Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

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. In response to these and other dilemmas, the authors define the processes involved in drug research, and examine 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.

'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.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Mastering management skills is hard to achieve by newcomers starting their careers in the chemical industry. The message coming from there is that good chemists swiftly have to become good managers if they are to survive and progress in today's competitive climate. This book is designed to help guide younger R & D chemists to ways in which they can quickly evolve skills which are built around three factors - people, knowledge and time. It covers the management of scientific personnel, management within a variety of R & D organisational structures, creating a climate of innovation, the management of projects including the time management and communication aspects of the job. The author, Peter Bamfield, is now working as a consultant. Due to his long experience in the chemical industry, he was elected President of the Royal Society of Chemistry's Industrial Affairs Division. This second edition of the book has been revised and updated to take recent global developments and restructuring in the chemical industry into account, as well as the rising importance of information technology in management.