Team:UCopenhagen/Human Practices
To develop Ovulaid and make it a better product for women, we have continuously integrated our findings from consulting multiple experts and listening to our target group internationally. We have directly integrated concerns regarding safety into our scientific project design and addressed issues of yeast survival and taste. We have confronted the legal and entrepreneurial difficulties our product could face and made a business plan for further ventures as well as a mobile application for easy analysis of the chewing gum. To communicate our project and the need for infertility awareness, the team has reached international as well as national media coverage, and worked towards engaging and educating both high and elementary school students in Ovulaid, iGEM, and synthetic biology. Read on through our human practices journey, click "see more" for brief descriptions, and go to the appendix in the bottom of the page for detailed reports and documentation.
Starting with the basics A scientific idea is only that - an idea. To translate that idea into something feasible that can touch peoplesâ lives for the better in a responsible manner, is just as important as the soundness of the theoretical concept. With this in mind we integrated considerations of our target groupsâ needs and our responsibility to them in our project development process.
Collaboration with Sund Hub Martin B. Justesen showed us the road from a great idea to a successful startup and connected us to CEO Tine Stampe. We integrated Tine's advice by basing the signal of the biosensor on color rather than taste.
Designing a mobile phone app To allow easy tracking and detection of color in the Ovulaid chewing gum we decided to make a mobile phone application. We met serial app entrepeneur Michael SchmĂźcker. âThere is great potential in the app as it could generate large amounts of data. This data could be used for fertility studies; helping society and women at large. This could be done in collaboration with universities, researchers, or even the medical industry to make sure the data was used for goodâ - Michael SchmĂźcker.
Creating the app at Vilnius Biohack- athon Our team went to the iGEM meetup 'BioHackathon' in Vilnius to develop our Ovulaid App. We received valuable insights from 3 meetings with mentors.
Integrated concerns from femtech expert Tine Stampe expressed concerns that many Danish women might have reservations against consuming a GM-product, and we therefore planned in-depth-interviews with our target group. âThere is a great need for your product on the market. The current products are stigmatising, troublesome, old fashioned and unsexy. There is a need for a product that makes it easier to know when the woman is in her fertile window.â - Tine Stampe.
How do we talk about infertility We wanted to make sure we addressed women with appropriate care and respect, so we contacted Bjarne B. Christensen, general secretary in Sex & Samfund.
Fertility treatments and developing countries; A medical professionalâs insights Prof. Lone Schmidt taught us about the importance of fertility innovation and the movement of Fertility Awareness - a larger movement of technologies, solutions, and education that Ovulaid is a part of. She told us to focus on developing countries, to really make a difference where it matters just as much as in developing countries.
Visit to fertility clinic in rural India Dr. Kathya Nallapothula confirmed that there is indeed a great need for Ovulaid in India in part due to a rapid increase in infertility and hormonal imbalances. We integrated her and Dr.Schmidt's insights by including Indian women in our target group.
Ovulaid could substitute invasive blood tests Dr. Norbert KetskĂŠs, one of the most acknowledged gastroenterologist in Hungary, pointed out to us that if our chewing gum can be precise enough then it could replace several blood tests that women who are undergoing fertility treatment go through.
Quantitative market analysis The analysis confirmed experts opinions: the existing method for tracking ovulation is not appreciated - women think that they are too expensive, uncomfortable, and imprecise.
Qualitative in-depth-interviews We collected subjective opinions and personal stories from our target group by conducting qualitative in-depth-interviews (IDIs) under guidance of Market researcher Erik Arvid Hosszu. Based on these interviews, women are not satisfied with the existing methods for ovulation tracking and would like to use Ovulaid. We integrated the results by finally deciding on the yeast to be in a chewing gum and not on a wrapper.
Feasibility of Ovulaid: scientific expertsâ opinions There is both a need and want for Ovulaid, but could it work? We turned to scientific experts to explore the feasibility. While liking the idea, doctors expressed concerns towards personal safety and yeast survival.
Integrated Kill Switch Several stakeholders expressed concerns about personal safety if the yeast escapes to the mouth. We therefore decided upon the addition of a kill switch for the yeast biosensor system, which we have characterized.
Contacted toxicologists Toxicologist Dr. GĂĄbor Zacher would not believe the yeast biosensor to be toxic in any way. Other toxicologists Merielen Nascimento, ViktĂłria Zelenak, and Astrid Skovmand refrained from expressing any opinion.
Viability of yeast in saliva Yeast survival and hormone availability are not issues according to professor of odontology. She explained that: âIt makes great sense to make chewing gum that measures hormones from saliva both because it stimulates salivary flow rates for better sampling, but especially because the hormones are available and reflect blood concentrations".
Survival test at chewing gum compa- ny Fertin Pharma To test whether yeast can survive in chewing gum, we went to Fertin Pharma, a Danish medicated chewing gum company. We found that yeast easily survives being chewed for at least 5 minutes in their mouth model machine.
How should the gum taste? Like apples! Yeast flavored chewing gum might seem unappetizing. We spoke to Belinda Lange. She told us that developing a new flavour might also be better than masking the yeast flavor with sweeteners. To integrate her advice we asked an external panel of teenagers to play with different tastes in combination with yeast. The winners were: apple, peppermint, and raspberry.
Understanding the legal situation To understand the legal aspects and challenges Ovulaid would face we contacted Postdoc. Jakob Wested. We first needed to determine what legal category Ovulaid falls under - food item, a medical device, or pharmaceutical?
Ovulaid is a Medical device After tireless research into Danish and European legislation, we concluded that Ovulaid would fall somewhere in between a food item and a medical device. To clarify, we contacted the FDA in the United States and Danish equivalent LĂŚgemiddelstyrelsen. They both judged that Ovulaid is a medical device.
Addressing GMO concerns with an open letter We published an open letter in a recognized danish news paper. With this, we help pave the way for future scientists in realizing their projects.
Survey on medical GMOs Together with the iGEM team Leiden and the iGEM team Oxford, we conducted a survey on GMOs in pharmaceuticals. The survey showed that people are quite positive towards GMOs and would use products containing GMO in general.
The great potential of Ovulaid Ovulaid has received so much interest! Women would love to use it: over 90% of women would use our chewing gum despite the fact that it contains a GMO.
Integrated a business plan We were repeatedly asked about price and whether the chewing gum would be competitive with current market standards. We therefore ventured forward to create a business plan, where we address all these questions.
Outreach events iGEM is about connecting people, sharing knowledge, spreading aware- ness, and sparking interest in our peers for the science that connects us all and the ideas that we believe in. We talked at multiple events and presented our project and synthetic biology.
