Trail-blazing social entrepreneurs are tackling the world's most pressing problems that government, business, or charity have failed to solve. They are creating businesses with a primary mission of social change. Scott Boyer is one such social entrepreneur. This 28-year veteran of Big Pharma left a six-figure salary to start OWP Pharmaceuticals and the ROW Foundation. This commercial business and non-profit organization exist in a symbiotic relationship we call a "tandem hybrid social enterprise." This model combines a multimillion dollar business with a foundation that's on track to become the largest funder of projects serving people with epilepsy and associated psychiatric disorders in the world. The tandem hybrid incorporates the principles learned by Scott and others for building a truly unique social enterprise from the ground up; one that is: Driven by a compelling social mission Financed by commercial success Structured to retain control Scalable and sustainable for the long haul Powering Social Enterprises With Profit And Purpose offers a detailed blueprint that has proven commercially and philanthropically successful and that can be replicated in most business sectors.

This book examines the strategic aspects of outsourcing in relation to the firm. It provides a holistic view of the outsourcing process, starting with conceptualization, through to implementation and management of the process. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries.

Americans seeking herbal medicines now face confusion and even danger. There is great potential for these medicines to improve the health of consumers--if current regulations can be revised!Herbal Medicine: Chaos in the Marketplace is a prize-winning critique of the regulation and business of herbal medicine in the United States. It is the first book that examines the big picture issues-it tells the story of how the present situation developed, looks at what it means for consumers, compares approaches taken in other industrialized countries, and recommends where we need to go from here. Convenient reference tables provide easy access to information.Concerns about herbal medicines are hitting the headlines regularly, yet no other book has examined the core issues in depth from a public health perspective. Herbal Medicine: Chaos in the Marketplace fills that gap. It is highly relevant today, and you'll find it will continue to be indispensable reading for years to come as the situation plays out.This balanced, unique, and insightful volume will add to your knowledge of herbal medicine regulation and its impact on consumer health by: framing the limitations of the current situation with brief examples reviewing the regulatory history of herbal medicines in the United States placing the situation in an international context by also examining regulations in Canada, Germany, France, and the United Kingdom illustrating the practical implications of U.S. regulations with six examples that demonstrate how herbal medicines could contribute more to consumer health--and the public health risks associated with the current regulatory situation analyzing the public health issues related to safety, research, clinical practice, consumer interests, business, media, and federal government offering key, high-impact recommendations for future policyConsumers, health care professionals, business people in the domestic and foreign herb industries, researchers, health plan executives, food and drug attorneys and policymakers, as well as educators and students, will all find this book essential to their understanding of the workings of the herbal medicine industry. Visit the author's website at http://www.herbalchaos.com

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators. Contributors: R. Arnold, M.A. Bagley, B. Domeij, J. Drexl, R.C. Dreyfuss, C.R. Fackelmann, T. Imura, R. Iseki, N. Lee, R. Moufang, H. Ullrich

The world production of citrus fruit has risen enormously in the last few decades, leaping from forty-five million tons a year in the early 1970's to eighty-five million in the season of 1996-1997. More than thirty per cent of these fruits go into industrial production in which essential oils and juice are the principal products. The main applications of essential oils are as flavourings for alcohol, soft drinks, food, pharmaceutical products and as fragrances for cosmetics and beauty products. Today, the potential applications of these essential oils are growing wider because they are environmentally 'safer' than the petrochemical products they can sometimes replace.
This book offers comprehensive coverage on all aspects of the botany, cultivation, processing industry, chemistry and uses of Citrus and its oils. Anyone involved in food sciences, pharmaceutical sciences, cosmetics, pharmacy and plant sciences will no doubt find this volume to be of great value and interest.

eBook available with sample pages: 020321661X

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

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.

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.

Multicultural Pharmaceutical Education spotlights methods and theory on how to increase representation of minorities in pharmacy schools and practice settings. Many of the ideas presented in this book are unique, and all provide an opportunity for institutions with few minority students to greatly improve their recruitment and retention efforts geared toward these students. The contributing authors, representing all levels of academia--deans, undergraduate students, vice provosts, executive directors, a National Professor of the Year, and faculty members--have all had experience in some aspect of minority pharmaceutical education. It is through their practical experiences that they offer suggestions and commentary on pharmacy programs of study. Historical accounts or examples of success that could be emulated at other institutions are included. With the help of Multicultural Pharmaceutical Education, colleges and universities and their faculty can forge ahead in attracting and retaining minority students to their pharmacy programs and into the world of pharmacy practice. Structured around four major areas (foundation, commitment, actuation, and conclusion), the authors remove the option of traditional excuses of failure in this important area of education. All those involved in pharmacy education should read this book whether deans, admissions counselors, professors, or students. Multicultural Pharmaceutical Education provides an easy-to-read, practical and theoretical approach to improving the opportunity and quality of education that minority students can achieve in pharmaceutical programs.

