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 Pharmaceutical Studies Reader is an engaging survey of the field that brings together provocative, multi-disciplinary scholarship examining the interplay of medical science, clinical practice, consumerism, and the healthcare marketplace. * Draws on anthropological, historical, and sociological approaches to explore the social life of pharmaceuticals with special emphasis on their production, circulation, and consumption * Covers topics such as the role of drugs in shaping taxonomies of disease, the evolution of prescribing habits, ethical dimensions of pharmaceuticals, clinical trials, and drug research and marketing in the age of globalization * Offers a compelling, contextually-rich treatment of the topic that exposes readers to a variety of approaches, ideas, and frameworks * Provides an accessible introduction for readers with no previous background in this area

A visit to a physician these days is cold: physicians spend most of their time typing at computers, making minimal eye contact. Appointments generally last only a few minutes, with scarce time for the doctor to connect to a patient's story, or explain how and why different procedures and treatments might be undertaken. As a result, errors abound: indeed, misdiagnosis is the fourth-leading cause of death in the United States, trailing only heart disease, cancer, and stroke. This is because, despite having access to more resources than ever, doctors are vulnerable not just to the economic demand to see more patients, but to distraction, burnout, data overload, and their own intrinsic biases. Physicians are simply overmatched. As Eric Topol argues in Deep Medicine, artificial intelligence can help. Natural-language processing could automatically record notes from our doctor visits; virtual psychiatrists could better predict the risk of suicide or other mental health issues for vulnerable patients; deep-learning software will make every physician a master diagnostician; and we could even use smartphone apps to take our own medical "selfies" for skin exams and receive immediate analysis. . On top of that, the virtual smartphone assistants of today--Alexa, Siri, Cortana--could analyze our daily health data to reduce the need for doctor visits and trips to the emergency room, and support for people suffering from asthma, epilepsy, and heart disease. By integrating tools like these into their daily medical practice, doctors would be able to spend less time collecting and cataloging information, and more time providing thorough, intimate, and meaningful care for their patients, as no machine can. Artificial intelligence can also help remedy the debilitating cost of healthcare, both for individuals and the economy writ large. The medical sector now absorbs 20 percent of the US gross domestic product--it is largest sector by dollars and jobs. And it's very inefficient. Take the cost of medical scans: There are over 20 million medical scans performed in the US every day, and an MRI, for example, costs hundreds to thousands of dollars. AI could process 260 million medical scans (more than 2 weeks' worth) in less than 24 hours for a cost of only $1000. We pay billions and billions of dollars for the same work today. The American health care system needs a serious reboot, and artificial intelligence is just the thing to press the restart button. As innovative as it is hopeful, Deep Medicine ultimately shows us how we can leverage artificial intelligence for better care at lower costs with more empathy, for the benefit of patients and physicians alike.

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.

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.

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.

International standards ensure that organisations operate the right processes to support their objectives. International Standards for Design and Manufacturing is an accessible guide for manufacturing and production managers and students. It guides readers through the standards needed to build operating systems which are robust and integrated. International Standards for Design and Manufacturing is based on a collaboration between Swansea University, BSI and manufacturing and production practitioners from key companies who have supplied cases of using standards in practice, such as Bosch, BP, Tesco, M&S and Toyota. Each chapter includes an introduction to the standards being discussed, definitions, case studies of using the standards in practice, statistics, why these standards are important, conclusions, seminar topics and exam questions.

Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.

Alderley Park Discovered is written by former AstraZeneca chemist George Hill, whose carefully researched text is presented in a wonderfully lively and readable style. The 400-acre site is a unique and beautiful natural environment with a rich, varied history, beginning with the creation of the Park by the Stanley family from the sixteenth century. It is also home to a diverse range of wildlife, and George Hill's considerable knowledge in this area reveals its wealth in the middle section of the book. He then tells of the Park's remarkable scientific inception by ICI, moving on to its huge growth under Zeneca and AstraZeneca, revealing the inside stories of the groundbreaking heart and cancer drugs discovered on the site. Now, under the auspices of Manchester Science Partnerships, Alderley Park has become a hub for Life Sciences, and is set to be developed for new residential and leisure purposes into the future. This fascinating, lavishly illustrated and beautifully produced book will be of huge appeal to anyone with connections to the Park, including current and former employees, local people and historians.

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

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.

