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.

The development and marketing of drugs since the Second World War offers an exemplary demonstration of the impact of technology on competitiveness in a major industry. While focusing primarily on the market in the USA, this study examines also the activities of European firms, their contribution to the industry's technological evolution and the impact of their entry into the US market.

The main concern of the book, however, is to examine all the elements which go to make up the evolving landscape of competition, and their interaction. Thus, the effects of technological change are viewed in the context of changes in the legal and regulatory environment, and in competitive practice. For both the market as a whole and the individual firm this analysis illustrates how competitive positions actually emerge as a result of such interactions.

Consistent with this wider view, both the technological and the non-technological competencies of firms are discussed, and the concept of core competence is used extensively to show how individual firms developed and maintained their competitive strengths, as the industry moved from deep-tank fermentation through to the first decade of biotechnology. The final chapter highlights the key role of biotechnology in shaping the future of the industry, at a time of increased regulation and accelerating market driven change.

Alzheimer's Disease (AD) is a growing global public health challenge. The development of new therapies is urgently needed, and a complex ecosystem of organizations has grown to facilitate AD drug discovery and development. Masterfully collating information on the drug development ecosystem, this book emphasizes the contributions of each aspect in the pipeline with a uniform approach to chapters, enabling readers to access relevant information quickly. Topics covered include the use of non-clinical laboratory studies, biomarker development, artificial intelligence, design and management of clinical trials, and funding and financing models. Also discussed is the critical role of advocacy fundraising for drug development. With the approval of aducanumab, the function of the ecosystem has become apparent. This is a definitive overview of how the ecosystem works in transferring an AD drug from its discovery in the laboratory through clinical trial testing to regulatory review and eventual marketing.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic "Pharmaco-complexity: Non-linear Phenomena and Drug Product Development".

The pharmaceutical industry has long and vehemently insisted that it has the willingness, the dedication, and the ability to police itself to insure that the public will not be unnecessarily harmed or defrauded. As the record shows with painful clarity, however, virtually no industry or professional group has ever adequately policed itself, and the pharmaceutical industry is no exception. Where the most flagrant abuses have been exposed and corrected, major credit must probably be divided among the media that publicized the situation, consumer groups that applied pressure, government officials who took actions that were often unpopular, and individual members of the pharmaceutical industry who had the courage to face up to their social responsibilities.
In this book, the authors turn their attention to what happened in Third World countries when, because of worldwide pressures, the multinational drug companies largely corrected their notorious abuses. On the basis of painstaking research, much of it conducted in a great many Third World countries, the authors conclude that a plethora of small local firms have filled the dishonest sales channels vacated by the multinationals. The authors show in great detail how local drug firms in the Third World have taken advantage of loose regulatory practices and unscrupulous behavior on the part of regional and national health care professionals to promote the sale of dangerous or worthless drugs as remedies for diseases for which they were never intended. Warnings of bad side effects are omitted from promotional literature, drugs are sold that have not had proper trials, and drug firms have often bribed government officials, doctors, and hospital administrators in order to gain favorable treatment in the importation and sale of their products. Among the many topics treated in this book are the controversy over inexpensive generic drugs (including disclosures of fraud and bribery in the U.S. Food and Drug Administration), the actions of consumer groups, and the key role of government in preventing abuses by drug firms. The authors describe a remarkable attempt in Bangladesh, one of the poorest of all the developing countries, to develop a high-quality local drug industry. They also present as case histories reports on three extremely important drug products or groups--the dipyrones (for control of pain and fever), high-dosage estrogen-progesterone hormone products (for use in pregnancy tests), and clioquinol or Enterovioform (for treatment of diarrhea)--all of which were or still are centers of worldwide, heated controversy.

Five years after publication of the third edition, and reflecting the dynamic nature of the pharmaceutical and medical device industries (as well as the many different areas of law that pertain to the management of these medical technologies), the Fourth Edition incorporates the latest legislative, regulatory, and judicial developments, describes recent scientific advances, and excerpts or references new scholarly contributions to this broad field (the wealth of citations should facilitate use in a seminar setting). Measured by volume, more than 20% of the previous edition has been replaced with new material. The latest edition retains the same basic thematic approach and modular structure of the original, which allows instructors to pick and choose the materials to cover based on their own tastes and areas of expertise.

Most people marvel at the level of innovation demonstrated by the biopharmaceutical industry in bringing new products to the market - especially in the past 20 years. However, there is a crisis looming in the industry that should be a concern to all of us who take for granted the constant pace at which new treatments, and increasingly cures, have emerged from the laboratories of current sector incumbents. In the book, we examine the evolution of the biopharmaceutical industry to understand how it became what we term a "unicorn industry" with a unique, US-centered business model that has led to multiple blockbuster products (aka, unicorns) year after year. We explore how past success has created perceived barriers to innovation diversification beyond the chemical or biological-based biopharmaceutical product, and highlight the warning signs of the industry's decline. We define a potential pathway for transforming the industry's business model by broadening the definition, sources, and enablers of innovation beyond the traditional biopharmaceutical product. We introduce and advocate for the 80-80 Rule - "Being 80% confident that you will only be 80% right the first time should feel normal." The 80-80 Rule is a theme that emphasizes speed and willingness to embrace uncertainty and overcome internal barriers to change. It sets the standard for redefining innovation as a platform to reignite growth of the biopharmaceutical industry.

