This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter "SSA" or "Africa"). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime's inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

This book explains how government support and institutional set up facilitated the evolution of the Indian pharmaceutical industry and provides an economic analysis of firm strategies due to recent policy changes. The book is useful for researchers interested in understanding the transition of a lifeline sector for an emerging economy like India. Students of public policy, health administrators and health economists who are interested in the functioning of the pharmaceutical sector that produces life saving drugs in developing nations will find this book useful. The book also provides good coverage on data envelopment analysis (DEA), a useful technique for understanding productivity and efficiency. It can provide guidance to the research students on the applicability of DEA technique to address various research questions for analysis. The book will be a valuable addition to libraries in colleges of pharmacy and medicine as well as to all other academic and research centers.

Our recent understanding of the cellular and molecular defects and the regulation of the apoptotic signalling pathways has resulted in rationally designed anticancer strategies and the development of novel agents that regulates apoptosis. A comprehensive review of all apoptotic-related anticancer therapies is not the purpose of this book. However, in the volume of this book with 11 chapters, we have described a number of novel apoptotic regulators that have shown promising value and also great feasibility for cancer treatment. These novel agents either occur naturally or are chemically synthesized. While we are excited about the discovery and development of these novel apoptotic regulators as potential anticancer agents, a degree of caution should be always borne in mind when interpreting the success of preclinical pro-apoptotic candidates since potential problems inevitably lie ahead. These problems usually include target specificity, unanticipated toxicity, compound stability, formulation issues, pharmacokinetic and pharmacodynamic profiles. Nevertheless, we believe that this collection of 11 chapters by established leaders in the area of apoptosis will be of great interest to not only academics working in the field of cancer research and apoptosis but also pharmaceutical and pharmacological industries that . We are looking forward to the further development to push these potential agents toward clinical stage.

Bernadette Gral examines the relationship between financial slack and corporate performance in the European pharmaceutical industry during the financial crisis of 2007 to 2010. Her investigation includes correlational and regression analyses as well as the qualitative content analysis of newspaper articles. The results show that financial slack influences corporate performance measured as ROA based on net income, thus implying that firms use slack resources to enhance performance during crises. The findings support the arguments for a beneficial effect of financial slack on performance according to the resource based view and behavioral theory of the firm.

European and American drug regulators govern a multi-billion-dollar pharmaceutical industry selling its products on the world's two largest medicines markets. This is the first book to investigate how effectively American and supranational EU governments have regulated innovative pharmaceuticals regarding public health during the neo-liberal era of the last 30 years. Drawing on years of fieldwork, the authors demonstrate that pharmaceutical regulation and innovation have been misdirected by commercial interests and misconceived ideologies, which induced a deregulatory political culture contrary to health interests. They dismantle the myth that pharmaceutical innovations necessarily equate with therapeutic advances and explain how it has been perpetuated in the interests of industry by corporate bias within the regulatory state, unwarranted expectations of promissory science, and the emergent patient-industry complex. Endemic across both continents, the misadventures of pharmaceutical deregulation are shown to span many therapeutic areas, including cancer, diabetes and irritable bowel syndrome. The authors propose political changes needed to redirect pharmaceutical regulation in the interests of health.

Some two decades will shortly have passed since the WTO's Trade Related Aspects of Intellectual Property Rights agreement came into force in 1995. TRIPS is widely considered to have had a negative impact on access to medicines through its rules on pharmaceutical patents. This volume is the first cross-country analysis of how TRIPS has affected the capacity of 11 major low or medium income countries to produce generic drugs and assesses the wider political economy of drug production and consumption in the Global South.

Melville's Monumental Imagination explores the connection between the contested 19th century American monument tradition and one of the nation's most revered authors, Herman Melville (1819-1891). The book was written to fill a void in recent Melville scholarship. To date, there has not been a monograph that focuses exclusively on Melville's incorporation of monuments in his fictional world. The book charts the territory of Melville's novels in order to provide a trajectory of the monumental image in one particular literary form. This feature allows the reader to gradually see the monumental image as an important marker that sheds light into Melville's eventual abandonment of long fiction. Melville'sMonumental Imagination combines literary analysis and cultural criticism for a long neglected aspect of our nation's iconic development in statuary.

This collection takes the perspective that the historiography of science, technology, and medicine needs a broader approach toward regulation. The authors explore the distinct social worlds involved in regulation, the forms of evidence and expertise mobilised, and means of intervention chosen to tame drugs in factories, consulting rooms and courts.

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.

This book demonstrates how the Thalidomide catastrophe of the 1960s and the BSE crisis of the 1990s led to regulatory regimes for pharmaceuticals and foodstuffs in Europe. However, the developmental paths of these regimes differ - and so does the efficiency and legitimacy of regulatory policy-making.

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.