The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection, and pipelines have been unable to fill the gap. This book explores the evolving definition of innovation in therapeutic product development and begins to examine its effects on the life sciences R&D industry. Historically, scientific innovation alone was sufficient to maintain ROI and deliver on unmet medical needs. However, with many forces now conspiring to increase pressures on the commoditization of drug development, industry support for truly novel, often high-risk development has eroded. This calls for a drastic redefinition of what "innovation" is. While innovation in the pharmaceutical R&D industry has historically been applied to major advances in therapy and unmet medical needs, we now need to see innovation increasingly defined in terms of financial, marketing (e.g. branded generics and emerging markets), pharmacoeconomic, and operational innovation. In this book, contributors drawn from the executive ranks of clinical development practitioners and stakeholders-from biopharmaceutical companies, clinical research organizations, academia, the financial community, and the patient perspective-have all come together to provide their expertise and visions. Their goal is to start a dialogue about ways to radically improve therapeutics development and get more and better medicines to the patients who need them, as fast as possible, in the most cost-efficient manner.

The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.

Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.

Long the scourge of developing countries, fake pills are now increasingly common in the United States. The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers. Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become "medical tourists" seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA. Bitter Pills will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves. Author Muhammad H. Zaman pays special attention to the science and engineering behind both counterfeit and legitimate drugs, and the role of a "technological fix" for the fake drug problem. Increasingly, fake drugs affect us all.

The continuing quest for new drugs and agrochemicals has seen researchers looking to the natural world for potential products. Plants and microorganisms have long been investigated as sources of new lead compounds, but the scope of this book has been widened to include substances derived from marine organisms. Advances in genetic engineering, high throughput screening and structure elucidation have also opened up further avenues for exploration. Competitive pressure from the field of combinatorial chemistry has expedited new approaches to natural product analysis and stimulated debate on the industrial utilization of natural products. Biodiversity: New Leads for the Pharmaceutical and Agrochemical Industries reviews and discusses aspects of modern natural products research. The central theme of many articles is the sustainable use of global biodiversity. Microbial, plant and marine products are presented as the sources of new drugs, including antifungal products, antibiotics, anticancer agents and animal health products. There is also coverage of the biosynthesis of polyketides and the chemical synthesis of natural products and their derivatives. A unique blend of industrial and academic perspectives on the importance of biodiversity and natural products, this book will prove an important source of state-of-the-art information for researchers, teachers and graduates in the chemical and biological sciences.

In Transforming Big Pharma John Ansell addresses critically how strategy works in the pharmaceutical industry. The long-standing dearth of new products has led to a growing shortfall in revenues. Ansell assesses the wide range of alternative strategies big pharma companies have been pursuing in recent years in attempting to overcome this. He shows that there is sound evidence to expect the recent upturn in the number of new products reaching the market to go on to greater heights. Chapters assess the complex trends in attrition rates, show how rife spectacular sales underestimation in the industry remains, and explain how conventional wisdom on the chances of product profitability also seriously undersells the industry. The surest route to transforming the prospects for big pharma, Ansell contends, is to step up activity in acquiring and developing new products. This is now realistic because, as he shows, the amount of intellectual property available is much greater than it was a decade ago. Ansell believes that no other strategies have sufficient transformative powers, though they may be useful as a stopgap whilst the sales of forthcoming new products mature. He argues for a reversal of big pharma's recent cutbacks in R&D and licensing, and re-focussing on new product development. Transforming Big Pharma is intended for those in senior and middle management in the pharmaceutical industry. It will also be valuable to students, as well as to all those dealing with the industry, including biotech companies and those providing services and products to the pharmaceutical industry.

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

This title includes a number of Open Access chapters. Pharmaceutical technology deals with the discovery, production, processing, and safe and effective delivery of medications to patients. Technologies involved include computer modeling for research, bioengineering for research instrumentation, processes and methods for increasing production, and computing technology and biosystematics for the management and analysis of data. This new book covers a wide range of important topics on today's pharmaceutical technology, such as in vitro drug release and controlled drug delivery, the use of nanotechnology in pharmaceuticals, quantum dot imaging, assessment and efficacy of pharmaceuticals, and much more.

This book explores why Japan, despite being a world leader in many high technology industries such as automobiles and consumer electronics, is only a minor player in the global pharmaceutical industry. Japan provides a huge market for pharmaceuticals as the second largest consumer of prescription drugs after the United States, and is a massive importer of prescription drugs, relying on discoveries made elsewhere. This book charts the development of the industry, from the devastation resulting from the Second World War to its performance in the present day. Focusing in particular on antibiotics and anticancer drugs, the book analyses factors that have prevented Japan from leading the rapid advances in science and technology that have occurred globally over recent decades. Looking at the pharmaceutical industry, the book argues that the Japanese government's research and development policies were not sufficiently incentivising. It also shows how the nature of capitalism in Japan - which featured close relations between government and industry as well as between and within firms - was appropriate for nurturing industrial development in the immediate post-war decades, but became much less effective in later years.

