The internationalization of research and technology is one key component of the globalization of trade and business, with potentially major impacts on patterns of economic development and public policies worldwide. Although certain aspects of this internationalization trend are well documented, and some effects can be quantified, the overall processes are extremely complex and the outcomes are highly uncertain. The existence of the phenomenon is generally accepted, but its importance and the trends are currently the topic of a lively debate. This study on "New Ways in Drug Development in Pharmaceuticals" is part of a three year project which aims at investigating how new concepts of industrial knowledge creation are implemented in the different environ ments of the innovation systems of the United States and Germany. The main focus of the overall project is a series of case studies of innovation practice in different national and sectoral contexts. The following sectors and technological fields are investigated: pharmaceuticals and new ways in drug development by the Fraunhofer Institute for Systems and Innovation Research (ISI), advanced materials by the University Hohenheim, Insti tute of International Management and Innovation (Alexander Gerybadze), financial services and home banking by the Massachusetts Institute of Tech nology (MIT), Center for Industrial Performance (Richard Lester) and the Sloan School of Management (Edward Roberts). Financially the project was supported by the German-American Academic Council, the German Federal Minstry of Education, Science Research and Technology and the Fraunhofer Society."

"This book reports empirical material from three case studies in the pharmaceutical industry, the biotechnology industry and the domain of academic research. New technoscientific frameworks that have not yet translated into new therapies, in the future, may play a more central role in the late-modern society"--

"This book shows why contests over intellectual property rights and access to affordable medicines emerged in the 1990s and how they have been resolved so far. It argues that the current arrangement mainly ensures wealth for some rather than health for all, and points to broader concerns related to governing intellectual property solely as capital"--Provided by publisher.

Silas Burroughs arrived in London from America in 1878 and proved himself an exceptional entrepreneur, taking the pharmaceutical business by storm. He was the brains and energy behind Burroughs Wellcome & Co. With his business partner Henry Wellcome he created an internationally successful firm, the legacy of which can be found in the charity the Wellcome Trust, yet few now remember him and the impact he made in his short lifetime. A consummate salesman, Burroughs was also an astute businessman, with new ideas for marketing, advertising and manufacturing: his writings describe sales trips around the world and the people he met. He was also a visionary employer who supported the eight-hour working day, profit-sharing, and numerous social and radical political movements, including the single tax movement, free travel, Irish Home Rule and world peace. In this first biography of Burroughs, Julia Sheppard explores his American origins, his religion and marriage, and his philanthropic work, as well as re-evaluating the dramatic deterioration of his relationship with his partner Wellcome.

The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on:

• The use of isolator and barrier concepts for aseptic processing and assembly.
• The application of robotics as an alternative to gowned personnel.
• The increasing reliance on automation to minimize or eliminate operator intervention.
• The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing.

Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

Parallel trade occurs if international price differences for identical products are high and a policy of regional or international exhaustion of the respective property right has been implemented in the high price country. The work by C. Poget analyses how parallel imports of pharmaceuticals are affecting end consumer prices and drug expenditures in three Scandinavian countries, Sweden, Denmark and Norway. Based on his observations he derives proposals for policy reforms in EU member countries and Switzerland.

How to hone your analytical skills and obtain high-quality data in the era of GMP requirements

With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features:

• The drug development process in the pharmaceutical industry
• Uniform and consistent interpretation of GMP compliance issues
• A review of the role of statistics and basic topics in analytical chemistry
• An emphasis on high-performance liquid chromatographic (HPLC) methods
• Chapters on detectors and quantitative analysis as well as data systems
• Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
• Extensive appendixes for unifying terms, symbols, and procedural information

This book proposes an integrated approach to patent risk and capital budgeting in pharmaceutical research and development (R and D), developing an option-based view (OBV) of imperfect patent protection, which draws upon contingent-claims analysis, stochastic game theory, as well as novel numerical methods. The text re-initiates a discussion about the contribution of quantitative frameworks to value-based R and D management.

The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year."

The pharma and medtech sectors are evolving rapidly, driven by science, technology, economics, politics and globalization. In the new industry landscape, creating strong brand strategies is ever more difficult and ever more vital. Brand Therapy gives pharma and medtech brand teams the tools to understand their market, create strong strategies and translate them into actionable plans. Written in 16 short, easy chapters, it is essential reading for anyone who works in or with brand teams in the life sciences industry.

For most Western audiences, Cuba is a touristic paradise stuck in time and virtually detached from world technology networks by the US embargo - anything but a hub of industrial innovation and high value-added biotechnology. However, a closer look reveals more subtle but equally powerful stories that challenge the homogenizing assumptions of conventional economics and open up scope for more sophisticated reflections on Cuban economy and industry. From this kind of enquiry emerges the case of the internationally respected Cuban biotech industry as the most successful case of science and technology policy in the country's economic history. The book takes an interdisciplinary approach, exploring issues such as interdependency, purpose and history as natural constituencies of the innovation process. It also examines the dynamic and crucial role played by the state in the formation of innovative business enterprises. This book will be of interest to academic researchers in the fields of innovation and economic development.