This volume provides information on how to select and screen plants for their medicinal properties. It describes phytopharmacological techniques for extracting and qualitatively and quantitatively analyzing a plant's phytochemicals. After a detailed in vitro investigation including nutritional and anti-nutritional analyses, medicinal properties were tested with various in vivo models for anti-inflammatory, analgesic, anti-pyretic, anticancer and anti-diabetic properties, as well as wound healing, neurodegenerative diseases, etc. Compound identification and purification techniques include, among others, TLC and column chromatography, as well as molecular docking with specific proteins.

Pharmaceutical Economics begins with an investigation of the structure of the industry and its three main components: the research firms which produce innovative products; the generic drug industry and its expanding role; and the biotech industry, which is regarded as the future for pharmaceuticals. Further sections discuss topics including demand and incentives, pricing and regulation. Professor Comanor and Professor Schweitzer have selected the most significant articles by leading academics, in order to offer a blend of standard economic interpretations of pharmaceutical policy and important new topics including biosimilars, insurance coverage for pharmaceuticals, price-fixing and direct-to-consumer advertising. An authoritative new introduction by the editors provides an insightful guide to these important topics.

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering.

This path-breaking book addresses the ongoing implications for traditional pharmaceutical companies and biopharmaceutical start-ups of the realignment of the industry knowledge-base. The theoretical approach draws on the modern theory of the firm and related ideas in order to better define the concept of the business model, which is employed to guide the case studies and empirical analysis in the book. The author shows that while traditional pharmaceutical companies have successfully adjusted their business models to meet the challenges of biotechnology, biopharmaceutical start-ups have experienced more problems. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. However, this has been captured disproportionately by a handful of large, fully-integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical companies.This highly focused book will be a captivating read for innovation and biopharmaceutical industry analysts, as well as advisers formulating policies to support the development of the biopharmaceutical sector. Academics working on innovation and biotechnology, as well as scientists engaged in research in the life sciences, will also find this book of particular interest.

Covers advances in particulate drying and its importance in the process industry Highlights recent developments in conventional drying techniques and new drying technologies Helps readers gain insight into selecting the appropriate drying techniques for a particular product Summarizes various applications from a wide range of industries, including chemical, food, pharma, biotech, polymer, mineral, and agro-industries Envisages future research trends and demands in particulate drying

This book discusses and chronicles various types of manufacturing processes, including casting and molding, machining, joining, shearing, and forming. It refers to repetitive, discrete, job shop, process manufacturing (continuous), and process manufacturing (batch). It also offers detailed examples from the nuclear, electronic, plastics, adhesives, inks, packaging, chemical, and pharmaceutical industries. Advanced Manufacturing Operations Technologies: Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice fills the gap in the connection between production and regulated applications in several industries. It highlights established concepts and provides a new fresh outlook by concentrating on and creating linkages in the implementation of practices in manufacturing and safe clean energy systems. Case studies for the overall design, installations, and construction of manufacturing operations in various industries as well as the standard operating procedures are offered. The book also discusses the correlation between design strategies including step-by-step processes to ensure the reliability, safety, and efficacy of products. The fundamentals of controlled techniques, quality by design, risk assessment, and management are covered in support of operations applications and continuous improvement. This comprehensive book is helpful to all professionals, students, and academicians in many scientific disciplines that utilize fundamental principles of chemical engineering. It is engineering-driven and will be of use to those in industrial and manufacturing, chemical, biochemical, mechanical engineering, and automated control systems fields.

This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups.
The journey from application of an orphan drug designation to a reimbursed market- approved drug is long and many obstacles occur during the journey.
After reading the book, readers will: Understand who the players/stakeholders are in the rare orphan disease field and their specific needs and concerns: patients and patient organizations, researchers and treating physicians within the field, industry, regulatory and reimbursement bodies* Understand the strong partnership between the different players and the various initiatives to improve and increase access to treatment for patients; minimizing the gap between numbers of known diseases, orphan designations, approved drugs and paid drugs.
The book also provides short practical case stories from patients and researchers, as well as representatives from industry and authorities on the challenges they came across in developing orphan drugs or getting access to orphan drugs.
A comprehensive overview of strategy, key activities and considerations of how to bring an orphan drug from concept to the market and make it available to patientsA source of updated information, news and trends for those who are already active in this fast-evolving fieldCovers the global definitions and the criteria for getting an orphan drug designation in, for example, the US and Europe

