand. In largely untethering the profit incentive from pharmaceutical production, Craddock shows, PDPs exhibit more creative and efficient scientific practices, reshaping regulatory norms and implementing more ethical forms of clinical trials that enhance community engagement and capacity building. An unparalleled, interdisciplinary analysis of PDPs as politically, socially, scientifically, and economically innovative sites of pharmaceutical production, Compound Solutions is a must for readers in the fields of public health, science and technology studies, and medical social science.

Gene Patents and Collaborative Licensing Models

Author : Geertrui van Overwalle
Publisher : Cambridge University Press
ISBN 13 : 0521896738
Total Pages : 517 pages
Book Rating : 4.5/5 (218 download)

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Book Synopsis Gene Patents and Collaborative Licensing Models by : Geertrui van Overwalle

Download or read book Gene Patents and Collaborative Licensing Models written by Geertrui van Overwalle and published by Cambridge University Press. This book was released on 2009-06-11 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cost of patent licenses needed to design a new genetic test or treatment may ultimately prevent research projects getting started, as individual components are protected by different patent owners. This book examines legal measures which might be used to solve the problem of fragmentation of patents in genetics.

Global Pharmaceutical Policy

Author : Frederick M. Abbott
Publisher : Edward Elgar Publishing
ISBN 13 : 1849801843
Total Pages : 319 pages
Book Rating : 4.8/5 (498 download)

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Book Synopsis Global Pharmaceutical Policy by : Frederick M. Abbott

Download or read book Global Pharmaceutical Policy written by Frederick M. Abbott and published by Edward Elgar Publishing. This book was released on 2009-01-01 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a strong argument that people throughout the world have a right to receive the medicines they need in an appropriate, affordable, and timely way. Global Pharmaceutical Policy describes the laws, policies, and customs relating to the development and provision of medicines, identifies their strengths and weakness, and then proposes global solutions for getting things better. Here is a masterpiece written in a clear and elegant style. Together, Dukes and Abbott have experience and insight that are unrivalled. Joe Collier, Emeritus Professor of Medicines Policy, St George s, University of London, UK Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world s poor see little effort to address diseases prevalent in less affluent societies, while the world s wealthy are overusing prescription drugs, risking their health and wasting resources. As the global economic crisis exacerbates pressure on health care budgets, a new presidential administration in Washington, DC has committed to broad health care reform. These circumstances form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.

New Drug Approval

Author : Marcia Crosse
Publisher : DIANE Publishing
ISBN 13 : 1437924603
Total Pages : 71 pages
Book Rating : 4.4/5 (379 download)

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Book Synopsis New Drug Approval by : Marcia Crosse

Download or read book New Drug Approval written by Marcia Crosse and published by DIANE Publishing. This book was released on 2010-08 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: Before approving a drug, the FDA assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint (SE) -- a laboratory measure, such as blood pressure -- instead of more direct clinical evidence, like preventing strokes. After approval, FDA requires a drug sponsor to further study the drug. There have been concerns about FDA's reliance on SE and its oversight of post-marketing studies (PS). This report provides info. on: (1) all drug applications approved based on SE in FDA's accelerated approval process; (2) a subset of applications for potentially innovative drugs approved based on SE under FDA's traditional process; and (3) FDA's oversight of PS. Illustrations.

Genetic Resources and Traditional Knowledge

Author : Tania Bubela
Publisher : Edward Elgar Publishing
ISBN 13 : 1781002622
Total Pages : 393 pages
Book Rating : 4.7/5 (81 download)

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Book Synopsis Genetic Resources and Traditional Knowledge by : Tania Bubela

Download or read book Genetic Resources and Traditional Knowledge written by Tania Bubela and published by Edward Elgar Publishing. This book was released on 2012-01-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fascinating study describes efforts to define and protect traditional knowledge and the associated issues of access to genetic resources, from the negotiation of the Convention on Biological Diversity to the Declaration on the Rights of Indigenous Peoples and the Nagoya Protocol. Drawing on the expertise of local specialists from around the globe, the chapters judiciously mix theory and empirical evidence to provide a deep and convincing understanding of traditional knowledge, innovation, access to genetic resources, and benefit sharing. Because traditional knowledge was understood in early negotiations to be subject to a property rights framework, these often became bogged down due to differing views on the rights involved. New models, developed around the notion of distributive justice and self-determination, are now gaining favor. This book suggests – through a discussion of theory and contemporary case studies from Brazil, India, Kenya and Canada – that a focus on distributive justice best advances the interests of indigenous peoples while also fostering scientific innovation in both developed and developing countries. Comprehensive as well as nuanced, Genetic Resources and Traditional Knowledge will be of great interest to scholars and students of law, political science, anthropology and geography. National and international policymakers and those interested in the environment, indigenous peoples' rights and innovation will find the book an enlightening resource.

