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Phantom Democracy
by Carl BoggsBoggs explores the evolution of concentrated corporate and military power through American history andits impact on our democracy. The events of 9/11 and their aftermath have only deepened the trend toward ever-more concentrated forms of power in a society that ostensibly embraces democratic values. Such developments, Boggs argues, have deep origins in American history going back to the founding documents, ideological precepts of the Constitution, early oligarchic rule, slavery, the Indian wars, and westward colonial expansion. "
Pharma: Greed, Lies, and the Poisoning of America
by Gerald PosnerAward-winning journalist and New York Times bestselling author Gerald Posner traces the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and uncovers how those once entrusted with improving life have often betrayed that ideal to corruption and reckless profiteering—with deadly consequences. Pharmaceutical breakthroughs such as antibiotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. Pharma introduces brilliant scientists, in-corruptible government regulators, and brave whistleblowers facing off against company executives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry&’s DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America&’s wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers&’ rise to power—revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. Pharma reveals how and why American drug companies have put earnings ahead of patients.
Pharma and Profits: Balancing Innovation, Medicine, and Drug Prices
by John L. LaMattinaHigh-level commentary on various facets of the pharmaceutical industry from a key leader in the field This book clearly explains the value that the pharmaceutical industry offers to society which is often underreported against the more negative topic of high drug prices. It also offers an overview for drug discovery and development professionals, highlighting the challenges that such drug hunters should be aware of when developing new drugs. Case studies to illustrate topics like hepatitis C, mRNA vaccines, insulin, and price controls are included to aid in seamless reader comprehension. Written by John LaMattina, former president of Pfizer Global Research and Development and well-known speaker and writer for the pharma industry, sample topics covered and questions explored within the work include: Fiscal consequences of curing hepatitis C mRNA vaccines and the race for a cure Why the government does not deserve a piece of Biopharma’s profits Paying for drugs whose ultimate value is unknown The impact of reduced revenues on R&DThis book is a must-read for biopharmaceutical professionals and executives who wish to gain high-level insight into key challenges that must be first understood, then overcome, within the pharmaceutical industry.
PharmAccess and the M-TIBA Platform: Leveraging Digital Technology in the Developing World
by Anant Vasudevan Kevin Schulman Sashidaran MoodleyPharmAccess is an Amsterdam based NGO working to support the development of the private health care market in Africa. This work is critical as over 50% of care is delivered through the private sector, but well-intentioned efforts to address global health through the public sector have the unintended consequence of crowding-out capital formation in the private sector. PharmaAccess is working to crowd-in funding instead through the development of a three-pronged effort in Kenya. They are working to address supply through efforts to improve the quality of health care facilities through education and through a micro-lending program. At the same time, they are working to address demand through the development of the M-TIBA mobile health wallet. The critical question for this case is whether these efforts, in essence the development of a novel platform simultaneously addressing supply and demand, will be enough to change the dynamics of the private health care market. The case provides a background on private health care in Africa and in Kenya.
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
by Orlando LopezValidation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Pharmaceutical Industry: Challenges in the New Century
by Stephen P. Bradley James WeberProvides a broad overview of the numerous internal and external forces that were driving change in the global pharmaceutical industry in 2003. These forces--including downward price pressures, political and social pressures, increased development costs, new technologies, new and different competitors, consolidation, and threats to its basic business models--were changing the way drugs were discovered, developed, manufactured, tested, regulated, marketed, sold, and purchased. A rewritten version of an earlier case.
The Pharmaceutical Industry: Better Medicine for the 21st Century
by Malinda MillerWe can see the future developing all around us, from sustainable flooring under our feet to solar panels on our rooftops. The construction industry is changing to become greener and these changes will have a lasting impact on the world and on construction workers of the future, because with a new world comes new career opportunities. The young adults of today will be the job force of tomorrow, so choosing a career that will best fit with the needs of the changing world will be important to job satisfaction and a successful life. With the vast array of career and job options, it will also be important for young adults to understand which work will be the best match for their interests, talents, goals, and personality types. Certain careers are expected to gain importance within the early decades of the twenty-first century. According to the United States Bureau of Labor Statistics, jobs in the construction industry are expected grow faster than the average rate for all occupations. If you are interested in a career in construction, learning how to "build green" now will give you an edge over other workers in the future.
Pharmaceutical industry 4.0: Future, Challenges & Application (River Publishers Series in Biotechnology and Medical Research)
by Rishabha Malviya Sonali Sundram Shivkanya Fuloria Dhanalekshmi Unnikrishnan MeenakshiThe pharmaceutical industry is on the cusp of a new age, with the need for personalized therapy, more complex production processes, smaller batch sizes and rising manufacturing costs. It is necessary to continuously adapt to the rapidly changing environment using novel technology and improved operational efficiency and flexibility. To achieve this, intelligent manufacturing seems to be a definite answer. Pharma 4.0 is a framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing. This book provides a deep insight into key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. Throughout the book we discuss technologies, application and challenges for applying digital technology in pharmaceutical industry, including: • Focus on an overview of Industry 4.0 and its application in the pharmaceutical field • Most recent advances in the pharmaceutical industry • Understanding the concepts of emerging technology trends for drug discovery.