Each year hundreds of new drugs are approved for the marketplace. The approval of a single new drug is the result of years of screening tens of thousands of compounds, performing pre-clinical research on their effects, and designing, implementing, and analyzing the results of clinical trials. This book provides a general guide to statistical methods used in the pharmaceutical industry, and is aimed at graduate students and researchers who want to know more about statistical applications in all phases of the drug development process. The 19 chapters authored by over 30 statisticians working in the industry follow the general sequence of drug development, from pre-clinical research and saftey assessment to dose finding, safety studies, large clinical trials, analysis of health economic data, and fianlly manufacturing and production. Special topics such as single patient analysis and the impact of patient compliance show the broad spectrum of applications of data analysis methods. Each chapter illustrates a practical problem using data from actual studies by describing the study, the data, the methods, and the results. All of the analyses are done with S-PLUS, and the data and code are provided both in appendices to the chapters and on the companion Springer-Verlag web site, making it possible to reproduce the results and extend the analyses. Prior knowledge of the software is not required to follow the analyses. Steven P. Millard is a statistical consultant and also Manager of Consulting Services for MathSoft, Inc. (Data Analysis Products Division.) He has applied statistical methods to projects ranging from quality control in bioassay to measuring water quality to automating home appraisal, and has taught courses in S-PLUS for over 10 years. He is the author of the book Environmental Statistics with S-PLUS (CRC Press) as well as the S-PLUS add-in module ENVIRONMENTALSTATS for S-PLUS. Andreas Krause is a statistical consultant in the pharmaceutical industry and works for Novartis Pharma AG. He has extensive experience in graphical and numerical data analysis as well as programming, has taught numerous classes with and on S-PLUS, and is an S_PLUS user from the early days on. He is also author of the book The Basics of S and S-PLUS (Springer).

India is the largest provider of generic drugs globally. The Indian pharmaceutical sector supplies over 50 per cent of the global demand for various vaccines, and as a result, holds an important position in the global pharmaceutical sector. This book is a comprehensive study of pharmaceutical marketing management in the Indian context and similar growth markets. The book introduces the fast-paced and multi-faceted discipline of pharmaceutical marketing management through an in-depth discussion on the genesis and evolution of its marketing concept. Combining theory and practice, it offers a strategic approach to pharmaceutical marketing from an organisational and business perspective and explicates the practical applications of it. Richly supported by case studies, the book brings together fresh perspectives and approaches equally useful for students and professionals. This book will be of interest to academicians, advanced students, and practitioners of pharmaceutical marketing and pharmaceutical management. It will also be beneficial to those interested in business strategy, decision making, and international marketing.

Key Account Management Excellence in Pharma & Medtech is designed to help life sciences practitioners develop and execute innovative and effective key account management (KAM) strategies and capabilities. Pharmaceutical and medtech companies are increasingly pursuing KAM in response to the rapid rise of large, sophisticated and complex healthcare provider and payer systems and groups. Those that invest the time to get KAM right will protect their business and grow with these rising customers. This book is groundbreaking in both its scope and its tailoring of leading KAM practices specifically for life sciences. The central theme is that "key account management is an organization-wide business strategy, not just a role or a sales-specific initiative." KAM is a strategy focused on providing unique offerings and value through an orchestrated, cross-functional, go-to-market model designed specifically to address the needs and engagement preferences of a unique segment of customers. The insights and practices shared in this book are designed to be a valuable reference at every stage of the KAM journey. The book has been designed to facilitate a common language and deep understanding of KAM issues and leading practices organization-wide-particularly for life sciences leaders, account managers and cross-functional team members responsible for building, transforming and supporting their organization's KAM strategies and capabilities.

Harrison analyzes how the U.S. research pharmaceutical industry, faced with domestic political opposition to the prices it charged for prescription drugs, chose to pursue its policy goal of greater appropriability of its intellectual property through the institutions of foreign economic policymaking. As Harrison explains, a new body of literature has developed to analyze the emergence of intellectual property as a major international trade issue. For many researchers, the inclusion of trade related intellectual property (TRIPS) into the Uruguay round of the General Agreement on Tariffs and trade (GATT) negotiations marks an important demonstration of the political influence of U.S. knowledge-intensive industries. However, as he demonstrates, a more thorough specification of the domestic political environment reveals that the research pharmaceutical industry was incapable of achieving its domestic policy objectives at the same time that it is credited with immense international political power. By providing a theory of institutional choice, Harrison reconciles this incongruity. He explains the strategic choices of the research pharmaceutical industry as a function of the transaction costs associated with pursuing its policy objectives within a variety of institutional alternatives. He concludes that he internationalization of intellectual property rights was a result of the changing domestic political environment in which the research pharmaceutical industry found itself the loser in a series of domestic economic policy battles. A thoughtful analysis of particular important to scholars, researchers, and policy makers involved with international trade, intellectual property, the pharmaceutical industry, and public policy.

Trail-blazing social entrepreneurs are tackling the world's most pressing problems that government, business, or charity have failed to solve. They are creating businesses with a primary mission of social change. Scott Boyer is one such social entrepreneur. This 28-year veteran of Big Pharma left a six-figure salary to start OWP Pharmaceuticals and the ROW Foundation. This commercial business and non-profit organization exist in a symbiotic relationship we call a "tandem hybrid social enterprise." This model combines a multimillion dollar business with a foundation that's on track to become the largest funder of projects serving people with epilepsy and associated psychiatric disorders in the world. The tandem hybrid incorporates the principles learned by Scott and others for building a truly unique social enterprise from the ground up; one that is: Driven by a compelling social mission Financed by commercial success Structured to retain control Scalable and sustainable for the long haul Powering Social Enterprises With Profit And Purpose offers a detailed blueprint that has proven commercially and philanthropically successful and that can be replicated in most business sectors.