Pharmaceutical Outsourcing Discovery And Preclinical Services

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.

"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

Women Entrepreneurs offers a collection of almost two dozen cases that explore the process by which women become entrepreneurs, as well as the opportunities and challenges they face in growing their businesses. With a particular focus on the intersection between entrepreneurship and economic development, the cases are drawn from across a range of industries and countries. They offer insights into a number of issues women entrepreneurs face, such as launching a business, diversification and internationalization, as well as covering a number of business functions, including finance, marketing and human resource management. Each case is presented with a summary highlighting the themes it covers, and ends with a set of questions to guide classroom discussion. The book also includes a summary of existing literature on entrepreneurship to help contextualize the cases. This casebook would be the ideal companion in an entrepreneurship class, particularly for students with an interest in female entrepreneurship or economic development. With data from a Goldman Sachs/Lauder Institute study.

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

This book comprehensively explores the many different forms of collaboration in government, both formal and informal, including strategic alliances, intergovernmental networks, and public-private partnerships. Contemporary US governmental and public organizations are changing to better cope after several decades of pressures to downsize, as well as to deliver new services with declining resources and, in many cases, decaying infrastructure. To meet these challenges, public managers are developing new networks, partnerships, collaborations, alliances and coalitions to deliver government services. Collaboration in Government is designed to help public organizations parse the new and emerging forms of public partnerships and to develop the skills needed to manage them. Each chapter offers examples of how each type has been used in real public organizations, providing the reader with an understanding of how these partnerships may be applied in a variety of contexts, as well as lessons that may be gleaned from the successes (and failures) of these collaborative models. This book will be of interest to public servants who collaborate in their daily work, as well as students of public administration and public policy.