Revision as of 07:21, 15 September 2015

Stakeholders

To obtain more insight in the feasibility of our idea, we talked to many experts within different fields. Among the people we approached are doctors, researchers, students, but also people working in non-academic fields such as at ministeries and professional advisors. Each of them was invited to give their perspectives on our work. We also wondered if they could see the benefits of our device within our application scenarios and if they had any other suggestions for usage. Moreover, we gave them space to criticize our idea, and thereby advise us about aspects of our design that could be perfected. With their involvement, we could further develop our ideas. A short overview of each talk is given below.

General

RIVM & Rathenau

RIVM is the national institute involved in regulation of safety and environment. The Rathenau Institute is involved in the consideration of technological advancements and their role in society. Both institutes regularly experience the clash that occurs when technological novelties are presented to a poorly informed public. To promote dialogue between society and technological researches the RIVM and Rathenau Institute together organized a symposium about synthetic biology and its role in society.
The iGEM-teams of the Netherlands had an active role in the organization of the symposium and were given an opportunity to present their projects to a diverse audience (consisting of amongst others employees of the RIVM and Rathenau and ministries). The presentation was followed by a discussion about societal problems that play a role when considering synthetic biology. Read more on this event here:

We presented our project to policymakers attending the SynBio convention and held a discussion afterwards.
Bureau GGO

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Virgil Rerimassie

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RIVM Regelgeving

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Intellectual Property Rights

A possible obstacle for our design is the fact that we make use of aptamers as one of the main components; many of the discovered aptamers are currently still patented. Therefore, it was interesting to explore if this could pose any further problems in the future. Therefore, we contacted some experts on the area of patent law. An overview is given below:

Ir. P.H. (Peter) van Dongen - RVO/Agentschap NL - Patent advisor for universities and technological institutes

Ir. Van Dongen is very experienced when it comes to patent law. He explained to us some of the basic principles behind it and some factors we should pay attention to.
Patents are granted to any scientist who applied for it and who came up with a novel invention that was never earlier described anywhere in the world, that is not obvious and that could be exploited economically. Hereby it is important to consider that patents are granted per country and it might not be economically favourable for some companies to apply for a patent in small countries like the Netherlands. Patent keepers need to pay tax for the patent they hold in each country, so sometimes it is not beneficious to have a patent-right in each country.
Once a company/institute has patent on a specific invention, it has rights to exploit this product economically for 20 years. People can buy the patent or ask for a license, in which case part of the profit is directly transferred to the company who owns the patent.
Ir. Van Dongen doesn’t foresee much problems in our research. He could tell us that there is an exception to the patent law when it comes to the use of a product for scientific research. Only if we were to introduce our device to the market we would encounter patent regulation.

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Ir. Annika van Rosmalen - Responsible at HollandBio for communication about bio-based technologies

We talked to Ir. Van Rosmalen about the potential of our device. Since Ir. Van Rosmalen works at HollandBio, a Dutch association for companies involved in the production of bio-based technologies, we figured she would have some insights into regulation involved in bio-based technologies like ours.
Ir. Van Rosmalen was quite enthusiastic about the idea of an quick and easy detection-device. She advised us to further emphasize the advantages of using bacteria in order to avoid a lot of ethical complaints.
About patent-regulation she could tell us that the 20 years of patent rights usually only give the patent-holder only 15 years to earn back his/her expenses. This is because an application for patents on different aspects of the design is made at the beginning of the research. However usually it takes at least 5 more years for the research to be published.
One other important aspect is that the patent-holders themselves are responsible to keep check of any illegal use of their product. This is not supported by any other agency. Therefore it takes quite some work to keep your patented product safe.

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Patentpunt

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Existing biosensor methods

With our sensor-device we want to find a way to produce a universal sensing method. Therefore it is interesting to look at requirements for sensor-systems and the techniques other sensor-systems use. To learn more about sensor techniques we spoke with Dhiredj Jagesar, working for DSM (a dutch institute involved in the application of scientific researches in health, nutrition and materials) and involved in the development of one of the most frequently used tests in livestock: the Delvo Test. Furthermore we talked to Menno Prins, professor at the university of Eindhoven, who is very much involved in research towards new sensing techniques. Short summaries of these talks are presented below:

D. (Dhiredj) Jagesar – Scientist working for DSM, in 2006 finished his PhD thesis about “Intercomponent Interactions and Mobility in Hydrogen-Bonded Rotaxane”

During the talk with Dhiredj Jagesar we learned about a test that made use of bacteria as basis for detection, but still used these bacteria in a completely different fashion. The Delvo Test makes use of bacterial growth as an indicator of the presence of antibiotics in milk. Therefore this test doesn’t make use of modified bacteria, but simply exploits their intrinsic capacity. Since dr. Jagesar was involved in the production of the test he could tell us more about the requirements that need to be met before bringing such a device to the market. DSM performed as merchandizer of their product. Therefore they performed extensive internal validation to be able to present the customer with a decent product. To gain credibility also external validation of the product was performed. Dr. Jagesar however opted that our product would probably have to deal with different regulation, since it involved the use of modified organsims.
Finally we requested dr. Jagesar to give some feedback on our device. Thereby he emphasized that we should be able to defend the use of bacteria in a sensor-system and he referred us to research on different sensor-systems as comparison. Furthermore he had some concerns about the use of our system in the human body. Thereby he warned for possible immune reactions and competition with other “naturally-occurring” bacteria.

