Every year the average number of prescriptions purchased by Americans increases, as do healthcare expenditures, which are projected to reach one-fifth of the U.S. gross domestic product by 2020. In "Drugs for Life," Joseph Dumit considers how our burgeoning consumption of medicine and cost of healthcare not only came to be, but also came to be taken for granted. For several years, Dumit attended pharmaceutical industry conferences; spoke with marketers, researchers, doctors, and patients; and surveyed the industry's literature regarding strategies to expand markets for prescription drugs. He concluded that underlying the continual growth in medications, disease categories, costs, and insecurity is a relatively new perception of ourselves as inherently ill and in need of chronic treatment. This perception is based on clinical trials that we have largely outsourced to pharmaceutical companies. Those companies in turn see clinical trials as investments and measure the value of those investments by the size of the market and profits that they will create. They only ask questions for which the answer is more medicine. "Drugs for Life" challenges our understanding of health, risks, facts, and clinical trials, the very concepts used by pharmaceutical companies to grow markets to the point where almost no one can imagine a life without prescription drugs.

Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry.

The widespread condemnation of drastic price increases on life-saving drugs highlights our growing dependency on and vulnerability to international pharmaceutical conglomerates. However, aren't the interests of the public supposed to supersede the pursuit of private profit? In his new work, Private Profits versus Public Policy, Joel Lexchin addresses this question as he examines how public policy with respect to the pharmaceutical industry has evolved in Canada over the past half century. Although the Canadian government is supposed to regulate the industry to serve the needs of public health, waves of deregulatory reforms and intellectual property rights legislation have shifted the balance of power in favour of these companies' quest for profit. Joel Lexchin offers a series of recommendations to tip the scale back in the public's favour. This enlightening work is the first book that deals exclusively with the pharmaceutical industry in Canada in over thirty years.

The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.

Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation.

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

Mathematics for Physical Chemistry, Fifth Edition includes exercises that enable readers to test their understanding and put theory into practice. Chapters are constructed around a sequence of mathematical topics, progressing gradually into more advanced material, before discussing key mathematical skills, including the analysis of experimental data and-new to this edition-complex variables. Includes additional new content on Mathematica and its advanced applications. Drawing on the experience of its expert authors, this book is the ideal supplementary text for practicing chemists and students wanting to sharpen their mathematics skills and understanding of key mathematical concepts for applications across physical chemistry.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

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.

In this unprecedented account of the dynamics of Nigeria's pharmaceutical markets, Kristin Peterson connects multinational drug company policies, oil concerns, Nigerian political and economic transitions, the circulation of pharmaceuticals in the Global South, Wall Street machinations, and the needs and aspirations of individual Nigerians. Studying the pharmaceutical market in Lagos, Nigeria, she places local market social norms and credit and pricing practices in the broader context of regional, transnational, and global financial capital. Peterson explains how a significant and formerly profitable African pharmaceutical market collapsed in the face of U.S. monetary policies and neoliberal economic reforms, and she illuminates the relation between that collapse and the American turn to speculative capital during the 1980s. In the process, she reveals the mutual constitution of financial speculation in the drug industry and the structural adjustment plans that the IMF imposed on African nations. Her book is a sobering ethnographic analysis of the effects of speculation and "development" as they reverberate across markets and continents, and play out in everyday interpersonal transactions of the Lagos pharmaceutical market.  

Even for highly qualified candidates, becoming a Medical Science Liaison is a challenging endeavor It's nearly impossible to achieve on your own without the proper preparation and guidance... The Medical Science Liaison Career Guide: How to Break into Your First Role will show you, step by step, how to search for, apply, and interview for your first MSL role. The book reveals strategies for standing apart from the competition, what hiring managers look for when considering candidates, and what gets the right candidates hired. Dr. Samuel Jacob Dyer shares his years of experience as a hiring manager at some of the world's top pharmaceutical companies and as chairman of the board for the MSL Society. In three easy-to-read sections, he discusses the Medical Science Liaison role, presents your MSL job search strategy, and reveals the inner workings of the MSL hiring process. His proven techniques and insights will increase your chances of starting your career as a highly paid Medical Science Liaison.

Six Sigma Healthcare is a quality improvement methodology that also improves patient and stakeholder satisfaction. Six Sigma Healthcare delivery means helping improve patient outcomes while driving down the cost of patient care. Doing so empowers healthcare providers to become more productive. Now, more than ever, the healthcare industry needs to embrace the economic value proposition of improving productivity. Healthcare sector can learn a good deal from industries that are working toward the Six Sigma goal. Let's try it in healthcare and see how close we can get.

In the last quarter of the 20th century, politicians in Washington, as well as interest groups, regulatory policy makers, and drug industry leaders were forced to confront the hot-button issue of pharmaceutical regulation. The struggle always centered on product innovation, consumer protection, and choice in the free market. As the American economy stuttered in the late 1970s, the stakes were extremely high for the powerful drug industry and the American public. At the center of this drama was the Food and Drug Administration, which was censured from both the left and right of the political spectrum for being too strict and too lenient in the application of its regulatory powers. Lucas Richert explores the FDA, drugs, and politics in the context of the watershed Reagan era, a period when the rhetoric of limited government, reduced regulation, and enhanced cooperation between businesses and U.S. regulatory agencies was on the ascent. As he investigates the controversies surrounding Laetrile, Reye's Syndrome, Oraflex, patient package inserts, diet pills, and HIV/AIDS drugs, Richert argues that the practical application of conservative economic principles to the American drug industry was A Prescription for Scandal.