Synthetic biology case for high school students We have established a collaboration with Biotech Academy, where we are creating a biosensor case for high school students, to teach them about synthetic biology in their own labs.
End of the journey⌠Or is it? Our hard work, fun, and endless hours in our labs are paying of. Even as we are finishing iGEM the Ovulaid hype is now going international with an article in The Guardian (UK) and many other international medias. This is not the last you will hear of Ovulaid!
Starting with the basics
A scientific idea is only that - an idea. To translate that idea into something feasible that can touch peoplesâ lives for the better in a responsible manner, is just as important as the soundness of the theoretical concept. With this in mind we integrated considerations of our target groupsâ needs and our responsibility to them in our project development process. We wanted to ensure we not only finished with a sound scientific product, but with something that could actually make the world a better place. This is what iGEM calls human practices, and to get started on Ovulaidâs human practices journey, we met with former UCPH human practice manager Victoria SvĂŚrke Rasmussen (PharMARSy, 2018), who helped structure all our ideas that we then set out to realize.
Collaborating with SUND Hub
SUND Hub is a part of UCPH innovation house, and here we met daily leader, Martin B. Justesen. Martin B. Justesen showed us the road from a great idea to a successful startup and put us in contact with Tine Stampe, CEO and founder of La Roar Life Science. Drawing on her experience working with supplements for pregnant women, we decided on making the signal of the biosensor a color change rather than a taste change and knew we should use natural pigments as this would be an important selling point for our target group. Furthermore, she adviced us on making the packaging of the product discrete to respect women's privacy when buying the product.
Developed the Ovulaid app
Click here to take a look at the app page!
Designing a mobile phone app
To allow easy tracking and detection of color in the Ovulaid chewing gum we decided to make a mobile phone application. Therefore, we contacted Michael SchmĂźcker; a serial app entrepreneur and mentor for several startups, founder of SchmĂźcker Management Aps. Michael advised us on software implementations, color detection, and personal security measures as to comply with GDPR which we integrated in our app. Michael also opened our eyes to the possible benefits of the data generated, and we, therefore, integrated a central survey feature as a part of the app. This would allow researchers to gather interesting data about behaviors in relation to hormonal health which is important to ensure the best possible care for women all over the world, where women still face unequal healthcare due to systemic discrimination according to the WHO.. Click here to read the full summary of the meeting with Michael.
Creating the app at Vilnius Biohackathon
Three of our team members went to a BioHackathon in Vilnius, generously hosted by the Vilnius-Lithuania iGEM team to develop our application. Here we received valuable insights from 3 meetings with mentors.
âStress is affecting fertility and incorporation tools for measuring this could be a possibility e.g. Samsung Health,â advised Paulius Briedis founder of Robotics in Vilnius. He also added: âHealth apps (eg. Google Fit, Health on ios) found on most smartphones today or smartwatches could be incorporated as well to get access to data from peopleâ. In these apps factors like steps, sleep, weight etc. is already stored and could be integrated to increase the accuracy of the Ovulaid app. In summary, this would ensure that we had a fully functional health and fertility tracker with enough information to make it dependable. Click here to read the full summary of the meeting with the mentors.
Educated ourselves on fertility awareness and integrated developing countries in the product design
Integrated concerns from femtech expert
We set out to determine and understand our target group and Tine Stampe was our first stop. She is the founder and CEO of La Roar Life Science Aps, a company making supplements for women struggling with infertility - something she herself has personal experience with. Tine Stampe expressed concerns that many Danish women might have reservations against consuming a GM-product, and we, therefore, planned in-depth interviews with our target group. The full summary of the meeting, click here to read the full summary of the meeting with Tine. âThere is a great need for your product on the market. The current products are stigmatizing, troublesome, old fashioned and unsexy. There is a need for a product that makes it easier to know when the woman is in her fertile window,â - Tine Stampe.
How do we talk about infertility?
The subject of infertility is for many a very private and sensitive topic. We wanted to make sure we addressed the women with appropriate care and respect, so we contacted Bjarne B. Christensen, general secretary in Sex & Samfund. Sex & Samfund is a danish family planning association, and a member organization of the international Planned Parenthood Federation. Bjarne shared how their organization addresses and educates about fertility and infertility and we integrated his insights for preparing a respectful interview guide for our qualitative analysis. To read the full summary of the meeting, click here to read the full summary of the meeting with Bjarne B. Christensen.
A medical professionalâs insights into fertility treatments
To further understand the medical procedures that women in fertility treatment undergo, we contacted Prof. Lone Schmidt, Section of Social Medicine, University of Copenhagen, who taught us the basis of current treatments and the importance of fertility innovation and how Ovulaid is a part of a larger movement of technologies, solutions, and education called fertility awareness. She advised us to focus on developing countries , which are too often forgotten in fertility awareness, but where women often face burdens of stigma and taboo in relation to infertility that we western women can hardly imagine. We want Ovulaid to really make a difference where it matters so we integrated her advice by deciding to consider the needs of women in developing countries at least equally alongside those of more privileged women. To read the full summary of the meeting, click here to read the full summary of the meeting with Lone.
Visit to a fertility clinic in rural India
Inspired by Prof. Schmidt and realizing the potential of Ovulaid to help women in rural India, our indian team member Hitesh utilized a family visit to seek out gynecologist & fertility specialist Dr. Kathya Nallapothula in her fertility clinic in the small city of Proddatur, Andhra Pradesh. She confirmed that there is indeed a great need for Ovulaid in India , where the discretion of Ovulaid could ease the stress and stigma Indian women face, but also due to a rapid increase in infertility and hormonal imbalances caused by environmental factors such as pollution, which calls for cheap and easy hormone monitoring, which Ovulaid could provide. She also saw the biodegradability of Ovulaid as a major asset, as it could be a small, but important step fighting plastic pollution. We decided to integrated India as a target group for Ovulaid, and integrated biodegradability, but also discretion in the product design. To read the full summary of the meeting, click here to read the full summary of the meeting with Dr. Kathya Nallapothula.
Ovulaid could substitute invasive blood tests
Dr. Norbert KetskĂŠs, one of the most acknowledged gastroenterologist in Hungary, pointed out to us that if our chewing gum can be precise enough then it could replace several blood tests that women who are undergoing fertility treatment go through.
Quantitative market analysis
To best address the possible GM-concerns of our target group we conducted a quantitative market analysis. More than 1500 women participated in a survey we created for this purpose. The survey confirmed experts opinions: the existing method for tracking ovulation is not appreciated - women think that they are too expensive, uncomfortable, and imprecise . Click here to read more about our quantitative market analysis.