Alderley Park Discovered is written by former AstraZeneca chemist George Hill, whose carefully researched text is presented in a wonderfully lively and readable style. The 400-acre site is a unique and beautiful natural environment with a rich, varied history, beginning with the creation of the Park by the Stanley family from the sixteenth century. It is also home to a diverse range of wildlife, and George Hill's considerable knowledge in this area reveals its wealth in the middle section of the book. He then tells of the Park's remarkable scientific inception by ICI, moving on to its huge growth under Zeneca and AstraZeneca, revealing the inside stories of the groundbreaking heart and cancer drugs discovered on the site. Now, under the auspices of Manchester Science Partnerships, Alderley Park has become a hub for Life Sciences, and is set to be developed for new residential and leisure purposes into the future. This fascinating, lavishly illustrated and beautifully produced book will be of huge appeal to anyone with connections to the Park, including current and former employees, local people and historians.

A visit to a physician these days is cold: physicians spend most of their time typing at computers, making minimal eye contact. Appointments generally last only a few minutes, with scarce time for the doctor to connect to a patient's story, or explain how and why different procedures and treatments might be undertaken. As a result, errors abound: indeed, misdiagnosis is the fourth-leading cause of death in the United States, trailing only heart disease, cancer, and stroke. This is because, despite having access to more resources than ever, doctors are vulnerable not just to the economic demand to see more patients, but to distraction, burnout, data overload, and their own intrinsic biases. Physicians are simply overmatched. As Eric Topol argues in Deep Medicine, artificial intelligence can help. Natural-language processing could automatically record notes from our doctor visits; virtual psychiatrists could better predict the risk of suicide or other mental health issues for vulnerable patients; deep-learning software will make every physician a master diagnostician; and we could even use smartphone apps to take our own medical "selfies" for skin exams and receive immediate analysis. . On top of that, the virtual smartphone assistants of today--Alexa, Siri, Cortana--could analyze our daily health data to reduce the need for doctor visits and trips to the emergency room, and support for people suffering from asthma, epilepsy, and heart disease. By integrating tools like these into their daily medical practice, doctors would be able to spend less time collecting and cataloging information, and more time providing thorough, intimate, and meaningful care for their patients, as no machine can. Artificial intelligence can also help remedy the debilitating cost of healthcare, both for individuals and the economy writ large. The medical sector now absorbs 20 percent of the US gross domestic product--it is largest sector by dollars and jobs. And it's very inefficient. Take the cost of medical scans: There are over 20 million medical scans performed in the US every day, and an MRI, for example, costs hundreds to thousands of dollars. AI could process 260 million medical scans (more than 2 weeks' worth) in less than 24 hours for a cost of only $1000. We pay billions and billions of dollars for the same work today. The American health care system needs a serious reboot, and artificial intelligence is just the thing to press the restart button. As innovative as it is hopeful, Deep Medicine ultimately shows us how we can leverage artificial intelligence for better care at lower costs with more empathy, for the benefit of patients and physicians alike.

Pharmaceutics: Basic Principles and Application to Pharmacy Practice, Second Edition is a valuable textbook covering the role and application of pharmaceutics within pharmacy practice. This updated resource is geared toward meeting and incorporating the current curricular guidelines on pharmaceutics and laboratory skills mandated by the American Council for Pharmacy Education. It includes a number of student-friendly features, including chapter objectives and summaries, practical examples, case studies, numerous images and key-concept text boxes. Two new chapters are included, as well as a new end of chapter section covering "critical reflections and practice applications". Divided into three sections – Physical Principles and Properties of Pharmaceutics; Practical Aspects of Pharmaceutics; and Biological Applications of Pharmaceutics – this new edition covers all aspects of pharmaceutics and providing a single and compelling source for students.

"Smart, funny, clear, unflinching: Ben Goldacre is my hero." --Mary Roach, author of "Stiff," "Spook," and "Bonk
"We like to imagine that medicine is based on evidence and the results of fair testing and clinical trials. In reality, those tests and trials are often profoundly flawed. We like to imagine that doctors who write prescriptions for everything from antidepressants to cancer drugs to heart medication are familiar with the research literature about these drugs, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators have some code of ethics and let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients.
All these problems have been shielded from public scrutiny because they are too complex to capture in a sound bite. Ben Goldacre shows that the true scale of this murderous disaster fully reveals itself only when the details are untangled. He believes we should all be able to understand precisely how data manipulation works and how research misconduct in the medical industry affects us on a global scale.
With Goldacre's characteristic flair and a forensic attention to detail, "Bad Pharma "reveals a shockingly broken system in need of regulation. This is the pharmaceutical industry as it has never been seen before.

