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.

Polymeric Nanosystems: Theranostic Nanosystems, Volume One examines the applications of nanotherapeutic systems and nanodiagnostics in relation to polymeric nanosystems. In the last decade, numerous biopolymers have been utilized to prepare polymeric nanosystems for therapeutic applications. These biopolymers include polylactic acid, polylactide-co-glycolide, polycaprolactone, acrylic polymers, cellulose and cellulose derivatives, alginates, chitosan, gellan gum, gelatin, albumin, chontroitin sulfate, hyaluronic acid, guar gum, gum Arabic, gum tragacanth, xanthan gum, and starches. Besides these biopolymers, grafted polymers are also being used as advanced polymeric materials to prepare many theranostic nanocarriers and nanoformulations. This book explores the array of polymeric nanosystems to understand therapeutic potentials. It will be useful to pharmaceutical scientists, including industrial pharmacists and analytical scientists, health care professionals, and regulatory scientists actively involved in the pharmaceutical product and process development of tailor-made polysaccharides in drug delivery applications.

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries.

Using clear and practical examples, Polymorphism in Pharmaceutical Solids, Second Edition presents a complete examination of polymorphic behavior in pharmaceutical development.
Ideal for pharmaceutical development scientists and graduate students in pharmaceutical science, this updated edition includes:
NEW CHAPTERS - on the latest developments and methods in the field that give pharmaceutical development scientists the up-to-date information they need to successfully implement new drug development techniques and methods
EXPERT EDITORSHIP - from Dr. Harry G. Brittain, whose vast experience and knowledge of the pharmaceutical industry provides readers with the authoritative advice they need and trust
COMPREHENSIVE CONTENT - that includes information appropriate for all levels of expertise in the field, from experienced pharmaceutical scientists to graduate students in physical pharmacy
200 HIGH QUALITY ILLUSTRATIONS - that present readers with a visual blueprint to the methods and techniques involved in polymorphism and solvatomorphism

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.

Nervous System Drug Delivery: Principles and Practice helps users understand the nervous system physiology affecting drug delivery, the principles that underlie various drug delivery methods, and the appropriate application of drug delivery methods for drug- and disease-specific treatments. Researchers developing nervous system putative therapeutic agents will use this book to optimize drug delivery during preclinical assessment and to prepare for regulatory advancement of new agents. Clinicians will gain direct insights into pathophysiologic alterations that impact drug delivery and students and trainees will find this a critical resource for understanding and applying nervous system drug delivery techniques.

Written by Lawton R. Burns and a panel of expert contributors, from the prestigious Wharton School, The Health Care Value Chain analyzes the key developments and future trends in the United States' health care supply chain. Based on a groundbreaking research initiative underwritten by the industry/university consortium— the Center for Health Management Research— this important book offers an in-depth examination of how the health care supply chain helps create value and competitive advantage.
The Health Care Value Chain offers a thorough examination of the trading relationships among the manufacturers of health care products, the distributors, the group purchasing organizations, and the hospital customers and end users of those products. And the authors show how health care professionals and manufacturers can work together to form beneficial strategic alliances.

The Core Model: A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care develops the innovative core model, an organizational research and design paradigm and economic theory that proposes a collaborative approach to resolving global health issues and improving the productivity of drug development. The model proposes that scientific collaboration does not occur in an unstructured manner, but actually takes place within a highly structured order where knowledge is transferred, integrated and finally translated into commercial products. An understanding of this model will help solve the global pharmaceutical industrys productivity problems and address important global health care and economic issues. This book is useful to researchers, advanced students, regulators, and management in pharmaceutical industries, as well as healthcare professionals, those working in health economics, and those interested in scientific innovation processes.

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Businesses that produce bioscience products--gene tests and therapies, pharmaceuticals, vaccines, and medical devices--are regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work.
This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of fields, including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making.

In the US alone, pharmaceutical companies spend around $7 billion a year on clinical trials for drugs; all this in a global market where increasing competition and pressure on healthcare financing are both impacting on margins and profitability. One solution for pharmaceutical companies lies within the clinical trials themselves. If only you can communicate the trial findings to the right people, in the right way, you can benefit from this huge investment and add significant value to your product range and your brand. Successfully Marketing Clinical Trials Results is a comprehensive guide for every marketing professional faced with the challenge of using marketing to convert scientific data into sales. The book offers you practical knowledge on how to use medical research data to maximise the revenue from your products. There are sections explaining how to: identify your market and devise your strategy; develop your content and translate data into a message that has impact; use language, layout and illustrations to best effect; communicate internally as well as externally; make best use of the resources available; align your sales force and the external agencies with whom you work; lead the people in the project team; co-operate with the medical researchers, external experts and the press. In this book are answers for everything from how to handle class-effect questions to developing a shared brand vocabulary. There are plenty of vivid examples and real-life applications to reinforce the ideas. Cases studies illustrate solutions to problems; checklists and tips will help to implement the suggestions and recommendations. Gunter Umbach has distilled the essence both of 25 years' experience in the healthcare market and of his highly successful seminar series on marketing clinical trials into the professional advice given in this book. The text is accompanied by a CD ROM containing detailed Powerpoint slides supporting e