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Prof. dr. ir. M.W.J. (Menno) Prins – Professor in the department of Molecular Biosensors for Medical Diagnostics at the Technical University Eindhoven

Menno Prins himself is working mostly with enzyme-sensors and immunosensors. Therefore he couldn’t tell us much about specific regulation involved in the use of biosensors. However he cooperated with us in a brainstorm-session about the use of our device. He advised us to focus on the mechanism within the cell. How can this be tuned to allow the cell to give a useful output? In other words: what biological readouts can we get? He was enthusiastic about the idea to allow the bacteria to (produce and) secrete medicines/pesticides as a reaction to pathogen-detection. However he also expressed concerns about the storage of these compounds within the cells. How are we going to make sure that our cell doesn’t degrade by itself and deposits its contents in the environment?
Furthermore he advised us to extend our system by not solely focusing on the use of aptamers on the outside of the bacterial membrane. If another detection system provides more stability under certain circumstances, detection components can easily be modified to be used in our system.
Finally he made us consider the option of using our system in a different cell. This could maybe help us overcome certain barriers imposed by law.

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Q Fever

One of our application-scenarios involves the use of bacteria in the detection of Q fever in domestic animals. Generally, people are quite enthusiastic that we are dealing with a local problem. However, to get an overview of the challenges within Q fever detection, we needed to talk to experts on this area. Therefore, we approached Anja Garritsen, who is a researcher from InnatOss, a research institute involved in the development of new detection methods for Q-fever. We also talked to one of the farmers who had a Q-fever infection on her farm who was very interested and involved in the development of new techniques to eradicate Q-fever. Finally, we had contact with Q-fever researchers from the University of Wageningen and GDdiergezondheid (the centre for animal health). An overview of these talks is presented below:

Dr. Anja Garritsen - Scientist working at InnatOss

Anja Garritsen is working at InnatOss and is greatly involved in the development of new techniques to detect Q-fever. In InnatOss they make use of the detection of IFN-gamma for identification. She could tell us that this technique is only applicable after a person/animal has been infected with Q-fever for 2 weeks already. Since the formation of antibodies is essential.
Dr. Garritsen herself was very much interested in new techniques to detect acute prevalence of Q-fever. This is currently only possible within the first 2 weeks of infection and requires the PCR of bacterial DNA. She could, however, also tell us that the development of new techniques is hindered by a reduction of the occurrences of acute infections. This makes it hard to study the development of particles in the blood that accompanies infection. When we asked her about particles that are prevalent after acute Q-fever infection, she expected that Interleukin 2 and 10 and IFN-gamma might be the most readily available to detect. However these particles also occur in different bacterial infections and are therefore not specific.
Since we would like to use our device for the detection of particles associated with Q-fever in milk of the animals, we further informed about the possibilities. Currently PCR-detection is used. Dr. Garritsen agreed that it is easier to get permission for the use of new treatment/detection methods in animals. Furthermore she could tell us that nearly everything that can be detected in the blood, can also be detected in the milk (including blood cells). She proposed to detect antibodies produced as a result of vaccination. By tracking the antibodies in milk we could determine whether goats are still sufficiently protected against Q-fever. Thus our device could be used to track when new vaccination is needed.
Finally we asked her general opinion about our device. She reasoned that if we could design a method that is easy in use and gives a quick output, there will be a market for many other veterinary and human diseases.

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Jeanette van der Ven – Owner of a goat’s farm near Eindhoven and one of the board members of the ZLTO (association for entrepreneurs in the green sector)

Jeanette van der Ven owns a farm where there has been an infection with Q-fever and therefore we were very curious about her experiences with detection and treatment of Q-fever so far.
Mrs. Van der Ven explained that in her case it has been very hard to clarify that an Q-fever infection had occurred on her farm. She told us that the rate of abortion rate on her farm rose, after which she got suspicious and sent several fetuses and placentas for examination. However only in the last case, several months later one could find traces of an Q-fever infection. We asked mrs. Van der Ven what she thought about the application of our device for detection of Q-fever in milk. Mrs. Van der Ven was very positive about the idea of having a toolkit that farmers can use themselves to check their cattle for diseases. She said there would be great interest from farmers for such early-warning systems. Thereby she also emphasized the need for detection-systems for chlamydia and salmonella in animals. Definitely the application in milk could be easy. However she was not completely convinced about the usage of antibody-detection. She told us, some of the goats that she knows were infected with Q-fever still score negative for an antibody-test. Thus she emphasized that a more reliable technique is needed for antibody-detection.
About the use of GMO’s mrs. Van der Ven was quite open-minded. She says: As long as the environment, people and animal don’t suffer, there is no reason to be opposed of genetically engineered organisms. However she can imagine bigger steps can be made in the applications on cattle, than in humans. She predicts GMO’s in humans will be mostly used in prevention rather than treatment.

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Dr. H.I.J. (Hendrik-Jan) Roest – Head of the department Bacteriology and TSEs of the Central Veterinary Institute (CVI) of the University of Wageningen

Via the secretary of the Central Veterinary Institute, we were brought into contact with Dr. Roest, a veterinary microbiologist who is strongly involved in the research towards Q-fever. Dr. Roest kindly provided us with information about some substantive questions about the detection of Q-fever. Therefore he referred us to some interesting articles.

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Dr. R. (René) van den Brom – Researcher working for the “Gezondheidsdienst voor Dieren” (a national institute that focusses on animal well-being)

We were brought into contact with Dr. Van den Brom via HollandBio, a national institute that is involved in technical advancements in the field of biology. Dr. Van den Brom also helped us to answer some of our questions about the development of Q-fever, by handing us his thesis.

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