Introduction to Drug Development
The only way to keep your health is to eat what you don’t want, drink what you don’t like, and do what you’d rather not.
–Mark Twain
THREE CONCEPTUAL LEVELS FOR VIEWING PHARMACEUTICAL ACTIVITIES
Mark Twain’s words reflect a common and long-held notion—that achieving and maintaining optimal health is difficult and unpleasant. Notwithstanding the widely touted health claims for the benefits of drinking wine, most people still view the attainment of good health as an arduous task. This book focuses on the industry that discovers, develops, manufactures, and markets drugs and devices designed to improve health and prevent or cure disease. While most chapters and discussions focus on “drugs,” the points covered usually apply to biotech products and to devices as well. The reader is encouraged to explore similarities and differences between these three categories when distinctions are not provided in the text.
The many issues involving individual pharmaceutical companies and the overall pharmaceutical industry may be conceptualized and written about in many ways. This brief introduction describes the frame of reference used in this book, but it could also be applied to a number of other books and articles about drugs and their discovery, development, production, and marketing.
Most issues and activities relating to pharmaceuticals fall into one of three categories:
The industry—when the issues discussed or the data presented relate to a group of pharmaceutical companies. This macro level is best covered by the trade press on a daily and weekly basis, as well as in various journal articles and books, and by annual compilations of data on the industry presented by trade associations, contract research organizations, publishers, and the trade press.
The company—concerning the activities and issues of a single company, either as a single corporate entity or as one or more departments or functions within the company. While some of the activities of publicly traded companies are presented in their annual reports, there are few sources of general principles and practices (that remain fairly consistent over time) that are followed by many, if not most, companies.
The drug or device—relating to one or more drugs or devices; these issues are usually discussed in terms of a specific activity or discipline (e.g., clinical, marketing, regulatory). This category could be viewed as having various sublevels, such as the number of drugs in the specific therapeutic area(s) of interest. This level is primarily described and discussed in the scientific and medical literature. Numerous stories of specific drugs have been published and provide useful case studies in some instances. A few collections of drug discoveries have also been published (Maxwell and Eckhardt 1990).
This book focuses on the second of these categories or levels (the company). While the three-level concept is used as the underlying organizational basis of this book, little information is presented or discussed at the first or third levels. The individual disciplines or functions within a pharmaceutical company (e.g., discovery research, regulatory affairs, marketing, patents, production) that deal with various pharmaceutical issues may readily be discussed at each of the three levels described on the previous page. Specific activities and technologies of these functions are widely covered in textbooks, magazines, and newsletters, as well as professional meetings, and are discussed in this book in terms of company-level activities.
FOUR VALUES OF A DRUG: COMMERCIAL, MEDICAL, SCIENTIFIC, AND IMAGE
A concept underlying many of the ideas presented in this book is that a drug has several different types of values. Four major ones are discussed in numerous chapters: commercial, medical, scientific, and image.
The commercial value is primarily a financially based determination concerned with sales, cost of goods, profits, and related fiscal parameters. Other commercial factors include the ability of sales representatives to promote a new drug, the ability of a drug to obtain competitive advantage(s) and increase market share, or simply, the ability for a new product to gain market share.
The medical value is a clinically based determination concerned with therapeutic benefits, risks, and similar clinical parameters of the product itself. Because of differences in the medical practices in various countries, a drug with a high medical value in one country may not have high medical value in another. Drugs with very high prices will clearly have very different patterns of use in different countries, depending on their fiscal status and healthcare systems. Medical value differs from medical need, which refers to the public health need for a new product. Medical value addresses how well a specific product meets the medical need.
The scientific value is based on the scientific interest and uniqueness of a drug in terms of its properties and based on the drug’s mechanism of action and importance of the drug to bolster a known scientific theory or to help create a new one. This characteristic is often considered when studying compounds, drugs, and diseases and scientific value is achieved through study of the compound or drug.
The image value refers to nontangible benefits in terms of goodwill, publicity, and related public relations concepts that are associated with a drug and with the sponsor or others (e.g., licensee) that develop and/or market it. This characteristic may be a result of one or more of the three other types of values mentioned earlier.
Many new drugs that are new molecular entities have similar degrees of medical and scientific value, although their commercial value is often vastly different. The image value of a new drug is usually correlated most closely with its medical value. A number of marked exceptions to these principles are shown in Table 1.1. Sometimes, great differences among the four values exist and a company must determine whether or not a drug (e.g., orphan drug) that it has discovered will be developed and marketed.
THE ROLE OF COMMON SENSE IN DEVELOPING DRUGS
It is common to claim that the myriad of activities associated with the development of a drug require the application of common sense. This belief assumes that correct decisions may be made by asking oneself which approach, option, or choice makes the most sense. While most people do not claim that using common sense prevents one from considering the complex pros and cons of an issue or the implications of various choices based on extensive experience and detailed knowledge, it appears that this is essentially what they are stating.
Table 1.1 Values for selected medical and scientific discoveries or developments: examples of marked differences in valuesa | ||||||||||||||||||||||||||||||||||||||||||
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