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| Author | : United States. Congress. House. Committee on Science and Technology. Subcommittee on Natural Resources, Agriculture Research, and Environment |
| Publisher | : |
| Total Pages | : 260 |
| Release | : 1982 |
| Genre | : Drugs |
| ISBN | : |
| Author | : United States. Congress. House. Committee on Science and Technology. Subcommittee on Natural Resources, Agriculture Research, and Environment |
| Publisher | : |
| Total Pages | : 237 |
| Release | : 1982 |
| Genre | : |
| ISBN | : |
| Author | : Stuart O. Schweitzer |
| Publisher | : Oxford University Press |
| Total Pages | : 433 |
| Release | : 2018 |
| Genre | : Business & Economics |
| ISBN | : 0190623780 |
The pharmaceutical industry -- The biotechnology industry -- Generics and biosimilars -- The global pharmaceutical industry -- The demand for pharmaceuticals -- The demand for pharmaceuticals in major international markets -- Pharmaceutical prices -- Economic evaluation of new drugs -- Pricing pharmaceuticals in a world environment -- Pharmaceutical marketing -- Patent protection -- Drug approval process in the United States -- Pharmaceutical regulation in the European Union -- Pharmaceuticals and public policy : a look ahead
| Author | : Oliver Gassmann |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 194 |
| Release | : 2008-02-19 |
| Genre | : Business & Economics |
| ISBN | : 3540776362 |
Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.
| Author | : Erika Lietzan |
| Publisher | : |
| Total Pages | : 48 |
| Release | : 2019 |
| Genre | : |
| ISBN | : |
Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money -- three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent protection and regulatory exclusivity. Both are designed to provide the innovator with a temporary period of exclusive sales for the use in question. In theory, a generic should be dispensed for all other uses, but the innovator should enjoy all sales for the new use. In fact, though, the sales are not excludable; the incentives are nothing more than paper promises. Generic companies generally enjoy the new-use sales as well. This is flatly inconsistent with the goal of the federal laws governing new-use patents and new-use regulatory exclusivity, and it needs to stop. It happens because we have acquiesced to FDA practices and policies, state laws and policies, and healthcare professional and payer behaviors that work together to gut the incentives put in place by Congress. This Article considers ways of reforming practices at the agency and elsewhere in the healthcare system, so that we can have prompt approval of lower cost generic drugs when patents and exclusivity on a brand drug's underlying compound and initial use expire, and automatic substitution of those generics when the brand drug is prescribed for the initial use, without the gutting of incentives enacted by Congress.
| Author | : Ralph Landau |
| Publisher | : Chemical Heritage Foundation |
| Total Pages | : 442 |
| Release | : 1999 |
| Genre | : Business & Economics |
| ISBN | : 9780941901215 |
Documents how science has provided an astonishing array of medicines for coping with human ailments. This volume addresses industry leaders, economic influences, and the development of individual products. It is suitable for policy makers, economists, corporate executives, research managers, and historians of science, technology, and medicine.
| Author | : Oliver Gassmann |
| Publisher | : Springer |
| Total Pages | : 179 |
| Release | : 2019-01-12 |
| Genre | : Business & Economics |
| ISBN | : 9783030097820 |
Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.
| Author | : John L. LaMattina |
| Publisher | : John Wiley & Sons |
| Total Pages | : 173 |
| Release | : 2012-12-10 |
| Genre | : Medical |
| ISBN | : 1118511255 |
An expert's view on solving the challenges confronting today's pharmaceutical industry Author John LaMattina, a thirty-year veteran of the pharmaceutical industry and former president of Pfizer's Global R&D Division, is internationally recognized as an expert on the pharmaceutical industry. His first book, Drug Truths: Dispelling the Myths About Pharma R&D, was critically acclaimed for clearing up misconceptions about the pharmaceutical industry and providing an honest account of the contributions of pharmaceutical research and development to human health and well-being. As he toured the country discussing Drug Truths, Dr. LaMattina regularly came across people who were filled with anger, accusing the pharmaceutical industry of making up diseases, hiding dangerous side effects, and more. This book was written in response to that experience, critically examining public perceptions and industry realities. Starting with "4 Secrets that Drug Companies Don't Want You to Know," Devalued and Distrusted provides a fact-based account of how the pharmaceutical industry works and the challenges it faces. It addresses such critical issues as: Why pharmaceutical R&D productivity has declined Where pharmaceutical companies need to invest their resources What can be done to solve core health challenges, including cancer, diabetes, and neurodegenerative diseases How the pharmaceutical industry can regain public trust and resuscitate its image Our understanding of human health and disease grows daily; however, converting science into medicine is increasingly challenging. Reading Devalued and Distrusted, you'll not only gain a greater appreciation of those challenges, but also the role that the pharmaceutical industry currently plays and can play in solving those challenges. Get to know the author: Read an interview with John LaMattina or watch a video on ChemistryViews! Interview: John LaMattina: 30 Years in Pharma Video: Can the Pharmaceutical Industry Restory its Broken Image?
| Author | : Stuart O. Schweitzer |
| Publisher | : Oxford University Press |
| Total Pages | : 362 |
| Release | : 2007 |
| Genre | : Business & Economics |
| ISBN | : 9780195300956 |
Publisher description
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 107 |
| Release | : 2014-02-06 |
| Genre | : Medical |
| ISBN | : 0309292492 |
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.
