A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

This book provides a fresh, multidisciplinary, and exciting look at the making and remaking of pharmaceutical patents at the GATT/WTO, by utilising a Coxian political economy of continuity and change in the global political economy (GPE). Marcellin focuses on the role of the transnational drug industry in the making of the patent provisions in the original TRIPS Agreement and consequently, the role of the African Group at the WTO in the remaking of those patent provisions.

The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

Written by John Lidstone and Janice MacLennan, the second edition of Marketing Planning for the Pharmaceutical Industry became accepted as the bible for the industry. In this new companion book Janice MacLennan picks up two of the themes touched on in Marketing Planning - market segmentation and branding, and the inter-relationship between these two - and with this book makes them key topics for discussion. Brand Planning for the Pharmaceutical Industry begins by exploring what branding is and why it is of importance, particularly to the pharmaceutical sector. The book then goes on to show how branding can be integrated into the early stages of the commercialization process for new products, both in theory and in the 'real' world. The book provides a step-by-step guide to brand planning, using market segmentation as the starting point. The book is split into two parts, the first dealing comprehensively with brand planning for products yet to get to the market, with the second part applying the same process to products that are already on the market. Both parts are extremely pragmatic, full of pertinent examples and insights from the pharmaceutical industry, and are directly applicable to your own brand planning. Brand Planning for the Pharmaceutical Industry concludes by confronting the problems that organizations are likely to have in actually making brand planning an integral part of their work and presents strategies for dealing with them.

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

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.

This book examines the nature and extent of competition in the pharmaceutical industry and analyses the interaction between market structure and selected elements of the marketing mix. It provides valuable insights into the level of promotional expenditure required to achieve a significant market share for new products; the use of price, new products and promotional strategies to protect market share; the effects of patent expiration on price levels and the use of pricing strategy to achieve market share. The book includes a brief comparative analysis of competition and marketing strategies in the US ethical pharmaceutical market.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Global Issues in Pharmaceutical Marketing presents a balanced, research-based perspective combined with a practical outlook on the current issues faced by the ethical, biotech, and generic segments of the pharmaceutical industry. It integrates an analytical approach with a global view to examine such issues as market access, digital marketing, emerging markets, branding, and more. The book covers not only the North American and Western European markets, but focuses on non-Western markets, such as Latin America and Asia. Each chapter is written as an individual essay about a given issue, and where relevant, original cases are provided to illustrate how these issues are currently managed by the global industry. This book offers a thoughtful and thorough description of the industry's current situation and integrates the latest scholarly and industry research from different disciplines in one place for convenient reference. It may be used in the following ways: To stimulate class discussions and inspire new streams of research for academics and graduate students; To introduce the industry to those interested in a career, to orient new industry hires, or to provide experienced practitioners with current research that will enhance their knowledge; To provide an understanding of the industry for those in the healthcare sector, such as physicians, pharmacists, as well as medical and pharmacy students; and To present recent and relevant research for those in government, public or private payers, and public policy environments to facilitate their decision making. This book will prove to be a useful resource and an important source of information for academics and their students, professionals, and policymakers around the world.

Research and Development is the vehicle by which organizations and economies create opportunity, innovation and secure a stream of future products and services.These outcomes are all critically important sources of sustainability in a world that is changing faster than most companies can keep up.The challenge behind them is the fundamental unpredictability of R which is why effective project management is so important. Ron Basu's Managing Projects in Research and Development explains how and why project management can provide a means of helping to plan, organise and control multi-disciplinary research activities without stifling innovation. Combining research with practical examples and experience from a career that has included blue chip organizations such as GSK, GlaxoWellcome and Unilever, Ron Basu offers a rigorous guide to the fundamentals of R&D project management including project lifecycle management, risk management, cost, time quality and other success measures as well as the keys to operational excellence in this complicated world.

This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure - about 60 per cent - and characterised by very high share of medicines in total health expenditure. A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.