Qualitative In-depth interviews
We wanted to collect subjective opinions and personal stories from the target group by conducting qualitative in-depth interviews (IDI). Erik Arvid Hosszu, market researcher, helped us make a sampling strategy and an IDI guide. We then conducted 15 interviews with women that had faced fertility-related issues. They made us realize that the women do not like the existing method - they think they are imprecise and that they affect their sex life negatively. They liked that Ovulaid would not change their natural habits, and that it gives a complete picture of their hormonal changes which can make them understand their body better. On the basis of these positive testimonials, we finally decided to integrate the Ovulaid yeast into the chewing gum, rather than having it on the chewing gum wrapper, as was our fall back option for the project design, if women had strong reservations against GM products. While it might be easier to make a biosensor on a wrapper, rather than in chewing gum, we were convinced that ease of use was the most important factor, since women (and the media) simply loved the idea of the color-changing chewing gum. To read the notes from the meeting with Erik click here
Integrated safety concerns with a kill switch system
Feasibility of Ovulaid: scientific expertsâ opinions
Having established that there is both need and want for Ovulaid, we turned to scientific experts to explore the feasibility of Ovulaid. For this purpose, we first went to the Fertility Department at Rigshospitalet and met with Dr. Ziebe, Head of the fertility Department at Rigshospitalet, Copenhagen and Biologist Morten Rønn Petersen, Laboratory manager of the fertility Department at Rigshospitalet, Copenhagen. They expressed concerns about a chewing gum containing a GMO and stressed both the necessity of biocontainment of the yeast for personal safety, but on the other hand foresaw possible issues with yeast survival . This lead us to test the yeast survival and also solve the issue of personal safety.
Integrated Kill Switch
We presented our project at the Nordic iGEM conference (NiC) and just like Tine Stampe, Dr. Ziebe, and Morten Rønn Petersen, the NiC judges expressed concerns about personal safety and yeast survival. Taking these concerns seriously, we decided to address them by the integration of a kill switch for the yeast biosensor system , continuing the work of previous iGEM team (NAU, 2017). Click here to see the design of the kill switch.
Contacted toxicologists
Toxicologist Dr. GĂĄbor Zacher would not believe the yeast biosensor to be toxic in any way. Other toxicologists Merielen Nascimento, ViktĂłria Zelenak, and Astrid Skovmand refrained from expressing any opinion.
Survival and taste addressed
Viability of yeast in saliva
To examine the feasibility of measuring hormones in saliva and having a yeast biosensor in the mouth, we spoke with Prof. Anne Marie Lynge Pedersen, the Department of Odontology, UCPH. She explained that âit makes great sense to make chewing gum that measures hormones from saliva; both because it stimulates salivary flow rates for better sampling, but especially because the hormones are available and reflect blood concentrations". This means that saliva sampling is perfect for testing and tracking fertility. Furthermore, Prof. Pedersen would not expect the yeast to die but encouraged us to experiment with yeast viability. Click here to read the full summary of the meeting with Anne Marie.
Survival test in chewing gum company Fertin Pharmaâs R&D facility
To integrate Prof. Pedersen's advice and test whether yeast can survive in chewing gum, we went to Fertin Pharma, a Danish medicated chewing gum company to see their facilities and use their mouth model - a machine constructed for testing chewing gum. From the experiments, we found that yeast easily survives being chewed for at least 5 minutes in their model system. Click here to read the full rapport for the yeast survival assay.
How should the chewing gum taste? Like apples!
Since yeast flavored chewing gum might seem unappetizing we spoke to Belinda Lange, Coordinator at the Department of Food Science, University of Copenhagen. According to Belinda the setting and context of the food is more important than taste. She would not expect the yeast flavor to be an issue for the chewing gum and developing a new flavour might be better than masking the yeast flavor with sweeteners. She suggested to experiment with flavors like lemon, mint or cocoa as these flavours go well with the umami of the yeast. To read the full summary of the meeting, click here. We integrated her advice and to test it, we asked an external panel of teenagers to play with different tastes in combination with yeast. The winners were: apple, peppermint, and raspberry, which make these flavors suitable for the future Ovulaid chewing gum. To read more about the taste test and our education and engagement, click here.
Researched and determined Ovulaidâs place in the legal landscape of GM products
Understanding the legal situation
To understand the legal aspects and challenges Ovulaid would face we contacted Postdoc Jakob Wested, Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen. Jakob made us realize that it is difficult and often impossible to put a GM product on the market. Our first struggle was the categorization of Ovulaid as a product - is it a food item, a medical device, or a pharmaceutical? Depending on category, widely different regulations and legal processes apply. Click here to read the full summary of the meetings with Jakob.
Ovulaid is a medical device
After tireless research into Danish and European legislation, we concluded that Ovulaid would fall somewhere in between a food item and a medical device. To clarify, we contacted the FDA in the United States and Danish equivalent LĂŚgemiddelstyrelsen. The FDA responded that Ovulaid would be a medical device , and we would, therefore, comply with regulations for medical devices in the United States. LĂŚgemiddelstyrelsen also judged that Ovulaid is a medical device and should therefore comply with European regulations for medical devices until May 2020 . Due to new regulations, Ovulaid would then no longer be classified as a medical device in its entirety, but instead, the Ovulaid app would classify as a medical device and the Ovulaid chewing gum would classify as a food supplement. This means that our final product needs to comply with several different rule sets to be used, but that it is possible to actually process Ovulaid for approval under Danish (and American) law! Click here to read the summary of these inquiries.
Published open letter in impactful Danish Newspaper Information
Addressing GMO subject with an open letter
Our investigation into the danish population's thoughts on the use of GMOs indicated both ignorance and fear. This stance is also reflected in the Danish laws concerning GMOs. Since it is possible that ignorance is one of the causes of these fears of GMO we chose to help spread awareness of GMO use in the form of an open letter. These efforts will obviously not change any laws to benefit the realization of Ovulaid, but it is our hope that by contributing to the public debate and advocating responsible use of scientific GM-solutions, we help pave the way for future scientists in realizing their projects , which could make the world a better place. Click here to read the open letter.
Survey on medical GMOs
Together with the iGEM team Leiden and the iGEM team Oxford, we conducted a survey on GMOs in pharmaceuticals. The survey showed that people are quite positive towards GMOs and would use products containing GMO in general, especially if the product is effective. However, we have to be careful drawing conclusions from the survey since it could be biased as it was distributed through social media and reached acquaintances of iGEM participants. To view the full collaboration click here.
