Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.

Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts discuss the bioequivalence of dermatological and transdermal dosage forms. They explore the biochemistry and treatment of skin diseases, the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules).

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

This definitive reference explores the various aspects of multiparticulate dosage form development-assessing the in vivo behavior and performance of multiparticulates as well as comparing their market position to other dosage forms. Discussing-for the first time in a comprehensive manner-alternative pelletization techniques such as balling (spherical agglomeration), spray congealing, and cryopelletization, Multiparticulate Oral Drug Delivery describes formulation and processing variables that affect the formation, integrity, and performance of coatings derived from molten materials and polymeric solutions and dispersions analyzes the biopharmaceutical aspects and in vivo performance of multiparticulate drug delivery systems details the idiosyncrasies of the manufacturing process of hard-shell gelatin capsules explains the different kinds of packaging materials and machinery and the importance of packaging during the development phase and beyond previews the marketing considerations of multiparticulate systems in the years to come presents practical solutions to problems encountered in the area of film-coating processes and more!

Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

Appraising cancer as a major medical market in the 2010s, Wall Street investors placed their bets on single-technology treatment facilities costing $100-$300 million each. Critics inside medicine called the widely-publicized proton-center boom "crazy medicine and unsustainable public policy." There was no valid evidence, they claimed, that proton beams were more effective than less costly alternatives. But developers expected insurance to cover their centers' staggeringly high costs and debts. Was speculation like this new to health care? Cancer, Radiation Therapy, and the Market shows how the radiation therapy specialty in the United States (later called radiation oncology) coevolved with its device industry throughout the twentieth-century. Academic engineers and physicians acquired financing to develop increasingly powerful radiation devices, initiated companies to manufacture the devices competitively, and designed hospital and freestanding procedure units to utilize them. In the process, they incorporated market strategies into medical organization and practice. Although palliative benefits and striking tumor reductions fueled hopes of curing cancer, scientific research all too often found serious patient harm and disappointing beneficial impact on cancer survival. This thoroughly documented and provocative inquiry concludes that public health policy needs to re-evaluate market-driven high-tech medicine and build evidence-based health care systems.

The healthcare professionals who save and extend our lives are helpless without the medicines and technologies that have revolutionised medical care. But the industry that invents, makes and provides these indispensable tools is transforming under the pressure of ageing populations, globalisation and revolutions in biological and information technology. How this industry adapts and evolves is vitally important to every one of us. This book looks inside the heads and hearts of the people who lead the global pharmaceutical and medical technology industry. It describes how they make sense of their markets and the wider life sciences economy. It reveals what they have learned about how to lead large, complex organisations to compete in dynamic, global markets. Leadership in the Life Sciences is essential reading for anyone working in or with the pharmaceutical and medical technology industry and its halo of supporting companies. Written as ten succinct lessons, it gives the reader unique insight into what the industry's leaders are thinking. Covering topics from leadership to organisational culture, from change management to digital disruption and from competitive strategy to value-creation, each chapter distils the accumulated wisdom of those who lead the complex and turbulent life sciences industry.

Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry's main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.

Modern Strategy for Preclinical Pharmaceutical R&D Towards the Virtual Research Company David Cavalla Arachnova Ltd, Cambridge, UK With contributions from: John Flack AMRAD Corporation, Richmond, Australia and Richard Jennings Wolfson Industrial Liaison Office, University of Cambridge, UK The twentieth century has been a great success for modern medicine, and has resulted in the generation of a plethora of drugs to treat most common illnesses. However, in the light of increasing regulatory demands, spiralling costs and diminishing commercial returns, the question of how, when, where and whether to conduct pharmaceutical R&D has profound implications, and not just for those within the pharmaceutical industry. Modern Strategy for Preclinical Pharmaceutical R&D gets to the heart of the debate that surrounds this topic and asks the questions: Can the economies of scale of large multinational pharmaceutical companies adequately compensate for the loss of creative individualism that is essential for the process of drug discovery and development? Might technological experts provide better services to a number of clients rather than work within a single large infrastructure where confidentiality is paramount and synergy of multi-disciplinary operation readily possible? What are the long-term prospects for the latest alternatives to large pharmaceutical R&D companies? In response to these and other dilemmas, the authors define the processes involved in drug R&D, explore the advantages and disadvantages of collaborative methods of drug research, and examine the roles that academia, CROs, small 'biotechnology' companies and 'research boutiques', and possibly even the 'virtual research company'might play as contractors and collaborators. Without a doubt, Modern Strategy for Preclinical Pharmaceutical R&D is essential reading for all those interested in making sense of the confusion that surrounds today's pharmaceutical industry.

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.

Nanostructures for Oral Medicine presents an up-to-date examination of the applications and effects of nanostructured materials in oral medicine, with each chapter addressing recent developments, specific applications, and uses of nanostructures in the oral administration of therapeutic agents in dentistry. The book also includes coverage of the biocompatibility of nanobiomaterials and their remarkable potential in improving human health and in reducing environmental pollution. Emerging advances, such as Dr. Franklin Tay's concept of a new nanotechnology process of growing extremely small, mineral-rich crystals and guiding them into the demineralized gaps between collagen fibers to prevent the aging and degradation of resin-dentin bonding is also discussed. This work will be of great value to those who work in oral medicine, providing them with a resource to gain a greater understanding of how nanotechnology can help them create more efficient, cost-effective products. In addition, it will be of great interest to those who work in materials science who wish to gain a greater appreciation of how nanostructured materials are applied in this field.

Scientific communication is challenging. The subject matter is complex and often requires a certain level of knowledge to understand it correctly; describing hazard ratios, interpreting Kaplan Meier curves and explaining confounding factors is different from talking about a new car or clothing range. Processes, for example in clinical trials, are laborious and tedious and knowing how much of the detail to include and exclude requires judgement. Conclusions are rarely clear cut making communicating statistical risk and probability tough, especially to non-statisticians and non-scientists such as journalists. Communicating Clearly about Science and Medicine looks at these and many more challenges, then introduces powerful techniques for overcoming them. It will help you develop and deliver impactful presentations on medical and scientific data and tell a clear, compelling story based on your research findings. It will show you how to develop clear messages and themes, while adhering to the advice attributed to Einstein: 'Make things as simple as possible...but no simpler.' John Clare illustrates how to communicate clearly the risks and benefits contained in a complex data set, and balance the hope and the hype. He explains how to avoid the 'miracle cure' or 'killer drug' headlines which are so common and teaches you how to combine the accuracy of peer-to-peer reviewed science with the narrative skills of journalism.

Appraising cancer as a major medical market in the 2010s, Wall Street investors placed their bets on single-technology treatment facilities costing $100-$300 million each. Critics inside medicine called the widely-publicized proton-center boom "crazy medicine and unsustainable public policy." There was no valid evidence, they claimed, that proton beams were more effective than less costly alternatives. But developers expected insurance to cover their centers' staggeringly high costs and debts. Was speculation like this new to health care? Cancer, Radiation Therapy, and the Market shows how the radiation therapy specialty in the United States (later called radiation oncology) coevolved with its device industry throughout the twentieth-century. Academic engineers and physicians acquired financing to develop increasingly powerful radiation devices, initiated companies to manufacture the devices competitively, and designed hospital and freestanding procedure units to utilize them. In the process, they incorporated market strategies into medical organization and practice. Although palliative benefits and striking tumor reductions fueled hopes of curing cancer, scientific research all too often found serious patient harm and disappointing beneficial impact on cancer survival. This thoroughly documented and provocative inquiry concludes that public health policy needs to re-evaluate market-driven high-tech medicine and build evidence-based health care systems.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.