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

Blockbuster drugs-each of which generates more than a billion dollars a year in revenue-have revolutionized the industry since the early 1980s, when sales of Tagamet alone transformed a minor Philadelphia-based firm into the world's ninth-largest pharmaceutical company. In Blockbuster Drugs, Jie Jack Li tells the fascinating stories behind the discovery and development of these highly lucrative medicines, while also exploring the tumult the industry now faces as the "patent cliff" nears. Having spent most of his career in drug research and development, Li brings an insider's eye to the narrative as he recounts the tales of discovery behind such drugs as Tagamet, Zantac, Claritin, Prilosec, Nexium, Serouquel, Plavix, and Ambien. As he discusses each breakthrough, Li also shows that scientific research is filled with human drama-serendipitous discoveries, sudden insights, tense confrontations. For instance, the author tells of James Black, who persisted in the research that led to Tagamet-and that would ultimately win him a Nobel Prize-despite pressure from top executives to pursue "more profitable" work. The book shows how research behind Prilosec combined creativity, international cooperation, and luck-the turning point being a chance encounter of American and Swedish scientists at a conference in Uppsala. There are also tales of fabulous rewards-George Rieveschl, the chemist who invented Benadryl, made a fortune on royalties-and of unjust desserts. Finally, Li shows that for the world's largest prescription drug manufacturers, recent years have been harrowing, as many popular drugs have come off patent in the U.S. market, meaning hundreds of billions of dollars in lost revenue. Anyone who enjoys tales of scientific discovery, or is curious about the history behind the prescriptions they take, or wants a revealing inside look at the pharmaceutical industry will find this book well worth reading.

This book includes information about the express assessment of cell viability in biological preparations, interfacial tension, and phase behaviour in emulsions of associative biopolymers. Also discussed are the conditions of shear flow, and interaction and structure formation of gelatin type A with thermo aggregates of bovine serum albumin, and perspectives of application of multi-angle laser light scattering and methods for quality control of medicines. A new approach to the creation of biocompatible magnetically targeted nanosystems for a smart delivery of therapeutic products, polyelectrolyte microsensors as a new tool for metabolites' detection, and improvement of the functional properties of lysozyme by interaction with 5-methylresorcinol is also reviewed. The methods of study of the processes of the issue of the optical information biological object, polyelectrolyte enzyme-bearing microdiagnosticum, and a new step in clinical-biochemistry analysis and introductions in culture in in-vitro rare bulbous plants of the Sochi Black Sea Coast (Scilla, Muscari, Galanthus) are studied.

A practical guide for those in pharmaceutical companies considering a reclassification (switch) project including Rx to OTC, POM to P, and P to GSL. The book covers past UK switches with key learning and a framework for initiating, setting up and running switch projects within companies. Plus case studies, insight and practical experience to help companies manage and implement successful switch projects.

The pharmaceutical revolution that gathered pace in the 1930s delivered a plethora of almost magical new drugs such as penicillin, streptomycin, cortisone, and the birth control pill. This revolution grew from academic-business relationships in five countries: USA, Germany, Great Britain, Switzerland, and France. Many other countries tried and failed to replicate this success, yet a handful of Scandinavia companies made important breakthroughs in a narrow band of specialities. This is the story of how one Norwegian company- Nyegaard & Co. -achieved international success from the 1970s onwards with a breakthrough product facilitating X-ray pictures of the soft tissues of the body. The company succeeded by harnessing research skills and creating scientific and business alliances abroad, building its own momentum step by step: the corporation as entrepreneur. It thereby broke with the conventional way a national medical ecosystem facilitated the crucial scientific progress. This is a story both of personal initiatives and great organizational transformations in several stages. In the 1950s, Nyegaard & Co. was a small hierarchical home market-oriented generics company. By the end of the 1990s, it had developed into a fairly large and multinational hierarchical company, preoccupied as much with shareholder value as scientific progress. It has also become a company that no longer had the same ability to innovate as before and therefore became merged into another one.

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

At present, human society is facing a health care crisis that is affecting patients worldwide. In the United States, it is generally believed that the major problem is lack of affordable access to health care (i.e. health insurance). This book takes an unprecedented approach to address this issue by proposing that the major problem is not lack of affordable access to health care per se, but lack of access to better, safer, and more affordable medicines. The latter problem is present not only in the United States and the developing world but also in countries with socialized health care systems, such as Europe and the rest of the industrialized world. This book provides a comparative analysis of the health care systems throughout the world and also examines the biotechnology and pharmaceutical industries.

Examines the health care structure of the United States, Europe, and the third world, both separately and comparativelyOffers primary source insight through in-depth interviews with pharmaceutical and health care industry leaders from around the worldCarefully explains, in clear terms, the intricacies of the health care and pharmaceutical system and how these intricacies have led to the current crisisOffers concrete, comprehensive solutions to the health care crisis

Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study -- prepared at the request of the Senate Majority Leader -- reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D.

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