Panel discussion
In the very beginning of our iGEM journey, we arranged brainstorming sessions to discuss both global and local problems that are affecting the society. During our brainstorming phase, we also organised a panel discussion with researchers from different fields to discuss our four project ideas. Different team members got to present the projects in front of the experts and after every presentation, the experts got time to ask questions and give us feedback.
It was important for us to have different experts in the panel so we can get help with different parts of our project. Therefore, we contacted both researchers from academia and industry but also experts within product development. The panel included experts from KTH, SciLifeLab, AstraZeneca, KI Innovation and Merck Innovation hub.
Doctor interviews
In order to understand the current incidence, risks, diagnosis and treatment of pernicious anaemia, but also to understand what types of solutions are needed in the clinic, during our iGEM year we had a close contact with our main stakeholders: doctors. To gain a broader knowledge about this field and to ensure that we can meet the needs of the society, we chose to integrate with doctors that have different backgrounds and are working in different fields of medicine.
Dr. Haitham Aldaher
Dr. Haitham Aldaher is working in a child-care centre in Stockholm. He is a specialist in paediatric neurology and has been working with children for decades. Even though we are focusing on pernicious anaemia, a disease that is not so common among children and young people, which also was confirmed by him, we still wanted to hear more about his experience with pernicious anaemia.
Dr. Qian and Dr. Hou
Since our project is focusing on anaemia, it was important to also get in contact with haematologists, doctors who probably have most experience with patients with pernicious anaemia. Dr. Qian and Dr. Hou are two doctors from China, both working at the department of hematology, at Nantong University Affiliated Hospital and the Second Affiliated Hospital of Nanjing Medical University respectively.
Dr. Sunil Sonwalkar
Apart from haematology and internists, gastroenterologists are also involved in diagnosis and treatment of pernicious anaemia. In order to hear about their opinion and experience with current diagnosis and treatment, we contacted Dr. Sunil Sonwalkar. Dr. Sonwalkar is a consultant gastroenterologist working at the Calderdale & Huddersfield NHS trust UK, and is mainly involved in diagnosis of pernicious anaemia.
Summary of interviews
When we asked about their opinion regarding our solution, all doctors were very positive about it. The current treatment of pernicious anaemia is mainly intramuscular injections of vitamin B12 and according to them, the development of oral vitamin B12 drug with intrinsic factors would be meaningful for the clinical treatment of pernicious anaemia and would also make life a bit easier for the patients. Our solution would also solve the problem at its root, unlike the treatment that currently exists today. Dr. Sonwalkar also came with another point of view regarding this question. Our solution would probably mean that patients would need to consume a pill every day, while today's treatment involves injections once every three months. Therefore, some patients would maybe find current treatment easier than our solution.
When we further asked about diagnosis, all four doctors agreed that the diagnosis process of pernicious anaemia is complicated, and the symptoms are easily confused with other diseases. Therefore, it may be misdiagnosed. Apart from these difficulties, according to Dr. Aldaher another reason for pernicious anaemia being underdiagnosed could be that the diagnostic tools we are using today, at least in Sweden, are very expensive and therefore they only get used if the doctor suspects that the patient has a serious enough condition to warrant the cost.
To integrate their feedback into our project we decided to spend some time on working with possibilities to develop a more cost-effective diagnostic tool. Thanks to the interviews we realised that our project has broad potential in various fields. Not only that it can be a template for improving treatment for other autoimmune diseases, but the project and technology itself can also be applied in diagnostics.
Almedalen
On July 4th, our human practices team went all the way to Gotland to attend the Almedalen. Almedalen is a democratic meeting place and a political event in Sweden organised by the parliamentary political parties. The aim of attending this event was to investigate how much Swedish politicians know about GMOs, synthetic biology, and their possibilities.
