During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now, it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing, and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices.This book is a must-have for pharmaceutical, biotechnology, and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.

The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.

'What gets measured gets fixed' and this is as true of the pharmaceutical industry as any other. The problem is that pharmaceutical businesses are complex. Drug research and development involves extended and expensive processes; defining appropriate metrics for these processes is not easy, yet ineffective or misguided metrics can be more damaging than none at all. David Zuckerman's Pharmaceutical Metrics is an extremely practical guide to selecting a system, selling it to top management, choosing and defining the right metrics for your system, communicating and displaying the results. And because metrics are about how to shape and develop your business, he explores how to deploy them organization-wide and make sure that they are driving business improvement. In order to reflect the needs of different types of pharmaceutical company the author uses four sample companies, throughout the book, to illustrate the principles for 'big pharma', 'micro pharma', a virtual development company and a CRO. This highly practical book provides a step-by-step guide to creating a state-of-the-art, strategy-driven metrics system for pharmaceutical R&D, supported by case studies of the techniques applied and tips for optimizing the system.

Written by John Lidstone and Janice MacLennan, the second edition of Marketing Planning for the Pharmaceutical Industry became accepted as the bible for the industry. In this new companion book Janice MacLennan picks up two of the themes touched on in Marketing Planning - market segmentation and branding, and the inter-relationship between these two - and with this book makes them key topics for discussion. Brand Planning for the Pharmaceutical Industry begins by exploring what branding is and why it is of importance, particularly to the pharmaceutical sector. The book then goes on to show how branding can be integrated into the early stages of the commercialization process for new products, both in theory and in the 'real' world. The book provides a step-by-step guide to brand planning, using market segmentation as the starting point. The book is split into two parts, the first dealing comprehensively with brand planning for products yet to get to the market, with the second part applying the same process to products that are already on the market. Both parts are extremely pragmatic, full of pertinent examples and insights from the pharmaceutical industry, and are directly applicable to your own brand planning. Brand Planning for the Pharmaceutical Industry concludes by confronting the problems that organizations are likely to have in actually making brand planning an integral part of their work and presents strategies for dealing with them.

Extensively revised, with an updated title that reflects its expanded scope, International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products, Second Edition provides the practical labeling information you need to achieve rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, the book explains the relevant laws, regulations, and requirements in major markets worldwide. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. This is not a "cookbook" of easy-to-follow recipes. It is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment.

Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development-utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds.

Drug-related morbidity and mortality is rampant in contemporary industrial society, despite or perhaps because, government has assumed a critical role in the process by which drugs are developed and approved. Parrish asserts that, as a people, Americans need to understand how it is that government became the arbiter of pharmaceutical fact. The consequences of our failure to understand, he argues, may threaten individual choice and forestall the development of responsible therapeutics. Moreover, if current standards and control continues unabated, the next therapeutic reformation might well make possible the sanctioned commercial exploitation of patients. In "Defining Drugs," Parrish argues that the federal government became arbiter of pharmaceutical fact because the professions of pharmacy and medicine, as well as the pharmaceutical industry, could enforce these definitions and standards only through police powers reserved to government. Parrish begins his provocative study by examining the development of the social system for regulating drug therapy in the United States. He reviews the standards that were negotiated, and the tensions of the period between Progressivism and the New Deal that gave cultural context and historical meaning to drug use in American society. Parrish describes issues related to the development of narcotics policy through education and legislation facilitated by James Beal and Edward Kremers, and documents the federal government's evolving role as arbiter of market tensions between pharmaceutical producers, government officials, and private citizens in professional groups, illustrating the influence of government in writing enforceable standards for pharmaceutical therapies. He shows how the expansion of political rights for practitioners and producers has shifted responsibility for therapeutic consequences from individual practitioners and patients to government. This timely and controversial volume is written for the scholar and the compassionate practitioner alike, and a general public concerned with pharmacy regulation in a free society. Richard Henry Parrish II is assistant professor of pharmacy practice at the Bernard J. Dunn School of Pharmacy at Shenandoah University. "Defining Drugs documents the evolution of social thought and action about pharmaceuticals in the United States in the 20th century. Written from a free-market perspective, Richard Parrish demonstrates how industry, goverment, and profressional leaders used science to justify the expansion of goverment power over standards and people. The Politicized definition of pharmaceutical fact cemented the foundation of pharmacotherapy in the modern pharmacratic state. Parrish's thesis will affect the current debates on federal power concerning the proper role of pharmacists, physicians, prescription laws, and Medicare prescription benefits; dietary supplements and herbal remedies; and nanotechnologies and pharmacgenomics. Scholary in documentation and persuasive in tone, "Defining Drugs" is an indispensable contribution to our understanding of the debate about drugs and drug policy." --Dr. Thomas Szasz, State University of New York "Parrish provides an invaluable analysis of the transformation of pharmaceutical regulation over the past millennium."--Peter Barton Hutt, Esq., Covington and Burling ""Defining Drugs" is an essential key for the medical profession and any who would understand the drug industry's regulation processes." uThe Midwest Book Review

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.

