In the decades following the Civil War, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.

While there are a growing number of books based on the Toyota Production System, or lean, focused on healthcare, there are very few that detail the tools that make lean more than just a way of thinking and put the methodology into practice. Based on Hiroyuki Hirano's classic 5 Pillars of the Visual Workplace and modeled after the Shingo Prize-winning Shopfloor Series for Lean Manufacturers, 5S for Healthcare adopts a proven reader-friendly format to impart all the information needed to understand and implement this essential lean methodology. It provides examples and cased studies based on the experiences of the principals involved with the Rona Consulting Group, who were responsible for the groundbreaking implementation of the Toyota Production System at the Virginia Mason Medical Center. Written to readily assist with hands-on implementation efforts, this volume offers innovative features designed to improve understanding and support application. This includes helpful how-to steps and practical examples taken directly from the healthcare industry.

Bernadette Gral examines the relationship between financial slack and corporate performance in the European pharmaceutical industry during the financial crisis of 2007 to 2010. Her investigation includes correlational and regression analyses as well as the qualitative content analysis of newspaper articles. The results show that financial slack influences corporate performance measured as ROA based on net income, thus implying that firms use slack resources to enhance performance during crises. The findings support the arguments for a beneficial effect of financial slack on performance according to the resource based view and behavioral theory of the firm.

European and American drug regulators govern a multi-billion-dollar pharmaceutical industry selling its products on the world's two largest medicines markets. This is the first book to investigate how effectively American and supranational EU governments have regulated innovative pharmaceuticals regarding public health during the neo-liberal era of the last 30 years. Drawing on years of fieldwork, the authors demonstrate that pharmaceutical regulation and innovation have been misdirected by commercial interests and misconceived ideologies, which induced a deregulatory political culture contrary to health interests. They dismantle the myth that pharmaceutical innovations necessarily equate with therapeutic advances and explain how it has been perpetuated in the interests of industry by corporate bias within the regulatory state, unwarranted expectations of promissory science, and the emergent patient-industry complex. Endemic across both continents, the misadventures of pharmaceutical deregulation are shown to span many therapeutic areas, including cancer, diabetes and irritable bowel syndrome. The authors propose political changes needed to redirect pharmaceutical regulation in the interests of health.

Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.

Some two decades will shortly have passed since the WTO's Trade Related Aspects of Intellectual Property Rights agreement came into force in 1995. TRIPS is widely considered to have had a negative impact on access to medicines through its rules on pharmaceutical patents. This volume is the first cross-country analysis of how TRIPS has affected the capacity of 11 major low or medium income countries to produce generic drugs and assesses the wider political economy of drug production and consumption in the Global South.

Drug Law Reform in East and Southeast Asia is a multi-author look at drugs in East and Southeast Asia, on drug policy, patterns and trends, local problems, human rights abuses, treatment prospects, and potential reforms. From the history of drugs in Asia, the book examines recent trends in illicit drugs, especially the present enormous amphetamine problems. It addresses recent policy shifts, especially harm reduction responses to the devastating drug-associated HIV epidemics. It explores further necessary reform, especially in regard to the abysmally inhuman current emphasis on detention and the death penalty for drug offences, and present the most recent evidence on effective and humane approaches to drug treatments. As the first comprehensive collection on illicit drug and harm reduction in East and Southeast Asia, it will be a vital resource for health professionals, policymakers, and others working there and elsewhere on drug policy reform. As the first comprehensive collection on illicit drugs and harm reduction in East and Southeast Asia, it will be a vital resource for health professionals, policymakers, and others working on East and Southeast Asia--and elsewhere--on drug policy."

Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.

The pharmaceutical industry is one of today's most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success-or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: * An extensive literature review, including coverage of research from fields other than marketing * an overview of how practitioners have addressed the topic * introduction of relevant analytical tools, such as statistics and ethnographic studies * suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

This collection takes the perspective that the historiography of science, technology, and medicine needs a broader approach toward regulation. The authors explore the distinct social worlds involved in regulation, the forms of evidence and expertise mobilised, and means of intervention chosen to tame drugs in factories, consulting rooms and courts.