We interviewed all eight main political parties from Sweden, where questions regarding healthcare, synthetic biology, GMOs and regulations regarding GMOs were asked. At the end of the day, we came to know that the majority of politicians we talked to ad limited knowledge, and capability of GMOs and synthetic biology. Therefore, we decided to continue with this work even after Almedalen by sending surveys and emails to all eight parties in order to get more useful information and insights from their side. We also wanted to raise awareness about synthetic biology among politicians and explain how it can be used to make a more sustainable society and therefore, politicians became one of our main target groups in outreach. Reaching out to them was a bit difficult, but we kept the communication intact by sending them informative emails and messages. We also attempted, in vain, to organize an interview to establish a dialogue and discussion with experienced parliamentarians.
Carousel. Pictures of our team members discussing synthetic biology with politicians at Almedalen
EMA
To discuss regulations regarding our project and product, we contacted the European Medicines Agency which is an agency within the EU. We got the opportunity to talk with Lorenzo Montrazio, who has been representing Italy in EMA.
After explaining our project to him, Lorenzo explained that, in order to move from our research phase and perform toxicological and clinical trials, we would need 5 000 patients and 10 000 euros/patient. Since this requires a lot of money, usually the drug is first sold to a company that has all the resources. Lorenzo also explained that it takes 210 days for a concerned ministry to decide whether the product can enter the market and how the product will be used. This is because it requires different expertise, e.g. animal testing, testing and manufacturing.
We also got to know that we can ask EMA for advice and help regarding if we should continue with a certain decision. This is similar to peer review, experts with national authorities discuss our product with EMA and later on also with their national agency. All countries would provide us with questions and answers in relation to the development of the product. But for now, according to him, it is too early for us to consider regulations at this phase.
Figure. Picture of the interview with Lorenzo Montrazio from EMA
Gentekniknämnden
We also wanted to discuss regulations at the local level but also learn how the interaction between politicians and experts within gene technology works in Sweden. We had a meeting in late September with Gentekniknämnden, Swedish Gene Technology Advisory Board. Gentekniknämnden works mainly with ethical issues regarding gene technology. Their main goal is to promote the safe use of gene technology so that different parts of society are protected. A large part of this work is to spread information and news about new technologies and discoveries within gene technology among not only the general public but also politicians. They also meet with politicians nine times a year to discuss new developments and spread knowledge. In terms of biosafety, they mainly focus on the spread of GMOs in nature, but also safety around genetic considerations in clinical trials.
We also got the opportunity to talk about our project during the meeting. After a discussion with Gentekniknämnden we came to the conclusion together with them that our project and product wouldn’t be affected by the Swedish regulations regarding GMOs, since our final product is not a GMO by itself.
Bioethics
Our aim is to be best prepared for a successful launch of our product. While ethical questions would traditionally be associated with safety and security, we thought that they are an important part of the core business concept. In order to assure that our business follows guidelines and references relating to human rights, we discussed our project with Lee Hibbard from the Council of Europe (CoE) Bioethics group. What we were able to apply to our business model was the importance of securing and storing patient data and any human data that we produce during our research. Private healthcare companies that store data can be seen as a threat, especially if they are able to sell data further, which is why we would need to make sure that this is protected against. Fortunately, we should only need to access sensitive patient data only during clinical trials, which would take place in partnership with a hospital, meaning that their guidelines would be followed.
KI Innovation and KI Development
We contacted KI Innovations and KI Development in order to get feedback concerning our project from an entrepreneurial point of view. Much of the advice we obtained ended up shaping our project’s business plan and approach for after iGEM.
KI Innovations runs Karolinska Institutet's innovation office and an incubator. It is committed to transforming inventions and innovations from research into services and products, creating value for patients and society. With KI Innovation we had an in-depth communication with Patrik, who is the business coach of KI Innovation. Not only were we able to draft the business plan with their input, we discussed different approaches for our product, namely whether to propose a pill or a supplement.
With the help of KI Innovation we came in contact with Karolinska Development AB, which is an investment company focused on identifying medical innovations and investing in those. We had a meeting with Linda, who is the investment manager of Karolinska Development. We presented our business plan in detail and she gave us a lot of suggestions on how to improve it. We made subsequent refinements to our company structure and discussed intellectual property in further detail.
Most of the results from the discussions with KI Innovation and KI Development can be read on our Entrepreneurship page.