An evaluation of the stability of a pharmaceutical biotechnology product for
licensing purposes
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10th April 2015
An evaluation of the stability of a pharmaceutical biotechnology product for
licensing purposes
Starting from 1980 numerous firms that concentrate in the field of biotechnology
pharmaceutical products were started. Biotechnology Pharmaceutical products are meant to
treat an extensive range of diseases. There are some that treat common illnesses such as
diabetes, and others that treat very rare diseases like Gaucher's disease. More than half of
biotechnology pharmaceutical products treat orphan diseases. These orphan diseases affect
very few people. In the United States, for instance, they affect less than 200,000 people
Biotechnology Pharmaceutical products differ from conventional small molecule
pharmaceuticals in their research methods. Biotechnology innovation is heavily dependent on
molecular biology. The drugs are synthesized using living organisms; this makes process
innovations a significant component of biotechnological studies. Furthermore, the
biotechnology discovery procedure is more directed than that involved in small molecule
researches. For instance, a specific protein may be acknowledged to be lacking for a specific
patient population. The subsequent research then concentrates on coming up with ways to
synthesize this protein. Conventional pharmaceutical firms dealing with small molecule
research cannot make use of their research abilities to assist them in developing
biotechnology drugs. Normally, this is not the case with firms that have set up marketing
relationships with traditional pharmaceuticals. Such firms can use this experience to market
their biotechnology pharmaceutical products successfully. Normally, pharmaceutical firms
are more directly involved in the marketing of their drugs than in the actual innovation of the
drugs (Boekestein 2009, p. 389).
One of the models employed in the marketing of pharmaceuticals is the direct to
physician marketing model. The model is an important feature of marketing drugs in the
biotechnology pharmaceutical sector. In several cases, drugs are used to treat life-threatening
diseases and, therefore, the significance of direct to consumer advertising diminishes greatly
Direct to Physician marketing comprises of making visits to doctors, designing events that
will be attended by doctors and making advertisements in the publications read by doctors
(Manchanda & Honka 2005, p. 785). The process of establishing and preserving contact with
doctors is both expensive and important. Furthermore, relationships with doctors can be used
with several different drugs. For instance, various pharmaceutical firms normally hire a sales
team for a specific physician specialty, such as cardiology, and one member of the team can
then market several drugs to the same doctors.
Selling of the marketing rights occurs in two ways; either for a lump sum in one
payment or a lump sum topped up with a royalty. Furthermore, numerous innovating firms
are bought by larger firms. At the end of 2007, for example, out of one hundred innovating
firms, thirty-one were still functioning independently. The rest of the other firms were either
bought, merged with other firms or had filed for bankruptcy (Boekestein 2009, p. 389).
Licensing