Pharmaceutical Industry and Public Policy in Post-reform India (Critical Political Economy of South Asia)
by Reji K. JosephThis 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. A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.
Pharmaceutical Industry in 2005
by John R. Wells Elizabeth A. RaabeThe entire pharmaceutical industry faced uncertain times in 2005. Many of the industry's most pressing issues--patent expirations, new drug pipeline development, price pressures, regulatory issues, and political pressures--were long standing. Fundamentally new technologies were changing the way drugs were discovered, developed, and tested, allowing smaller, specialized competitors to enter the industry, compete in new ways, and grow to challenge the majors. Some observers were even questioning whether the blockbuster model on which the industry was based could continue. Blockbuster drugs, with sales of more than $1 billion a year, were becoming increasingly difficult and costly to develop. In this context, and with stock prices depressed, the industry majors were reflecting on their strategies.
Pharmaceutical Industry in the 1990s
by John F. Mcguire Anita M. Mcgahan Greg KellerDescribes the pharmaceutical industry in the 1990s, with particular emphasis on the mergers between American manufacturers and prescription-benefits managers (PBMs). PBMs are distributors with unprecedented access to information on patient and physician characteristics. Students have an opportunity to analyze the mergers using transactions-cost techniques.
Pharmaceutical Metrics: Measuring and Improving R & D Performance
by David S. Zuckerman'What gets measured gets fixed' and this is as true of the pharmaceutical industry as any other. The problem is that pharmaceutical businesses are complex. Drug research and development involves extended and expensive processes; defining appropriate metrics for these processes is not easy, yet ineffective or misguided metrics can be more damaging than none at all. David Zuckerman's Pharmaceutical Metrics is an extremely practical guide to selecting a system, selling it to top management, choosing and defining the right metrics for your system, communicating and displaying the results. And because metrics are about how to shape and develop your business, he explores how to deploy them organization-wide and make sure that they are driving business improvement. In order to reflect the needs of different types of pharmaceutical company the author uses four sample companies, throughout the book, to illustrate the principles for 'big pharma', 'micro pharma', a virtual development company and a CRO. This highly practical book provides a step-by-step guide to creating a state-of-the-art, strategy-driven metrics system for pharmaceutical R&D, supported by case studies of the techniques applied and tips for optimizing the system.
Pharmaceutical Process Design and Management
by Kate McCormick D. Wylie JrA 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.
Pharmaceutical Public Policy
by Thomas R. Fulda Alan Lyles Albert I WertheimerAs the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn‘t always work well. Pharmaceu
Pharmaceutical Research, Democracy and Conspiracy: International Clinical Trials in Local Medical Institutions
by Edison BicudoClinical trials used to be conducted overwhelmingly in the US and Europe but for a range of economic, technical and ethical reasons, the number of multicentre studies recruiting subjects in different regions of the World has grown exponentially. New medicines are tested in vast research networks involving several countries, hospitals and other medical institutions, and hundreds of individual subjects. In Pharmaceutical Research, Democracy and Conspiracy, Edison Bicudo examines the connections between global and local scales, exploring how it is possible for social actors as different as global companies and patients of local hospitals to come together and establish social relationships that may last many years. He also identifies the implications of these global-local relationships for the financial, technical and cultural structures of the participating hospitals. His study draws on fieldwork conducted in five countries: the UK, Spain, France, Brazil and South Africa. Shining a light on the social mediations that enable the encounter between these rationalities, the author concludes that this has the practical effect of subjecting countries hosting trials to institutional engineering. Hospitals and research agencies create new, sometimes surprising, institutional arrangements to cope with international research projects, which change relations between physicians and patients, as they acquire new roles as clinical investigators and research subjects. Frequently, such shifts deviate the institutional structures of medical institutions away from democratic, and towards conspiratorial, schemes. The book reviews the concept of mediation in sociological thought, proposes further developments in Habermas’ theory of communicative action, and offers some political reflection about the role of institutions in contemporary democracies.
Pharmaceutical Supply Chain: Drug Quality and Security Act
by Fred A. KuglinError-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Securi
Pharmaceutical Supply Chains - Medicines Shortages (Lecture Notes in Logistics)
by João Luís de Miranda Ana Paula Barbosa-Povoa Helena JenzerThis book provides an insight of relevant case studies and updated practices in “PharmaceuticalSupply Chains” (PharmSC) while addressing the most relevant topics within the COST Action “Medicines Shortages” (CA15105).The volume focuses on the most recent developments in the design, planning and scheduling ofPharmSC, broadening from the suppliers’ selection to the impact on patients and healthcaresystems, addressing uncertainty and risk mitigation, and computational issues. It is directed at MSc/PhD students and young researchers (Post-Docs) in Pharmaceutics/Pharmaceutical sciences, Engineering fields, Economics/Management, as well as pharmaceutical decision makers, managers, and practitioners, and advanced readers demanding a fresh approach to decision making for PharmSC. The contributed chapters are associated with the homonymous COST Training Schools (TS), and the book creates a better understanding of the Action “Medicines Shortages” challenges and opportunities.
Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval
by Erfan Syed AsifThis book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Pharmacogenomics in Clinical Practice
by Dragan Primorac Wolfgang Höppner Lidija Bach-RojeckyThis book provides a practically applicable guide to the applications of pharmogenomics across medicine. Background information is provided on the mechanisms associated with membrane transporters, drug-metabolizing enzymes and their importance in pharmagenomics. Detailed guidance is subsequently presented on how to apply these techniques in disciplines including cardiology, gastroenterology, oncology, transplantation surgery, infectious diseases, anesthesia and analgesia, neurology, psychiatry, primary care, and public health. Clear easy-to-follow instructions are given on how to use big data technologies and public health databases in day-to-day clinical practice. Pharmacogenomics in Clinical Practice concisely covers how pharmacogenomic technologies and techniques can be applied in daily medical practice. It is therefore an ideal up-to-date resource for any medical practitioner, trainee or researcher across all medical disciplines who want to better understand how to use these techniques.
Pharmacy on a Bicycle: Innovative Solutions for Global Health and Poverty
by Eric G. Bing Marc J. EpsteinEvery four minutes, over 50 children under the age of five die. In the same four minutes, 2 mothers lose their lives in childbirth. Every year, malaria kills nearly 1.2 million people, despite the fact that it can be prevented with a mosquito net and treated for less than $1.50.Sadly, this list goes on and on. Millions are dying from diseases that we can easily and inexpensively prevent, diagnose, and treat. Why? Because even though we know exactly what people need, we just can’t get it to them. They are dying not because we can’t solve a medical problem but because we can’t solve a logistics problem. In this profoundly important book, Eric G. Bing and Marc J. Epstein lay out a solution: a new kind of bottom-up health care that is delivered at the source. We need microclinics, micropharmacies, and microentrepreneurs located in the remote, hard-to-reach communities they serve. By building a new model that “scales down” to train and incentivize all kinds of health-care providers in their own villages and towns, we can create an army of on-site professionals who can prevent tragedy at a fraction of the cost of top-down bureaucratic programs. Bing and Epstein have seen the model work, and they provide example after example of the extraordinary results it has achieved in Africa, Asia, and Latin America. This is a book about taking health care the last mile—sometimes literally—to prevent widespread, unnecessary, and easily avoided death and suffering. Pharmacy on a Bicycle shows how the same forces of innovation and entrepreneurship that work in first-world business cultures can be unleashed to save the lives of millions.
Pharmacy Practice Research Methods
by Zaheer-Ud-Din BabarThe first edition of Pharmacy Practice Research Methods provided a contemporary overview of pharmacy practice research, discussing relevant theories, methodologies, models and techniques. It included chapters on a range of quantitative, qualitative, action research and mixed methods as well as management theories underpinning change in pharmacy practice.This new edition of the book is much broader and more diversified. It includes the quality improvement methods in pharmacy practice research, focusing on the key differences between high and low-income countries with regard to pharmacy practice research, as well as the main challenges faced when conducting such research – areas of significant global interest. In addition, a number of the chapters covering fast-moving fields where new methods have been developed and published have been updated. Featuring seven new topics and presenting future trends, the book also explains in detail methods used in covert and overt observations in pharmacy practice, as well as methods involved in realist research, which are important to countries seeking to produce evidence-based information in this area.
Pharmacy Service Improvement at CVS (A)
by Andrew McafeeCVS's retail pharmacy operations are functioning poorly and dissatisfying customers. Many customers are defecting as a result. A pharmacy service improvement team has documented the current prescription fulfillment process, its exception rates, and the problems generated by exceptions. The company must now decide how to change this process, and what information system changes to make in support of the redesigned process.
Pharmacy Service Improvement at CVS (B)
by Andrew McafeeAn abstract is not available for this product.
Pharmacy Service Improvement at CVS (B)
by Andrew McAfeeAn abstract is not available for this product.
Pharmacyclics: Financing Research & Development
by Aldo Sesia Richard S. Ruback Malcolm P. BakerPharmacyclics (NASDAQ: PCYC), a pharmaceutical company that manufactures products that will improve existing therapeutic treatments for cancer, arteriosclerosis, and retinal disease, was considering a $60 million private placement in February 2000. The company had more cash than ever before, but projections of R&D and marketing expenses were also unprecedented. PCYC's most promising oncology drug, a radiation enhancer called Xcytrin, was in Phase III clinical trials--the rigorous final phase before FDA approval for commercialization. Analysts gave the drug a slightly better than 50% chance of success. This case focuses on stage financing and a simple decision-tree evaluation. Students have the opportunity to consider the impact of past staged financing decisions on the ownership structure of the firm and to evaluate the current stock market price in light of analyst forecasts of the cash flow and the probability of success for each drug. These two analyses help inform the private placement decision.