Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry's main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.

The fields of pharmaceutical economics and health economics/policy are reaching a point of convergence. This is due to both the widespread availability of pharmaceutical treatments, accompanied by broader insurance coverage, and the regulation of prescription drugs in both private and government plans. This book will bridge the gap. We will explore developments in both U.S. and International setting. The system of the U.S. is characterized by a mix of private and government insurance for prescription drugs with the expansion of Medicare Part D. Most other developed countries are characterized by social insurance with either the government as a single payer such as in Canada or Australia, or a national health service as in many other European countries.

How often do we stop to recognize what pharmaceutical advertisements are telling us? Broadcast Pharmaceutical Advertising in the United States: Prime Time Pill Pushers engages with this question to include how pharmaceutical companies are shaping the meaning of drug interventions for individuals and the ways in which pharmaceutical advertisements frame issues of identity and representation for patients and health care. Such issues highlight how patients are being framed as consumers in these advertisements, which then permits the commodification of health care to be celebrated. Such a celebration has strong ideological implications, including definitions of "the good life," patient agency, and the role of DTCAs in such depictions. By defining and discussing medicalization, pharmaceuticalization, and commodity fetishism, this book introduces how the term "pharmaceutical fetishism" can act as a means for describing the commodification of brand-name pharmaceutical drugs, which, via advertising and promotional culture, ignores large-scale production and for-profit motives of "big pharma."

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure - about 60 per cent - and characterised by very high share of medicines in total health expenditure.

The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. * First book of its kind focusing strictly on CMC Bayesian case studies * Case studies with code and output * Representation from several companies across the industry as well as academia * Authors are leading and well-known Bayesian statisticians in the CMC field * Accompanying website with code for reproducibility * Reflective of real-life industry applications/problems

Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world's poor see little effort to address diseases prevalent in less affluent societies, while the world's wealthy are overusing prescription drugs, risking their health and wasting resources. The debate over health care reform and the ongoing global economic crisis form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.

Appraising cancer as a major medical market in the 2010s, Wall Street investors placed their bets on single-technology treatment facilities costing $100-$300 million each. Critics inside medicine called the widely-publicized proton-center boom "crazy medicine and unsustainable public policy." There was no valid evidence, they claimed, that proton beams were more effective than less costly alternatives. But developers expected insurance to cover their centers' staggeringly high costs and debts. Was speculation like this new to health care? Cancer, Radiation Therapy, and the Market shows how the radiation therapy specialty in the United States (later called radiation oncology) coevolved with its device industry throughout the twentieth-century. Academic engineers and physicians acquired financing to develop increasingly powerful radiation devices, initiated companies to manufacture the devices competitively, and designed hospital and freestanding procedure units to utilize them. In the process, they incorporated market strategies into medical organization and practice. Although palliative benefits and striking tumor reductions fueled hopes of curing cancer, scientific research all too often found serious patient harm and disappointing beneficial impact on cancer survival. This thoroughly documented and provocative inquiry concludes that public health policy needs to re-evaluate market-driven high-tech medicine and build evidence-based health care systems.

Businesses that produce bioscience products--gene tests and therapies, pharmaceuticals, vaccines, and medical devices--are regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work.
This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of fields, including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

The global pharmaceutical industry is currently estimated to be worth $1 trillion. Contributors chart the rise of scientific marketing within the industry from 1920-1980. This is the first comprehensive study into pharmaceutical marketing, demonstrating that many new techniques were actually developed in Europe before being exported to America.

This book provides a fresh, multidisciplinary, and exciting look at the making and remaking of pharmaceutical patents at the GATT/WTO, by utilising a Coxian political economy of continuity and change in the global political economy (GPE). Marcellin focuses on the role of the transnational drug industry in the making of the patent provisions in the original TRIPS Agreement and consequently, the role of the African Group at the WTO in the remaking of those patent provisions.

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

Written by John Lidstone and Janice MacLennan, the second edition of Marketing Planning for the Pharmaceutical Industry became accepted as the bible for the industry. In this new companion book Janice MacLennan picks up two of the themes touched on in Marketing Planning - market segmentation and branding, and the inter-relationship between these two - and with this book makes them key topics for discussion. Brand Planning for the Pharmaceutical Industry begins by exploring what branding is and why it is of importance, particularly to the pharmaceutical sector. The book then goes on to show how branding can be integrated into the early stages of the commercialization process for new products, both in theory and in the 'real' world. The book provides a step-by-step guide to brand planning, using market segmentation as the starting point. The book is split into two parts, the first dealing comprehensively with brand planning for products yet to get to the market, with the second part applying the same process to products that are already on the market. Both parts are extremely pragmatic, full of pertinent examples and insights from the pharmaceutical industry, and are directly applicable to your own brand planning. Brand Planning for the Pharmaceutical Industry concludes by confronting the problems that organizations are likely to have in actually making brand planning an integral part of their work and presents strategies for dealing with them.