Finalized 25 page business plan
The great potential of Ovulaid
The sheer amount of positive interest in a novel fertility tracking test has amazed and humbled us. According to our survey, over 90% of women would use our chewing gum despite the fact that it contains a GMO . Furthermore, after influencers shared our project, many women with fertility issues contacted us to tell us that they loved our project and that they would love to use it in the future, so the Ovulaid definitely has commercial potential according to our target group!
Planning a business plan
Meanwhile, at the inParis meetup, we were repeatedly asked about price and whether the chewing gum would be competitive with current market standards. To put Ovulaid to the test of whether we could ever possibly accommodate the interest of these many women and potential future buyers in a responsible way, we ventured forward to create a business plan, following the principles of Bruce I. Barringerâs Preparing Effective Business Plans: and entrepreneurial approach, and the advice of many established entrepreneurs, companies, and mentors. To see the full business plan and our other entrepreneurial adventures click here.
Connected to our younger peers and the public
Outreach events
For us, iGEM is not just about addressing scientific, safety, and entrepreneurial concerns, trying to win a competition, and launch a startup. First and foremost iGEM is about connecting people, sharing knowledge, spreading awareness, and sparking interest in our peers for the science that connects us all and the ideas that we believe in. We talked at multiple events and have fond memories of all the people and especially all the young to-be scientists that listened to us at a symposium, three different biotech camps and did an experiment with taste. Read more.
Synthetic biology case for high school students
We have initiated a collaboration with Biotech Academy, a student run Danish educational company connecting university students with younger students by producing teaching material, where we are creating a biosensor case for high school students, to teach them about synthetic biology in their own labs. It is important to support future scientists, especially the future female scientist, and as our project is so easy to communicate, we also believe it is our responsibility.Click here to see the full summary of the meetings.
Appendix
On the 18th of July we went to Michael SchmĂźckerâs offices. Michael works with entrepreneurship, IT, and is mentoring startups. He has 25 years of experience with developing successful apps, experience he was happy to share with us for our own app.
Input
When making our app, we want to collect data to see if other things like sleep, mood, sex and so on could effect hormone levels. Do you have any proposal on how to do this in a user-friendly way? Michael suggested that we make a survey/questionnaire that all women would answer when they log into the app. In the survey could be questions like: âHow has your day been?â, âHow have you slept?â, âWhat have you been doing today?â. . The survey could get more personalized according to what people had answered before. E.g. if somebody answers they have problems with sleeping, then the next time they could be asked how they have slept. He thinks it is important to include the function to turn off the survey if they think it is annoying as well. Is there other data you think would be relevant to get from women? Michael thinks that things like age, nationality, diet, origin, sickness, etc. would also be relevant. It could be interesting to see if there would be any pattern between these factors and pregnancy. He pointed out that we could incorporate these things into our survey. There would be a big potential in the app as we would generate big amounts of data This data could be used for fertility studies and thereby helping society. We could collaborate with universities, researchers, or even the medical industry to make sure the data was used for good. Furthermore, the questions in the app could be formulated in collaboration with researchers and professionals, and thereby be changed according to scientific interest. How do we take care of peopleâs data? How do we make sure people can feel secure using our app? First of all, we have to comply with GDPR. Michael thought that it was a good idea to make a function in the app that could delete people's data if they wish to. An idea could be to make people sign up by mail and also by mail could people delete their information again. If we had their email, then we also had a way to contact the user in a proper manner, in the case that their hormonal profile was exceptional and of interest to researchers. He also told us that we should handle the usersâ data anonymously, so the user (or other people) cannot see who is using the app. We should consider what data is relevant for us and we should try not to get any irrelevant personal data from people like their address, CPR, name, etc. as the userâs personal identity does not concern us. Michael also told us that another way of taking peoples security into account would be to make a security login to the app. This login could be personalised by using fingerprint or face recognition. Is there anything you think we should incorporate into our app? He thought it would be a good idea to have push notification. The app could then say when you ovulate, but also when you should have had your period if you experience irregular menstruation cycles. There could also be a push message saying that people should contact their doctor. A push notification could also be used to tell people that they need to come back and put in there data if they want accurate measuring. How feasible would it be to make color detection in our app? He though color detection in our app was a feasible project and he suggested that we made a color scale with different tones of the colors we want to detect on the app. What is the first you should do as a start up? Michael told us that normally when start-ups comes to him, the first thing they do together is to make an IVS for the firm. After this, the regulations should be done, the registration of the address and finally the start-up should find a bank. At the bank, an account should be created. In this account, manager and division should also be put. A business plan should also be made. He advised to make one for a short time period and not for 5 years as it is hard to say how everything will be looking in 5 years. Michael also commented that as a start-up it is important so see your weaknesses. He told us that we are lacking marketing and sales and that we should think about this.
Integration
Moving on from the meeting we took Michaels advice. We will integrate the following in the app design: • Make a survey the women need to answer when the login to the app and make it personalized from what they answer. The survey should also have an âturnoffâ function. • Change the question asked in the app so we could generate these big amounts of data with big potentials. • Make a function so people can delete their own data, only ask people for the relevant data and implement some kind of security login. • Incorporate push notifications in the app. • Make a color scale.
On the 3th of August we went to the Biohackathon in Vilnius Lithuania where we met with different mentors: Paulius Briedis, Gediminas PekĹĄys and Dalius Rupainis. Paulius Briedis is one of the founders of Robotics in Vilnius. He has experience in designing medical, agricultural inventions, programming real robots for industrial applications, consulting start-ups on establishment and scaling-up.
Gediminas PekĹĄys is specialist in focus and sound experience in strategy formulation, funding, business development, and artificial intelligence.
Dalius Rupainis is experienced in all sorts of technology - from mainframes to high-end cloud services as well as knowledge in affiliate marketing and ad campaigns, currently working on an e-book publishing business.
The contact with the mentors was made as we wanted their views and expertise on our app, our business plan and advertising since they had done work in this area before. KEY POINTS • Consider using a white color standardization for the color detection in the app • Incorporate other application like Samsung heart rate monitoring for checking stress levels or other âhealthâ/tracking apps • Incorporate existing health technology that are tracking hormones as these could easily be used on estrogen and LH • We could choose to address that our product is GMO differently. We could be up front about it and embrace it as a part of our branding by saying on the packing that the gum is âproduced with genetic engineeringâ, and thereby 'play' the science angle • The following is needed in our business plan: team description, product description, marked analysis, completion and a roadmap of what we want to achieve. • Estimation of price: a lower and over bound should be made. We should make different scenarios for were we could end with different estimate of the price • Short term scenarios: MVP (minimal viable product) â product that could track ovulation. Focus first on user, maybe then get experts on the team to fill out weak spots. • Long term scenarios: Look into the big amount of data we generate and AI (artificial intelligence) could be connected to this. • Advertising: empathize user friendly, biodegradable and the big amount of data. Advertising our product in countries outside the EU e.g. India or the US.
