What's the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

In the post-liberalization period, India has slowly but steadily tried to foster innovation to improve competitive efficiency of Indian manufacturing and thus boost global competitiveness of the industrial sector. Foreign direct investment was looked upon as a major source of technology paradigm shift; in recent times, industrial firms have been investing overseas, even in countries to which they used to export, based on their technological capabilities. Firms in Indian manufacturing industries have also attempted to bring about technological upgrades through imports of design and drawings (disembodied technology) against lump sum, royalty and technical knowhow fees, and imports of capital machinery (embodied technology) where the technology is embodied in the capital good itself. This volume comprises empirical contributions on this emerging phenomenon, on a range of issues including the role of R mergers, acquisitions and technological efforts; technological determinants of competitive advantages; the role of small and medium enterprises and regional patterns; technological efforts and global operations; and the role of industrial clusters in promoting innovation and competitiveness. This book was originally published as a special issue of Innovation and Development.

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.

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

Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development.

Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent need for novel therapies cannot stem the skyrocketing costs and plummeting productivity plaguing R&D, and many key products are facing patent expiration. Dr. Rathnam Chaguturu presents a case for collaboration between the pharmaceutical industry and academia that could reverse the industry's decline. Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Founder and CEO of iDDPartners, focused on pharmaceutical innovation, Founding president of the International Chemical Biology Society, and Senior Director-Discovery Sciences, SRI International, Dr. Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement. * Gain global perspectives on the benefits and potential issues surrounding collaborative innovation * Discover how industries can come together to prevent another "Pharma Cliff" * Learn how nonprofits are becoming the driving force behind innovation * Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration * Explore government initiatives that help foster cooperation between industry and academia Dr. Chaguturu s thirty-five years of experience in academia and industry, managing new lead discovery projects and forging collaborative partnerships with academia, disease foundations, nonprofits, and government agencies lend him an informative perspective into the issues facing pharmaceutical progress. In Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships, he and his expert team provide insight into the various nuances of the debate.

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.

Medicines for Cancer: Mechanism of Action and Clinical Pharmacology of Chemo, Hormonal, Targeted, and Immunotherapies is a comprehensive volume covering most of the known anti-cancer therapeutics. Cancer is the second leading cause of death worldwide, with its various forms resulting in nearly one out of every six mortalities each year. This book describes all US FDA-approved drugs (up to 2021), such as small molecules, peptides, monoclonal antibodies, whole antibodies, gene therapy, antibody-drug conjugates, and cell therapy, and immunotherapies are considered, and information about their generic and brand names, medical uses, details dosage, mechanisms of actions, pharmacokinetics, and side effects. Chemical structures of small molecules, small peptides, antibody-drug conjugates are also provided. Medicines for Cancer: Mechanism of Action and Clinical Pharmacology of Chemo, Hormonal, Targeted, and Immunotherapies is ideal for medicinal chemists, oncologists, and pharmacologists, this book will be indispensable for professional researchers, whether they are working in the clinic or the pharmaceutical industry.

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

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.

A free open access ebook is available upon publication. Learn more at www.luminosoa.org. Capitalizing a Cure takes readers into the struggle over a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When curative treatments for hepatitis C launched in 2013, sticker shock over their prices intensified the global debate over access to new medicines. Weaving historical research with insights from political economy and science and technology studies, Victor Roy demystifies an oft-missed dynamic in this debate: the reach of financialized capitalism into how medicines are made, priced, and valued. Roy's account moves between public and private labs, Wall Street and corporate board rooms, and public health meetings and health centers to trace the ways in which curative medicines became financial assets dominated by strategies of speculation and extraction at the expense of access and care. Provocative and sobering, this book illuminates the harmful impact of allowing financial markets to determine who heals and who suffers and points to the necessary work of building more equitable futures.

Advances in Epidemiological Modeling and Control of Viruses covers recent and advanced research works in the field of epidemiological modeling, with special emphasis on new strategies to control the occurrence and reoccurrence of viruses. The models included in this book can be used to study the dynamics of different viruses, searching for control measures, and epidemic models under various effects and environments. This book covers different models and methods of modeling, including data-driven approaches. The authors and editors are experienced researchers, and each chapter has been designed to provide readers with leading-edge information on topics discussed.

Experiments on patients, processes or plants all have random error, making statistical methods essential for their efficient design and analysis. This book presents the theory and methods of optimum experimental design, making them available through the use of SAS programs. Little previous statistical knowledge is assumed. The first part of the book stresses the importance of models in the analysis of data and introduces least squares fitting and simple optimum experimental designs. The second part presents a more detailed discussion of the general theory and of a wide variety of experiments. The book stresses the use of SAS to provide hands-on solutions for the construction of designs in both standard and non-standard situations. The mathematical theory of the designs is developed in parallel with their construction in SAS, so providing motivation for the development of the subject. Many chapters cover self-contained topics drawn from science, engineering and pharmaceutical investigations, such as response surface designs, blocking of experiments, designs for mixture experiments and for nonlinear and generalized linear models. Understanding is aided by the provision of "SAS tasks" after most chapters as well as by more traditional exercises and a fully supported website. The authors are leading experts in key fields and this book is ideal for statisticians and scientists in academia, research and the process and pharmaceutical industries.

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective.
HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.
* Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
* Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
* Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

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 introductory textbook of pharmacoeconomics is ideal for all those working in, aspiring to work in or interested in the pharmaceutical industry. It assumes no prior knowledge of this subject but is written at a level appropriate, for example, for those studying for a postgraduate degree or diploma in pharmaceutical medicine and who already have a first degree in science or medicine. Emphasizes how pharmacoeconomics can be of assistance in "real world" decision making. Covers the development of insuring, financing and delivery of health care in the developed world and the increasing role of governments. Explains the trend towards the critical scrutiny of health service activity. All topics explained assuming no specialist knowledge.