In 1950, a diagnosis of cancer was all but a death sentence. Mortality rates only got worse, and as late as 1986, an article in the New England Journal of Medicine lamented: We are losing the war against cancer." Cancer is one of humankind's oldest and most persistent enemies it has been called the existential disease.But we are now entering a new, and more positive, phase in this long campaign. While cancer has not been cured,and a cure may elude us for a long time yet,there has been a revolution in our understanding of its nature. Years of brilliant science have revealed how this individualistic disease seizes control of the foundations of life,our genes,and produces guerrilla cells that can attack and elude treatments. Armed with those insights, scientists have been developing more effective weapons and producing better outcomes for patients. Paul A. Marks, MD, has been a leader in these efforts to finally control this devastating disease.Marks helped establish the strategy for the war on cancer" in 1971 as a researcher and member of President Nixon's cancer panel. As the president and chief executive officer for nineteen years at the world's pre-eminent cancer hospital, the Memorial Sloan-Kettering Cancer centre, he was instrumental in ending the years of futility. He also developed better therapies that promise a new era of cancer containment. Some cancers, like childhood leukemia and non-Hodgkin's lymphoma, that were once deadly conditions, are now survivable,even curable. New steps in prevention and early diagnosis are giving patients even more hope. On the Cancer Frontier is Marks' account of the transformation in our understanding of cancer and why there is growing optimism in our ability to stop it.

This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry. Key features include: Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter. This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

This book examines the nature and extent of competition in the pharmaceutical industry and analyses the interaction between market structure and selected elements of the marketing mix. It provides valuable insights into the level of promotional expenditure required to achieve a significant market share for new products; the use of price, new products and promotional strategies to protect market share; the effects of patent expiration on price levels and the use of pricing strategy to achieve market share. The book includes a brief comparative analysis of competition and marketing strategies in the US ethical pharmaceutical market.

First made in the late 19th century, paracetamol is now widely used in a variety of pharmaceutical products. It is used as a painkiller and to reduce the temperature of patients with a fever. Aimed at post-16 students, this book provides a series of classroom activities, both written and practical, relating to paracetamol. The activities can be carried out singly, or as a coherent package, and are supported by a guide for teachers and technicians.

Global Issues in Pharmaceutical Marketing presents a balanced, research-based perspective combined with a practical outlook on the current issues faced by the ethical, biotech, and generic segments of the pharmaceutical industry. It integrates an analytical approach with a global view to examine such issues as market access, digital marketing, emerging markets, branding, and more. The book covers not only the North American and Western European markets, but focuses on non-Western markets, such as Latin America and Asia. Each chapter is written as an individual essay about a given issue, and where relevant, original cases are provided to illustrate how these issues are currently managed by the global industry. This book offers a thoughtful and thorough description of the industry's current situation and integrates the latest scholarly and industry research from different disciplines in one place for convenient reference. It may be used in the following ways: To stimulate class discussions and inspire new streams of research for academics and graduate students; To introduce the industry to those interested in a career, to orient new industry hires, or to provide experienced practitioners with current research that will enhance their knowledge; To provide an understanding of the industry for those in the healthcare sector, such as physicians, pharmacists, as well as medical and pharmacy students; and To present recent and relevant research for those in government, public or private payers, and public policy environments to facilitate their decision making. This book will prove to be a useful resource and an important source of information for academics and their students, professionals, and policymakers around the world.

Global Issues in Pharmaceutical Marketing presents a balanced, research-based perspective combined with a practical outlook on the current issues faced by the ethical, biotech, and generic segments of the pharmaceutical industry. It integrates an analytical approach with a global view to examine such issues as market access, digital marketing, emerging markets, branding, and more. The book covers not only the North American and Western European markets, but focuses on non-Western markets, such as Latin America and Asia. Each chapter is written as an individual essay about a given issue, and where relevant, original cases are provided to illustrate how these issues are currently managed by the global industry. This book offers a thoughtful and thorough description of the industry's current situation and integrates the latest scholarly and industry research from different disciplines in one place for convenient reference. It may be used in the following ways: To stimulate class discussions and inspire new streams of research for academics and graduate students; To introduce the industry to those interested in a career, to orient new industry hires, or to provide experienced practitioners with current research that will enhance their knowledge; To provide an understanding of the industry for those in the healthcare sector, such as physicians, pharmacists, as well as medical and pharmacy students; and To present recent and relevant research for those in government, public or private payers, and public policy environments to facilitate their decision making. This book will prove to be a useful resource and an important source of information for academics and their students, professionals, and policymakers around the world.