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.

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.

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.

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.

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.

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."

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

Since the 1950s, the American pharmaceutical industry has been heavily criticized for its profit levels, the high cost of prescription drugs, drug safety problems, and more, yet it has, together with the medical profession, staunchly and successfully opposed regulation. "Pills, Power, and Policy" offers a lucid history of how the American drug industry and key sectors of the medical profession came to be allies against pharmaceutical reform. It details the political strategies they have used to influence public opinion, shape legislative reform, and define the regulatory environment of prescription drugs. Untangling the complex relationships between drug companies, physicians, and academic researchers, the book provides essential historical context for understanding how corporate interests came to dominate American health care policy after World War II.

Neoliberals often point to improvements in public health and nutrition as examples of globalisation's success, but this book argues that the corporate food and medicine industries are destroying environments and ruining living conditions across the world. Scientist Stan Cox expertly draws out the strong link between Western big business and environmental destruction. This is a shocking account of the huge damage that drug manufacturers and large food corporations are inflicting on the health of people and crops worldwide. Companies discussed include Wal-Mart, GlaxoSmithKline, Tyson Foods and Monsanto. On issues ranging from the poisoning of water supplies in South Asia to natural gas depletion and how it threatens global food supplies, Cox shows how the demand for profits is always put above the public interest. While individual efforts to 'shop for a better world' and conserve energy are laudable, Cox explains that they need to be accompanied by an economic system that is grounded in ecological sustainability if we are to find a cure for our Sick Planet.

In some parts of the world spending on pharmaceuticals is astronomical. In others people do not have access to basic or life-saving drugs. Individuals struggle to afford medications; whole populations are neglected, considered too poor to constitute profitable markets for the development and distribution of necessary drugs. The ethnographies brought together in this timely collection analyze both the dynamics of the burgeoning international pharmaceutical trade and the global inequalities that emerge from and are reinforced by market-driven medicine. They demonstrate that questions about who will be treated and who will not filter through every phase of pharmaceutical production, from preclinical research to human testing, marketing, distribution, prescription, and consumption.

Whether considering how American drug companies seek to create a market for antidepressants in Japan, how Brazil has created a model HIV/AIDS prevention and treatment program, or how the urban poor in Delhi understand and access healthcare, these essays illuminate the roles of corporations, governments, NGOs, and individuals in relation to global pharmaceuticals. Some essays show how individual and communal identities are affected by the marketing and availability of medications. Among these are an exploration of how the pharmaceutical industry shapes popular and expert understandings of mental illness in North America and Great Britain. There is also an examination of the agonizing choices facing Ugandan families trying to finance AIDS treatment. Several essays explore the inner workings of the emerging international pharmaceutical regime. One looks at the expanding quest for clinical research subjects; another at the entwining of science and business interests in the Argentine market for psychotropic medications. By bringing the moral calculations involved in the production and distribution of pharmaceuticals into stark relief, this collection charts urgent new territory for social scientific research.

"Contributors." Kalman Applbaum, Joao Biehl, Ranendra K. Das, Veena Das, David Healy, Arthur Kleinman, Betty Kyaddondo, Andrew Lakoff, Anne Lovell, Lotte Meinert, Adriana Petryna, Michael A. Whyte, Susan Reynolds Whyte

An in-depth look at big pharma's flagship company
The Merck Druggernaut takes readers inside Merck, the world's second most profitable drug company and maker of the world's bestselling drug, Prilosec. Consistently named one of Fortune magazine's Most Admired Companies, Merck struggles to maintain its reputation for being the most ethical of the big drug makers, refusing to slash research and development budgets in the face of declining profits, falling stock market prices, and questionable accounting. Author Fran Hawthorne, one of the leading journalists covering healthcare, has written an excellent examination of a business paragon with much-needed insight on the cutthroat world of pharmaceuticals. It's a story that will interest the business world as well as consumer and healthcare advocates by detailing the vital issues in medicine and healthcare today. More than just a compelling story of success in a difficult industry, more than simply the biography of one of big business's most recognizable names, The Merck Druggernaut takes a thoughtful look at some of the major issues of our time and the way those issues intertwine with the world of business.

