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.

This work examines an increasingly important phenomenon for competitiveness and innovation in industry: namely, the growing use of scientific principles in industrial research. Industrial innovation still arises from systematic trial-and-error experiments with many designs and objects, but these experiments are now being guided by a more rational understanding of phenomena. This has important implications for market structure, firm strategies and competition. Science and innovation focuses on the pharmaceutical industry. It discusses the changes that the notable advances in the life sciences since the 1980s have exerted on the strategies of drug companies, the organization of their internal research, their relationships with scientific institutions, the division of labour between large pharmaceutical firms and small research-intensive suppliers, the productivity of drug discovery and the productivity of R & D.

Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.

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).

Compaction of powder constituents-both active ingredient and excipients-is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application. This unique reference covers: The physical structure of pharmaceutical compacts Bonding phenomena that occur during powder compaction Compression mechanisms of pharmaceutical particles Theories and basic principles of powder compaction New topics include: Compaction data analysis techniques The migration of powder constituents into commercial manufacture Instrumentation for compaction Compaction functionality testing, which is likely to become a USP requirement Design space for compaction Metrics required for scalability in tablet compression Interactive compaction and preformulation database for commonly used excipients

A Mechanistic Approach to Medicines for Tuberculosis Nanotherapy examines drug carrier development for controlled, targeted, pH and stimuli responsive drug releases for tuberculosis. The book provides in-depth information about mycobacterium tuberculosis, tuberculosis formation, and synthetic procedures for carrier synthesis, characterizations and mechanistic approaches. Key topics include the properties and functions of nanomedicines and how they might be applied for clinical diagnosis and treatment. Emphasis is placed on the basic fundamentals, biomaterial formulations, design principles, fabrication techniques, and transitioning bench-to-bed clinical applications. This book is useful for new researchers who focus on nanomedicine, stem cell therapy and bone tissue engineering. In addition, it introduces experienced researchers and clinicians to key trends, thus increasing their knowledge in drug discovery for tuberculosis and nanomedicine.

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.

Pharmacy Practice Research Case Studies provides examples and details regarding how pharmacy practice research has transformed over the past decade and how this is impacting overall health. This book presents several methodologies and techniques used in current pharmacy practice. According to the United Nations Sustainable Development Goals, countries around the world are aiming to achieve Universal Health Coverage. In this context, pharmacists are a vital part of the healthcare teams and the book portrays the research methods used in conducting pharmacy practice and medicines use research. The professional role of pharmacists has evolved tremendously over the past few decades across the globe and the pace of change has been interestingly phenomenal in varying aspects. The book provides a great resource for pharmacists, pharmaceutical scientists, policymakers, and researchers to understand the dimensions of practice, education, research, and policy concerning pharmacy, and it provides the synthesis of the development so far, pointing to the needs and demands of the future.

Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.

Drug Delivery Devices and Therapeutic Systems examines the current technology and innovations moving drug delivery systems (DDS) forward. The book provides an overview on the therapeutic use of drug delivery devices, including design, applications, and a description of the design of each device. While other books focus on the therapy, the primary emphasis in this book is on current technologies for DDS applications, including microfluidics, nanotechnology, biodegradable hydrogel and microneedles, with a special emphasis on wearable DDS. As part of the Developments in Biomedical Engineering and Bioelectronics series, this book is written by experts in the field and informed with information directly from manufacturers. Pharmaceutical scientists, medical researchers, biomedical engineers and clinical professionals will find this an essential reference.

The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics.

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

Advances and Avenues in the Development of Novel Carriers for Bioactives and Biological Agents provides sound data on the utility of biological and plant-based drugs and describes challenges faced in all aspects offering indispensable strategies to use in the development of bioactive medicines. Bioactive based medications are commonly used throughout the world and have been recognized by physicians and patients for their therapeutic efficacy. Bioactive formulations, including their subordinates and analogs, address 50% of all medicines in clinical practice. Novel bioactive medicine transporters can cure many disorders by both spatial and transitory approaches and have various justifications in medicinal potential. This book presents information on the utility of natural, plant, animal and bioengineered bioactive materials. It is a fundamental source of information and data for pharmacognosists, pharmaceutical analysts, drug transport scientists and pharmacologists working in bioactive medications.

* provides an in-depth discussion of recent advances in sterilization * identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions * explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results * New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.

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.

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.

Drug Delivery Systems examines the current state of the field within pharmaceutical science and concisely explains the history of drug delivery systems, including key developments. The book translates the physicochemical properties of drugs into drug delivery systems administered via various routes, such as oral, parenteral, transdermal and inhalational. Regulatory and product development topics are also explored. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of drug delivery systems within the pharmaceutical sciences industry and research, as well as in chemical engineering. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists. This book provides a comprehensive examination that is suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnologies, and related industries.

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. It also covers the industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases, and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences.

Polymer-Drug Conjugates: Linker Chemistry, Protocols and Applications discusses important concepts, fundamentals and prospective applications of 'Linker Chemistry' in a clear-and-concise manner. The book provides vital information on chemical entities binding with the drug-polymer complex for targeted drug delivery systems. It highlights roles and significance, different classes and synthetic protocols as well as mechanisms of chemical bond formation in drug-polymer conjugation in drug delivery, also offering insights into the mechanism of polymer interaction with linker and drug molecules by biodegradable chemical bonding. The protocol of binding with drug molecules is clearly explained and justified with case studies, helping researchers and advanced students in the pharmaceutical sciences understand fundamentals involved and related aspects in molecule designing for effective therapeutic benefits.

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management.

Nucleic Acids as Gene Anticancer Drug Delivery Therapy highlights the most recent developments in cancer treatment using nucleic acids, nanoparticles and polymer nanoparticles for genomic nanocarriers as drug delivery, including promising opportunities for targeted and combination therapy. The development of a wide spectrum of nanoscale technologies is beginning to change the scientific landscape in terms of disease diagnosis, treatment, and prevention. This book presents the use of nanotechnology for medical applications, focusing on its use for anticancer drug delivery. Various intelligent drug delivery systems such as inorganic nanoparticles and polymer-based drug delivery are discussed. The use of smart drug delivery systems seems to be a promising approach for developing intelligent therapeutic systems for cancer immunotherapies and is discussed in detail along with nucleic acid-targeted drug delivery combination therapy for cancer. Nucleic Acids as Gene Anticancer Drug Delivery Therapy will be a useful reference for pharmaceutical scientists, pharmacologiests, and those involved in nanotechnology and cancer research.