This book explains how government support and institutional set up facilitated the evolution of the Indian pharmaceutical industry and provides an economic analysis of firm strategies due to recent policy changes. The book is useful for researchers interested in understanding the transition of a lifeline sector for an emerging economy like India. Students of public policy, health administrators and health economists who are interested in the functioning of the pharmaceutical sector that produces life saving drugs in developing nations will find this book useful. The book also provides good coverage on data envelopment analysis (DEA), a useful technique for understanding productivity and efficiency. It can provide guidance to the research students on the applicability of DEA technique to address various research questions for analysis. The book will be a valuable addition to libraries in colleges of pharmacy and medicine as well as to all other academic and research centers.

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.

Our recent understanding of the cellular and molecular defects and the regulation of the apoptotic signalling pathways has resulted in rationally designed anticancer strategies and the development of novel agents that regulates apoptosis. A comprehensive review of all apoptotic-related anticancer therapies is not the purpose of this book. However, in the volume of this book with 11 chapters, we have described a number of novel apoptotic regulators that have shown promising value and also great feasibility for cancer treatment. These novel agents either occur naturally or are chemically synthesized. While we are excited about the discovery and development of these novel apoptotic regulators as potential anticancer agents, a degree of caution should be always borne in mind when interpreting the success of preclinical pro-apoptotic candidates since potential problems inevitably lie ahead. These problems usually include target specificity, unanticipated toxicity, compound stability, formulation issues, pharmacokinetic and pharmacodynamic profiles. Nevertheless, we believe that this collection of 11 chapters by established leaders in the area of apoptosis will be of great interest to not only academics working in the field of cancer research and apoptosis but also pharmaceutical and pharmacological industries that . We are looking forward to the further development to push these potential agents toward clinical stage.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. "Contract Research and Development Organizations: Their Role in Global Product Development" has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.

Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs. "

"This book reports empirical material from three case studies in the pharmaceutical industry, the biotechnology industry and the domain of academic research. New technoscientific frameworks that have not yet translated into new therapies, in the future, may play a more central role in the late-modern society"--

As the scope of available drug therapies expands, spending on prescription drugs has become the fastest-growing category of total spending on health care in the United States. Recently, that growth has slowed and that slowdown reflects changes in both the supply and demand for prescription drugs. This book examines the innovation, development and complexity issues present in the pharmaceutical industry.

"This book shows why contests over intellectual property rights and access to affordable medicines emerged in the 1990s and how they have been resolved so far. It argues that the current arrangement mainly ensures wealth for some rather than health for all, and points to broader concerns related to governing intellectual property solely as capital"--Provided by publisher.

The internationalization of research and technology is one key component of the globalization of trade and business, with potentially major impacts on patterns of economic development and public policies worldwide. Although certain aspects of this internationalization trend are well documented, and some effects can be quantified, the overall processes are extremely complex and the outcomes are highly uncertain. The existence of the phenomenon is generally accepted, but its importance and the trends are currently the topic of a lively debate. This study on "New Ways in Drug Development in Pharmaceuticals" is part of a three year project which aims at investigating how new concepts of industrial knowledge creation are implemented in the different environ ments of the innovation systems of the United States and Germany. The main focus of the overall project is a series of case studies of innovation practice in different national and sectoral contexts. The following sectors and technological fields are investigated: pharmaceuticals and new ways in drug development by the Fraunhofer Institute for Systems and Innovation Research (ISI), advanced materials by the University Hohenheim, Insti tute of International Management and Innovation (Alexander Gerybadze), financial services and home banking by the Massachusetts Institute of Tech nology (MIT), Center for Industrial Performance (Richard Lester) and the Sloan School of Management (Edward Roberts). Financially the project was supported by the German-American Academic Council, the German Federal Minstry of Education, Science Research and Technology and the Fraunhofer Society."