Input
Do you have any advice on how we should do the color detection? We have been concerned about the recognition of the different colors in our app as lighting and shadow so far has interfered. Paulius thinks that the easiest and most accurate way of doing color detection would be by using white color standardization. This would be done by wrapping the chewing gum in a white paper and putting this underneath when taking the picture of the gum. The app will then standardized to the white color and the color of the gum will be more accurate. Lighting and other things that could interfere with the color when taking the picture would then not be a problem. What other things could be incorporated into our app? Paulius also though if stress could affect the hormone cycle in the body and thereby would also the period you are fertile. He thinks it would be a good idea to look into if stress is affecting the fertility and maybe also incorporation a tool to measure stress levels. Samsung had an application that works as a heart rate monitoring. This works by using the camera and the phone light can measure the stress levels, O2 and the heartbeat. He also suggested to incorporate other already existing application or health technology. Application like the âhealthâ app (eg. Google Fit and Health on ios) found on most smartphones today or smartwatches could be incorporated to get access to data from people. In these apps steps, sleep, weight and so on is already stored and people would therefore not need to put it into our app. Other apps like Strava, Edomondo, Lifesum would also store some interesting data. For health technology Paulius suggested that we looked into which other hormone tracking devices there is e.g insulin tracking devices. These devices could probably quit easy be changed so they could be used for tracking of estrogen and LH. How would you address that we are using a GMO organism? We found it hard how to address that we are using an engineered modified organism (GMO) and wanted Paulius' advice on how to address it. He suggested that we should be up front about it and not try to go around it. This could be by marketing our product as a genetic modified gum. By addressing that our gum is GMO and not hiding it some people might be scared, but this might also attract the right target group. What would be a part of the business plan? Before starting our work on our business plan would we like to have an overview of what would be relevant for us to know. Gediminas told us that from where we are now we would need the following in our business plan: team description, product description, marked analysing, completion and a roadmap of what we want to achieve. How can we estimate the price of our product? Gediminas said that it would in our case be hard to estimate the price of our product, but that we should have a lower and over bound of the price. He suggested that we should make different kinds of scenarios (the scenarios should also be a part of our roadmaps). The scenarios would be for the different places we could end up and would have different estimated prices for our product. In this way everything could be taken into account for the estimate. What would you see as long term and short term scenarios? For the short term Gediminas said that we should think of the MVP (minimal viable product), which for us would be to get a product that could track ovulation and firstly focus on the user and then maybe get experts in and the areas we are weak in. For the long term he said that we could look into the big amount of data we generate and AI (artificial intelligence) could be connected to this. How should we advertise Ovulaid? Dalius said that it is important to empathize that our product is user friendly (easy to use) and biodegradable. He also thought that we might should look into advertising our product in countries out of the EU e.g. India or the US as they have a different look on these kinds of devices. Besides that, he told us that the bigger picture and the data we get would also be a really good selling point.
Integration
After the talks with the mentors we decided that we will:
• Incorporate other applications like Samsung heart rate monitoring for checking stress levels or other âhealthâ/tracking apps
• Consider to incorporate existing health technologies in the future (not in the course of iGEM).
• Incorporate the advice we got on how to do the business plan.
• Take the mentor's advice about advertising our product e.g. address that our product is GMO or to advertise it in other countries outside Europe such as India or Asia.
Thursday the 27th of June the Human Practices group met with Tine Stampe, founder and CEO of La Roar Life Science ApS, a company that makes food supplements for women trying to get pregnant. She has also struggled to conceive and maintain a pregnancy for a long time. We contacted Tine, because she knows our target group very well, since she has been a part of it and since her product is also meant for women with fertility problems. She could therefore help us to define our target group better and to reach out to them.
Input
What do you think about the current ovulation tests, and is there a need for our new version of an ovulation test? She thought that there was a great need for our product on the market. She said that the current products available are stigmatising, troublesome, old fashioned and unsexy. To be considered as âinfertileâ, a couple has to have tried to conceive for over a year. It is only after two years of trying that the couple will get fertility treatment. This process is very long and hard. It would therefore help to have a product on the market that makes it easier to know when the woman is in her fertile window. Do you think our chewing gum should change taste or colour? She preferred that the chewing gum would change colour over a change of taste, because she thought that it was more safe. She said that she would be more scared of tasting the wrong taste than seeing the wrong colour. What do you think about the fact that our chewing gum contains GMO? Her product is GMO-free, because she thinks that people are scared of GMO because of their lack of knowledge on the subject (this is why we chose to make an open letter, to raise a debate around GMO). What can we do to make our product more attractive? She said that our product should be discreet and suggested that we make a sleeve stating that it is a chewing gum that detect ovulation, that can be taken off so that the chewing gum is neutral. She told us that if the oroduct was organic, it would sell well, and thought it would be good Ovulaid if the chewing gum could be biodegradable. How could we improve our app? She recommended that the app that we make should not only have a calendar feature, but also a feature for tracking sleep, food and other lifestyle aspects that improve fertility. She suggested that the app could also be used as a platform to sell our product, and emphasized that the product should also be available in online stores, making it easier for buyers to buy it anonymously.
Integration
To move forward with our project, we decided to adapt our project and take Tineâs advice into account. Our chewing gum will therefore change colour and not taste. We will make an open letter, and try to impact the popular opinion around GMO. We will make a discreet packaging for the chewing gum.
Questions and notes from the meeting with Bjarne B. Christensen â Sex & Samfund:
Is fertility and pregnancy a topic that Sex&Samfund addresses?
Sex&Samfund are working with fertility awarenes, and are aiming to do even more, as they usually focus mostly on contraception, sex education, gender identity, sexuality etc. They educate people, but are careful not to influence people's decisions of whether should have children or not. One of their main areas is education in elementary schools with an exclusive dedicated week (Week 6 / Uge 6) where they talk about everything concerning sexuality and health. For this they have made specific educational material where they are talking about reproduction (the elementary schools can choose subject from a list where reproductivity is one of the subjects to choose from).
What is Sex&Samfundâs advice on fertility problems? Does Sex&Samfund talk about infertility and how does Sex&Samfund talk about it? What does Sex & Samfund think about the already existing methods for ovulation tracking?