Power Recruiting unfolds the mystery of how to effectively recruit for every industry. Diana Y. Ji is the founder and president of Bongene Search, an executive search firm dedicated to handling critical talent search needs in the biopharma industry. In Power Recruiting, she brings her twenty years of experience in corporate talent acquisition and executive search fields to teach hiring managers and recruiting professionals: The key to finding top talents and getting them onboard How to identify a good hire and avoid the bad ones The best strategies to make their company more attractive to potential hires Guarantee a successful hire every time Tips to getting ahead in the hiring game

Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications provides a thorough discussion of the most state of the art material and polymer exploitations for the delivery of bioactive(s) as well as their current and clinical status. The book enables researchers to prepare a variety of smart drug delivery systems to investigate their properties as well as to discover their uses and applications. The novelty of this approach addresses an existing need of exhaustively understanding the potential of the materials including polymeric drug delivery systems that are smartly designed to deliver bioactive(s) into the body at targeted sites without showing side effects. The book is helpful for those in the health sector, specifically those developing nanomedicine using smart material-based nano-delivery systems. Polymers have unique co-operative properties that are not found with low-molecular-weight compounds along with their appealing physical and chemical properties, constituting the root of their success in drug delivery. Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications discusses smart and stimuli responsive polymers applicable in drug delivery, followed detailed information about various concepts and designing of polymeric novel drug delivery systems for treatment of various type of diseases, also discussing patents related to the field. The book helps readers to design and develop novel drug delivery systems based on smart materials for the effective delivery of bioactive that take advantage of recent advances in smart polymer-based strategies. It is useful to those in pharmaceutical sciences and related fields in developing new drug delivery systems.

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.

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 pharma and medtech sectors are evolving rapidly, driven by science, technology, economics, politics and globalization. In the new industry landscape, creating strong brand strategies is ever more difficult and ever more vital. Brand Therapy gives pharma and medtech brand teams the tools to understand their market, create strong strategies and translate them into actionable plans. Written in 16 short, easy chapters, it is essential reading for anyone who works in or with brand teams in the life sciences industry.

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.

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.

Long the scourge of developing countries, fake pills are now increasingly common in the United States. The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers. Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become "medical tourists" seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA. Bitter Pills will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves. Author Muhammad H. Zaman pays special attention to the science and engineering behind both counterfeit and legitimate drugs, and the role of a "technological fix" for the fake drug problem. Increasingly, fake drugs affect us all.

International standards ensure that organisations operate the right processes to support their objectives. International Standards for Design and Manufacturing is an accessible guide for manufacturing and production managers and students. It guides readers through the standards needed to build operating systems which are robust and integrated. International Standards for Design and Manufacturing is based on a collaboration between Swansea University, BSI and manufacturing and production practitioners from key companies who have supplied cases of using standards in practice, such as Bosch, BP, Tesco, M&S and Toyota. Each chapter includes an introduction to the standards being discussed, definitions, case studies of using the standards in practice, statistics, why these standards are important, conclusions, seminar topics and exam questions.

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.

Increased governance of international trade through supra-national institutions such as the World Trade Organization (WTO) has meant that national trade and organisational strategies need to be compatible with the norms of global institutions. Global institutional change impacts national economies and necessitates adaptation in ways that balance adherence to emerging norms while maintaining broad socioeconomic national objectives. This book focuses on two sector-specific global institutional changes initiated and implemented by the WTO in 2005 and examines how India's textile and pharmaceutical industries coped with these changes through coordinated efforts in the multi-level national institutional system comprised of the state, industry and individual business organisations. The findings of the book, which show both convergence and divergence across the two industries in the processes and outcomes of dealing with global institutional change, would be of interest to national policymakers as well as to scholars in multiple disciplines interested in the study of institutions and institutional change.

This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.

This book examines an 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 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.

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.

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Merck and the pharmaceutical industry are headline news today. Controversies over public safety, prices, and the ability of the industry to develop the new drugs and vaccines that society needs have been covered worldwide. Roy Vagelos, who was head of research and then CEO at Merck from the mid-1970s through the early 1990s, addresses these issues here. Success with targeted research started Merck on a path that would lead to a series of block-buster therapies that carried the firm to the top of the global industry in the 1990s and Vagelos into the top position at the company. Trained as a physician and scientist, he had to learn how to run a successful business while holding to the highest principles of ethical behavior. He was not always successful. He and his co-author explain where and why he failed to achieve his goals and carefully analyze where he succeeded.