Ronald P. Evens

Editors and Authors 2

Editor 2

Editorial Board 2

Chapter/Section Authors 3

This book and CD-ROM contain an extensive discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, and through life cycle management for the new researcher in academia or industry. The primary goal is the education of new researchers in the academic medical center and industry environments about industry-based research and product development. The perspective is product development (drugs and biologicals) especially from the industry situation, along with collaboration with medical center scientists. References are quite extensive to support the work, numbering more than 500. The authors collectively have several hundred years of experience at senior levels in product development in the industry or research experience in the academic or clinical setting. The book has many tables of data and information, illustrations, and examples to elaborate on the issues, problems, challenges, and successes in product development.

The collaboration of industry scientists and marketers with their university and medical center colleagues, as advisors and key investigators, is an indispensable key to successful drug development and an important part of this book's discussion as well. Drug research by the pharmaceutical and biotechnology industry has been a success story over the past 40 years with hundreds of new products advancing the state of medicine, plus some products each year for previously untreatable or poorly managed diseases. Four constituencies are engaged: (1) patients in meeting unmet medical needs, (2) companies in both financial success and research advances, (3) universities, who obtain research grants, create drug discoveries as well, and conduct much of the clinical and other research leading to product approval, and (4) government regulators, responsible for both public safety and health, industry regulation, and new product approvals. The needs, challenges, and controversies in the industry are also addressed throughout the chapters. This book shares how this success and the challenges are accomplished by the various groups of specialized people, with all the organization requirements, in compliance with the many laws and regulations, and with the many processes and outcomes necessary from each contributing industry department.

This preface and introduction to the book provides a discussion on the needs and use for the book, brief biographies of the editorial board, a brief description of each of the authors, acknowledgments, and a list of key information sources about the industry and related information.

The format is optimized for the education and training of health care professionals, especially fellows (M.D., Pharm.D., and Ph.D.) in training at universities and other new researchers. The format of the book is uniquely geared for the training setting with PowerPoint style slides to summarize the information and give illustrations (that is, tables, lists, and diagrams) and accompanied by detailed narrative descriptions for explanation and elaboration. Industry and research experts (multidisciplinary: M.D., Pharm.D., and Ph.D.) are the editors and authors. An added CD-ROM is available to enhance the utility of the book for course directors, providing them with highly sought after slides to deliver lectures. No single book employs such an educational format for fellows or new researchers and covers the full scope of drug development from discovery through a product's life cycle.

Drug research is a major mission at all medical and pharmacy colleges and medical centers. Collaboration between a drug company and universities in drug research is the typical and indispensable arrangement for drug development, wherein the university provides the patients, research staff, investigators, and expert advisors. At these health science campuses, fellows and residents in medicine (M.D., D.O.), pharmacy fellows (Pharm.D.), and graduate candidates (Ph.D., M.S.N., M.P.H.) strive to understand the drug development process and increase their related research skills. They also desire to improve their collaboration with industry scientists, both in seeking research funding and conducting drug studies. Their university faculty often has limited practical expertise in the breadth and details of work and the nuances of industry-based research, such that they seek outside assistance from the industry to help train the fellows. Also, R&D departments in the industry, as well as their marketing divisions, have new staff entering the industry without formal training in drug development. Job effectiveness is needed as soon as possible; this book and CD-ROM can be part of their education.

The book covers in 12 chapters all the steps in drug and biological product development by a company from discovery to marketing and later life cycle management: Health Care and Industry Overview, Planning and Governance, R&D Outcomes, Discovery, Types of Clinical Studies, Metabolism and Pharmacokinetics, Regulations and Laws, Clinical Operations, Manufacturing and Formulations, Commercialization Division, Medical Affairs and Professional Services, and Special Considerations for Research in five selected therapeutic areas (cardiovascular, infectious diseases, oncology, pediatrics, and psychiatry). Two appendices are included to assist the reader in the jargon common to the industry.

The book includes four components for each chapter: (1) brief introductions for each chapter and major section in a chapter; (2) copies of PowerPoint type figures and tables, including any necessary illustrations, lists, graphics, compilation of terms, and data; (3) narratives accompanying and following each slide that explain and elaborate upon the content on the slides, cover real-life company examples and industry controversies, and include graphs, tables, and figures for illustration of key points; (4) references for further study and resources. A few slides and concepts were repeated in multiple chapters wherein the topic could be addressed from a different and useful perspective for the reader.

The content can be used at two levels. In each chapter, a subset of slides (about 10) can offer an overview on the subject, which is used for more general audiences. Detailed slides (up to 20 to 30 more) are available to fully elucidate the subject for fellows or staff needing more education for their jobs or coursework. In educational terms, the overview would be equivalent to 1 credit hour course (10-12 lecture hours); the total material would be equivalent to a 3-4 credit hour course (30-40 hours of lecture/discussions).

Individual courses in drug development often cover one or two semesters (10-60 lectures or workshops) at many health science universities, for example, Northwestern University, University of Chicago, Campbell University, University of North Carolina, Duke University, University of California at San Diego; New York University, Drexel University, Boston

University, Tufts University, Georgetown University, University of Texas, University of Kentucky, and University of Florida. Master's degree or postgraduate programs addressing drug development also are common in fellowship training at medical and pharmacy schools. We hope that this book will support these educational initiatives.

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