In the US alone, pharmaceutical companies spend around $7 billion a year on clinical trials for drugs; all this in a global market where increasing competition and pressure on healthcare financing are both impacting on margins and profitability. One solution for pharmaceutical companies lies within the clinical trials themselves. If only you can communicate the trial findings to the right people, in the right way, you can benefit from this huge investment and add significant value to your product range and your brand. Successfully Marketing Clinical Trials Results is a comprehensive guide for every marketing professional faced with the challenge of using marketing to convert scientific data into sales. The book offers you practical knowledge on how to use medical research data to maximise the revenue from your products. There are sections explaining how to: identify your market and devise your strategy; develop your content and translate data into a message that has impact; use language, layout and illustrations to best effect; communicate internally as well as externally; make best use of the resources available; align your sales force and the external agencies with whom you work; lead the people in the project team; co-operate with the medical researchers, external experts and the press. In this book are answers for everything from how to handle class-effect questions to developing a shared brand vocabulary. There are plenty of vivid examples and real-life applications to reinforce the ideas. Cases studies illustrate solutions to problems; checklists and tips will help to implement the suggestions and recommendations. Gunter Umbach has distilled the essence both of 25 years' experience in the healthcare market and of his highly successful seminar series on marketing clinical trials into the professional advice given in this book. The text is accompanied by a CD ROM containing detailed Powerpoint slides supporting e

In the US alone, pharmaceutical companies spend around $7 billion a year on clinical trials for drugs; all this in a global market where increasing competition and pressure on healthcare financing are both impacting on margins and profitability. One solution for pharmaceutical companies lies within the clinical trials themselves. If only you can communicate the trial findings to the right people, in the right way, you can benefit from this huge investment and add significant value to your product range and your brand. Successfully Marketing Clinical Trials Results is a comprehensive guide for every marketing professional faced with the challenge of using marketing to convert scientific data into sales. The book offers you practical knowledge on how to use medical research data to maximise the revenue from your products. There are sections explaining how to: identify your market and devise your strategy; develop your content and translate data into a message that has impact; use language, layout and illustrations to best effect; communicate internally as well as externally; make best use of the resources available; align your sales force and the external agencies with whom you work; lead the people in the project team; co-operate with the medical researchers, external experts and the press. In this book are answers for everything from how to handle class-effect questions to developing a shared brand vocabulary. There are plenty of vivid examples and real-life applications to reinforce the ideas. Cases studies illustrate solutions to problems; checklists and tips will help to implement the suggestions and recommendations. Gunter Umbach has distilled the essence both of 25 years' experience in the healthcare market and of his highly successful seminar series on marketing clinical trials into the professional advice given in this book. The text is accompanied by a CD ROM containing detailed Powerpoint slides supporting e

Darwin's Medicine is the sequel to Brian D. Smith's influential and critically acclaimed Future of Pharma (Gower, 2011). Whereas the earlier book predicted the evolution of the pharmaceutical market and the business models of pharmaceutical companies, Darwin's Medicine goes much deeper into the drivers of industry change and how leading pharmaceutical and medical technology companies are adapting their strategies, structures and capabilities in practice. Through the lens of evolutionary science, Professor Smith explores the speciation of new business models in the Life Sciences Industry. This sophisticated and highly original approach offers insights into: The mechanisms of evolution in this exceptional industry; The six great technological and social shifts that are shaping its landscape; The emergence of 26 distinct, new business models; and The lessons that enable firms to direct and accelerate their own evolution. These insights map out the industry's complex, changing landscape and provide an invaluable guide to those firms seeking to survive and thrive in this dynamic market. The book is essential reading for anyone working in or studying the pharmaceutical, medical technology and related sectors. It provides a unique and novel way of making sense of the transformation we can see going on around us and a practical, focused approach to managing a firm's evolutionary trajectory.