Advances and Avenues in the Development of Novel Carriers for Bioactives and Biological Agents provides sound data on the utility of biological and plant-based drugs and describes challenges faced in all aspects offering indispensable strategies to use in the development of bioactive medicines. Bioactive based medications are commonly used throughout the world and have been recognized by physicians and patients for their therapeutic efficacy. Bioactive formulations, including their subordinates and analogs, address 50% of all medicines in clinical practice. Novel bioactive medicine transporters can cure many disorders by both spatial and transitory approaches and have various justifications in medicinal potential. This book presents information on the utility of natural, plant, animal and bioengineered bioactive materials. It is a fundamental source of information and data for pharmacognosists, pharmaceutical analysts, drug transport scientists and pharmacologists working in bioactive medications.

While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

Polymers are one of the most fascinating materials of the present era finding their applications in almost every aspects of life. Polymers are either directly available in nature or are chemically synthesized and used depending upon the targeted applications.Advances in polymer science and the introduction of new polymers have resulted in the significant development of polymers with unique properties. Different kinds of polymers have been and will be one of the key in several applications in many of the advanced pharmaceutical research being carried out over the globe. This 4-partset of books contains precisely referenced chapters, emphasizing different kinds of polymers with basic fundamentals and practicality for application in diverse pharmaceutical technologies. The volumes aim at explaining basics of polymers based materials from different resources and their chemistry along with practical applications which present a future direction in the pharmaceutical industry. Each volume offer deep insight into the subject being treated. Volume 1: Structure and Chemistry Volume 2: Processing and Applications Volume 3: Biodegradable Polymers Volume 4: Bioactive and Compatible Synthetic/Hybrid Polymers

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management.

Nucleic Acids as Gene Anticancer Drug Delivery Therapy highlights the most recent developments in cancer treatment using nucleic acids, nanoparticles and polymer nanoparticles for genomic nanocarriers as drug delivery, including promising opportunities for targeted and combination therapy. The development of a wide spectrum of nanoscale technologies is beginning to change the scientific landscape in terms of disease diagnosis, treatment, and prevention. This book presents the use of nanotechnology for medical applications, focusing on its use for anticancer drug delivery. Various intelligent drug delivery systems such as inorganic nanoparticles and polymer-based drug delivery are discussed. The use of smart drug delivery systems seems to be a promising approach for developing intelligent therapeutic systems for cancer immunotherapies and is discussed in detail along with nucleic acid-targeted drug delivery combination therapy for cancer. Nucleic Acids as Gene Anticancer Drug Delivery Therapy will be a useful reference for pharmaceutical scientists, pharmacologiests, and those involved in nanotechnology and cancer research.

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Medicine Price Surveys, Analyses and Comparisons establishes guidelines for the study and implementation of pharmaceutical price surveys, analyses, and comparisons. Its contributors evaluate price survey literature, discuss the accessibility and reliability of data sources, and provide a checklist and training kit on conducting price surveys, analyses, and comparisons. Their investigations survey price studies while accounting for the effects of methodologies and explaining regional differences in medicine prices. They also consider policy objectives such as affordable access to medicines and cost-containment as well as options for improving the effectiveness of policies.

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. It also covers the industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases, and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences.

A Handbook of Artificial Intelligence in Drug Delivery explores the use of Artificial Intelligence (AI) in drug delivery strategies. The book covers pharmaceutical AI and drug discovery challenges, Artificial Intelligence tools for drug research, AI enabled intelligent drug delivery systems and next generation novel therapeutics, broad utility of AI for designing novel micro/nanosystems for drug delivery, AI driven personalized medicine and Gene therapy, 3D Organ printing and tissue engineering, Advanced nanosystems based on AI principles (nanorobots, nanomachines), opportunities and challenges using artificial intelligence in ADME/Tox in drug development, commercialization and regulatory perspectives, ethics in AI, and more. This book will be useful to academic and industrial researchers interested in drug delivery, chemical biology, computational chemistry, medicinal chemistry and bioinformatics. The massive time and costs investments in drug research and development necessitate application of more innovative techniques and smart strategies.

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 to 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."

Economic Evaluation of Pharmacy Services provides the latest on the trend to a more product-centered and service-centered practice, eschewing traditional economic evaluation techniques that focus on product-to-product comparisons in favor of evaluating processes that measure costs and health outcomes. Complete with examples focusing on best practices, including various study designs, types of pharmacy services, and types of outcomes being evaluated, the book emphasizes case studies and examples that help readers understand economic evaluation techniques. Many of these techniques are transferable across countries, especially where there are advanced and stable health systems in place. With the help of this practical guide, readers will gain a thorough understanding of the application of economic evaluation of pharmacy services.