In pharmaceutical patent law, the problem of lack of policy direction and inappropriate legal framework is widespread - particularly among jurisdictions with little to no pharmaceutical research or manufacturing. This book aims to inform public policy and influence debate through a comprehensive review of Hong Kong's pharmaceutical patent law. By demonstrating the need for a holistic review of pharmaceutical patent laws and evaluating Hong Kong's system in light of health policy, economic and social factors, Bryan Mercurio recommends changes to the legal framework and constructs a more efficient and effective system for Hong Kong. He thoroughly evaluates the international framework and best practice models to offer a global perspective to each issue before providing local context in the analysis. While the focus of the book is Hong Kong, the analysis on pharmaceutical patent law and policy extends to other jurisdictions facing issues on reforming their national system.

The last two decades have seen great economic change in Asia and this has impacted upon the vexed question of access to affordable healthcare and medicines in many Asian states. In this book Locknie Hsu examines the issue of access to medicines in Asia from a fresh perspective which embraces trade and investment law, innovation, intellectual property law, competition policy and public health issues. Hsu explores the key evolving legal issues in these areas, including ASEAN integration, free trade agreement negotiations (such as those for the TPP), bilateral investment agreements and significant court decisions. The book goes on to present proposals for steps to be taken in addressing access to medicines in Asia and will be useful to academic researchers, regulators, law-makers and global organizations involved in the issues surrounding access to affordable healthcare and medicines.

Originally published in 1992, this study of Glaxo, from its beginnings to 1962, was based on unprecedented and unparalleled archival access to the company records. It gives a detailed account of the global operations of Glaxo, and describes not only the evolution of its international business, but studies its research and development programmes, its products, and its marketing and management. It was the first comprehensive study of a UK-based drugs company and one of the relatively few scholarly studies written of front-ranking world companies.

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."

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain uninformed of the core issues and are ill-prepared to understand pharmaceutical industry promotion. Furthermore, few medical curricula address this issue, despite warnings of the imperative need to address this gap in the education of tomorrow's physicians. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry.

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain uninformed of the core issues and are ill-prepared to understand pharmaceutical industry promotion. Furthermore, few medical curricula address this issue, despite warnings of the imperative need to address this gap in the education of tomorrow's physicians. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry.

Experiments on patients, processes or plants all have random error, making statistical methods essential for their efficient design and analysis. This book presents the theory and methods of optimum experimental design, making them available through the use of SAS programs. Little previous statistical knowledge is assumed. The first part of the book stresses the importance of models in the analysis of data and introduces least squares fitting and simple optimum experimental designs. The second part presents a more detailed discussion of the general theory and of a wide variety of experiments. The book stresses the use of SAS to provide hands-on solutions for the construction of designs in both standard and non-standard situations. The mathematical theory of the designs is developed in parallel with their construction in SAS, so providing motivation for the development of the subject. Many chapters cover self-contained topics drawn from science, engineering and pharmaceutical investigations, such as response surface designs, blocking of experiments, designs for mixture experiments and for nonlinear and generalized linear models. Understanding is aided by the provision of "SAS tasks" after most chapters as well as by more traditional exercises and a fully supported website. The authors are leading experts in key fields and this book is ideal for statisticians and scientists in academia, research and the process and pharmaceutical industries.

Situated at the crossroads between the history of colonialism, of modern Southeast Asia, and of medical pluralism, this history of medicine and health traces the life of pharmaceuticals in Vietnam under French rule. Laurence Monnais examines the globalization of the pharmaceutical industry, looking at both circulation and consumption, considering access to drugs and the existence of multiple therapeutic options in a colonial context. She argues that colonialism was crucial to the worldwide diffusion of modern medicines and speaks to contemporary concerns regarding over-reliance on pharmaceuticals, drug toxicity, self-medication, and the accessibility of effective medicines. Retracing the steps by which pharmaceuticals were produced and distributed, readers meet the many players in the process, from colonial doctors to private pharmacists, from consumers to various drug traders and healers. Yet this is not primarily a history of medicines as objects of colonial science, but rather a history of medicines as tools of social change.

Brand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies. "Pay-for-delay" agreements are "win-win" for the companies: brand name pharmaceutical prices stay high, and the brand and generic share the benefits of the brand's monopoly profits. Consumers lose, however: they miss out on generic prices that can be as much as 90 percent less than brand prices. For example, brand-name medication that costs $300 per month, might be sold as a generic for as little as $30 per month. This book examines the "pay-for-delay' program and how drug company pay-offs cost consumers billions.

