Introduction

Pharmaceutical companies, like other commercial entities, depend almost exclusively on product sales in order to generate revenue and maintain a healthy profit margin. That the goods being proffered happen to be medicines and other biological agents as opposed to automobiles, appliances, or soft drinks does not mitigate the need for a drug company to promote and manage customer awareness and relationships, establish name brand recognition, develop and employ a solid marketing plan, monitor the competitive environment, and generally position itself and its products in the most positive light.

Marketing is an integral part of the entire drug discovery and development process. It is common to have the commercial

plan for a new product in place before that product enters phase III. Laboratory research doesn't even begin until extensive market research is conducted on various key commercial drivers such as: potential patient populations, demographics, unmet health needs, emergent diseases, and epidemiology. This information establishes the overall strategic direction of the company. Decisions to pursue certain drug candidates or therapeutic categories are usually based upon these commercial forecasts. Market research groups rely heavily on quantitative data in order to perform their analyses. They require access to specialized resources, which provide detailed sales figures, market share, incidence and prevalence data, etc.

Once a new product enters the pipeline, marketing efforts center around commercial branding, pricing and reimbursement, launch schedules, peer-reviewed publications, scientific meetings and congresses, physician and consumer awareness, and other similar activities. In today's economic and regulatory climate, marketing groups depend on evidence-based medicine and pharmacoeconomic studies to substantiate product claims and justify usage. They are heavy users of clinical literature, both to monitor their own products and those of their competitors, as well as to respond to physician and customer inquiries. Marketing may also encompass disease management and product life cycle management. Information to support these areas is often found in syndicated market research reports, specialized databases, and other online tools.

The front line of any pharmaceutical company is its sales force. Selling directly to physicians and healthcare facilities, or "detailing," is getting more and more difficult in the era of managed care, cost-containment measures, and generic competition. Physicians are under pressure to increase their number of patient consultations, while at the same time they are required to perform more administrative tasks. This leaves little time for sales reps. According to research conducted by Reuters, physicians now spend an average of only 7min/day with reps, down from 12 minutes in 1995 (Reuters Business Insight, 2003). The advent of Contract Sales Organizations has allowed companies to outsource this function in order to cut back on the costs associated with maintaining a large sales force. Many companies also rely on technology and the Internet to reach their customers. The concept of "eDetailing," in which physicians are contacted via email, Web, or even personal digital assistant (PDA) is becoming more widely utilized. Companies are also becoming involved in the sponsorship of online continuing medical education (CME) courses as well as online physician forums. This ever-increasing need for high-quality electronic medical and clinical information is one in which pharmaceutical information specialists should be well equipped to meet.

One thing to keep in mind is that the promotion and sale of drugs, unlike that of cars, electronics and other manufactured goods, is strictly controlled by regulatory organizations and the relevant governmental authorities in most countries. In the United States, the Federal Food, Drug, and Cosmetic Act and subsequent Food and Drug Administration (FDA) Modernization Act of 1997 specifically address the use and application ofadvertising, promotional events, labeling, and marketing efforts as they apply to prescription drugs and biological products. The FDA is charged with industry oversight of these activities and periodically publishes guidances and other documents to assist with corporate compliance. The FDA will not hesitate to penalize companies who violate these rules, so it is essential that these resources be readily available to relevant groups within the organization. I have included a listing of several of these FDA documents under the heading "Regulations." All are currently available on the FDA Web site and are in force at the time of this writing.

One further note about this chapter: certain topics mentioned in the Introduction above, such as Pharmacoeconomics and Competitive Intelligence, are covered in great detail in other chapters. I have therefore chosen not to include resources specific to those subjects in the following bibliography.

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