Research on reproductive medicine in the pharmaceutical industry

Abstract

The selection of research projects in the pharmaceutical industry depends on different criteria from those used by academic researchers, who have more freedom to follow an intellectually exciting scientific topic even though it may have little immediate or obvious practical value. Fundamental, untargeted research is rarely carried out in industry except by collaboration with academic workers: such collaborations can offer advantage to both parties. The issues that are considered before research programmes are initiated in the pharmaceutical industry are: • medical need • commercial potential • scientific rationale • drug discovery feasibility • drug development feasibility • competitive position • ethical considerations Most pharmaceutical companies would not commit to a research programme unless the medical need was readily apparent and a drug with advantages over existing products would offer clear medical benefit. These prerequisites are strongly linked to commercial potential which is governed by market size and this, in turn, is related to the incidence of the disease, the extent of the existing need and the degree of differentiation that a new drug could achieve from existing therapies. However, even if the existing need was great but either the incidence of the disease was small, or it was largely confined to developing countries which would be unable to meet drug costs, research projects would be difficult to justify in a commercial environment. Therefore, it is imperative that national and international funding agencies concentrate resources on such diseases. In reproductive medicine, many pharmaceutical companies conclude that the contraceptive pill remains one of the most effective and well tolerated medicines available despite occasional criticisms. Improvement and increased safety in such efficacious drugs are difficult to achieve. It is not perceived that advancement is not possible, only that the chances of achieving improvement are far less than in other therapeutic areas, which makes research into contraception relatively unattractive except to pre-existing major players. The need for new approaches to male fertility control has been recognized, although it is appreciated that even if advances were made many women would still prefer to use contraceptive methods within their control. The scientific challenge to regulate male fertility is so much greater than that for female fertility, namely, to find an antifertility agent that preserves libido. As a consequence, many pharmaceutical companies have focused research in reproductive medicine on approaches to sex hormonedependent cancers and benign prostate and gynaecological diseases. The scientific rationale behind any drug discovery project is of paramount importance in ensuring eventual success. Issues of drug target, potency, selectivity, drug distribution and pharmacokinetics, and safety all need to be evaluated throughout any drug development programme and the project sponsor must be as confident as the research managers that a well differentiated and effective medicine can eventually be produced. It is not enough to have an original approach to disease therapy if redundancy in the factors driving the disease means that blocking the production or action of a single factor will have only a marginal or transient effect on the disease. Moreover, however effective a novel therapy may be, if it has serious side effects based on the mode of action of the drug it is unlikely to have a significant clinical impact. Even when there are feasible drug discovery approaches, it is important to consider the feasibility of demonstrating un