Global Issues in Pharmaceutical Marketing presents a balanced, research-based perspective combined with a practical outlook on the current issues faced by the ethical, biotech, and generic segments of the pharmaceutical industry. It integrates an analytical approach with a global view to examine such issues as market access, digital marketing, emerging markets, branding, and more. The book covers not only the North American and Western European markets, but focuses on non-Western markets, such as Latin America and Asia. Each chapter is written as an individual essay about a given issue, and where relevant, original cases are provided to illustrate how these issues are currently managed by the global industry. This book offers a thoughtful and thorough description of the industry's current situation and integrates the latest scholarly and industry research from different disciplines in one place for convenient reference. It may be used in the following ways: To stimulate class discussions and inspire new streams of research for academics and graduate students; To introduce the industry to those interested in a career, to orient new industry hires, or to provide experienced practitioners with current research that will enhance their knowledge; To provide an understanding of the industry for those in the healthcare sector, such as physicians, pharmacists, as well as medical and pharmacy students; and To present recent and relevant research for those in government, public or private payers, and public policy environments to facilitate their decision making. This book will prove to be a useful resource and an important source of information for academics and their students, professionals, and policymakers around the world.

The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. * First book of its kind focusing strictly on CMC Bayesian case studies * Case studies with code and output * Representation from several companies across the industry as well as academia * Authors are leading and well-known Bayesian statisticians in the CMC field * Accompanying website with code for reproducibility * Reflective of real-life industry applications/problems

The global pharmaceutical industry is currently estimated to be worth $1 trillion. Contributors chart the rise of scientific marketing within the industry from 1920-1980. This is the first comprehensive study into pharmaceutical marketing, demonstrating that many new techniques were actually developed in Europe before being exported to America.

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

This book examines the nature and extent of competition in the pharmaceutical industry and analyses the interaction between market structure and selected elements of the marketing mix. It provides valuable insights into the level of promotional expenditure required to achieve a significant market share for new products; the use of price, new products and promotional strategies to protect market share; the effects of patent expiration on price levels and the use of pricing strategy to achieve market share. The book includes a brief comparative analysis of competition and marketing strategies in the US ethical pharmaceutical market.

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

"The Future of Drug Discovery: Who decides which diseases to treat?" provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the "The Future of Drug Discovery" is a timely book for all those who care about the development needs for drugs for disease.

This thought-provoking book is the first to: provide an in-depth, broad perspective on the crisis in drug industry expose the disconnect between what society needs and what the drug companies are working on analyse and project over 10 years into the future explain what it means for scientists and society determine what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat"

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort.
Presents a comprehensive view of the field of quality assuranceAn approach grounded in direct experienceUses diagrams and figures to clarify analytical points

Within a mere decade, hospital pharmacies throughout the Tibetan areas of the People's Republic of China have been converted into pharmaceutical companies. Confronted with the logic of capital and profit, these companies now produce commodities for a nationwide market. While these developments are depicted as a big success in China, they have also been met with harsh criticism in Tibet. At stake is a fundamental (re-)manufacturing of Tibetan medicine as a system of knowledge and practice. Being important both to the agenda of the Party State's policies on Tibet and to Tibetan self-understanding, the Tibetan medicine industry has become an arena in which different visions of Tibet's future clash.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. "Contract Research and Development Organizations: Their Role in Global Product Development" has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.

Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs. "

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.

Based on interviews with industry professionals, the book presents an overview of the key challenges and discusses how leading biopharmaceutical companies handle these challenges. It exposes the underlying structures that support the biopharmaceutical supply chain, focusing specifically on distribution-the point at which manufacturers release a finished product to the time that it is administered, and the complicated set of channels that exist between these two points. This overarching view of the supply chain provides an important piece of intelligence that can inform business strategy for life sciences manufacturers and distributors and help them achieve success in this industry.

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.

First published in 1979, Supplies Management for Health Services looks at the characteristics and problems of hospital suppliers and examines the way in which the hospital and the National Health Service deal with supplies problems and relations with suppliers. Beginning with a description of the National Health Service and its supplies' organisations and the role of the Department of Health and Social Security in this field, the book then reports on the detailed studies made over two years of the supplies' problems of ten London area health authorities and ten London manufacturers of medical equipment. The NHS situation is then contrasted with the supplies' situation in three non-health organisations and with the health supplies situation in France and West Germany. The final part of the book analyses the information obtained, proposes a means of assessing supplies systems, and evaluates the NHS situation. This is followed by the realistic proposals for reform, advocating a system similar to that used in British defence services, based on a central procurement agency, close cooperation with private manufacturers, and manufacture by government where necessary. This book will surely interest students of economics and global health.