The extraordinary advances in digital, medical, and scientific technology over the past decade have had a tremendous impact on the way in which we live and work today. Nowhere is this more evident than in the high tech realm of pharmaceutical research. The completion of the Human Genome Project, the increased speed and power of computers, and the invention of sophisticated laboratory equipment and techniques have opened up new avenues of discovery that are rapidly paving the way toward tomorrow's blockbuster drugs. Outside the labs, both the Internet and the media have provided consumers and physicians alike with instant access to unprecedented amounts of medical news and information. This not only fuels the demand for better, faster treatments but it also redefines the arena in which companies vie for sales and market share.
This fast-paced, competitive environment has changed the way most pharmaceutical companies do business. Alliances with academic institutions and biotechnology firms pump new life into R&D, while at the same time license agreements and mergers offer a quick fix for dwindling iii pipelines. The regulatory agencies which oversee the industry have also begun implementing new guidelines and modernizing their processes in an effort to keep pace with the needs of the organizations they govern. Innovations such as ePrescri-bing, extranets, healthcare portals, electronic customer relationship management, and direct-to-consumer advertising have altered the relationship companies have with physicians and other customers, placing great emphasis on the need for timely, accurate information.
This work is intended to offer some assistance in this endeavor for those whose business is providing informational support to the pharmaceutical industry. We hope it will be helpful to both experienced pharmaceutical and medical information specialists as well as those who may first be embarking on their careers. Getting the "right information at the right time'' is important to the success of any enterprise, but it is absolutely essential to the industry leaders and strategists whose decisions impact our future health. Specific data is required along every step of the pipeline, from early discovery research straight through to marketing, sales, and beyond. The chapters in this book correspond to key stages or components of the drug development process and cover the types of information required at each point. Each chapter provides a background and general overview of each topic, with definitions of industry terminology, outlines of general policies and procedures, and other fundamental concepts. Following this introduction is a list of the specialized resources most often used for gathering information pertaining to this particular area.
As someone who has spent time working in the medical device industry, I know firsthand how difficult it can be to find information appropriate to that field. Most of the better known pipeline databases and other drug-centric resources contain very little useful information on devices or drug delivery systems. That is why I have chosen to devote an entire section ofthis book to resources targeted to those industries. There is of course a great deal of overlap among pharmaceutical and medical device resources; but for those of you whose primary focus is devices, it should be helpful to have all of those resources grouped together in one place. You will also notice that Intellectual Property has been afforded its own chapter. Intellectual Property is so crucial to all areas of pharmaceutical research and development that in order to be comprehensive and easily accessible to readers, this topic needed to be addressed separately.
One would naturally expect to see a large portion of a work such as this devoted to describing the clinical and biological literature, as these data are vital in all medical research. Nonetheless, the resources covered in this book pertain exclusively to the pharmaceutical and/or medical device industries. For those seeking comprehensive instruction on Medline®, Biological Abstracts® and the like, please consult the two other excellent books Using the Biological Literaturea and Using the Clinical & Healthcare Literature.b a Schmidt, Diane, et al. Using the Biological Literature: A Practical Guide, 3rd ed. New York, N.Y.: Marcel Dekker, Inc., 2002.
b Brewer, Karen. Using the Health and Clinical Literature. New York, N.Y.: Marcel Dekker, Inc., 2003.
The world of electronic publishing these days is arguably even more erratic and unsettled than that of the ever-merging pharmaceutical industry. Given this fact, we have trained our lenses on the core content itself, rather than on the packaging and presentation of the information. You will therefore not find sections devoted to aggregators, portals, and other services unless they happen to contain unique content not offered anywhere else. For the purposes of this publication, Current Contents® is still Current Contents® whether it is searched on Dialog, DataStar or OVID. Another note about content: products come and go; publishers merge; journals and books change names and go out of print at an alarming rate, so we apologize in advance for any inaccuracies or omissions as a result of our deadline. Please assume that these details were correct at press time.
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