Basic research focuses on many issues that are important for human health. However, despite of permanent scientific progress only a few innovative drugs actually reach the patient. Oncotyrol, the Center for personalized cancer medicine in Innsbruck, has developed an appropriate strategy in order to improve the rate at which research is implemented. Equitable distribution of intellectual property rights and risk minimization for the companies are the key factors.
The distribution of tasks between the state and the private sector in healthcare evolved on a historical basis. The state is positioned at the beginning and the end of the chain as it is in charge of the university-related basic research as well as the efficient patient care. The development, production and commercialization of drugs and medical products by the private sector is encompassed within these two points. Unfortunately research results are not always transferred in an optimal way from the industrial sector to medical practice. Therefore translational research, i.e. basic research, which is focused on concrete economic benefits, is increasingly promoted by the state.
Oncotyrol is a good example to illustrate this: It is a translational research center for personalized cancer medicine and is based on Public Private Partnership (PPP), thus a long-term partnership between public (research) institutions and the private sector. Within the scope of the COMET program of the Austrian Research Promotion Agency (FFG), 55 % of the research is funded by public authorities and 45 % by the industry.
Different Research Philosophies Inhibit Cooperation
There are many reasons, which complicate or inhibit cooperation between basic researchers and life science companies. The different philosophies behind academic or profit-oriented science play an essential role. The gain of scientific knowledge alone is all that counts at universities. Idealistically speaking research is driven by pure intellectual curiosity. Some researchers even condemn the idea of profitable commercialization. Academic research is particularly interested in fundamental questions, for example trying to prove that molecule xy inhibits the expression of gene yz, which is known to be involved in the development of a disease.
With regard to the industrial sector the real work starts at that point. In order to find out whether molecule xy is suitable as a target molecule for the development of active substances, it must undergo extensive testing. This target validation is very costly and time consuming but absolutely essential, since pharmaceutical companies often cannot afford expensive failures in later stages of the development.
Industrial Sector Avoids Major Investments Due to High Risk
Another problem is that industrial research must comply with certified experimental standards such as Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) to guarantee the strongest industrial protection rights and good conditions for admission to the market at a later stage. In academic research these experimental and technical conditions are generally not met.
For industrial partners this means that they have to invest significant amounts in the transition from academic to industrial standards. The financial risk is considerable, bearing in mind the relatively high probability of failure in the development. Companies only take this risk in exceptional cases, if they in return receive exclusive Intellectual Property Rights. On the other hand this poses a problem to researchers and public institutions.
Matter of Conscience for the Researchers: Publication or Patent
A fundamental problem for academic researchers in industrial cooperations is the manner in which scientific careers are closely linked to publications. Results have to be published in a most effective way. However this is where the dilemma begins. What is published cannot be patented because you cannot have patented what is published, and what is not protected by patent cannot be brought to the market. Vice versa researchers can often not afford to wait until results are being protected. It is possible that a competitor publishes the same "story" in the meantime and the publication that is so important for the career development is lost.
Oncotyrol‘s Deal: Risk Minimization Hand in Hand With Fair IPR Regulation
Oncotyrol works in research close together with company partners and these partners can make their technical and experimental requirements known from the very beginning. For this reason research is in the first place conducted in an industrially compatible way, allowing companies to avoid the expense of adaptation to industrial standards. In this way the financial risk of the companies is significantly reduced and the additional advantage of state funding makes cooperation more interesting to the sector. The companies benefit from early access to clinical and basic science expertise. Important for the researchers and their institutions is that the high scientific potential and the experience gained over the years remains on site and is not industrially outsourced.
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Keywords : Austrian Research Promotion Agency Brest Cancer Cancer cancer medicine Carola Hanisch COMET Program Cooperation Drug Development Elisabeth Müller-Holzner FFG GLP GMP Her2 Intellectual Property Rights K. Pfaller Life Science Marion Enthammer Molecular Biology Oncotyrol Personalized Medicine Translational Research Tyrolean Cancer Research CenterEmail requestCompany Homepage
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