The mission of ELTE Biotechnology FIEK
Our goal is to utilize more effectively and successfully the high-standard intellectual potential and instrument suite offered by the research teams of the Faculty of Science of Eötvös Loránd University (Eötvös Loránd Tudományegyetem, ELTE) and the Research Centre for Natural Sciences of the Hungarian Academy of Sciences (RCNS HAS) in line with the needs of the biotechnology and pharmaceutical biotechnology sectors and the national healthcare system. We are planning to establish an RDI base that represents outstanding biotechnological knowledge and services at international level. This can replace the research developments of domestic companies currently provided exclusively by foreign partners, and lay the foundations of developments for foreign companies in Hungary. The three points mentioned above are briefly set out below.
The primary goal of BIOTech FIEK is to implement the project titled „Establishment of the Molecular Biomarker Research and Service Centre to Meet Industrial Demands” (FIEK_16-1-2016-0005) in association with the current consortium members (led by the Eötvös Loránd University, and comprising the Research Centre for Natural Sciences of the Hungarian Academy of Sciences, the Servier Research Institute of Medical Chemistry Inc., and the CRU Hungary Healthcare Services Ltd.), in accordance with the grant offered by the Centre for Higher Education and Industrial Cooperation (Felsőoktatási és Ipari Együttműködési Központ, FIEK), and to become a self-sustaining unit following the funding period.
The project establishes an accredited molecular biomarker laboratory carrying out investigations in genetics and cell biology for the pharmaceutical industry and the national healthcare system employing methods already known or to be developed in the future. On the basis of our market research and current knowledge, we are optimistic: we expect a large number of domestic and foreign orders, which themselves will guarantee the self-sustaining operation of the BIOTech FIEK.
The project integrates research teams whose members are motivated to capitalize on their knowledge to serve the biotechnology and pharmaceutical biotechnology sectors and healthcare. These research teams are carrying out molecular biomarker research developments that may potentially yield new methods for tailor-made diagnostics and therapy. After the required administrative authorisation procedure, the newly developed methods can be utilized in different ways. On the one hand, they can be integrated in the accredited laboratory, and on the other hand, they can be sold after being provided with the appropriate protection certificates. We have also started the health economic analyses of these developments with the contribution of Professor Zoltán Kaló (head of the Institute of Economics at the Faculty of Social Sciences of ELTE and CEO of SYREON Research Institute).
At the same time, these developments are also suitable for strengthening the market competence (expertise, market motivation, instrument suite) of BIOTech FIEK. This means that the utilization of the expertise of the research groups is not limited to the molecular biomarkers, the development of which is referred to as their goal in the FIEK application, but they are also complemented by other biotechnological activities based on their knowledge. Of these, we would like to create a service portfolio that we can present at the domestic and foreign biotechnology and molecular biomarker markets.
That is why the idea presented itself that besides the FIEK project, funded by the National Research Development and Innovation Office (NRDI), BIOTech FIEK should join other biotechnology programs running at ELTE and RCNS HAS, so that combined together, these projects could be implemented in synergy.
Biotechnology business development can only be realized by experts who are themselves involved in biotechnology and are aware of the fundamentals of business development and innovation management, and also have an extended network of contacts. This potential already exists in part at BIOTech FIEK.
This aim is supported by our current projects and submitted applications to be implemented together with industrial partners (e.g. FIEK, VKE, joint ELTE–BME pharmaceutical biotechnology masters degree program, Protein Science and its Applications National Excellence Program grant – Diagnostics and Therapy Program). These projects and researchers involved in them are likely to create a critical mass of intellectual capacity (research staff, research results), which will be unique even by international standards. (It is important to emphasize that the grants listed above were provided by the grantor so that ELTE would create new capacity with them, that is, to strengthen its industrial – in our case, its biotechnological, pharmaceutical and healthcare – connections and to generate income through these fields.)
Benefits offered by ELTE Biotechnology FIEK
BIOTech FIEK, developing in the way detailed above, is equally beneficial for (1) the clients, (2) the participating researchers and (3) for ELTE.
The purpose of BIOTech FIEK is to facilitate communication between the participants of the project, and to provide assistance in performing organizational and administrative tasks throughout the duration of the projects, which ensures the successful implementation of the projects.
BIOTech FIEK is beneficial for the orderer (customer) of biotechnology RDI, because it provides a so-called “single-window” administration, that is it gathers the biotechnological competencies (scientific and methodological expertise, instrument suite, and motivation for industrial orders) of affiliated institutions and research groups, and from these it prepares biotechnology portfolios with the involvement of experts in finance, business development, law and innovation management. The interested customer consults the management of BIOTech FIEK that seeks the research team or teams who are the most experienced in the required RDI field, and conducts consultations with them and with the customer until the project is outlined.
Subsequently, the management plans the order fulfillment, which means that it prepares the description and assignment of tasks, develops risk assessment and management plans, analyzes issues related to the protection of intellectual property and commercial exploitation, and plans the time frame and budget required to complete the task. The management may involve domestic and international experts in this process. The management conducts legal and financial negotiations related to the conclusion of the contract and prepares the contract.
BIOTech FIEK is beneficial for researchers as it further promotes the possibility and potential of cooperation. The development of a certain diagnostic method or the production of a new drug molecule candidate cannot be imagined by the work of a single research team. These complex research developments can only be achieved together, integrating the capacities available at separate locations. ELTE BIOTech FIEK is able to create a system for this, for the first time in this area of research.
If an industrial partner contacts the researcher directly, the researcher will receive support from BIOTech FIEK in the processes described above, and can thus conclude the contract and carry out the task more professionally, more efficiently and faster.
BIOTech FIEK is beneficial for ELTE: the use of its instrument suite and knowledge capacity may intensify, and the income from industrial/external orders can significantly increase, which fits well in the long-term development plan of ELTE and also contributes to the fulfillment of mission 3 described in the Institution Development Plan of ELTE.
The domestic and potential foreign experts of BIOTech FIEK
The experts of EIT eHealth and the National Institute of Pharmacy and Nutrition are collaborating partners in business development in biotechnology and pharmaceutical industry. The internationalization of BIOTech FIEK is an important factor, in which eHealth and other private expert companies play a significant role. (http://www.sp-patent.de/patent-attorneys/team/graf-von-stosch.html; https://www.dlapiper.com/en/us/people/g/john-garvey-m/; http://www.immbicon.de/).
 The Contract Research Organization (CRO) is an organization that supports developments in the pharmaceutical and biotechnology industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical or biologic assay development, and preclinical research. CROs provide more cost-effective methods for developing new medicines requiring increasingly complex knowledge, every element of which cannot be realized in any pharmaceutical company currently.
 The application of GMP (Good Manufacturing Practice) is widespread in pharmaceutical and food industries. Its two main elements are the manufacturing process control and control regulations, which mutually complement each other. GLP (Good Laboratory Practice) ensures control procedures that are independent of production, and are comprehensively planned and correctly implemented.