The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.

I am encouraged to see healthcare leaders looking beyond the ways they have always done things in the past to implement innovative solutions to curb the industry's skyrocketing costs, poor quality, nursing shortages and employee dissatisfaction; all symptoms of deeper problems inherent in the system itself. Today's forward looking healthcare providers have realized the financial and moral imperatives for improving quality and safety and eliminating waste as strategies for responding to their pressing challenges. Lean Healthcare (adapted from the Toyota Production System) is not just for manufacturing or another short-term fix; it's a way to transform an entire organization into a safe and high-quality, high-performing healthcare delivery system. If implemented properly, it can be the "how to" for managing change and creating continuous improvement.

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.

From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful outcomes for patients of all ages. Over the last decade, an increasing number of prescription drugs -- including life-saving and life-sustaining drugs -- have been in short supply, preventing health care providers and patients from accessing medications that are essential for treatment. During shortages, providers -- including hospitals, physicians, and pharmacists -- may have to use medications that could be less effective for treating conditions or carry unwanted side-effects, if alternatives are available at all. The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. This book reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; examines the causes of drug shortages; and evaluates the progress FDA has made in addressing drug shortages.

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.

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.

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.

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."

As the scope of available drug therapies expands, spending on prescription drugs has become the fastest-growing category of total spending on health care in the United States. Recently, that growth has slowed and that slowdown reflects changes in both the supply and demand for prescription drugs. This book examines the innovation, development and complexity issues present in the pharmaceutical industry.

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.

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.

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.