Sex & Samfund advice people to seek out proper medical professional help. Infertility is not their main focus and they are not in charge of the treatments for the problems, but they would always happily refer people to the right place.
They had no comment on the existing methods for ovulation.
What subjects are Sex & Samfund focussing on at the moment and why are you focusing on these topics in particularly?
Sex & Samfund are focussing on many different topics. When it comes to reproductive health they are mostly focussing on talking with people about when they want to have children, how they want them (family planning), prevention of diseases as well as pregnancy and sexuality in generally.
They are also working on conquering myths that are associated to fertility e.g. *Danish saying* âĂnskebørn skaber gode hjemâ. In English: âChildren that are planned will make for a good homeâ.
Beside this, they fight for better laws in Denmark for people with diseases causing infertility that get fertility treatments. Sex & Samfund thinks that Denmark does not support these people enough and they really want to make a different for these people.
On the 21th of August we met Lone Schmidt. She is professor MSO, ph.d., dr.med. and her primary research fields are reproductive health, infertility, assisted fertilisation, family planning, social epidemiology and qualitative methods. The purpose of this meeting was to know our target group better and understand the problem of infertility better.
The meeting with Lone was very helpful. From the talk we got a better understanding of who our target group is. More specificly, we got an understanding of: who has problems with fertility, how big a problem infertility is, how these people feel, what these couples need and which health related factors that affect pregnancy. Besides this we talked about fertility awareness and how to take part in this movement. Lone also put us in contact with Bjarne Christensen from the Danish organisation âSex og Samfundâ.
Lone made it clear to us that we are a part of a movement and after the meeting we agreed that we wanted to take part in this and focus on spreading fertility awareness. Most of our efforts in this field can be seen i our Education and Public Engagement page.
Aim: understanding our target group and their needs on a deeper level. Participants and sample strategy: 6 - 20 persons (important as we need more view on the project) Best if we have some people we donât know. • Ask people from the team if they know somebody relevant. • Ask people on facebook (or Frederiksberg Campus group). • Facebook groups for focus groups Moderator: Signe - the person in charge of asking the questions Needs to be somebody with good social skills. Consider a moderator assistant: Swenja, if we are having in-person/skype interviews the moderator assistant will only take notes - the assistant can record the interview, if allowed, and also note non-verbal communications (e.g. reactions of participants, character traits of participants; quiet, dominant, taking control of conversation, etc.)) The moderator should control the situating and be sure to steer the conversation if a participant talks too much or someone is very quiet. Questions / interview guide: • The questions should be broad and open up a discussion • Maximum 10 questions (preferably under 10) • Short and precise Before asking the questions start with a description of our project and the app or give the participant something they can read before coming to the meeting. E.g. or show them the video we have made. Interviw guide: Probe questions (introduction to the topic and make them feel safe sharing their opinion) • (make people tell a little about themselves first. Introduce themselves and the moderator introduces herself as well â open up / warming up, let them know that there are no wrong answers) • Briefly introduce the general problem and our project. • Tell about the whole topic and not just our products. • Break the question into three sections with two questions in each. • How familiar are you with the currently available ovulation tests? • What would you think about having chewing gum as an ovulation test? • How familiar are you with GMO and what is your opinion on GMOs? Follow-up questions (go further into the discussion topic and the participants option) Brief introduction Ovulaid more detailed (play our film from facebook) • What are you expecting/want from an ovulation test? • How would you feel using a chewing gum for cycle tracking if it contained GMO? • What do you think about combining the chewing gum with an app (Show film of our app). • What do you like the best about our product? (both chewing gum & app) and what features would make it even better? (both chewing gum & app) • What are your problems or concerns using our products? (both chewing gum & app) and what would influence whether or not you would use our product? • How do you like the chewing gum (and our product in general) to be marketed? Exit question (check to insure that you did not miss anything) • Anything else you would like to say?
August 28th, 2019.
Hitesh Gelli, meeting diary
I visited Proddatur, a small city in the state of Andhra Pradesh in India. I met with a
gynecologist and also visited her fertility clinic. She showed me around the fertility
clinic and also the Invitro fertilisation lab. Then we had a chat in her room, where I
started explaining our project and she asked a lot of questions about our biosensor
and gave me some nice points about fertility from Indiaâs perspective.
Notes from Dr. Kathya Nallapothula:
• 15-20% Indian pop is affected by infertility, rising at a rapid pace.
• 20-25% due to hormonal imbalance
• Hormonal imbalance is caused due to environmental (food and water) micro plastics and pesticides )factors, obesity
• Itâs more of a social problem than a scientific problem, leads to depression, cardio vascular etc
• 20 -25 years hormonal imbalance and then in future all chronic disorders
• Patients are more open to talk to other infertile couples
• Usually patients come in groups to the doctors.
• For common hormonal diagnosis, blood is the major source.
• Urine based tests do not have quantitative analysis
• Most people in India are not aware of LH test kits, so they end up going to the doctors
• If infertility canât be fixed, IVF is the only solution.
• Very nice project, would be simple to use in rural India, where most of the hospitals donât have the Facilities for fertility check up and it is needed for a country like India, where the number of infertility issues is increasing very rapidly.
• Will be very nice if our project can be used for prognostic purposes
• Infertility issues are more prevalent in women above 25.
• Family harassment of women is still a big issue in India.
• LH peak is the most important for ovulation.
On the 28th of June we visited the fertility clinic at the Rigshospitalet in Copenhagen to meet the head of department, Søren Ziebe, and the laboratory manager Morten Rønn Petersen. From the meeting we hoped to get an expertâs opinion on our project, especially on the scientific part.
From left: Dr. Ziebe & Morten Rønn Petersen
Input
What challenges do you think we might face during our project? One concern of the two doctors was the sensitivity of our biosensor towards the hormones. They stated that the yeast would have to be highly sensitive in order to deliver the desired outcome resulting in a significant curve. In this context, they Furthermore, they emphasised the risk of potential false positive results and encouraged us to check whether there are other ligands capable of binding the receptors in use and think about how we could possibly circumvent the binding of such. Further false positives could arise as a result of the volatile conditions prevalent in the mouth, which are, among others, highly influenced by what we eat and drink. Here, they considered the pH to be of the highest importance as it might influence both the ligand/receptor binding and the survivability of the yeast. Thus, they recommended us to carry out experiments with varying pH values, but also to think about other potential disruptive factors, and on the basis of these create a survivability assay of the yeast. Another experiment they encouraged us to carry out was the quantification of LH or GPER receptors per yeast respectively and the determination of how many receptors per yeast will bind a ligand. The latter suggestion arose mainly from the question whether chewing would be sufficient enough to enable the receptors in the center of the gum to bind the hormones and thus, turn into a detectable colour or if only the surface would turn into a detectable colour. Further comments on the project: Apart from the scientific outline of our project, Søren Ziebe and Morten Rønn Petersen had further comments based on commercial aspects, one of which regarded the fact that our product was a GMO. In their believe, Denmarkâs population would at the time of speaking not yet be open enough towards GMOs to use our product. Furthermore, they were curious about how the gum would taste, given the fact that it would contain yeast. At last, they wanted to know the advantages of our gum towards existing urine-based tests and encouraged us to compare the market prices and false positives.