What's the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

In the post-liberalization period, India has slowly but steadily tried to foster innovation to improve competitive efficiency of Indian manufacturing and thus boost global competitiveness of the industrial sector. Foreign direct investment was looked upon as a major source of technology paradigm shift; in recent times, industrial firms have been investing overseas, even in countries to which they used to export, based on their technological capabilities. Firms in Indian manufacturing industries have also attempted to bring about technological upgrades through imports of design and drawings (disembodied technology) against lump sum, royalty and technical knowhow fees, and imports of capital machinery (embodied technology) where the technology is embodied in the capital good itself. This volume comprises empirical contributions on this emerging phenomenon, on a range of issues including the role of R mergers, acquisitions and technological efforts; technological determinants of competitive advantages; the role of small and medium enterprises and regional patterns; technological efforts and global operations; and the role of industrial clusters in promoting innovation and competitiveness. This book was originally published as a special issue of Innovation and Development.

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.

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.

Boosting Pharmaceutical Innovation In The Post-TRIPS Era investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, it identifies the key issues relevant to the revival of local pharmaceutical industries.Based on an understanding of the post-TRIPS environment and case studies of national innovation strategies, the book specifically addresses an important question - to what extent can lessons from national experiences be transferred to current policy developments for innovation in the pharmaceutical industry in a developing country context? The book sets out a number of recommendations on how this can be achieved. It suggests that it can be done in relation to the key development objectives of promoting the technological and scientific advancement of the country, enhancing local pharmaceutical innovation capacities, adapting patent law to own local realities, providing wide access to medicines and knowledge, safeguarding public health interests, and fostering innovation. Practitioners and policy planners within the pharmaceutical industry will deem this book invaluable as it addresses a number of practical implications for the promotion of the pharmaceutical industry. It will also be of enormous interest to students, researchers and academics specializing in intellectual property law and policy, science and technology, and the management of technology and innovation. Contents: 1. Introduction 2. Innovation 3. Innovation and the Pharmaceutical Industry 4. Looking at the Big Picture: National Innovation System 5. Innovation Country Case Studies 6. A Real Life Company Case Study; TEVA Pharmaceuticals Ltd. and its Distinctive Trajectories 7. Real life lessons for the developing world Bibliography Index

Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent need for novel therapies cannot stem the skyrocketing costs and plummeting productivity plaguing R&D, and many key products are facing patent expiration. Dr. Rathnam Chaguturu presents a case for collaboration between the pharmaceutical industry and academia that could reverse the industry's decline. Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Founder and CEO of iDDPartners, focused on pharmaceutical innovation, Founding president of the International Chemical Biology Society, and Senior Director-Discovery Sciences, SRI International, Dr. Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement. * Gain global perspectives on the benefits and potential issues surrounding collaborative innovation * Discover how industries can come together to prevent another "Pharma Cliff" * Learn how nonprofits are becoming the driving force behind innovation * Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration * Explore government initiatives that help foster cooperation between industry and academia Dr. Chaguturu s thirty-five years of experience in academia and industry, managing new lead discovery projects and forging collaborative partnerships with academia, disease foundations, nonprofits, and government agencies lend him an informative perspective into the issues facing pharmaceutical progress. In Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships, he and his expert team provide insight into the various nuances of the debate.

The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with 18 chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.

Written by Lawton R. Burns and a panel of expert contributors, from the prestigious Wharton School, The Health Care Value Chain analyzes the key developments and future trends in the United States' health care supply chain. Based on a groundbreaking research initiative underwritten by the industry/university consortium— the Center for Health Management Research— this important book offers an in-depth examination of how the health care supply chain helps create value and competitive advantage.
The Health Care Value Chain offers a thorough examination of the trading relationships among the manufacturers of health care products, the distributors, the group purchasing organizations, and the hospital customers and end users of those products. And the authors show how health care professionals and manufacturers can work together to form beneficial strategic alliances.

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.

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 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.

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.

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.

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.