Technology Transfer from Academia to Industry
Bennett’s Classification for Reading Medical Articles
Medical student | Reads entire article but does not understand what any of it means. |
Intern | Uses journal as a pillow during nights on call. |
Resident | Would like to read entire article but eats dinner instead. |
Chief resident | Skips articles entirely and reads the classifieds. |
Junior attending | Reads and analyzes entire article in order to pimp medical students. |
Senior attending | Reads abstracts and quotes the literature liberally. |
Research attending | Reads entire article, reanalyzes statistics, and looks up all references, usually in lieu of sex. |
Chief of service | Reads references to see if he was cited anywhere. |
Private attending | Doesn’t buy journals in the first place but keeps an eye open for medical articles that make it into Time or Newsweek. |
Emeritus attending | Reads entire article but does not understand what any of it means. |
Myths abound over whether academicians or industrial scientists deserve the most credit for discovering new drugs. Others promote the idea that government agencies such as the National Institute of Health deserve the credit for most new drugs. An exhaustive study of this issue (Maxwell and Eckhardt 1991) showed that between 20% and 40% of drugs are discovered in the academic environment. (The percentage varies depending on the criteria used to define a discovery as “originating” in academia—e.g., degree of involvement and the quality of the innovation involved.) This percentage is clearly a major portion of discoveries. [Approximately 75% of all Investigational New Drug Applications (INDs) submitted to the Food and Drug Administration are from academia, only 25%
are from the pharmaceutical industry. (www.fda.gov/cder. Original INDs received, 1986-2005)]
are from the pharmaceutical industry. (www.fda.gov/cder. Original INDs received, 1986-2005)]
Despite the fact that many drugs originate or are tested within academic institutions, almost all are developed by the pharmaceutical industry. This is because academic institutions lack many essential development functions, personnel, and technologies required to progress a new drug through the Food and Drug Administration to marketing approval of a New Drug Application. In addition, drug development has not been a designated academic function; such institutions are not in the business of marketing and selling products but are in the business of education and research and probably would be unwilling to risk the large amounts of money required to turn an interesting compound into a valuable drug. This chapter describes some aspects of the transfer of drug discoveries from academia to the pharmaceutical industry in the United States.
Another myth concerning the pharmaceutical industry and academia is that they are two separate worlds that do not collaborate. The truth is that there are many types of collaborations and relationships (see Chapters 31 and 106) and the quality of these collaborations is steadily improving in most developed countries. This chapter also describes some of the ways in which these collaborations take place.
WHAT IS TRANSFERRED?
License
Although the initial response to the question of what is being transferred appears straightforward (i.e., the drug and its patent) the correct answer often varies. Most often, what is transferred results from a license that the company obtains from an academic institution. What is licensed are rights to a compound, drug, technology, or model. A model could be a patent on an isolated and cloned receptor in the brain used to screen compounds for activity. The scientific technology applied to a drug’s discovery, manufacture, or other process may be licensed by a pharmaceutical company from an academic institution. This technology may provide an important competitive advantage for the licensee or it may merely expedite a specific process. Transfer may involve the concepts described in the following text.
Patent
There are various types of patents (e.g., compound, use, process) that are described elsewhere in detail. Patents also have different strengths and abilities to withstand a challenge. This is becoming an enormous issue, particularly in the field of biotechnology where having a strong patent, for example, on the sequence of a protein, may be insufficient protection to produce the protein. Another company may have a patent on the method of manufacture, and another person or group may have a patent on the method of purification. The ability to own a single patent and to make a drug without infringing on other patents is becoming increasingly difficult in the biotechnology field.
Knowledge
The compound of interest may require a great deal of expertise to develop, test, or otherwise use. This confidential scientific and practical knowledge or “know how” often is transferred to the company. A means of accomplishing this goal is through exchange of scientists; for example, company scientists may visit the academic laboratories and work with the scientists there to acquire a process or to learn relevant information, and vice versa.
Concept
In some cases, a pharmaceutical company licenses the concept (or rights to something yet to be discovered) for a particular compound or series of compounds, even though the compounds have never been synthesized. This practice occurs in a different guise when a company forms a strategic alliance with an academic group and the contract stipulates the right of the company to license any compounds of interest discovered as a result of the agreement.
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