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

By any standard, the pharmaceutical industry's history has been a successful one. In addition to its profits and shareholder dividends, it has been seen by investors as relatively low risk and, largely, counter-cyclical to stock market trends. However, that important contribution appears to be petering out, with significant global implications for employees, shareholders, governments and patients. This is not just caused by the economic crisis. Long before this, several distinct but related streams of evidence emerged that now point to the stalling of the pharmaceutical industry. The Future of Pharma examines the causes of the industry's potential decline and offers a convincing and rigorous analysis of the options open to it. What emerges is a landscape defined, on the one hand, by the changing marketplace of mass-market consumers, institutional healthcare systems and wealthy individuals; and on the other by the alternate sources of commercial value - innovative therapies; super-efficient processes, supply chains and operations; and closer customer relations and increasingly tailored health services. The challenges to the pharmaceutical industry now and in the medium and long-term are very significant. Brian Smith's highly readable research findings are a wake-up call and a first step forward for anyone concerned with the future of the industry; whether executive, customer, policymaker or investor.

In recent years there have been dramatic changes in the pharmaceutical promotional landscape, affecting both consumers and healthcare professionals. One consequence of these dynamics is the need for pharmaceutical companies to plan new kinds of dialogue and relationships with their stakeholders. The evolution has been from mass-channel "push" marketing to two-way, multi-channel relationship marketing. Targeted Emails, webinars, mobile messages, and social networks are expanding in usage. This book is a practical overview and resource guide for the design and measurement of pharmaceutical relationship marketing (RM) programs. There are descriptions of each aspect of pharmaceutical RM design and measurement, including a running case study with follow-up exercises. The author has also conducted interviews from several pharmaceutical marketing industry experts, each having 15 years or more of working healthcare RM knowledge, and each speaking on their specific specialities. For newcomers to healthcare marketing, this book can serve as a foundation and introduction that provides framework, details, and examples of both relationship marketing designs and associated measurement disciplines. Healthcare Relationship Marketing will also be valuable to readers currently working in pharmaceutical marketing or sales who may not have exposure to the particular disciplines of relationship marketing and direct response measurement and optimization. Even for the experienced practitioner this will serve as a convenient reference that pulls together all of the program components and measurement frameworks within a single book. This book may also serve as a textbook within a university course in marketing, or a pharmaceutical business program.

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume two presents: * Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. * A comprehensive chapter on pharmaceutical water systems. * A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. * A detailed chapter on processing of parenteral drug products (SVPs and LVPs). * Presentations on widely used sterilization technologies - steam, gas / chemical, radiation, filtration and dry heat. * An in-depth chapter on lyophilization.

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume three presents: * An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. * Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing. * Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems. * New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: c How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? c How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? c Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? c What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.

The pharmaceutical and healthcare industry is hugely complex because it involves so many markets, products, processes and intermediaries. It is also heavily regulated, global, and used by everyone at some stage in their life. No wonder the supply chain for delivery of healthcare services is often fragmented and understood only in discrete sections. Changes in one area impact upon the others, and environmental factors such as pricing, regulatory change or actions by competitors impact the whole supply chain in ways that are not easily understood or managed. Accelerating technology, the commoditization of healthcare, increasing demands from ageing populations all influence the approach that suppliers of pharmaceutical products and services worldwide need to take if they are to design and manage an effective supply chain that will be capable of: exploiting their intellectual property in a sustainable way; providing safe and continuous provision of drugs or devices; and sustaining with resilience, yet still be flexible and cost efficient. Supply Chain in the Pharmaceutical Industry offers the basis for organizations to develop their own blueprint for managing the opportunities and threats to the pharmaceutical supply chain. Using examples from companies and markets across the world Rob Whewell offers a very vivid picture of the developing trends for pharmaceutical companies; the customers and markets they serve and points to some of the elements that underpin sustainable pharmaceutical strategies. The current global banking and financial crisis illustrates the important role played by regulation. The healthcare industry is similar in scope, and complexity, yet the implications of error are worse - life threatening. This review of key industry parameters will provide senior executives in the industry and policy makers in healthcare with a broad perspective of the issues and illustrates an understanding of the task at hand.

This updated "Second Edition "details how marketers, forecasters, and brand planners can achieve optimal success by building internally consistent simulation models to project future behavior of patients, physicians, and R&D processes. By introducing the reader to the complexities facing many pharmaceutical firms, specifically issues around cross-functional coordination and knowledge integration, this guide provides a framework for dynamic modeling of interest to several pharmaceutical markets, including epidemiology, market definitions, compliance/persistency, and revenue generation in the context of patient flows or movements.

Features in the text include:

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New chapters cover:

• the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
• pharmacovigilance programs designed to prevent widespread safety issues
• legal issues surrounding the sourcing of foreign APIs
• the issues of counterfeit drugs
• updates on quality standards

Business Development in the Biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate take-overs are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects.The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over 700 illustrations it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format. New to the third edition:

This book reviews current health risk communication strategies, and examines and assesses the technical and psycho-sociological tools available to support risk communication plans. It brings together approaches to risk communication from a number of countries and describes the techniques, including drama, storytelling and scenarios that are used to identify and prioritise key communication issues, and to identify policy responses. The book also provides a review of the methods and tools available for risk assessment, risk communication and priority setting, which are relevant not only to practitioners but to health planning more generally, and to many other areas of public health and policy. The discussion of these techniques is supported by case studies, and is concluded by a chapter reflecting on the conceptual and research issues that still need to be addressed. It also proposes new directions for risk communication that key into the public imagination with the aim of gaining their trust and confidence in the risk messages. Communicating Health Risks to the Public: A Global Perspective brings together a wide variety of perspectives on risk communication, from the perspectives of health, anthropology, psychology, and media. It should be of interest not only to those involved in risk assessment or communication but to anyone interested in the role of science and the media in the political process.

During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now, it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing, and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices.This book is a must-have for pharmaceutical, biotechnology, and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.

The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.