Fran Hawthorne (New York, NY) is the Assistant Managing Editor at Crain's New York Business. She has been covering business for more than twenty years for such publications as Fortune, BusinessWeek, and Institutional Investor, with a prevailing interest in healthcare and pharmaceuticals. At Crain's, she spearheads the publication of two to three special healthcare issues per year.

This book provides a complete approach to the economics of financing medicines and policy implications for the efficiency and equity of health systems. In all health systems with majority public financing, pharmaceutical reimbursement is one of the key factors in policies of change and transformation of health services in order to face the future with guarantees of financial sustainability.The initial chapters seek to answer questions about the efficiency with which the public sector intervenes in the pharmaceutical industry: Is the present system of drug patents efficient and fair? What would be the best way to control drug prices? Is it possible to encourage competition in this market for the patient's benefit? The remainder of the book provides evidence on the impact of instruments and policies aimed at rationalising and controlling pharmaceutical expenditure: What can we expect from the application of reference pricing systems? When, how and where should the user be made to share the cost of medicines? What economic and non-economic incentives should be applied to drug prescription? Jaume Puig-Junoy has performed an invaluable task in creating a cohesive, and analytically rigorous book of specially commissioned chapters on this pertinent topic. The Public Financing of Pharmaceuticals will appeal to academics and researchers involved in public finance, health policy, health economics, industrial organisation and the pharmaceutical markets in Europe and in the US, where there is increasing public interest in drug coverage. The book is also intended for a wide variety of professionals in the health industries and policymakers.

Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided.

The first book to details the history and social implications of the little blue pill Since its introduction in 1998, Viagra has launched a new kind of sexual revolution. Quickly becoming one of the most sought after drugs in history, the little blue pill created a sea change within the pharmaceutical industry-from how drugs could be marketed to the types of drugs put into development-as well as the culture at large. Impotency is no longer an embarrassing male secret; now it is called "erectile dysfunction," and is simply something to "ask your doctor" about. And over 16 million men have. The Rise of Viagra is the first book to detail the history and the vast social implications of the Viagra phenomenon. Meika Loe argues that Viagra has changed what qualifies as normal sex in America. In the quick-fix, pill-for-everything culture that Viagra helped to create, erections can now be had by popping a pill, making sex on demand, regardless of age or infirmity, and, potentially, for the rest of one's life. Drawing on interviews with men who take the drug, their wives, doctors and pharmacists as well as scientists and researchers in the field, this fascinating account provides an intimate history of the drug's effect on America. Loe also examines the quest for the female Viagra, the impact of the drug around the world, the introduction of new erection drugs, like Levitra and Cialis, and the rapid growth of the multi-billion dollar pharmaceutical industry. This wide-ranging book explains how this medical breakthrough and cultural phenomenon have forever changed the meaning of sex in America.

This book is intended for scientists, engineers, physicians, business people, and service providers at all levels who are interested in and support the process of life science commercialization. - The authors provide a hands-on template for success based on their years of experience practicing and teaching bioentrepreneurship and consulting to clients, students, economic development agencies, and faculty around the world.

This book is intended to help newly graduated chemists, particularly organic chemists, at all levels from bachelors to post-doctorates, find careers in the North American pharmaceutical industry. It will serve as a practical, detailed guiedbook for job seekers as well a reference work for faculty advisers, research supervisors, development officers, employment agents, and personnel managers in the industry. The book gathers in a single volume the fundamentals of getting an industrial job as a medicinal or process chemist, and covers all aspects of a chemist's job--scientific, financial, and managerial--within a pharmaceutical/biotechnology company. Other scientists looking for jobs as analytical or physical chemists and even biochemists and biologists will find the book useful. The valuable appendix is a unique compendium of 365 commercial, governmental, or non-profit institutions that comprise the North American pharmaceutical industry.
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