A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands

The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, "Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand "explores this increasingly important field to help readers understand what they can--and must--do to get the most out of their brands.

Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future.

While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. "Pharmaceutical Lifecycle Management" walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.

Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation.

Evidence-Based Validation of Herbal Medicines brings together current thinking and practice in the areas of characterization and validation of natural products. This book reviews all aspects of evaluation and development of medicines from plant sources, including their cultivation, collection, phytochemical and phyto-pharmacological evaluation, and therapeutic potential. Emphasis is placed on describing the full range of evidence-based analytical and bio-analytical techniques used to characterize natural products, including -omic technologies, phyto-chemical analysis, hyphenated techniques, and many more.

Originally published in 1992, this study of Glaxo, from its beginnings to 1962, was based on unprecedented and unparalleled archival access to the company records. It gives a detailed account of the global operations of Glaxo, and describes not only the evolution of its international business, but studies its research and development programmes, its products, and its marketing and management. It was the first comprehensive study of a UK-based drugs company and one of the relatively few scholarly studies written of front-ranking world companies.

Mathematics for Physical Chemistry, Fifth Edition includes exercises that enable readers to test their understanding and put theory into practice. Chapters are constructed around a sequence of mathematical topics, progressing gradually into more advanced material, before discussing key mathematical skills, including the analysis of experimental data and-new to this edition-complex variables. Includes additional new content on Mathematica and its advanced applications. Drawing on the experience of its expert authors, this book is the ideal supplementary text for practicing chemists and students wanting to sharpen their mathematics skills and understanding of key mathematical concepts for applications across physical chemistry.

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

This book examines an 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 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.

At present, human society is facing a health care crisis that is affecting patients worldwide. In the United States, it is generally believed that the major problem is lack of affordable access to health care (i.e. health insurance). This book takes an unprecedented approach to address this issue by proposing that the major problem is not lack of affordable access to health care per se, but lack of access to better, safer, and more affordable medicines. The latter problem is present not only in the United States and the developing world but also in countries with socialized health care systems, such as Europe and the rest of the industrialized world. This book provides a comparative analysis of the health care systems throughout the world and also examines the biotechnology and pharmaceutical industries.

Examines the health care structure of the United States, Europe, and the third world, both separately and comparativelyOffers primary source insight through in-depth interviews with pharmaceutical and health care industry leaders from around the worldCarefully explains, in clear terms, the intricacies of the health care and pharmaceutical system and how these intricacies have led to the current crisisOffers concrete, comprehensive solutions to the health care crisis

Theoretical and Computational Photochemistry: Fundamentals, Methods, Applications and Synergy with Experimental Approaches provides a comprehensive overview of photoactive systems and photochemical processes. After an introduction to photochemistry, the book discusses the key computational chemistry methods applied to the study of light-induced processes over the past decade, and further outlines recent research topics to which these methods have been applied. By discussing the synergy between experimental and computational data, the book highlights how theoretical studies could facilitate understanding experimental findings. This helpful guide is for both theoretical chemists and experimental photochemistry researchers interested in utilizing computational photochemistry methods for their own work.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic "Pharmaco-complexity: Non-linear Phenomena and Drug Product Development".

"Smart, funny, clear, unflinching: Ben Goldacre is my hero." --Mary Roach, author of "Stiff," "Spook," and "Bonk
"We like to imagine that medicine is based on evidence and the results of fair testing and clinical trials. In reality, those tests and trials are often profoundly flawed. We like to imagine that doctors who write prescriptions for everything from antidepressants to cancer drugs to heart medication are familiar with the research literature about these drugs, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators have some code of ethics and let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients.
All these problems have been shielded from public scrutiny because they are too complex to capture in a sound bite. Ben Goldacre shows that the true scale of this murderous disaster fully reveals itself only when the details are untangled. He believes we should all be able to understand precisely how data manipulation works and how research misconduct in the medical industry affects us on a global scale.
With Goldacre's characteristic flair and a forensic attention to detail, "Bad Pharma "reveals a shockingly broken system in need of regulation. This is the pharmaceutical industry as it has never been seen before.

This book is a complete, authoritative resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents. Fourteen authors cover the industry's technologies. The book begins with a full discussion of the primary processes -- sugar coating, film coating, and microencapsulation -- as well as the rationale for coating, methodologies, formulations, processing methods, and equipment and cleaning. Then it explores automation of the coating process, including hardware and software requirements. Finally, the book examines major stability and quality control issues. Regulations underlie all discussions.

"Practical Utility of Biomarkers in Drug Discovery and Development" covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on:

• The use of isolator and barrier concepts for aseptic processing and assembly.
• The application of robotics as an alternative to gowned personnel.
• The increasing reliance on automation to minimize or eliminate operator intervention.
• The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing.

Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

Nanotechnology in Ophthalmology is a comprehensive and up-to-date reference on the role and applications of nanotechnology in ophthalmology, from drug delivery and treatment of ocular diseases to toxicity issues. Written by experts from the nanotechnology, ophthalmology, and pharmacology fields, this book has a unique, broad and diverse scope, including chapters on nanosensor-based diagnostic tools, delivery of nanobiomaterials, implantable materials and devices, delivery of nanobiomaterials, nanotechnology for medical and surgical treatment, regenerative medicine, and more. This book provides a valuable reference to researchers working in the areas of ophthalmology, nanoscience and pharmacology, and clinical fellows who are interested in nanoophthalmology as a reference for their practice and research.

For most Western audiences, Cuba is a touristic paradise stuck in time and virtually detached from world technology networks by the US embargo - anything but a hub of industrial innovation and high value-added biotechnology. However, a closer look reveals more subtle but equally powerful stories that challenge the homogenizing assumptions of conventional economics and open up scope for more sophisticated reflections on Cuban economy and industry. From this kind of enquiry emerges the case of the internationally respected Cuban biotech industry as the most successful case of science and technology policy in the country's economic history. The book takes an interdisciplinary approach, exploring issues such as interdependency, purpose and history as natural constituencies of the innovation process. It also examines the dynamic and crucial role played by the state in the formation of innovative business enterprises. This book will be of interest to academic researchers in the fields of innovation and economic development.

Tailor-Made Polysaccharides in Drug Delivery provides extensive details on all the vital precepts, basics and fundamental aspects of tailored polysaccharides in the pharmaceutical and biotechnological industry for understanding and developing high quality products. The book offers a comprehensive resource to understand the potential of the materials in forming new drug delivery methods. It will be useful to pharmaceutical scientists, chemical engineers, and regulatory scientists and students actively involved in pharmaceutical product and process development of tailored-made polysaccharides in drug delivery applications. The utilization of natural polymeric excipients in numerous healthcare applications demand the replacement of the synthetic polymers with the natural ones due to their biocompatibility, biodegradability, economic extraction and readily availability. The reality behind the rise in importance of these natural materials is that these sources are renewable if grown in a sustainable means and they can tender incessant supply of raw materials. Amongst these natural polymers, polysaccharides are considered as excellent excipients because of its non-toxic, stable, biodegradable properties. Several research innovations have been made on applications of polysaccharides in drug delivery.

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.

Originally published in 1992, this study of Glaxo, from its beginnings to 1962, was based on unprecedented and unparalleled archival access to the company records. It gives a detailed account of the global operations of Glaxo, and describes not only the evolution of its international business, but studies its research and development programmes, its products, and its marketing and management. It was the first comprehensive study of a UK-based drugs company and one of the relatively few scholarly studies written of front-ranking world companies.

This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.