In the US alone, pharmaceutical companies spend around $7 billion a year on clinical trials for drugs; all this in a global market where increasing competition and pressure on healthcare financing are both impacting on margins and profitability. One solution for pharmaceutical companies lies within the clinical trials themselves. If only you can communicate the trial findings to the right people, in the right way, you can benefit from this huge investment and add significant value to your product range and your brand. Successfully Marketing Clinical Trials Results is a comprehensive guide for every marketing professional faced with the challenge of using marketing to convert scientific data into sales. The book offers you practical knowledge on how to use medical research data to maximise the revenue from your products. There are sections explaining how to: identify your market and devise your strategy; develop your content and translate data into a message that has impact; use language, layout and illustrations to best effect; communicate internally as well as externally; make best use of the resources available; align your sales force and the external agencies with whom you work; lead the people in the project team; co-operate with the medical researchers, external experts and the press. In this book are answers for everything from how to handle class-effect questions to developing a shared brand vocabulary. There are plenty of vivid examples and real-life applications to reinforce the ideas. Cases studies illustrate solutions to problems; checklists and tips will help to implement the suggestions and recommendations. Gunter Umbach has distilled the essence both of 25 years' experience in the healthcare market and of his highly successful seminar series on marketing clinical trials into the professional advice given in this book. The text is accompanied by a CD ROM containing detailed Powerpoint slides supporting e

New Look to Phytomedicine: Advancements in Herbal Products as Novel Drug Leads is a compilation of in-depth information on the phytopharmaceuticals used in modern medicine for the cure and management of difficult-to-treat and challenging diseases. Readers will find cutting-edge knowledge on the use of plant products with scientific validation, along with updates on advanced herbal medicine in pharmacokinetics and drug delivery. This authoritative book is a comprehensive collection of research based, scientific validations of bioactivities of plant products, such as anti-infective, anti-diabetic, anti-cancer, immune-modulatory and metabolic disorders presented by experts from across the globe. Step-by-step information is presented on chemistry, bioactivity and the functional aspects of biologically active compounds. In addition, the pharmacognosy of plant products with mechanistic descriptions of their actions, including pathogenicity is updated with information on the use of nanotechnology and molecular tools in relation to herbal drug research.

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines.

Looks at the significant political and economic impact that the modern pharmaceutical industry has had on society taking an analytical approach to this high profile and controversial topic.
It explains how and why the modern pharmaceutical industry evolved and explores important topics such as drug promotion and regulation. It provides
* informative accessible and relevant information for both professionals and students from all backgrounds
* takes an analytical rather than a purely descriptive approach
The book will supply valuable information for all those who work in or with the pharmaceutical industry, health economists and health service researchers.

This book is the definitive work on the theory and practice of pharmaceutical tablet and pellet coating. It describes both the practical and theoretical aspects of tablet coating, including the equipment and methods used in laboratory development, scale-up and production systems, More...as well as automation and validation. This book also discusses the problems of conforming to world-wide regulations, and the hazards of environmental pollution.

Inorganic Nanosystems: Theranostic Nanosystems, Volume Two examines the applications of nanotherapeutic systems and nanodiagnostics in relation to polymeric nanosystems. In the last decade, numerous biopolymers have been utilized to prepare polymeric nanosystems for therapeutic applications. These biopolymers include polylactic acid, polylactide-co-glycolide, polycaprolactone, acrylic polymers, cellulose and cellulose derivatives, alginates, chitosan, gellan gum, gelatin, albumin, chontroitin sulfate, hyaluronic acid, guar gum, gum Arabic, gum tragacanth, xanthan gum, and starches. Besides these biopolymers, grafted polymers are also being used as advanced polymeric materials to prepare many theranostic nanocarriers and nanoformulations. This book explores the array of polymeric nanosystems to understand therapeutic potentials. It will be useful to pharmaceutical scientists, including industrial pharmacists and analytical scientists, health care professionals, and regulatory scientists actively involved in the pharmaceutical product and process development of tailor-made polysaccharides in drug delivery applications.

Darwin's Medicine is the sequel to Brian D. Smith's influential and critically acclaimed Future of Pharma (Gower, 2011). Whereas the earlier book predicted the evolution of the pharmaceutical market and the business models of pharmaceutical companies, Darwin's Medicine goes much deeper into the drivers of industry change and how leading pharmaceutical and medical technology companies are adapting their strategies, structures and capabilities in practice. Through the lens of evolutionary science, Professor Smith explores the speciation of new business models in the Life Sciences Industry. This sophisticated and highly original approach offers insights into: The mechanisms of evolution in this exceptional industry; The six great technological and social shifts that are shaping its landscape; The emergence of 26 distinct, new business models; and The lessons that enable firms to direct and accelerate their own evolution. These insights map out the industry's complex, changing landscape and provide an invaluable guide to those firms seeking to survive and thrive in this dynamic market. The book is essential reading for anyone working in or studying the pharmaceutical, medical technology and related sectors. It provides a unique and novel way of making sense of the transformation we can see going on around us and a practical, focused approach to managing a firm's evolutionary trajectory.

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.

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.

Simultaneously examining four significant, never-before-combined case studies, this unique feminist analysis offers troubling revelations about the private-public interaction in U.S. policy affecting birth control drugs. Reproductive Rights and the State: Getting the Birth Control, RU-486, and Morning-After Pills and the Gardasil Vaccine to the U.S. Market tackles a subject that remains controversial more than 60 years after "the pill" was approved for use in the United States. The first book to examine the politicization of the FDA approval process for reproductive drugs, this study maps the hard-fought battles over the four major drugs currently on the U.S. market. To make her case, Melissa Haussman scrutinizes the history of the FDA and the statutes that have governed it, as well as interactions between the U.S. government, American pharmaceutical companies, and the medical community. The analysis centers on explaining how three reproductive drugs were kept off the U.S. market well after their efficacy had been proven, while the availability of the fourth, Gardasil, has less to do with helping girls than with preserving the financial wellbeing of Merck. Readers will come away understanding how, when it comes to reproductive drugs, women's health concerns have consistently taken a backseat to political agendas and corporate profits.

Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.