Alzheimer's Disease (AD) is a growing global public health challenge. The development of new therapies is urgently needed, and a complex ecosystem of organizations has grown to facilitate AD drug discovery and development. Masterfully collating information on the drug development ecosystem, this book emphasizes the contributions of each aspect in the pipeline with a uniform approach to chapters, enabling readers to access relevant information quickly. Topics covered include the use of non-clinical laboratory studies, biomarker development, artificial intelligence, design and management of clinical trials, and funding and financing models. Also discussed is the critical role of advocacy fundraising for drug development. With the approval of aducanumab, the function of the ecosystem has become apparent. This is a definitive overview of how the ecosystem works in transferring an AD drug from its discovery in the laboratory through clinical trial testing to regulatory review and eventual marketing.

Pharmaceutical Marketing in the 21st Century helps professionals in the pharmaceutical field anticipate and prepare for market changes and advances, and it guides them in adjusting their marketing strategies to remain competitive in the coming era. Ideal for product managers, planners, and strategists, this book puts the past twenty years of pharmacy into perspective and uses it as a basis for predicting the next twenty years. Internationally relevant, this book is now available in Japanese!Distinguished contributors provide a formal conjecture on the nature of various aspects of pharmaceutical marketing in the early part of the 21st century. Utilizing their experience and expertise, they provide pharmaceutical professionals with guidelines for marketing in the coming years. Readers gain insight into what the future may hold in these areas: pricing, product development, distribution, promotion, retailing, market research, and other areas. Experts who make professional speculations in Pharmaceutical Marketing in the 21st Century include these among others: William R. Mattson, Jr. (President, The Mattson Jack Group, St. Louis) and Evan G. Dick (Vice President and General Manager, MedStrategy Management Reports, St. Louis). They compare pharmaceutical marketing of 20 years ago with that of today and use the comparison as a basis for making projections 20 years into the future. David W. Newton (Albany College of Pharmacy). He predicts an increased importance and possible necessity of the pharmacist's role in direct/indirect patient care services. Jerome A. Reinstein (industry consultant and Director-General, World Federation of Proprietary Medicine Manufacturers, London). He explores the increasing number of prescription drugs becoming available over the counter. Pharmaceutical marketers and benefits managers, regulatory officials, drug product managers, advertising agency executives, and politicians will find Pharmaceutical Marketing in the 21st Century a must read as they work today in preparation for the future of pharmaceutical care and marketing.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.

The pharmaceutical industry is one of today's most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success-or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: * An extensive literature review, including coverage of research from fields other than marketing * an overview of how practitioners have addressed the topic * introduction of relevant analytical tools, such as statistics and ethnographic studies * suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

THE PHARMACEUTICAL INDUSTRY IS BROKEN From the American hedge fund manager who drastically hiked the price of an AIDS pill to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system built to drive innovation and improve patient care has been distorted to maximise profits. In Sick Money, the investigative journalist who exposed a billion-pound British price-hiking scandal goes inside the global battle over high drug prices. From secret deals to patients forced to turn to the black market, Billy Kenber reveals how medicines have become nothing more than financial assets. He offers a diagnosis of an industry in crisis - and a prescription for how it could be fixed.

In pharmaceutical patent law, the problem of lack of policy direction and inappropriate legal framework is widespread - particularly among jurisdictions with little to no pharmaceutical research or manufacturing. This book aims to inform public policy and influence debate through a comprehensive review of Hong Kong's pharmaceutical patent law. By demonstrating the need for a holistic review of pharmaceutical patent laws and evaluating Hong Kong's system in light of health policy, economic and social factors, Bryan Mercurio recommends changes to the legal framework and constructs a more efficient and effective system for Hong Kong. He thoroughly evaluates the international framework and best practice models to offer a global perspective to each issue before providing local context in the analysis. While the focus of the book is Hong Kong, the analysis on pharmaceutical patent law and policy extends to other jurisdictions facing issues on reforming their national system.

The last two decades have seen great economic change in Asia and this has impacted upon the vexed question of access to affordable healthcare and medicines in many Asian states. In this book Locknie Hsu examines the issue of access to medicines in Asia from a fresh perspective which embraces trade and investment law, innovation, intellectual property law, competition policy and public health issues. Hsu explores the key evolving legal issues in these areas, including ASEAN integration, free trade agreement negotiations (such as those for the TPP), bilateral investment agreements and significant court decisions. The book goes on to present proposals for steps to be taken in addressing access to medicines in Asia and will be useful to academic researchers, regulators, law-makers and global organizations involved in the issues surrounding access to affordable healthcare and medicines.