Integration
Our visit at the fertility clinic of the Rigshospitalet left us with a lot of room for thought and much helpful advice. In order to integrate this into our project, we decided to make an outline for a survivability assay of our yeast, in which we would take different factors such as chewing forces and varying pH into account. Moreover, the comments of the doctors further encouraged us in our intention to address the outdated legal status of and the deadlocked public opinion on GMOs.
Can the yeast survive in our chewing gum? How about in a human mouth?
We were asked this question multiple times, by ourselves, by our supervisors at the Nordic iGEM competition, by highschool students at NFU and at virtually all the presentations we have made on Ovulaid.
We have therefore addressed this concern by testing the viability of yeast in saliva.
For this purpose we first talked to Prof. Anne Marie Lynge Pedersen at the Department of Odontology at UCPH. She has specialized her carrier in saliva and the mouth microbiome, amongst other things. In her expert opinion survivability of the yeast would not be an issue, if we kept the chewing time to a couple of minutes. In fact, she was more concerned about flushing the yeast out of the gum, but also encouraged us to test the viability of our yeast in the chewing gum.
She put us in contact with a danish medical chewing gum company called Fertin Pharma. At Fertin Pharma they are experts at developing and testing medicated chewing gum, and luckily they were willing to let us use their mouth model specialized for chewing gum assays and even send us gum base, so we could do the initial tests in our own lab
The mouth model
Fertin has a specialized mouth model, which uses a KOH buffer and mimics the chewing and salivary flow rate (SFR) of the mouth during chewing.
In the machine, a pump flushes buffer through at a constant rate, mimicking the human salivary glands, while a set of teeth chews in two directions.
Conditions for viability
Different conditions will the survival of yeast in a mouth environment. Some of the most important factors are
• pH
• Flow
• Mechanical stress
• Amylases
• Other microorganisms
In our experiments we were not able to work with human saliva due to the very strict danish laws on registering biobanks. Instead we focussed on the effects of flow, and mechanical stress, imitating chewing. Furthermore, we were not able to work sterile, since the machine was not sterile. We prepared samples sterile in the university laboratories and transported them in eppendorf tubes to Vejle.
Materials
• 5 mL Falcon tubes
• YPD media
• YPD plates
• Chewing gum base pellets
• Dried yeast (store bought, non-GM)
• ethanol
Method
First we mixed dry yeast with chewing gum pellets with a mortar.
We then brought the pellets to Vejle and had the pellets âchewedâ in Fertinâs mouth model for the duration of 1 min, 3 min, and 5 min.
We made these tests in two sets.
For the first set, we stored the pellets dry in eppendorf tubes for the transportation back to Copenhagen.
For the second set we incubated the gum pellets in 1 mL YPD media.
We used these tests to see whether yeast cells survived the chewing, if they escape to the media, and if they survive in the media. We were not able to perform the experiments quantitatively, due to unforeseen circumstances, but could only make a rough estimate of whether yeast cells were washed out in the saliva buffer or died because of the chewing.
Upon the return to the laboratory (3-4 h incubation at room temperature) we mixed the dry pellets in media and immediately plated on YPD agar plates. We used this set to see if any yeast cells survived. If they did we should see a lot of growth when they are incubated for this long period of time.
We also collected the âsalivaâ buffer to see if it contains yeast cells.
Results
Unfortunately, the samples that were brought back from Vejle were heavily contaminated, and therefore non-conclusive. This was not unexpected, as the chewing machine was not sterilized beyond standard cleaning procedures and was not under a hood. There seems to be yeast growth in the chewing gum chewed for 1 minute and for 5 minutes, and none in the negative control (albeit much bacterial contamination). Due to extreme growth in the 3 minute plate, we cannot conclude anything. Buffer samples for gum chewed for 1- and 5 min also contained yeast growth, so we would need to address flush out of yeast in the chewing gum design.
Chewed gum base with yeast 'resuspended' in liquid media and plated after 4 h incubation.
Future additions
The next step would be to test the viability in actual saliva. To do such an experiment we would need to comply with standardized methods for collecting saliva and comply with danish legislation for biobanks.
A possible way to improve the survivability and limit the wash-out of the gum could be to microencapsulate the yeast with substances such as gum arabic or whey protein. By doing this, the yeast could both have increased mechanical protection and media components could be within the yeast.
On the 16th of July we met with Anne Marie Lynge Pedersen. Anne Marie is a professor at the Department of Odontology at the University of Copenhagen. Anne Marieâs academic work counts saliva based diagnostics and an intricate knowledge of salivary glands and the mouth microbiome, which made her the perfect person to ask about the feasibility of our project. KEY POINTS • Chewing gum is a good way to ensure a steady flow and proper sampling of saliva • Hormones are some of the most feasible molecules to measure in saliva, with similar concentration to that of blood • Our yeast would probably be able to survive within the gum, but we should test its survivability • We can use paraffin or gum base to test our yeast system • We need to use anonymized human saliva for experiments, and need to consider ethical issues with personal data in our app and in sampling
Input
How would the mouth react to chewing our chewing gum and would we be able to measure the hormones? Normally the secretion of saliva varies a lot during the day. The resting secretion of saliva is around 0.5 mL/min and the saliva has a large mucus concentration, which makes the saliva both very viscous and elastic (high viscoelasticity) and difficult to sample. When chewing a piece of chewing gum the secretion starkly increases (2-5 mL/min), which would be beneficial for sampling, because this decreases the great variation in secretion and salivary contents that you would otherwise see in the duration of a day. Luckily for our project, hormones are some of the biomarkers in saliva that are the best suited to test . This is because the salivary hormone content resembles that of the blood, so Anne Marie thought that our project was indeed feasible, if we could get our yeast biosensor to work, and make it stay within the chewing gum. Would the yeast be able to survive in the saliva? Based on her experience with different microorganisms within the mouth, yeasts included, Anne Marie would not think that the survival of the yeast would be an issue, but she encouraged us to test it. We therefore discussed, how we could perform such a survival assay. Anne Marie presented us with the two different options for our chewing gum. We could use paraffin or gum base. Anne Marieâs department makes their own paraffin for their experiments, and using paraffin might be an advantage in our project since it is lipid based, which could hold the yeast better than more traditional gum base. Anne Marieâs department gets their gum base from Fertin Pharma, a danish company specialized in medical chewing gum. We were of course very interested in Fertin and their experience and opinion on our idea, so Anne Marie put us in contact with them. *HYPERLINK *here*HYPERLINK*.