Marketing in the pharmaceutical and healthcare sector requires a particular set of skills; its intricacies mean planning is an essential prerequisite. The marketing planning system described in this book has been designed to enable marketing and product executives to produce a plan which serves as a dynamic management tool which will help them to get from where they are now to where they want to be next year and thereafter. Now in its second edition, this bestselling book has become the standard text for all product managers, marketing managers and directors working in this demanding industry. John Lidstone and Janice MacLennan have updated the book to embrace best current practice. A new orientation to external analysis and a reworking of the application of SWOT analysis, along with fresh material on sales forecasting and strategy implementation, bring the book up to date with current thinking and industry trends. Marketing Planning for the Pharmaceutical Industry is based on real life experience built up over many years. Each chapter takes the reader through the sequential stages of planning so that by the end they will be able to produce a practical plan ready for implementation. It is the only book of this type which tailors marketing to those working in the sector and as such is a unique, invaluable and indispensable resource.

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this three-volume reference provides detailed information on specialized products, such as emulsions, liposomes, polymers, and polymeric pharmaceutical excipients. Written by over twenty-five international experts, it explains the requirements for conducting clinical research and obtaining approval for new drug products-furnishing a current, comprehensive review of U.S. drug regulations.

Pharmaceutical Marketing in the 21st Century helps professionals in the pharmaceutical field anticipate and prepare for market changes and advances, and it guides them in adjusting their marketing strategies to remain competitive in the coming era. Ideal for product managers, planners, and strategists, this book puts the past twenty years of pharmacy into perspective and uses it as a basis for predicting the next twenty years. Internationally relevant, this book is now available in Japanese!Distinguished contributors provide a formal conjecture on the nature of various aspects of pharmaceutical marketing in the early part of the 21st century. Utilizing their experience and expertise, they provide pharmaceutical professionals with guidelines for marketing in the coming years. Readers gain insight into what the future may hold in these areas: pricing, product development, distribution, promotion, retailing, market research, and other areas. Experts who make professional speculations in Pharmaceutical Marketing in the 21st Century include these among others: William R. Mattson, Jr. (President, The Mattson Jack Group, St. Louis) and Evan G. Dick (Vice President and General Manager, MedStrategy Management Reports, St. Louis). They compare pharmaceutical marketing of 20 years ago with that of today and use the comparison as a basis for making projections 20 years into the future. David W. Newton (Albany College of Pharmacy). He predicts an increased importance and possible necessity of the pharmacist's role in direct/indirect patient care services. Jerome A. Reinstein (industry consultant and Director-General, World Federation of Proprietary Medicine Manufacturers, London). He explores the increasing number of prescription drugs becoming available over the counter. Pharmaceutical marketers and benefits managers, regulatory officials, drug product managers, advertising agency executives, and politicians will find Pharmaceutical Marketing in the 21st Century a must read as they work today in preparation for the future of pharmaceutical care and marketing.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close comparisons with the tobacco conglomerates, revealing the extraordinary truth behind efforts to confuse and distract the public and their politicians. The book addresses, in evidence-based detail, an extraordinary system failure caused by widespread crime, corruption, bribery and impotent drug regulation in need of radical reforms. "The main reason we take so many drugs is that drug companies don't sell drugs, they sell lies about drugs. This is what makes drugs so different from anything else in life...Virtually everything we know about drugs is what the companies have chosen to tell us and our doctors...the reason patients trust their medicine is that they extrapolate the trust they have in their doctors into the medicines they prescribe. The patients don't realise that, although their doctors may know a lot about diseases and human physiology and psychology, they know very, very little about drugs that hasn't been carefully concocted and dressed up by the drug industry...If you don't think the system is out of control, please email me and explain why drugs are the third leading cause of death...If such a hugely lethal epidemic had been caused by a new bacterium or a virus, or even one-hundredth of it, we would have done everything we could to get it under control." FROM THE INTRODUCTION

THE PHARMACEUTICAL INDUSTRY IS BROKEN From the American hedge fund manager who drastically hiked the price of an AIDS pill to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system built to drive innovation and improve patient care has been distorted to maximise profits. In Sick Money, the investigative journalist who exposed a billion-pound British price-hiking scandal goes inside the global battle over high drug prices. From secret deals to patients forced to turn to the black market, Billy Kenber reveals how medicines have become nothing more than financial assets. He offers a diagnosis of an industry in crisis - and a prescription for how it could be fixed.