Rising Plague

Author : Brad Spellberg, M.D.
Publisher : Prometheus Books
ISBN 13 : 1615929487
Total Pages : 266 pages
Book Rating : 4.6/5 (159 download)

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Book Synopsis Rising Plague by : Brad Spellberg, M.D.

Download or read book Rising Plague written by Brad Spellberg, M.D. and published by Prometheus Books. This book was released on 2009-12-04 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spellberg's book is a powerful and compelling journey into the antibiotic resistance problem . . . [written] in a personal, compelling, and easy-to-understand manner. It's a must read.--Michael Osterholm, M.D., author of "Living Terrors."

Food and Drug Administration

Author : Marcia Crosse
Publisher : DIANE Publishing
ISBN 13 : 1437920705
Total Pages : 81 pages
Book Rating : 4.4/5 (379 download)

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Book Synopsis Food and Drug Administration by : Marcia Crosse

Download or read book Food and Drug Administration written by Marcia Crosse and published by DIANE Publishing. This book was released on 2010 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: Twenty years ago, it was reported that the FDA was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products -- human drugs, biologics, and medical devices -- marketed for sale in the U.S. Since then, concerns have been raised regarding FDA's ability to meet its oversight responsibilities. This report reviews the resources supporting FDA's medical product oversight responsibilities. It examines trends in: (1) FDA's funding and staffing resources for its medical product oversight responsibilities from FY 1999 through 2008; and (2) FDA's medical product oversight responsibilities during this same period. Charts and tables.

Green and Sustainable Pharmacy

Author : Klaus Kümmerer
Publisher : Springer Science & Business Media
ISBN 13 : 3642051995
Total Pages : 312 pages
Book Rating : 4.6/5 (42 download)

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Book Synopsis Green and Sustainable Pharmacy by : Klaus Kümmerer

Download or read book Green and Sustainable Pharmacy written by Klaus Kümmerer and published by Springer Science & Business Media. This book was released on 2010-06-16 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within recent years pharmaceuticals have come into focus as contaminants of the environment (see for example Kümmerer, K. editor: Pharmaceuticals in the Environment). At the same time the issue of sustainable chemistry gained momentum. Bringing both together would result in sustainable pharmacy. Sustainable pharmacy is a totally new issue and approach. It addresses environmental, economical and social aspects of pharmacy. In the present stage the focus will be on environmental issues along the whole lifecycle of a pharmaceutical entity. That is dealing with resources and energy input but also with waste issues for example during the synthesis and production of an active pharmaceutical ingredient. Furthermore, it would also look on the compounds themselves and will aim to improve the degradability of the compounds after their use in the environment to reduce the environmental risk caused by pharmaceuticals in the environment. Another issue is the people using pharmaceuticals such as pharmacists, medical doctors and patients. How can they contribute to more efficient use of pharmaceuticals with less environmental burden and less risk for drinking water. The book "Sustainable Pharmacy" will address all these issues and will be the first one dealing with this important topic.

Medical Aspects of Chemical Warfare

Author :
Publisher :
ISBN 13 :
Total Pages : 854 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Medical Aspects of Chemical Warfare by :

Download or read book Medical Aspects of Chemical Warfare written by and published by . This book was released on 2008 with total page 854 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Aspects of Chemical Warfare

Author :
Publisher : Government Printing Office
ISBN 13 :
Total Pages : 850 pages
Book Rating : 4./5 ( download)

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Book Synopsis Medical Aspects of Chemical Warfare by :

Download or read book Medical Aspects of Chemical Warfare written by and published by Government Printing Office. This book was released on 2008 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Schizophrenia Bulletin

Author :
Publisher :
ISBN 13 :
Total Pages : 1500 pages
Book Rating : 4.3/5 (126 download)

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Book Synopsis Schizophrenia Bulletin by :

Download or read book Schizophrenia Bulletin written by and published by . This book was released on 2007 with total page 1500 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Real World Drug Discovery

Author : Robert M. Rydzewski
Publisher : Elsevier
ISBN 13 : 0080914888
Total Pages : 535 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Real World Drug Discovery by : Robert M. Rydzewski

Download or read book Real World Drug Discovery written by Robert M. Rydzewski and published by Elsevier. This book was released on 2010-07-07 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research presents this kind of map of the landscape of drug discovery. In a single, readable volume it outlines processes and explains essential concepts and terms for the recent science graduate wondering what to expect in pharma or biotech, the medicinal chemist seeking a broader and more timely understanding of the industry, or the contractor or collaborator whose understanding of the commercial drug discovery process could increase the value of his contribution to it. - Interviews with well-known experts in many of the fields involved, giving insightful comments from authorities on many of the sub-disciplines important to cutting edge drug discovery. - Helpful suggestions gleaned from years of experience in biotech and pharma, which represents a repository drug discovery "lore" not previously available in any book. - "Periodic Table of Drugs" listing current top-selling drugs arranged by target and laid out so that structural similarities and differences are plain and clear. - Extensive use of diagrams to illustrate concepts like biotech startup models, preteomic profiling for target identification, Gantt charts for project planning, etc.