Integration
After our discussion with Anne Marie we decided that we needed to test the survivability of yeast in a chewing gum. • Experimental setup • We contacted Fertin and arranged a meeting with them.
Belinda Lange is a coordinator of design and consumer behavior at the Department of Food Science at the University of Copenhagen. At her department they work with food tastings and even have an experimental food lab, where they test products, develop new flavours and more. KEY POINTS • Setting/context is sometimes more important than taste • New flavour might be better than masking flavour • Lemon, mint, or cocoa could create good flavours with yeast
Input
When designing a food and determining a taste, especially for a new food, it is important to take the setting of the eating and the ceremonies around the food into account. In our case, the setting for the tasting will be in a chewing gum and the chewing gum is very much a means to serve the purpose of tracking fertility. In this sense, the taste is secondary to this goal, and while the chewing gum should not be foul tasting, it would not necessarily need to be delicious for people to use the product. A chewing gum that tastes like yeast is very unconventional, and we can take two routes in developing the taste: One approach is to try to mask the yeast taste with other strong taste profiles, such as sweeteners. A second approach can be to develop a new taste where the rather umami yeast flavour is complemented. Belinda suggesting trying out mint-yeast, lemon-yeast, or cocoa-yeast.
Integration
After the great input from Belinda we were ready to test different flavours. First of all, we did a simple in-office test, where we blended dried store bought bakers yeast with a unflavored chewing gum base we received from danish medical chewing gum company Fertin. We then tried yeast chewing gum in combinations with a mint, with lemon juice, and with a cocoa powder. The taste profiles were very interesting. While none of the combinations were foul tasting, the cocoa powder was the least pleasant. Mint was the most pleasant taste. The mint blended well with the yeast giving the chewing gum a more rounded taste, while the coolness of the mint kept the yeast flavour from dominating. It does not taste like a conventional mint chewing gum, but for the purpose of a medical device it would be more than satisfactory. Another aspect is the lasting of the flavour. Instead of aiming at a long lasting flavourful chewing gum, we can use the lasting of the flavour as a timer, for when the gum has been sufficiently blended for the device to be saturated.
On the 10th of July we met with Jakob Wested. Jakob is a postdoc at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen. We had contacted Jakob because we wanted: 1) to know how our project would fare within the framework of Danish and European law and 2) a legal scholarâs input on what problems synthetic biology faces in general and what we can do about it. Our largest concern was the feasibility of Ovulaid, since we basically want to put a genetically engineered organism into a chewing gum. KEY POINTS • Research what legal categories Ovulaid falls under: medical device, food or pharmaceutical • Avoid the category of pharmaceuticals • Assess the degree of invasiveness • Use the directive 2001/83 for gathering arguments • Use public platforms to argue for our case • Meet with a law firm to get legal advice
Input
What legal framework does Ovulaid lie within? According to Jakob, the first thing that we need to make very clear is what our product actually is. We need to ask if it is a medical device, a pharmaceutical or a food. Different directives are in place for these different categories, with the strictest being pharmaceuticals. A priori he thought Ovulaid would fit best into the category of medical devices, but that we might also need to seek further approvals in as a food. In any case, Jakob discourages us from presenting Ovulaid as a pharmaceutical since it would require clinical trials to get our product approved for use as such, which would require very large investment sums, which our project does not justify. He furthermore encouraged us to read the directives for these different categories (2001/83), and use the definitions of this directive to categorize Ovulaid. There are also different categories within medical devices, and the safety requirements rise with the level of invasiveness. We therefore needed to assess how invasive Ovulaid is, and perhaps adjust the product to avoid further invasiveness. What do we do if Ovulaid falls in between current legislation? We were concerned that Ovulaid will be a GMO device that you put in your mouth, which might place Ovulaid within the legislation of both, a medical device and a food. The question is then: If your product does not really fit into any legal category, what action do you take to get an approval? Jakob told us that this is when you become argumentative. It requires work and you will have to extract current definitions and argue, in our case why our device is actually a medical device and not a pharmaceutical. It can be very difficult though, since legislation concerning GMO crops is based on a precautionary principle. Jakob encouraged that what we can do, as students, is to raise awareness. We discussed the different platforms best suited for this purpose, and ideas were 1) writing open letters to politicians, challenging them to take an informed stance on the use of synthetic biology and 2) writing articles for critical newspapers to target the environmentally aware segment of the public, whereof many still associate GMOs with risk, pollution, and the use of pesticides. What problems does current legislation pose in regards to good use of synthetic biology? In Jakobs opinion we can and should question the application of the precautionary principle. We can discuss the justification of a continued use of the precautionary principle that has largely blocked wide use and innovation of GMOs in Europe since the implementation of the Worldâs Charter for Nature in 1982. The principle of caution regarding GMOs was established in the 80âs and the current technology has changed rapidly since then. Another problem is the innovation in synthetic biology products. Because the access to the market is so heavily regulated, it also effectively hinders the interest in innovating already existing products, and Jakob stresses that the greatest innovation is often accumulative - small steps is better for innovation than great leaps, which is also called incremental innovation. The current legal landscape does not allow incremental innovation. The final points we discussed are unequal market access, and the issues of responsibility in terms of safety. Due to the large costs tied to getting approvals for GMOs it is only the very large and wealthy companies that actually have the necessary funds to put their products on the market. This favours products for a very large market, and hinders the development of small markets.
Integration
To move forward with our project we decided to take these different legal aspects to heart. We therefore researched legislation on medical devices and found that although we live up to article 2 definition 1 of a medical device, we • Got legal counsel from law firm • Planned to write an open letter to politicians • Write news paper article posted in TheGuardian
About Us
We are Ovulaid: a team of 13 students from the University of Copenhagen working on a novel ovulation detection system, using synthetic biology.
Keep in Touch
iGEM Team Copenhagen
iGEM_Copenhagen
iGEM_Copenhagen
UCPH.IGEM2019@gmail.com
Address
University of Copenhagen
Thorvaldsensvej 40, Frederiksberg C
Denmark