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.

The pharmaceutical industry is one of today's most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success-or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: * An extensive literature review, including coverage of research from fields other than marketing * an overview of how practitioners have addressed the topic * introduction of relevant analytical tools, such as statistics and ethnographic studies * suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies examines recent advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation optimization, Quality by design (QbD), process analytical technology, and the uses of various pharmaceutical biomaterials, including natural polymers, synthetic polymers, modified natural polymers, bioceramics, and other bioinorganics. In addition, the book covers rapid advancements in the field by providing a thorough understanding of pharmaceutical processes, formulation developments, explorations, and exploitation of various pharmaceutical biomaterials to formulate pharmaceutical dosage forms.

In Longshot, investigative journalist David Heath takes readers inside the small group of scientists whose groundbreaking work was once largely dismissed but whose feat will now eclipse the importance of Jonas Salk's polio vaccine in medical history. With never-before-reported details, Heath reveals how these scientists overcame countless obstacles to give the world an unprecedented head start when we needed a COVID-19 vaccine. The story really begins in the 1990s, with a series of discoveries that were timed perfectly to prepare us for the worst pandemic since 1918. Readers will meet Katalin Kariko, who made it possible to use messenger RNA in vaccines but struggled for years just to hang on to her job. There's also Derrick Rossi, who leveraged Kariko's work to found Moderna but was eventually expelled from his company. And then there's Barney Graham at the National Institutes of Health, who had a career-long obsession with solving the riddle of why two toddlers died in a vaccine trial in 1966, a tragedy that ultimately led to a critical breakthrough in vaccine science. With both foresight and luck, Graham and these other crucial scientists set the course for a coronavirus vaccine years before COVID-19 emerged in Wuhan, China. The author draws on hundreds of hours of interviews with key players to tell the definitive story about how the race to create the vaccine sparked a revolution in medical science.

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.

As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP’s consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants’ profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.

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.

Dukes, Braithwaite and Moloney reach the depressing conclusion that 'corporate crime in the pharmaceutical industry appears to be on the rise.' Their approach to this problem is much more nuanced than just throwing people in jail. They advocate for a pyramid of regulatory strategies including qui tam legislation and equity fines. There is an opportunity for a radical transformation of the pharmaceutical industry and the authors offer us a road map to begin that journey.' - Joel Lexchin MD, York University, CanadaThe pharmaceutical industry must exist to serve the community, but over the years it has engaged repeatedly in corporate crime and anti-social behavior, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health, with deep experience of the industry, documents problems ranging from false advertising and counterfeiting to corruption, fraud and overpricing. It is a fresh and revealing look at the unacceptable pressures brought to bear on doctors, politicians, patients and the media. Uniquely, the book presents realistic and worldwide solutions for the future, with positive policies encouraging honest dealing, as well as partial privatization of enforcement and a transformation of science policy to develop the medicines that society needs most. The authors examine in turn each of the main facets of the pharmaceutical industry's activities - research, manufacturing, information, distribution and pricing - as well as some questionable aspects of its relationship with society. Offering a considered analysis of pharmaceutical rights and wrongs as they have developed, particularly over the last half-century, this book is rich in new insights for managers in the pharmaceutical industry, regulatory agencies and health agencies. Contents: Essay Part I: Setting the Scene Introduction Part II: A View of Rights and Wrongs 1. Creating a Medicine: Why, How and How Not 2. Safe, Unsafe and Improper Manufacturing Practices 3. Aggressive or Misleading Promotion 4. The Dark Art of Manipulation: The Industry and its Puppets 5. Corruption, Counterfeiting and Fraud 6. Prices, Monopolies, Abuses and the Law Part III: Transforming the Way Ahead 7. A Criminological Perspective on a Worsening Crisis 8. Positive Regulation: The Complementary Role of Supports and Sanctions 9. A Responsive Criminal Law of Pharmaceuticals 10. Privatising Enforcement 11. A New Capitalism: A New Drug Diplomacy Index

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region. ​        

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest - with the most up to date research updates - in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.