This work examines an increasingly important phenomenon for competitiveness and innovation in industry: namely, the growing use of scientific principles in industrial research. Industrial innovation still arises from systematic trial-and-error experiments with many designs and objects, but these experiments are now being guided by a more rational understanding of phenomena. This has important implications for market structure, firm strategies and competition. Science and innovation focuses on the pharmaceutical industry. It discusses the changes that the notable advances in the life sciences since the 1980s have exerted on the strategies of drug companies, the organization of their internal research, their relationships with scientific institutions, the division of labour between large pharmaceutical firms and small research-intensive suppliers, the productivity of drug discovery and the productivity of R & D.

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 declinedWhere pharmaceutical companies need to invest their resourcesWhat can be done to solve core health challenges, including cancer, diabetes, and neurodegenerative diseasesHow 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 PharmaVideo: Can the Pharmaceutical Industry Restory its Broken Image?

A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands

The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, "Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand "explores this increasingly important field to help readers understand what they can--and must--do to get the most out of their brands.

Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future.

While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. "Pharmaceutical Lifecycle Management" walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.

The pharmaceutical industry is broken. From the American hedge fund manager who hiked the price of an AIDS pill from $17.50 to $750 overnight to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system that was designed to drive innovation and patient care has been relentlessly distorted to drive up profits. Medicines have become nothing more than financial assets. The focus of drug research, how drugs are priced and who has access to them is now dictated by shareholder value, not the good of the public. Drug companies fixated on ever-higher profits are being fined for bribing doctors and striking secret price-gouging deals, while patients desperate for life-saving medicines are driven to the black market in search of drugs that national health services can't afford. Sick Money argues that the way medicines are developed and paid for is no longer working. Unless we take action we risk a dramatic decline in the pace of drug development and a future in which medicines are only available to the highest bidder. In this book investigative journalist Billy Kenber offers a diagnosis of an industry in crisis and a prescription for how we can fight back.

The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? "Reputation and Power" traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.

Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.

"Reputation and Power" demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

Bioprospecting--the exchange of plants for corporate promises of royalties or community development assistance--has been lauded as a way to develop new medicines while offering southern nations and indigenous communities an incentive to preserve their rich biodiversity. But can pharmaceutical profits really advance conservation and indigenous rights? How much should companies pay and to whom? Who stands to gain and lose? The first anthropological study of the practices mobilized in the name and in the shadow of bioprospecting, this book takes us into the unexpected sites where Mexican scientists and American companies venture looking for medicinal plants and local knowledge.

Cori Hayden tracks bioprospecting's contentious new promise--and the contradictory activities generated in its name. Focusing on a contract involving Mexico's National Autonomous University, Hayden examines the practices through which researchers, plant vendors, rural collectors, indigenous cooperatives, and other actors put prospecting to work. By paying unique attention to scientific research, she provides a key to understanding which people and plants are included in the promise of "selling biodiversity to save it"--and which are not. And she considers the consequences of linking scientific research and rural "enfranchisement" to the logics of intellectual property.

Roving across UN protocols, botanical collecting histories, Mexican nationalist agendas, neoliberal property regimes, and North-South relations, "When Nature Goes Public" charts the myriad, emergent publics that drive and contest the global market in biodiversity and its futures.

The Pharmaceutical Studies Reader is an engaging survey of the field that brings together provocative, multi-disciplinary scholarship examining the interplay of medical science, clinical practice, consumerism, and the healthcare marketplace. * Draws on anthropological, historical, and sociological approaches to explore the social life of pharmaceuticals with special emphasis on their production, circulation, and consumption * Covers topics such as the role of drugs in shaping taxonomies of disease, the evolution of prescribing habits, ethical dimensions of pharmaceuticals, clinical trials, and drug research and marketing in the age of globalization * Offers a compelling, contextually-rich treatment of the topic that exposes readers to a variety of approaches, ideas, and frameworks * Provides an accessible introduction for readers with no previous background in this area

Give and Take looks at local drug manufacturing in Kenya, Tanzania, and Uganda, from the early 1980s to the present, to understand the impact of foreign aid on industrial development. While foreign aid has been attacked by critics as wasteful, counterproductive, or exploitative, Nitsan Chorev makes a clear case for the effectiveness of what she terms "developmental foreign aid." Against the backdrop of Africa's pursuit of economic self-sufficiency, the battle against AIDS and malaria, and bitter negotiations over affordable drugs, Chorev offers an important corrective to popular views on foreign aid and development. She shows that when foreign aid has provided markets, monitoring, and mentoring, it has supported the emergence and upgrading of local production. In instances where donors were willing to procure local drugs, they created new markets that gave local entrepreneurs an incentive to produce new types of drugs. In turn, when donors enforced exacting standards as a condition to access those markets, they gave these producers an incentive to improve quality standards. And where technical know-how was not readily available and donors provided mentoring, local producers received the guidance necessary for improving production processes. Without losing sight of domestic political-economic conditions, historical legacies, and foreign aid's own internal contradictions, Give and Take presents groundbreaking insights into the conditions under which foreign aid can be effective.

