Large multinational companies usually conduct research and develop drugs at two or more sites in different countries. If a company has two or more such groups, their organization and coordination may either be centralized or decentralized. Some advantages and disadvantages of decentralization are described below. Those for centralization at a corporate level are discussed in Chapter 19.

The research effort at most companies is more formal and organized today than it has been in past decades. Like most industries, pharmaceutical companies are primarily organized around basic functions such as research, marketing, finance, legal, personnel, and manufacturing. There are two general approaches that pharmaceutical companies have followed in organizing their overall R and D activities. These are to organize by discipline (Fig. 41.1) and by therapeutic teams (Fig. 41.2).

In the more common approach, scientific disciplines such as pharmacology, toxicology, clinical, and organic chemistry are established as separate departments (Fig. 41.1). The progress of a compound through the three stages of discovery, development, and marketing involves “passing” the compound along from department to department, but activities also persist for a long period within any one department. Also, multiple departments must work closely together at most stages of a drug’s development. Even when a drug’s application for regulatory approval is submitted to a government agency, the organic chemistry department may be synthesizing additional compounds for patent protection, and the pharmacology department may be learning more about the drug’s mechanism of action. Other departments are also involved in studying the drug and are equally busy. Individual departments may be grouped into multi-department groups, divisions or units of research, technical development, medical personnel, and support services (Fig. 41.1). Another way of grouping departments is to divide them into drug discovery and drug development divisions.

Large departments may be divided into sections that each reflects specific therapeutic areas or on another basis. For example, both pharmacology and medical departments are usually divided into sections specializing in therapeutic areas such as cardiovascular, central nervous system, gastrointestinal, or respiratory therapy. If size warrants, these groups may be further subdivided, generally by specific diseases. For example, a cardiovascular section could be divided into separate groups working on hypertension, angina, and congestive heart failure. Another type of subdivision is based on the type of drug under study. For example, a cardiovascular section could have separate groups working on calcium channel blockers, beta-receptor antagonists, and angiotensin-converting enzyme inhibitors.

Another major organizational structure is the therapeutic team. In this approach, the entire R and D unit involving both drug discovery and development functions is divided into therapeutic areas like cardiovascular, gastrointestinal, or central nervous system (Fig. 41.2). This approach was used by The Upjohn Company for many years. Their experiences over a number of years have been summarized (Weisblat and Stucki 1974). In this general model, each group contains representatives of all scientific disciplines (e.g., biochemistry and pharmacology) and a clinical department, while other groups (e.g., patents, regulatory affairs, and toxicology) are centralized and provide general services to all therapeutic groups. The major advantage of this approach is that it brings people together from numerous disciplines and increases their collaboration and hopefully their productivity. People from various disciplines within the larger group (e.g., cardiovascular) can easily be assigned to develop a specific drug. Medtronic is currently organized in this manner.