Boosting Pharmaceutical Innovation In The Post-TRIPS Era investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, it identifies the key issues relevant to the revival of local pharmaceutical industries.Based on an understanding of the post-TRIPS environment and case studies of national innovation strategies, the book specifically addresses an important question - to what extent can lessons from national experiences be transferred to current policy developments for innovation in the pharmaceutical industry in a developing country context? The book sets out a number of recommendations on how this can be achieved. It suggests that it can be done in relation to the key development objectives of promoting the technological and scientific advancement of the country, enhancing local pharmaceutical innovation capacities, adapting patent law to own local realities, providing wide access to medicines and knowledge, safeguarding public health interests, and fostering innovation. Practitioners and policy planners within the pharmaceutical industry will deem this book invaluable as it addresses a number of practical implications for the promotion of the pharmaceutical industry. It will also be of enormous interest to students, researchers and academics specializing in intellectual property law and policy, science and technology, and the management of technology and innovation. Contents: 1. Introduction 2. Innovation 3. Innovation and the Pharmaceutical Industry 4. Looking at the Big Picture: National Innovation System 5. Innovation Country Case Studies 6. A Real Life Company Case Study; TEVA Pharmaceuticals Ltd. and its Distinctive Trajectories 7. Real life lessons for the developing world Bibliography Index

Collaborative Creativity is a powerful methodology for groups that uses short bursts of creative challenges to help people go beyond rational/conscious thinking and uncover, with constructive consequences, the emotional/irrational sphere that influences behaviour. It was developed by Peter Comber specifically for the complex environment of the healthcare industry, and this how-to manual for managers of healthcare companies offers practical advice on how to employ creative processes in their sector.

Situated at the crossroads between the history of colonialism, of modern Southeast Asia, and of medical pluralism, this history of medicine and health traces the life of pharmaceuticals in Vietnam under French rule. Laurence Monnais examines the globalization of the pharmaceutical industry, looking at both circulation and consumption, considering access to drugs and the existence of multiple therapeutic options in a colonial context. She argues that colonialism was crucial to the worldwide diffusion of modern medicines and speaks to contemporary concerns regarding over-reliance on pharmaceuticals, drug toxicity, self-medication, and the accessibility of effective medicines. Retracing the steps by which pharmaceuticals were produced and distributed, readers meet the many players in the process, from colonial doctors to private pharmacists, from consumers to various drug traders and healers. Yet this is not primarily a history of medicines as objects of colonial science, but rather a history of medicines as tools of social change.

While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

The fascinating story of Tamiflu's development and stockpiling against global health threats.orld's most prominent medical countermeasure, Tamiflu. A pill can strengthen national security? The suggestion may seem odd, but many states around the world believe precisely that. Confronted with pandemics, bioterrorism, and emerging infectious diseases, governments are transforming their security policies to include the proactive development, acquisition, stockpiling, and mass distribution of new pharmaceutical defenses. What happens-politically, economically, and socially-when governments try to protect their populations with pharmaceuticals? How do competing interests among states, pharmaceutical companies, regulators, and scientists play out in the quest to develop new medical countermeasures? And do citizens around the world ultimately stand to gain or lose from this pharmaceuticalization of security policy? Stefan Elbe explores these complex questions in Pandemics, Pills, and Politics, the first in-depth study of the world's most prominent medical countermeasure, Tamiflu. Taken by millions of people around the planet in the fight against pandemic flu, Tamiflu has provoked suspicions about undue commercial influence in government decision-making about stockpiles. It even found itself at the center of a prolonged political battle over who should have access to the data about the safety and effectiveness of medicines. Pandemics, Pills, and Politics shows that the story of Tamiflu harbors deeper lessons about the vexing political, economic, legal, social, and regulatory tensions that emerge as twenty-first-century security policy takes a pharmaceutical turn. At the heart of this issue, Elbe argues, lies something deeper: the rise of a new molecular vision of life that is reshaping the world we live in.

The Price of Global Health is a unique book that describes the pharmaceutical pricing process and its business, economic and social challenges. Global drug pricing is one of the most hotly debated yet least understood aspects of the pharmaceutical industry. How should drug prices be set and what does it mean for patients? Why do governments increasingly get involved, and what is its impact on the global competitive environment? How can a life-saving industry have a poorer image than gun and tobacco industries, whose products are associated with death? The pharmaceutical industry is under unprecedented pressure due to a combination of declining R&D productivity, payer/provider demands for better value and public pressures to show pricing restraint. Rapidly increasing cost of healthcare, shifts from fee-for-service to value-based reimbursement, public pressure on drug pricing and an increasingly vocal medical community have empowered public and private payers worldwide to be more demanding on evidence of value for the prescription drugs that are brought to market. Pharmaceutical companies have often failed to deliver evidence of patient value, as development decision-making is overly focused on speed to FDA approval rather than speed to commercial success by effectively addressing the many "Access Journey" obstacles that typify today's much changed pharmaceutical environment. This 3rd edition is significantly expanded with ten new chapters and revised and updated throughout to reflect today's environment. The contents are reorganized to directly address critical pricing and patient access issues. Ed Schoonveld explains how pharmaceutical prices are determined in a complex global payer environment and what factors influence the process. His insights will help a wide range of audiences from healthcare industry professionals to policy makers, consumers, pharmaceutical company leaders and access and pricing professionals to gain a better understanding of this highly complex and emotionally charged field.