The dean of business historians continues his masterful chronicle of the transforming revolutions of the twentieth century begun in "Inventing the Electronic Century,"

Alfred Chandler argues that only with consistent attention to research and development and an emphasis on long-term corporate strategies could firms remain successful over time. He details these processes for nearly every major chemical and pharmaceutical firm, demonstrating why some companies forged ahead while others failed.

By the end of World War II, the chemical and pharmaceutical industries were transformed by the commercializing of new learning, the petrochemical and the antibiotic revolutions. But by the 1970s, chemical science was no longer providing the new learning necessary to commercialize more products, although new directions flourished in the pharmaceutical industries. In the 1980s, major drug companies, including Eli Lilly, Merck, and Schering Plough, commercialized the first biotechnology products, and as the twenty-first century began, the infrastructure of this biotechnology revolution was comparable to that of the second industrial revolution just before World War I and the information revolution of the 1960s. "Shaping the Industrial Century" is a major contribution to our understanding of the most dynamic industries of the modern era.

Millions of people in the third world die from diseases that are rare in the first world--diseases like malaria, tuberculosis, and schistosomiasis. AIDS, which is now usually treated in rich countries, still ravages the world's poor. Vaccines offer the best hope for controlling these diseases and could dramatically improve health in poor countries. But developers have little incentive to undertake the costly and risky research needed to develop vaccines. This is partly because the potential consumers are poor, but also because governments drive down prices. In Strong Medicine, Michael Kremer and Rachel Glennerster offer an innovative yet simple solution to this worldwide problem: "Pull" programs to stimulate research. Here's how such programs would work. Funding agencies would commit to purchase viable vaccines if and when they were developed. This would create the incentives for vaccine developers to produce usable products for these neglected diseases. Private firms, rather than funding agencies, would pick which research strategies to pursue. After purchasing the vaccine, funders could distribute it at little or no cost to the afflicted countries. Strong Medicine details just how these legally binding commitments would work. Ultimately, if no vaccines were developed, such a commitment would cost nothing. But if vaccines were developed, the program would save millions of lives and would be among the world's most cost-effective health interventions.

Irving Kirsch has the world doubting the efficacy of antidepressants. Based on fifteen years of research, The Emperor's New Drugs makes an overwhelming case that what the medical community considered a cornerstone of psychiatric treatment is little more than a faulty consensus. But Kirsch does more than just criticize: He offers a path society can follow to stop popping pills and start proper treatment.

A free open access ebook is available upon publication. Learn more at www.luminosoa.org. Capitalizing a Cure takes readers into the struggle over a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When curative treatments for hepatitis C launched in 2013, sticker shock over their prices intensified the global debate over access to new medicines. Weaving historical research with insights from political economy and science and technology studies, Victor Roy demystifies an oft-missed dynamic in this debate: the reach of financialized capitalism into how medicines are made, priced, and valued. Roy's account moves between public and private labs, Wall Street and corporate board rooms, and public health meetings and health centers to trace the ways in which curative medicines became financial assets dominated by strategies of speculation and extraction at the expense of access and care. Provocative and sobering, this book illuminates the harmful impact of allowing financial markets to determine who heals and who suffers and points to the necessary work of building more equitable futures.

This searing indictment, David HealyOCOs most comprehensive and forceful argument against the pharmaceuticalization of medicine, tackles problems in health care that are leading to a growing number of deaths and disabilities. Healy, who was the first to draw attention to the now well-publicized suicide-inducing side effects of many anti-depressants, attributes our current state of affairs to three key factors: product rather than process patents on drugs, the classification of certain drugs as prescription-only, and industry-controlled drug trials. These developments have tied the survival of pharmaceutical companies to the development of blockbuster drugs, so that they must overhype benefits and deny real hazards. Healy further explains why these trends have basically ended the possibility of universal health care in the United States and elsewhere around the world. He concludes with suggestions for reform of our currently corrupted evidence-based medical system.

Ernest Solvay, philanthropist and organizer of the world-famous Solvay conferences on physics, discovered a profitable way of making soda ash in 1861. Together with a handful of associates, he laid the foundations of the Solvay company, which successfully branched out into other chemicals, plastics and pharmaceuticals. Since its emergence in 1863, Solvay has maintained world leadership in the production of soda ash. This is the first scholarly book on the history of the Solvay company, which was one of the earliest chemical multinationals and today is among the world's twenty largest chemical companies. It is also one of the largest companies in the field to preserve its family character. The authors analyze the company's 150-year history (1863-2013) from economic, political and social perspectives, showing the enormous impact geopolitical events had on the company and the recent consequences of global competition.