Ernest Solvay, philanthropist and organizer of the world-famous Solvay conferences on physics, discovered a profitable way of making soda ash in 1861. Together with a handful of associates, he laid the foundations of the Solvay company, which successfully branched out into other chemicals, plastics and pharmaceuticals. Since its emergence in 1863, Solvay has maintained world leadership in the production of soda ash. This is the first scholarly book on the history of the Solvay company, which was one of the earliest chemical multinationals and today is among the world's twenty largest chemical companies. It is also one of the largest companies in the field to preserve its family character. The authors analyze the company's 150-year history (1863-2013) from economic, political and social perspectives, showing the enormous impact geopolitical events had on the company and the recent consequences of global competition.

This book provides evidence to support the health-promoting components of green tea for human health. It explores the significance of green tea and its catechins represented by epigallocatechin gallate (EGCG), demonstrating their beneficial effects on diseases including cancer, obesity, arteriosclerosis, diabetes, hepatitis, and neurodegenerative diseases. The present status of human studies and avenues for future research are discussed. It is written by a team of experts from across the globe and makes significant Japanese findings available to international researchers. It is an essential resource for researchers interested in the biochemistry and pharmacology of green tea, and functional foods and beverages.

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

The development and marketing of drugs since the Second World War offers an exemplary demonstration of the impact of technology on competitiveness in a major industry. While focusing primarily on the market in the USA, this study examines also the activities of European firms, their contribution to the industry's technological evolution and the impact of their entry into the US market.

The main concern of the book, however, is to examine all the elements which go to make up the evolving landscape of competition, and their interaction. Thus, the effects of technological change are viewed in the context of changes in the legal and regulatory environment, and in competitive practice. For both the market as a whole and the individual firm this analysis illustrates how competitive positions actually emerge as a result of such interactions.

Consistent with this wider view, both the technological and the non-technological competencies of firms are discussed, and the concept of core competence is used extensively to show how individual firms developed and maintained their competitive strengths, as the industry moved from deep-tank fermentation through to the first decade of biotechnology. The final chapter highlights the key role of biotechnology in shaping the future of the industry, at a time of increased regulation and accelerating market driven change.

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".

Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Debates are raging over how the industry can and should be expected to act. In this volume leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, marketing and advertising. . Michael Santoro is Associate Professor with tenure in the Business Environment Department at Rutgers Business School, where he teaches courses on business ethics, public policy, labor and human rights, law, ethical issues in the pharmaceutical industry and China business strategy. As a Research Associate at Harvard Business School, he wrote or co-authored nearly thirty case studies and teaching notes on ethical and legal topics such as global protection of intellectual property, insider trading, the Federal Sentencing Guidelines and Fair Credit Reporting Act. Thomas Gorrie is Corporate Vice President, Government Affairs & Policy, at Johnson & Johnson, with responsiblity for all federal, state and international government affairs and policy. He completed post-doctoral studies at the Swiss Federal Institute of Technology in Zurich, following the receipt of his doctorate at Princeton University. Gorrie has over 30 years of worldwide health care experience and has worked with various Johnson & Johnson companies inresearch and development, marketing and sales, business development, strategic planning, general management, international, venture capital, and health policy.

The pharmaceutical industry worldwide is a rapidly burgeoning industry contributing to growth of gross domestic product and employment. Technological change in this field has been very rapid, with many new products being introduced. For this reason in part, health care budgets throughout the world have increased dramatically, eliciting growing pressures for cost containment. This book explores four important issues in pharmaceutical innovations: (1) the industry structure of pharmaceutical innovation; (2) incentives for correcting market failures in allocating resources for research and development; (3) competition and marketing; and (4) public evaluation of the benefits and costs of innovation. The lessons are applicable to countries all over the world, at all levels of economic development. By discussing existing evidence this book proposes incentive arrangements to accomplish social objectives.

Five years after publication of the third edition, and reflecting the dynamic nature of the pharmaceutical and medical device industries (as well as the many different areas of law that pertain to the management of these medical technologies), the Fourth Edition incorporates the latest legislative, regulatory, and judicial developments, describes recent scientific advances, and excerpts or references new scholarly contributions to this broad field (the wealth of citations should facilitate use in a seminar setting). Measured by volume, more than 20% of the previous edition has been replaced with new material. The latest edition retains the same basic thematic approach and modular structure of the original, which allows instructors to pick and choose the materials to cover based on their own tastes and areas of expertise.

Most people marvel at the level of innovation demonstrated by the biopharmaceutical industry in bringing new products to the market - especially in the past 20 years. However, there is a crisis looming in the industry that should be a concern to all of us who take for granted the constant pace at which new treatments, and increasingly cures, have emerged from the laboratories of current sector incumbents. In the book, we examine the evolution of the biopharmaceutical industry to understand how it became what we term a "unicorn industry" with a unique, US-centered business model that has led to multiple blockbuster products (aka, unicorns) year after year. We explore how past success has created perceived barriers to innovation diversification beyond the chemical or biological-based biopharmaceutical product, and highlight the warning signs of the industry's decline. We define a potential pathway for transforming the industry's business model by broadening the definition, sources, and enablers of innovation beyond the traditional biopharmaceutical product. We introduce and advocate for the 80-80 Rule - "Being 80% confident that you will only be 80% right the first time should feel normal." The 80-80 Rule is a theme that emphasizes speed and willingness to embrace uncertainty and overcome internal barriers to change. It sets the standard for redefining innovation as a platform to reignite growth of the biopharmaceutical industry.