Pharmaceuticals are an essential component of health care. But for many people in low- and middle-income countries, access to the medicines they need to prevent or treat severe illnesses is limited. Typical problems are lack of availability, costs that exceed the individual s purchasing power or lack of competent agents health workers that are well trained to give the correct advice on which medicines to take. Pharmaceutical policy is the part of health policy that aims at addressing these problems and increasing access to safe, effective and affordable medicines for all patients. There are many obstacles against achieving these goals. Such obstacles can arise from financial interests on the side of suppliers and health care providers, who may benefit from charging higher prices and issuing more prescriptions than might be justified from a clinical and economic viewpoint. Or from rogue suppliers trying to introduce low quality or counterfeit drugs into markets with less effective regulation. Also, corruption and ineffective bureaucracies sometimes interfere with well intended programs to offer access to essential medicines for the poor. This book offers policy makers a hands-on approach, tested in the World Bank s field work in many countries, for assessing the pharmaceutical sector, recognizing typical patterns of dysfunction and developing strategies to quickly deal with the most urgent problems while at the same time building a platform for sustainable long term policy. It offers examples from a variety of low- and middle income countries and provides practical assessment tools for policy makers. The book ends with the author s outlook on future developments in this complex policy field."

This book demonstrates how the Thalidomide catastrophe of the 1960s and the BSE crisis of the 1990s led to regulatory regimes for pharmaceuticals and foodstuffs in Europe. However, the developmental paths of these regimes differ - and so does the efficiency and legitimacy of regulatory policy-making.

This book provides evidence to support the health-promoting components of green tea for human health. It explores the significance of green tea and its catechins represented by epigallocatechin gallate (EGCG), demonstrating their beneficial effects on diseases including cancer, obesity, arteriosclerosis, diabetes, hepatitis, and neurodegenerative diseases. The present status of human studies and avenues for future research are discussed. It is written by a team of experts from across the globe and makes significant Japanese findings available to international researchers. It is an essential resource for researchers interested in the biochemistry and pharmacology of green tea, and functional foods and beverages.

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.

This book examines how firms adapt to the pressures of increasing international competition by testing the arguments on "strategy specialization" proposed in the competitiveness literature in general, and by contributors to the "varieties of capitalism" debate in particular. If different economies are characterized by distinct institutional arrangements, successful firms would be those that exploit the related comparative advantages and specialize in the competitive strategies facilitated by national institutions.
One Political Economy, One Competitive Strategy? begins with an assessment of how many pharmaceutical firms in Germany, Italy, and the UK pursue strategies facilitated by national institutions governing the financial markets, antitrust activities, and the labor market. Quantitative analyses reveal that deviant firms, competing through institutionally unsupported strategies, outnumber conforming firms by far. Not only does this finding run counter to the expectations of the competitiveness literature, it brings up a whole new line of inquiry. How can firms compete through strategies that are not supported by national institutions? The book addresses this question and illustrates that firms do not necessarily exploit comparative institutional advantages, but that they can also circumvent institutional constraints. International markets and individual collaboration on a contractual basis allow firms to compete despite comparative institutional disadvantages. These findings suggest that trade liberalization does not lead to strategy specialization but to strategy diversification, depending on the inventiveness of entrepreneurs to develop individual approaches to compete.

Parallel trade occurs if international price differences for identical products are high and a policy of regional or international exhaustion of the respective property right has been implemented in the high price country. The work by C. Poget analyses how parallel imports of pharmaceuticals are affecting end consumer prices and drug expenditures in three Scandinavian countries, Sweden, Denmark and Norway. Based on his observations he derives proposals for policy reforms in EU member countries and Switzerland.

When I first joined the industry I searched for a book which could give some guidance as to what this role was all about. I never found that book so four years into my career I began writing Pharmaceutical Sales for Phools. Medical sales representatives who read this book will not encounter many surprises once they take their first steps out into the field, as this book has been designed to equip readers with a robust understanding of all the key dynamics of this sales role. Sahil Syed is an award winning representative who is now in his eighth year of frontline pharmaceutical sales. During this time he has worked with some of the largest and most successful pharmaceutical companies in the world. In this book he has given a highly practical account of how the role of a medical sales representative actually operates. "This book is the perfect read - not only for those who are trying to get into the industry, but also for experienced representatives who just want to keep up to date on the mechanics of the job. It is essential reading" Niall Barry - Director, Gem Resourcing "This book gives the first example I have seen of a common sense approach to the job which leaves nothing to the imagination" Charles Marshall - Director, Axis Development "This book is the medical representatives bible - it is indispensable, every rep should have a copy" Gary Fagg - Principal Sales Representative, Novartis