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IMPROVING THE SCIENTIFIC BASE OF CLINICAL RESEARCH BY FACILITATING COLLABORATION AMONG ACADEMIA, THE PHARMACEUTICAL INDUSTRY, AND GOVERNMENT SIDNEY UDENFRIEND* My presentjob as director of the Roche Institute of Molecular Biology has placed me in an unusual position at the interface of the pharmaceutical industry and academic biomedical research. As a result, I have been a much closer observer of the overall translation process than have most scientists. I have long been aware that the various steps in the process, beginning with the acquisition of new knowledge and continuing through to its eventual application, are not fully recognized by most scientists in biomedical research, much less by lay people. Nor do they fully realize that bridging the two endeavors is what provides the continued support of basic science. They must be made to understand the process, recognize its component parts, actively support and participate in it, and see to it that each translation effort receives the necessary support, both financial and technical. I am convinced that the translation process is not as effective as it could be and that it must be accelerated. I also believe that this can be done withoutjeopardizing either the amount of basic research or the freedom of its practitioners. In fact, broad support and encouragement of a more rapid application of new knowledge will actually lead to greater support of basic research. Listed below are steps from a typical development in basic research to its application and the approximate duration of each step, exclusive of publication time: 1. Non-mission-oriented laboratory work leading to a significant basic observation; several years. 2.Recognition by the clinical sector and initial application in a clinical setting; 1-2 years. 3.Continued clinical investigation leading to the finding of meaningful medical effects; 2-3 years. ?Director,. Roche Institute of Molecular Biology, Nutley, New Jersey 071 10.© 1980 by The University of Chicago. 0031-5982/80/2322-0157$01.00 Perspectives in Biology and Medicine ¦ Winter 1980 · Part 2 S83 4.Attempts by the pharmaceutical industry to produce useful drugs based on all the above studies; 3-5 years. 5.Submission ofa new drug application (NDA) and its approval by the FDA; up to several years. Thus, exclusive of publication time, well over 15 years may be required for the entire translation process when it occurs in a stepwise procedure, as it frequently does. Let us examine each of the steps above and its relation to the next step and see what can be done to speed up the process of translation. Basic investigations must be supported at all cost because without them we would soon run out of ideas. It is up to the NIH not only to provide the funds but to see that all investigators, basic and applied, have available the newest instrumentation and specialized technologies. The latter are in the industrial domain but frequently require government subsidy. The clinical investigator learns of an interesting basic finding through the literature or at a scientific meeting, perhaps 1 or 2 years after the observation was submitted for publication. If he is interested in clinical applications of these findings, appreciable time is needed to transfer the technology to his laboratory. If the process is to be hastened, basic scientists and clinical investigators must be more in contact; hence additional financial support must be made available for travel and other expenses. Only industry, in collaboration with clinical investigators, can carry out the final translation to a useful therapeutic agent or diagnostic test that is directly applicable to the patient. Transfer to industry takes place from both the basic and the clinical sectors. Can this process be speeded up? My answer is yes, but certain requirements must be met. More academic scientists must be made conscious of their role and encouraged to participate . Such encouragement is not dependenton industry alone. Although chemists have long interacted with industry, biologists have frowned upon this practice until quite recently. A combination of public awareness by academic scientists and an amazing improvement in the caliber of their counterparts in the pharmaceutical industry have largely overcome this inhibition. When the transfer process flows smoothly and slowly, the final translation (i.e., a new drug) is made...


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