The last two decades have seen great economic change in Asia and this has impacted upon the vexed question of access to affordable healthcare and medicines in many Asian states. In this book Locknie Hsu examines the issue of access to medicines in Asia from a fresh perspective which embraces trade and investment law, innovation, intellectual property law, competition policy and public health issues. Hsu explores the key evolving legal issues in these areas, including ASEAN integration, free trade agreement negotiations (such as those for the TPP), bilateral investment agreements and significant court decisions. The book goes on to present proposals for steps to be taken in addressing access to medicines in Asia and will be useful to academic researchers, regulators, law-makers and global organizations involved in the issues surrounding access to affordable healthcare and medicines.

As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP’s consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants’ profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.

This book is a complete, authoritative resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents. Fourteen authors cover the industry's technologies. The book begins with a full discussion of the primary processes -- sugar coating, film coating, and microencapsulation -- as well as the rationale for coating, methodologies, formulations, processing methods, and equipment and cleaning. Then it explores automation of the coating process, including hardware and software requirements. Finally, the book examines major stability and quality control issues. Regulations underlie all discussions.

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest - with the most up to date research updates - in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region. ​        

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.

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.

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.

Combination Therapy against Multidrug Resistance explores the potential of combination therapy as an efficient strategy to combat multi-drug resistance. Multidrug resistance (MDR) occurs when microorganisms such as bacteria, fungi, viruses, and parasites are excessively exposed to antimicrobial drugs such as antibiotics, antifungals, or antivirals, and in response the microorganism undergoes mutations or develops different resistance mechanisms to combat the drug for its survival. MDR is becoming an increasingly serious problem in both developed and developing nations. Bacterial resistance to antibiotics has developed faster than the production of new antibiotics, making bacterial infections increasingly difficult to treat, and the same is true for a variety of other diseases. Combination therapy proves to be a promising strategy as it offers potential benefits such as a broad spectrum of efficacy, greater potency than the drugs used in monotherapy, improved safety and tolerability, and reduction in the number of resistant organisms. This book considers how combination therapy can be applied in multiple situations, including cancer, HIV, tuberculosis, fungal infections, and more. Combination Therapy Against Multidrug Resistance gathers the most relevant information on the prospects of combination therapy as a strategy to combat multridrug resistance and helping to motivate the industrial sector and government agencies to invest more in research and development of this strategy as a weapon to tackle the multidrug resistance problem. It will be useful to academics and researchers involved in the development of new antimicrobial or antiinfective agents and treatment strtategies to combat multidrug resistance. Clinicians and medical nurses working in the field of infection prevention and control (IPC) will also find the book relevant

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.

Originally published in 1992, this study of Glaxo, from its beginnings to 1962, was based on unprecedented and unparalleled archival access to the company records. It gives a detailed account of the global operations of Glaxo, and describes not only the evolution of its international business, but studies its research and development programmes, its products, and its marketing and management. It was the first comprehensive study of a UK-based drugs company and one of the relatively few scholarly studies written of front-ranking world companies.

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 fascinating and most timely critical medical anthropology study successfully binds two still emergent areas of contemporary anthropological research in the global world: the nature and significant impact of multinational pharmaceutical manufacturers on human social life everywhere, and the contribution of corporations to the fast-paced degradation of our life support system, planet Earth. . . . Focusing on a pharmaceutically-impacted town on the colonized island of Puerto Rico, Dietrich ably demonstrates the value of ethnography carried out in small places in framing the large issues facing humanity." -Merrill Singer, University of Connecticut The production of pharmaceuticals is among the most profitable industries on the planet. Drug companies produce chemical substances that can save, extend, or substantially improve the quality of human life.However, even as the companies present themselves publicly as health and environmental stewards, their factories are a significant source of air and water pollution--toxic to people and the environment. In Puerto Rico, the pharmaceutical industry is the backbone of the island's economy: in one small town alone, there are over a dozen drug factories representing five multinationals, the highest concentration per capita of such factories in the world. It is a place where the enforcement of environmental regulations and the public trust they ensure are often violated in the name of economic development. The Drug Company Next Door unites the concerns of critical medical anthropology with those of political ecology, investigating the multi-faceted role of pharmaceutical corporations as polluters, economic providers, and social actors. Rather than simply demonizing the drug companies, the volume explores the dynamics involved in their interactions with the local community and discusses the strategies used by both individuals and community groups to deal with the consequences of pollution. The Drug Company Next Door puts a human face on a growing set of problems for communities around the world. Accessible and engaging, the book encourages readers to think critically about the role of corporations in everyday life, health, and culture.

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain uninformed of the core issues and are ill-prepared to understand pharmaceutical industry promotion. Furthermore, few medical curricula address this issue, despite warnings of the imperative need to address this gap in the education of tomorrow's physicians. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry.

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain uninformed of the core issues and are ill-prepared to understand pharmaceutical industry promotion. Furthermore, few medical curricula address this issue, despite warnings of the imperative need to address this gap in the education of tomorrow's physicians. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry.