Investigator-sponsored Research Proposals Submitted to Industry
He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.
–William Osler
The cloning of humans is on most of the lists of things to worry about from Science, along with behaviour control, genetic engineering, transplanted heads, computer poetry and the unrestrained growth of plastic flowers.
–Lewis Thomas
The important thing in science is not so much to obtain new facts as to discover new ways of thinking about them.
–Sir William Bragg
While most of the discussion in this book focuses on initial regulatory applications to conduct human clinical trials [e.g., Investigational New Drug Applications (INDs)] that are applied for by a pharmaceutical company, there are situations when an investigator obtains an IND. In some of those situations, the pharmaceutical company may not have an IND for that specific indication or dosage form. Sometimes, both the pharmaceutical company and an academician may have an IND for the same product. This chapter describes situations when an academician contacts a pharmaceutical company with a proposal to conduct research under the academician’s or pharmaceutical company’s IND. (Note: The term sponsor does specifically mean a pharmaceutical company. Any “person” who holds an IND is the “sponsor.” If the holder of an IND is an “individual” then he or she is referred to as a “sponsor-investigator.”)
DIFFERING INVESTIGATIONAL NEW DRUG STANDARDS
Food and Drug Administration Standards for Approving Academic Investigator and Pharmaceutical Company Investigational New Drug Applications
To understand some of the thinking of the groups involved, it is important to know that the standards of the Food and Drug Administration (FDA) vary enormously in practice (but not in theory) for approving a pharmaceutical company’s IND versus an individual academician’s IND (sponsor-investigator IND). There are sound reasons for this distinction on the part of the FDA and the author is not criticizing this practice. First, it is extremely
unlikely that the investigator, usually an academician, is intending to develop the drug through to the New Drug Application stage or to market it. Second, the clinical study that the academician is intending to conduct is more likely to be one or a few clinical research studies, as opposed to a whole drug development program. Third, the academician is most likely looking to answer a specific scientific clinical question, publish the research, and to add to generalizable knowledge.
unlikely that the investigator, usually an academician, is intending to develop the drug through to the New Drug Application stage or to market it. Second, the clinical study that the academician is intending to conduct is more likely to be one or a few clinical research studies, as opposed to a whole drug development program. Third, the academician is most likely looking to answer a specific scientific clinical question, publish the research, and to add to generalizable knowledge.
(Note: The regulations in The Code of Federal Regulations, Section 21; 312 apply to all IND studies. The FDA does allow some leniency for investigator sponsored INDs. The FDA understands that academia does not have the resources that industry has. However, the investigator sponsored IND must contain sufficient data to support safe use in humans.)
Another aspect is that the previous distinction in standards applied to industry and an academic sponsor is also made by the FDA when they receive an IND application where the US government [e.g., the National Institutes of Health (NIH)] is acting as sponsor of the research. The internal clinical research program of NIH meets the same criterion of not being commercially oriented and the trials are primarily driven by science as opposed to commercial interests. Therefore, the FDA allows INDs sponsored by NIH to be accepted without the same rigorous requirements demanded of commercial sponsors.
Government-sponsored Investigational New Drug Applications
More than one company has been surprised to learn that the government’s IND they licensed or somehow obtained the rights to cross-license is of a lesser standard than the FDA demands from them as commercial sponsors. One case the author knows well required the company to spend a full year conducting additional preclinical studies than were required by the NIH, to supplement their cross-license to the NIH‘s IND, even though the NIH had conducted three separate clinical trials. During this time, the NIH was very cooperative with the commercial sponsor while the commercial sponsor obtained additional data and created a large number of additional (and more detailed) reports required for the IND.
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